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Contents

Interviews
23
Cover Story

Genetic Tests 24

Medical Sciences
All about interpreting
Stephen M Sammut, Senior Fellow,
Wharton Health Care Systems,
University of Pennsylvania and
Venture Partner, Burrill & Company, USA

Genetic Testing 28

Medical Sciences
The ethics side
Arthur Caplan, Emanuel & Robert Hart
Professor of Bioethics, Chair, Department of Medical
Ethics and Director Center for
Bioethics, University of Pennsylvania,
USA

MEDICAL SCIENCES Genetic Testing 30

Medical Sciences
Personalised Medicine 32 All set for growth
Future architecture Julian Awad, CEO & Co-Founder,
Timothy Yeatman, Executive Vice President, Translational Research Smart Genetics LLC,
H. Lee Moffitt Cancer Center & Research Institute, HIVmirror LLC,
USA
University of South Florida and President & CSO, M2Gen,
USA

Personalised Medicine 34 Life Sciences Industry 39

Convergence
An idea whose time is approaching Converging for better care
Robert Roberts, President & CEO, University of Ottawa Heart Institute, Robert Go, Managing Director,
USA Global Life Sciences and Health Care,
Deloitte Touche Tohmatsu,
TECHNOLOGY, EQUIPMENT & DEVICES USA

Convergence in the 36 Combination Products 41

Convergence
Life Sciences Industry Enabling localised care
Combination products show the way Chris Cramer, Principal, Life Sciences Practice,
Akhil Tandulwadikar, PRTM Management Consultants,
Healthcare Editorial Team USA

HEALTHCARE MANAGEMENT
Improving Patient
Health Insurance in Asia 06
Strengthening the insurer-healthcare provider Safety
relationship
Focussing on non-technical skills
Jean-Michel Chatagny, Managing Director, Strategic Corporate
Rachel J Vickers, Consultant Anaesthetist,
Development-Asia, Swiss Re,
Queen’s Hospital,
Singapore
England
15
08 Consumerism SURGICAL SPECIALITY
in Healthcare Laparoscopic Repair of Inguinal Hernia 17
Impact on business models Pradeep Chowbey, Chairman,
Minimal Access & Bariatric Surgery Centre,
Harald Pitz, Vice President,
Sir Ganga Ram Hospital, India
Industry Business Unit Healthcare Higher
Education and Research, SAP AG,
Germany DIAGNOSTICS
Rapid Diagnostics 20
Hospitals That Heal 11 Fighting emerging diseases
Hospital design for the 21st century Albert Cheung-Hoi Yu, Chairman & CEO,
Anjali Joseph, Director, Research, The Center for Health Design, Lok Ting Lau, COO & General Manager,
USA Hai Kang Life Corporation, Hong Kong

w w w. a s i a n h h m . c o m 
 Asian Hospital & Healthcare Management ISSUE-13 2007
CONTENTS

TECHNOLOGY, EQUIPMENT & DEVICES


Operating Room of the Future 43
Emerging technologies Issue 13 2007
Olivier Wenker, Professor of Anesthesiology, Division of Anesthesiology,
Critical Care and Pain Medicine, University of Texas,
USA Chief Editor : Rajeshwer Chigullapalli
Healthcare Editorial Team : Grace Jones
Medical Devices 47
Going the generic way Akhil Tandulwadikar
Prasanthi Potluri
Richard Kuntz, President & CEO, Generic Medical Devices, Inc.,
USA Aala Santhosh Reddy
Copy Editor : Jagdeesh Napa

FACILITIES & Operations


Art Director : Hannan M A

management
Product Manager : Yuvraj Sahni
Project Coordination Team : Sunny Roger
Stella Powell
Patient Safety 49 N Sweta
The next level Shadaan Osmani
James B Battles, Senior Service Fellow, Project Associates : Sam Smith
Patient Safety, CQuIPS, AHRQ, United States Bhavani Prasad Pasupuleti
Department of Health & Human Services,
Sreevardhan Rao
USA
Rajkiran Boda
Madhubabu Pasulla
INFORMATION TECHNOLOGY
Asian Hospital & Healthcare Management is published by
Cardiovascular Medicine 51 Ochre Media Pvt. Ltd. in association with Frost & Sullivan
Integrating IT for better care
Ravi Komatireddy, Resident in Internal Medicine,
Dartmouth-Hitchcock Medical School
Hanumanth K. Reddy, Adjunct Clinical Professor of Medicine,
University of Arkansas for Medical Sciences
Where knowledge talks business

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w w w. a s i a n h h m . c o m 
 Asian Hospital & Healthcare Management ISSUE-13 2007
Foreword

Healthcare Genomics
The healthcare markets are witnessing launch of genetic tests, personalised medicines,
therapies, which in turn are influencing the clinical care and patient outcomes.

E
ver since the beginning of the Human Genome Personalised medicine is another offshoot of
Project (HGP) in 1989, the talk of revolutionary progress in genomics. It is based on the premise that
changes it could unleash on medicine and each individual is unique in terms of genetic makeup
healthcare as a whole began. However, for a while it and use of traditional one-size-fits-all drugs has limited
appeared to be a mere mirage and science seemed to results in some cases and adverse patient outcomes in
enrich science without ever leading to delivery of any others. The products that emerged in this area include
useful products or services affecting human life. That ImClone Systems Incorporated's Erbitux for Cancer and
is now beginning to change. The lab-to-market place Genentech's Raptiva for Plaque Psoriasis.
transition seems to have begun. Against this backdrop, this issue presents a collection
The whole healthcare continuum is likely to be of articles and interviews focused on this topic. The articles
influenced by the progress in genomic science. The talk about how personalised medicine can transform the
healthcare markets are witnessing launch of genetic tests, treatment of Cancer and Cardiovascular diseases. The
personalised medicines, therapies, which in turn are three interviews give unique perspectives on the potential,
influencing the clinical care and patient outcomes. challenges of genetic testing. The cover story also presents
Genetic tests seek to identify an individual’s a perspective on the convergence in the life sciences
predisposition to a disease, given the genetic makeup and industry and how it can improve care. This convergence
hence susceptibility to disease, enabling the physicians to is also most likely to be influenced by genomics in the
customise the precise treatment option that is right for future.
that individual. This changes the healthcare paradigm However, it is still early days. Formidable challenges
into preventive care as opposed to the existing event- lie ahead for the full potential of genomics to emerge in
based, reactive healthcare. the healthcare arena. The significant ones among these are
Tests that are already available in this category include limited understanding of the interplay of genes as well as
BRACAnalysis from Myriad Genetics, a genetic test for effect of other aspects such as lifestyle, confidentiality, and
hereditary breast and ovarian cancer and HIVmirror ethical dilemmas.
which tests people for a gene that can slow the progress
of HIV.
The FDA too has taken cognizance of this potential
of genomics to revolutionise healthcare. It has issued Rajeshwer Chigullapalli
elaborate guidelines for data submissions, organises events Chief Editor
and publishes new considerations and findings regularly.

Essential reading for the


healthcare professional.

Subscribe / register online at

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Health Insurance in Asia


Strengthening the insurer-healthcare
provider relationship

As Asia’s MSPs evolve, so too will Asia’s health insurance sector—and the symbiotic
relationship that binds the two together. Indeed, it is not inconceivable that Asia’s large hospital
chains may one day seek to enter the health insurance industry themselves.

a proactive approach to dealing with insur- using the tools and products that deliver the
Jean-Michel Chatagny ers and Third Party Administrators (TPAs), most appropriate healthcare coverage in the
Managing Director who are destined to play an ever bigger role most efficient manner.
Strategic Corporate Development-Asia in controlling Asia’s healthcare costs, ensur- In India, until recently, cooperation
Swiss Re
ing quality healthcare, and laying the foun- between the insurance and healthcare in-
dation for sustainable growth of the health- dustries was minimal. In spite of this lack
care industry. of cohesion, private hospitals and health-
care providers have proliferated through-

A
cross Asia, governments are grap- China and India: Growing role of out the country. While this growth made
pling with the serious challenges insurers medical care accessible to many more Indi-
of providing adequate medical Any doubts about the radical changes ans, healthcare bills drove many into debt
coverage against a backdrop of rising costs, underway in Asia’s healthcare sector are and poverty—a situation which still exists
inefficient healthcare insurance systems, dispelled by examining recent history, par- today. In the last few years, however, insur-
and growing public pressure for change. ticularly in Asia’s future economic super- ers and medical service providers are work-
In many countries poverty exacerbates the powers, China and India. ing more closely together achieving very
need for change, particularly in rural com- In China, reform of the healthcare encouraging results.
munities, where medical expenses not only system is at the top of the State agenda: Several major changes have driven the
put earnings at risk but also destroy sav- in March, Premier Wen Jiabao announced trend for cooperation in India, namely the
ings. At the same time, a growing middle that the country would spend CNY10.1 introduction of TPAs for medical insurance.
class throughout the region is demanding billion (US$ 1.26 billion)
far more choice in the form of new and to extend coverage of the
innovative healthcare products. Rural Cooperative Medi- Growth trend in private healthcare provision
These challenges and their solutions cal Scheme, aiming to
will have a tremendous impact on Medical deliver basic medical cov- 300
Service Providers (MSP), insurers and the erage to 80% of the rural
increasingly demanding public that both population by the end of 250
serve. 2007. He also formed a
MSPs and insurers are bound to grow task force to draw up plans 200
closer in coming years, working together for reforming the urban
to provide creative solutions for patients’ healthcare system. 150
needs. In developed markets, insurers help Meanwhile, China’s
provide cost-effective healthcare, covering a insurance regulator is ac- 100
large range of both conventional and uncon- tively encouraging greater
ventional treatments. They also bring many partnership between local 50
benefits to hospitals, namely increased pa- authorities and private in-
tient traffic, cashless transactions and strong surers. Its goal is a multi- 0 India China Japan Korea Taiwan Australia
support for positive regulatory outcomes. level coverage system that
For Asia’s MSPs to enjoy the benefits such will serve different seg-
2001 2002 2003 2004 2005
a relationship can offer, they need to adopt ments of the community,

 Asian Hospital & Healthcare Management ISSUE-13 2007


H E A L T H C A R E M anagement

Key areas of cooperation between system that is already running at overcapac- arrangements. Such models also give doc-
insurers and MSPs ity. Although the solutions may differ by tors strong incentives to balance the needs
• Reimbursement models that encourage
country, what is certain is that the relation- of patients with economic realities.
cashless transactions ship between healthcare insurers and MSPs The fee-for-service model, moreover,
• Increased bed utilisation rates at will be strengthened. can encourage the prescription of unneces-
hospitals Many models exist to define the role sary medications and treatments, sharply
• Focussed cost cutting programs
• A broader range of services and
that both MSPs and insurers should play in raising costs for the party least able to af-
treatments for patients healthcare systems. Often, this depends on ford it—the patient. A more consistent fo-
the current market infrastructure, mainly cus on costs can also be of benefit to the
Although the hospital/TPA/insurance rela- the structure of the insurance industry and MSPs themselves, as ultimately a strong
tionship is complex, it has led to service im- medical service provider network, as well as relationship with insurers can provide the
provements at both hospitals and insurers, the regulatory frameworks that govern both. much needed quantum leap in patient traf-
with the end result of more affordable care Experience in developed markets shows that fic, which in turn boosts income needed to
for patients. Cashless transactions at hos- the more advanced the infrastructure, the upgrade facilities and enable expansion.
pitals have risen sharply and more hospital more interaction there is between insurers While the changing healthcare land-
beds are filled, boosting their profitability. and MSPs. A robust infrastructure provides scape in Asia presents many challenges for
Tellingly, Indian doctors and hospital ad- many incentives for MSPs and insurers to medical service providers, it also presents
ministrators are increasingly becoming con- work together, ensuring a closer alignment unprecedented opportunities for growth.
versant in TPA and insurance terminology of interests. Key areas for cooperation in- As Asia’s MSPs evolve, so too will Asia’s
and practice, helping them make the most clude mutually beneficial managed care and health insurance sector—and the symbiotic
of their partnerships with insurers. intervention programmes, guaranteed cus- relationship that binds the two together.
In the longer term, such partnerships tomer payments via cashless transactions, Indeed, it is not inconceivable that Asia’s
will yield even greater benefits. By 2050, guaranteed bed capacity and cost reduction large hospital chains may one day seek to
India is expected to be the world’s most strategies. enter the health insurance industry them-
populous nation with 1.63 billion people selves. Ultimately, the changes afoot across
compared to China’s projected 1.44 bil- Less cash, more cash flow Asia will result in more preferred provider
lion. If just 10% of this massive population In virtually every case, this closer interac- arrangements, with hospitals and insurers
buy healthcare insurance, it will represent tion has led to the gradual increase of ad- playing a dual role in customising afford-
a customer base of 307 million people. By vanced reimbursement models among the able solutions and designing affordable
fostering close relationships with insur- insurers, MSPs and insured—a great im- products for the most important party in
ers, healthcare providers will be ensured of provement over traditional fee-for-service the mix—the patient.
access to this large patient base.
Additionally, the emergence of medi-
cal tourism, with many hospital chains in
The trend is for markets to evolve and mature and then eventually reach
Asia setting themselves up as centres of
their natural saturation point. For private healthcare, this cycle will often take
excellence, will lead to increased collabora-
many years before the market reaches a natural state of equilibrium.
tion. Indeed, Asia's medical travel market
is projected to be worth US$ 7 billion in
the next five years, boosted in part by an
increasingly affluent consumer in India and
China alongside poor healthcare provision Managed
care
throughout the rest of the world. Growth trend in private
healthcare provision Full
reimbursement
Hospital
The winds of change across Asia Integrated state and
cash
private offering
Change is also underway in Asia’s other
Critical
countries, as the economic realities of Increasingly illness
mature market and
modern healthcare force governments to
sophisticated buyers
review their relationship with the popula-
tion in regard to healthcare costs. In Japan Regulatory burden, Life only
little incentive
and Korea, rising medical costs pose grave Stay away
problems for both the countries’ national Risk not insurable
Insurer's Involvement
No opportunity
healthcare systems. In Southeast Asia, the
public provision of healthcare is increasingly Administration Underwriting, Active claims
becoming unsustainable owing to increas- Product devt management
ing usage and expectations. In Australia,
an ageing population is putting strain on a

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H E A L T H C A R E M anagement

D
uring the last decade we have
seen significant efficiency gains
in many industries – specifi-
cally in industries such as manufacturing,
automotive, trading etc. Processes have
been optimised and streamlined within
enterprises, as also significantly across
enterprises. Costs have been reduced
through closer collaboration with suppli-
ers. Customer service has improved, for ex-
ample, through provision of information,
access to products and services any time
and anywhere.
The driving force of this change is com-
petition, which has been created by the

Consumerism
consumer, who is shopping for the best price
and best quality for almost every product or
service. This has forced enterprises to reduce
costs while improving services, and it has re-

in Healthcare
sulted in more intelligent business processes
and improved business models. Today,
flexibility, adaptability and speed of change
are the key for enterprises to survive in the

Impact on increasingly competitive environment.


All these changes have been enabled by

business models the increasing use of Information Technolo-


gy. In fact, many of the innovations wouldn’t

and processes have been possible without a strong IT


support. IT has become strategic in enter-
prises, enabling efficiency through standar-
disation, and providing the flexibility to
accelerate innovation.
In healthcare, we have seen great
innovations and significant improvement in
the healthcare product arena. The increase
Harald Pitz in life expectancy is an achievement which,
Vice President
to a high extent, comes from improved
Industry Business Unit medicines. It is very characteristic
Healthcare Higher Education and Research that a majority of the change has hap-
SAP AG pened in ancillary departments, but
Germany
not in core processes that directly face

Key challenges put the sustainability of


the current healthcare system at risk

Healthcare providers lag behind other industries as


far as transformation to customer-driven or customer-
focussed organisation is concerned. For this to happen,
the customer needs to be equipped with information
about products and services, which in turn necessitates
collaboration along healthcare continuum.

Figure 1

 Asian Hospital & Healthcare Management ISSUE-13 2007


H E A L T H C A R E M anagement

the healthcare customers. Little has been changed in the way


Collaboration along the complete healthcare continuum in a patient-
healthcare is approached and delivered. For example, little attention centric landscape enables pro-active health management
is being paid to prevention, which in other quality-critical industries
Figure 2
such as the airline industry, is fundamental to do business.
What is the reason for the lack of change and transformation in
healthcare? By nature, healthcare in terms of diagnostics and treat-
ment is something people need and nothing people want. Today in
most of the healthcare systems, health insurers or the government
are covering the majority of the cost, so that patients do not really
look at costs or better prices. Due to lack of incentives, individual
stakeholders such as provider organisations, insurers or pharmaceu-
tical companies have not driven cross-organisational change. The
patient today is not in a strong enough position to drive changes.
This is mainly because the patient does not have the necessary infor-
mation and understanding to assess, for instance, whether a service
or a treatment is good or bad, whether there are alternatives and
what a best choice can be. This is very different from other indus-
tries where product information is widely available that allows to
Patient Advocacy Groups and Health Information Broker to support
assess quality and go for the best alternative. Through making more
the patient in a patient-centric landscape
information available, the patient first needs to be enabled to behave
Figure 3
and act as a consumer.
In some areas, where the insurance system has cut funding
and where significant co-payments need to be made by patients, a
consumer-oriented environment has developed. For example, in-
surance coverage for eyeglasses has been significantly limited which
in turn has opened a competitive market where prices have fallen far
below the traditional levels. But consumerism, a key market force in
many other industries, so far has had limited effect in healthcare.
More significantly, healthcare faces major challenges which
have put its affordability and sustainability at significant risk. Key
challenges are ageing population, quality issues, increased cost and
skill shortage (Figure 1).
One impact of these challenges is that our daily life is more
affected than it has been before. While healthcare in general has
been very event-driven, so that the patient has had to deal with the Transformation through Collaborative and Patient-Centric
health system mainly when a disease had to be cured, the increase of Healthcare Network
chronic diseases, for example, makes healthcare much more home Figure 4
bound and affecting our daily life.
One of the impacts of an ageing population is that elderly
people living alone require more long-term care and a continuous
services support, less an event-based care.
The cost pressure has started to lead to more cost-effective mod-
els, e.g. we see more healthcare services being moved from inpatient
to outpatient and from outpatient to home. So the environment
where healthcare delivery is taking place becomes increasingly con-
sumer-driven. In addition, reduced insurance coverage leads to
more awareness and shopping attitude of the patients.
The discussion around increasing number and influence of dis-
eases such as obesity, diabetes and back pain causes recognition in
the population that we all can individually influence health, which
creates a demand for more and better information. As a first step, provider collaboration is the key, allowing shar-
These examples indicate that the health system needs to be ing of patient information not only between hospitals and primary
patient-centric in the future. A patient-centric system that is de- care providers, but also with pharmacies. This collaboration should
signed to provide more and better information and high quality also include other and new providers that will enter the market such
services will require true collaboration between all stakeholders, as home health organisations, disease management and wellness
collectively using and sharing knowledge and information. companies.

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H E A L T H C A R E M anagement

Collaboration along the healthcare and health awareness and in turn lead to a • Provider of unconventional medicine
continuum places the patient at the centre reduction of overall healthcare cost. as a response to increasing number of
of this ecosystem, creating what we call a Since health data is particularly sensitive diseases which cannot be related to a
patient-centric landscape (Figure 2). Pro- information, a legislation framework will be specific diagnosable issue
viding patients access to information that required that enables information exchange • Organisations that provide a more inte-
is available from all of these sources enables while protecting patient privacy and honor- grated view on chronic diseases
them to improve the decisions they make ing the consumer rights. (Figure 3).
concerning their health and their lifestyle. In summary, a collaborative healthcare Summary
Further down the road, more informed network that places the patient at the centre Consumerism has driven transformation
patients will wield more power to make the of the health system enables the transforma- and innovation in industries. Healthcare—
health system work in the interest of the pa- tion from a passive patient to an informed despite significant improvement in the
tients themselves. consumer who is able to select wellness healthcare product—has seen limited trans-
Patient advocacy groups will support maintenance and treatment from a collab- formation in the way it is approached and
individual patients in getting their interests orative global healthcare community that delivered. However, major challenges put
respected. provides personalised, evidence-based care the affordability and sustainability at risk.
We also believe that there will be an (Figure 4). The patient, in fact, may become Collaboration and patient-centricity
increasing need to support the patients in the owner of his data and decide about its will make information more easily available
understanding and handling the increasing distribution and use. and understandable, change the patients’
information flow they confront. 'Health The transformation creates space behaviour and give patients wider choice.
information brokers' will assist patients in for new or enhanced business models in The passive patient will be transformed to
making informed choices and decisions to healthcare. Examples for that are: an informed consumer who is able to se-
better manage their own health. • Walk-in clinics leveraging the infra- lect wellness maintenance and treatment
Incentives for healthy behaviour and structure of the retail industry from a collaborative global healthcare
healthy lifestyle from the payer community • Organisations providing combination community that provides personalised,
will increase patient interest in prevention of wellness and treatment evidence-based care.

10 Asian Hospital & Healthcare Management ISSUE-13 2007


H E A L T H C A R E M anagement

Hospitals
That Heal
Hospitalst design for
the 21 century

The evidence-based design elements are quickly becoming


mainstream in the design of US hospitals. Clearly, they are
as applicable and relevant to hospitals the world over.

overall quality of care. A large body of research


exists that attests to this. A study conducted
Anjali Joseph
by researchers at The Georgia Institute of
Director
Research Technology and Texas A&M University
The Center for Health Design in 2004 identified more than 600 articles,
USA most published in scientific peer-reviewed
journals linking the physical environment
of healthcare facilities with patient and staff
health, financial and operational outcomes

H
ospitals are extremely stressful (Ulrich, et al., 2004). Just as medicine has
places for patients, their families increasingly moved toward “evidence-based
and the staff who work there. Pa- medicine,” where clinical choices are in-
tients are not only faced with the prospect formed by research, healthcare design is in-
of dealing with their illness and injury but creasingly guided by rigorous research link-
are forced to reckon with an environment ing the physical environment of hospitals to
that further exacerbates their pain and patients and staff outcomes and is moving
stress. Hospitals that are noisy, have com- towards “evidence-based design”.
plicated layouts and confusing wayfinding Evidence-based design refers to the pro-
systems, poor ventilation and air quality cess of using the best available evidence from
and few positive distractions are common research and project evaluations to create
the world over. Such environments con- healthcare environments that are therapeu-
tribute to nosocomial infections, medical tic, supportive of family involvement, effi-
errors and other outcomes including lack cient for staff performance, and restorative
of sleep and increased anxiety. At the least, for workers under stress. Many new hospi-
this can slow down the healing process tals in the United States are being designed
and at work, may even result in death and based on evidence based design principles.
serious injury. Further, healthcare clients are now demand-
There is increasing awareness that the ing that architects be able to demonstrate
physical environment is a critical compo- their knowledge of evidence-based design
nent of the care provided in hospitals and process. Hospitals that carefully consider
plays an important role in promoting pa- how physical environmental design likely
tient and staff safety and health as well as impacts patient, staff and organisational

w w w . a s i a n h h m . c o m 11
H E A L T H C A R E M anagement

outcomes will go a long way toward sup- Access to windows and light
porting the efforts of healthcare administra- Single patient rooms with There is strong evidence that light is criti-
space for families
tors and clinicians as they deal with issues of cal to human functioning and can be ex-
patient safety and quality in their hospitals. tremely beneficial to patients as well as staff
The Center for Health Design, a non- in healthcare settings. Adequate lighting
profit research and advocacy organisation conditions are essential for performance of
has pioneered a joint research effort with visual tasks by staff in hospitals, and poor
healthcare providers called the Pebble Proj- lighting conditions can result in errors.
ect. These healthcare organisations are at There is also strong evidence that shows that
different stages in the design and construc- exposure to light helps in reducing depres-
tion of new replacement projects, renova- sion, alleviating pain, and improving sleep
tions or hospital additions. By becoming a and circadian rhythms among patients and,
Pebble Project Partner, these organisations thus, supports the healing process. Studies
commit to utilising the best available infor- conducted among different populations
mation to make informed decisions during show a strong preference for daylight over
this critical phase of their development and better communication from staff to pa- electric light. Building interiors are lit by a
to measure the outcomes of the decisions tients and from patients to staff, superior combination of daylight and electric light-
they make once the project is complete and accommodation of family and consistently ing. Daylight entering through windows
to share the results of these efforts with the higher satisfaction with overall quality of can be extremely beneficial to patients, pro-
design and healthcare community. Pebble care. This evidence is also reflected in the vided there is no glare and it is possible to
Partners such as Bronson Methodist Hospi- 2006 version of the AIA Guidelines for control light levels. However, in addition to
tal in Kalamazoo, Michigan, Clarian Meth- Design and Construction of Health care natural light, electric light is needed in all
odist Hospital, Indianapolis, Indiana and Facilities which recommends single bed- parts of the hospital, though the need for
St. Joseph’s Hospital, West Bend, Wisconsin rooms in all new hospitals under construc- artificial lighting can be reduced by efficient
have been very successful in incorporating tion in the United States. utilisation of sunlight wherever possible.
evidence based design principles in their Windows that let in natural light have
processes. These hospitals as well as others Acuity adaptable patient rooms the additional benefit of providing views
have received nationwide and international Patients are transferred from one room to to the outside that orient patients and staff
recognition for their work. Also, these or- another as often as 3 to 6 times during their to the time of day as well as provide posi-
ganisations have documented many positive short stay in the hospital in order to receive tive distraction. Ulrich (1984) found that
outcomes including increased patient and the care that matches their level of acuity. patients recovering from abdominal sur-
staff satisfaction, reduced staff turnover and This process results in increased costs, re- gery recovered faster, had better emotional
many other organisational efficiencies*. duced quality of care, reduced satisfaction, well-being, and required fewer strong pain
Some of the evidence-based design el- medical errors, wastage of staff time and re- medications if they had bedside windows
ements that are being incorporated by the duced staff productivity. The acuity adapt- with a nature view (looking out onto trees)
Pebble Project Partners and other hospitals able model potentially addresses this prob- than if their windows looked out onto a
in the United States, Europe and Asia and lem by providing different levels of care in brick wall.
the measured benefits of these designs for a single room so as to minimise the need
the patients and staff as well as the health- to transfer patients as patients’ acuity level HEPA filtration
care providers are discussed here. changes. Acuity adaptable patient rooms The importance of good air quality in con-
are single patient rooms with acuity adapt- trolling and preventing airborne infections
Single patient rooms with space able headwalls—which are equipped with in healthcare facilities cannot be overem-
for families the gases and equipment needed to provide phasised. Providing clean, filtered air and
Based on a large body of research evidence care as patient acuity changed. The impact effectively controlling indoor air pollution
as well as emerging information from Pebble of a 56-bed acuity adaptable unit (28 through ventilation are two key aspects of
Partners and others, most healthcare pro- rooms on two floors) at the Clarian Meth- maintaining good air quality. Several stud-
viders in the United States are moving to- odist Hospital in Indianapolis on different ies show that high-efficiency particulate air
wards providing all single bedrooms in their outcomes was measured by comparing two (HEPA) filters, in particular, are highly ef-
facilities. Some of the documented benefits years of baseline data (before the move) fective in filtering out harmful pathogens
of single bedrooms over double bedrooms and three years of data after the move. The and are strongly recommended in areas
or open bays include lower nosocomial in- researchers (Hendrich et al., 2004) found housing immunocompromised patients.
fection rates, fewer patient transfers and as- significant improvement post-move in Adequate ventilation rates and regular
sociated medical errors, far less noise, much many key areas: patient transfers decreased cleaning and maintenance of the ventilation
better patient privacy and confidentiality, by 90%, medication errors by 70% and system are critical for controlling the level of
*For more information please go to: http://www.healthde- there was also a drastic reduction in the pathogens in the air. Some special precau-
sign.org/research/pebble/data.php number of falls. tions to prevent infection during periods of

12 Asian Hospital & Healthcare Management ISSUE-13 2007


construction and renovation include using care unit and neurology unit, they found
Bringing natural light
portable HEPA filters and installing barri- that the number of staff injuries related to into the hospital
ers between patient care and construction patient handling came down from 10 in the Estrella Medical Center,
areas. two years preceeding lift installation to 2 in Phoenix, AZ
the three years after lift installation (Joseph
High performing sound absorbing & Fritz, 2006). The annual cost of patient
ceiling tiles handling injuries in these units was reduced
Hospitals are extremely noisy, and noise by 83% after the lifts were installed.
levels in most hospitals far exceed recom-
mended guidelines. The high ambient noise Decentralised work stations and
levels, as well as peak noise levels in hos- supplies
pitals, have serious impact on patient and Nurses spend a lot of time walking – usually
staff outcomes ranging from sleep loss and to locate and gather supplies and equipment
elevated blood pressure among patients to or to track down other staff members. One
emotional exhaustion and burnout among way to address this problem is to bring staff
staff. Poorly designed acoustical environ- and supplies physically and visually closer
ments can pose a serious threat to patient to the patients. To take this idea further,
confidentiality if private conversations be- new designs are incorporating decentralised
tween patients and staff or between staff nurses’ stations and alcoves outside patient
members can be overheard by unintended rooms so that staff is distributed around the
listeners. At the same time, a poor acoustical unit (as opposed to being in a single cen-
environment impedes effective communica- tral location), closer to the patient. In the
tion between patients and staff and between Clarian demonstration project described Decentralized alcoves
staff members by rendering speech and au- earlier, nursing stations with computer outside patient rooms
ditory signals less intelligible or detectable. access and servers for supplies were decen- Clarian Methodist Hospital,
Indianapolis, IN
Installing high-performance sound-absorb- tralised. Further, additional workspace was
ing acoustical ceiling tiles results in shorter provided outside each patient room. Also,
reverberation times, reduced sound propa- to reduce time spent walking back and forth
gation, and improved speech intelligibility. to the nursing station, necessary supplies
Also, this design measure increases speech were provided in each room. Hendrich and
privacy as less sound travels into adjoining colleagues (2004) assert that the efficient
spaces. In addition, providing single bed- unit design helped in reducing walking and
rooms and removing noise sources from supply trips, such that nursing time signifi-
the unit helps to reduce noise levels at the cantly increased allowing for a reduction in
patient’s bedside. budgeted staffing care hours while at the
same time increasing time spent in direct
Ceiling lifts patient care activities.
Patient lifting is a major cause of injury The evidence-based design elements
to healthcare workers. According to Fra- described here as well as others are quickly
gala and Bailey (2003), 44% of injuries to becoming mainstream in the design of US
nursing staff in hospitals that result in lost hospitals. Clearly, they are as applicable
workdays are strains and sprains (mostly of and relevant to hospitals the world over.
the back), and 10.5% of back injuries in One reason for their adoption is the fact
the United States are associated with mov- that these ideas are supported by a body of
ing and assisting patients. Reducing injuries evidence. The idea that the initial upfront
that result from patient-lifting tasks can not costs of construction can be recouped in
only result in significant economic benefit the long run through savings from fewer
(reduced cost of claims, staff lost workdays), falls, fewer nosocomial infections, fewer
but also in reducing pain and suffering medical errors, fewer staff injuries, in-
among workers. Ergonomic programs, staff creased staff recruitment and retention,
education, a no-manual lift policy, and use improved patient satisfaction and increased
of mechanical lifts have been successful in philanthropy makes a strong business case.
reducing back injuries that result from pa-
For access to additional information and free white-
tient-handling tasks. When PeaceHealth in
papers on several of these topics, please visit The Center for
Oregon, a Pebble Partner, installed ceiling Health Design website at www.healthdesign.org or contact
lifts in most patient rooms in their intensive the author at ajoseph@healthdesign.org.

w w w . a s i a n h h m . c o m 13
14 Asian Hospital & Healthcare Management ISSUE-13 2007
H E A L T H C A R E M anagement

Improving
Patient Safety
Focussing on non-clinical skills

Rachel J Vickers
Consultant Anaesthetist
Queen’s Hospital
England

C
lose analysis of aircraft crashes The aviation industry accidents. The issue of the hierarchy of the
let NASA conclude in the late has been aware of the flight team in particular and resulting in-
1970s that many of these were role of humans in safety, ability of crew to speak up when concerned
caused, or significantly influenced, by poor (empowerment) are now addressed. This
non-technical skills. In other words, they specifically the possession type of training is now mandatory on an
were not caused by technical failure of the of non-technical skills. annual basis in the aviation industry and
aircraft or the pilot not being sufficiently As a result, these skills assessments take place regularly and are as
trained to fly it. The type of non-techni- important in allowing crew to continue
cal skills referred to included communica- are taught and assessed. flying as assessments in technical skills.
tion, fixation on one thing so that other The healthcare profession The healthcare industry lags many
important details were missed and confu- has only recognised the years behind aviation industry in this as-
sion. Then training commenced for these pect of safety, despite many similarities
skills—this was initially referred to as cock- corresponding role only between the two, especially in acute hos-
pit resource management but later this be- recently and training in pital medicine – such as working within
came crew resource management with the such skills is developing (often unfamiliar) teams in an environ-
realisation that the whole crew (including ment in which emergency management of
ground staff) were involved in avoiding accordingly. the situation is crucial. The situations are

w w w . a s i a n h h m . c o m 15
H E A L T H C A R E M anagement

commonly stressful and fatigue is also an probably need separate teaching as well. At Burton on Trent, a District General
issue. At the beginning of the 21st century It has been acknowledged that they Hospital in the Midlands in England, we
awareness of the role of non-technical skills need to be taught specifically within a have set up such a course. The course idea
in healthcare and specifically their role in problem-based learning undergraduate originated following an incident in the in-
patient safety increased as a result of a num- curriculum. tensive care unit in which it was clear from
ber of publications and events. A report, • Should they be taught to a multidisci- retrospective analysis that the problem was
To Err is Human, published in 1999 in the plinary group? – Whilst the individual due the to failure of non-technical skills
US drew attention to vast numbers of ad- skills could be taught to a specific group and the difficulty nursing staff had in ques-
verse events (i.e. those caused by the teams of staff the social skills appear to require tioning the actions of a doctor, given the
looking after these patients) occurring multidisciplinary training—something traditional hierarchical structure within
within the healthcare environment. Many which does not commonly occur with- the unit. Discussions about this with a
studies since have confirmed this—ap- in the healthcare environment. non-clinician who had experience of the
proximately 10% of patients in hospitals • What teaching methods should be aviation industry highlighted the differing
will suffer such an event. used? – As with all teaching methods, approaches of the two industries.
The “Swiss cheese” model demonstrat- there are lots of appropriate differ- The aim of the course is to give the
ed that most adverse events do not happen ent approaches. The use of simulators staff tools to recognise a risky situation and
in isolation but as a result of many barriers has been widely advocated and cer- act as required. The tools are termed “bea-
and defences being breached. A number of tainly communication, leadership and cons” in recognition of their role as “warn-
high profile cases occurred in the UK (e.g. teamwork are well demonstrated in a ings”. As increasing beacons are noted, the
the wrong kidney being taken out during simulated setting. Though there is an situation is likely to be more risky and ex-
surgery, the wrong chemotherapy drug be- increasing number of simulators avail- tra attention is required. The beacons are:
ing injected into the spine). As a result of able for healthcare teaching, access is communication, confusion, policies and
the above, the profile of patient safety has still limited. Small group workshop- procedures, fixation, trepidation, leader-
considerably increased and the comparison based teaching allows in-depth discus- ship and team working and humanity.
with the aviation industry has led to aware- sion of subjects and a number of places, Problems relating to these can be seen as
ness of the role of non-technical skills in including the hospital I work with, are non-technical skills.
healthcare. developing such courses. In the UK the There are repeated references to car driv-
Non-technical skills in healthcare are National Patient Safety Agency have ing where similar non-technical skills are re-
similar to ones in aviation—those skills developed a course in association with quired and the concept of recognising and
which are neither based on knowledge nor the Royal College of Physicians which acting on risk is understood by the partici-
technical skills. They have been usefully can be downloaded from the internet pants. We also have developed a video about
divided into two groups—those which and taught to small groups. It is aimed a fictional character called Mildred, who is
are individual and those which are social at newly qualified doctors. followed on a patient journey through hos-
or interactive skills required within a team • Should non-technical skills be assessed? pital, encountering many different areas in
set up. Individual skills include planning, – Some form of assessment should fol- hospital and teams involved in her care.
prioritising, decision making and individ- low all training, both of the trainees Each scene portrays a different problem
ual situation awareness. Interactive skills and the trainers. The difficulty here is relating to non-technical skills—situational
include leadership, team working, empow- how to assess the skills. Patient safety, awareness, communication, leadership and
erment issues and team situation aware- including competency in non-technical team work and empowerment. These form
ness. Communication skills feature heavily skills, is a core component of the train- the base for the workshops. We run a fol-
within both groups. ing programme for newly qualified doc- low up half day session following the course.
A major challenge is how to improve tors in the UK. An assessment system We ask the participants to go back to their
these skills both in an individual and with- for anaesthetists has been developed but workplace and observe (and act on if re-
in a team. The following issues arise: we need to assess teams as well as indi- quired) situations from a safety perspective,
• Can these skills be taught? – The evi- viduals. However, these assessments take particularly with regard to non-technical
dence is that they can, although some place in the simulated settings and not skills and the beacons.
people naturally possess more than oth- in real workplace settings. The real test In conclusion, whilst as stated above,
ers is whether the number of adverse events the healthcare industry lags considerably
• When should they be taught? – As early occurring to patients is reduced. This is behind aviation, general awareness of and
as possible in training, so that the idea a long term project because of the dif- training in safety and specifically in the
of patient safety and management is in- ficulty in measuring such events—there subject of non-technical skills, recogni-
grained into staff is widespread underreporting of such tion of the value of these in healthcare is
• Should they be taught separately from events. Increased awareness of the staff increasing. There would appear to be ac-
technical skills? – Whilst problems with about patient safety issues results in ceptance of the fact that these skills can be
non-technical skills should be addressed an increased number of adverse events learnt and many differing ways are being
within technical skills training, they reported. used for the same.

16 Asian Hospital & Healthcare Management ISSUE-13 2007


SURGICAL SPECIALITY

Laparoscopic Repair
of Inguinal Hernia
A large series of randomised
controlled trials conducted
all around the world have
confirmed clearly the advantages
of endoscopic inguinal hernia
repair compared to the open
technique in terms of operative
complication, discomfort,
analgesic use and return to work.

Pradeep Chowbey
Chairman
Minimal Access & Bariatric Surgery Centre
Sir Ganga Ram Hospital
India

Figure 1: Inguinal canal

M
inimal access surgery has been Principle of endoscopic repair Anatomy
a surgical watershed which has Over the past decade, endoscopic hernia re- The anatomy of the inguinal region is one
ushered in a new era of tech- pair has changed from an operation in evo- of the most difficult to master and it needs
nology-enabled surgery. It has firmly estab- lution to several well-defined techniques to be relearned before embarking on endo-
lished itself in the armamentarium of most of transperitoneal or totally extraperito- scopic repair as the approach to the hernia
surgeons. With the advancement in the neal approaches. Almost all endoscopic is from inside out, which is just the opposite
technology and instrumentation, minimal repairs are now based on the principle of of what one learns in the anatomy class, i.e.
access surgery has been successfully applied Stoppa’s repair. All accomplish a posterior outside in. Hence, an overview.
to most surgical procedures with favour- reinforcement of the myopectineal orifice The inguinal region is a bridge between
able outcomes. One of the procedures to of Fruchaud with prosthetic material thus the abdomen and the thigh, allowing neces-
have benefited immensely from minimal taking care of existing and potential her- sary structures to traverse from one anatom-
access surgery has been the repair of her- nial sites (direct, indirect and femoral). ical region to the other while maintaining
nias, especially inguinal hernias. Effectiveness of this type of repair has been the sanctity of each region. Transmission
well-established by the open operation of of these structures creates potentially weak
Historical Background Nyhus and Stoppa. The endoscopic ap- spots in the otherwise uninterrupted three-
The initial enthusiasm for endoscopic herni- proach mimics this and can be considered layered abdominal wall resulting in inguinal
orrhaphy was driven by dissatisfaction with as a new method of performing an old es- and femoral hernias.
the pain, disability and recurrence follow- tablished open operation. Endoscopic TEP hernia repair is per-
ing traditional anterior hernia repairs. The There are two techniques available for formed in the preperitoneal space of Nyhus,
first endoscopic approach to the problem of preperitoneal herniorrhaphy—the Total which is a potential space created between
groin hernia is credited to Ger who intraab- extraperitoneal repair (TEP) and Trans- the fascia transversalis above and the peri-
dominally stapled the neck of a hernial sac abdominal preperitoneal repair (TAPP). toneum below. The lateral extent is from
in 1982. Schwartz in 1990 described a plug These two procedures differ in their ap- one Anterior Superior Iliac Spine (ASIS) to
repair. Arregui had described the transperi- proach to the preperitoneal space. In the other. This also includes the retropubic
toneal repair whereas Mckernan and Phillips TAPP approach, the preperitoneal space space of Retzius and Bogros. The region,
developed the totally extraperitoneal repair. is reached through the abdominal cavity which marks the inguinal and femoral
The intraperitoneal onlay mesh repair was whereas TEP repair is carried out without hernias, lies within a quadrangle known as
developed by Franklin and Rosenthal. breaching the peritoneum. myopectineal orifice of Fruchaud (Figure 1)

w w w . a s i a n h h m . c o m 17
SURGICAL SPECIALITY

which is bound medially by lateral border of infraumbilical 12 mm transverse incision. traction on the abdominal wall. The ana-
rectus abdominis, laterally by iliopsoas, su- After incising the rectus sheath, a space is tomical landmarks that would now become
periorly by conjoint tendon and inferiorly created between the rectus muscle and pos- visible are Cooper’s ligament, iliopubic
by the pectin pubis. The lateral limit of the terior rectus sheath. We use our indigenous tract, femoral ring and the inferior epigas-
visible pubic bone marks the site of Coo- balloon prepared using two fingerstalls of a tric vessels.
per ligament (pectineal ligament), which size 7.5 latex surgical glove for preperitoneal An indirect hernial sac is identified as a
extends along the superior pubic ramus dissection. A 10 mm Hasson cannula is in- white glistening structure lying anterolateral
lateral to the pubic tubercle. The iliopubic troduced in the preperitoneal tunnel. Two to the cord. An incomplete sac is dissected
tract (analogue to the inguinal ligament) working ports are placed in the preperito- off the cord and completely reduced. No
extends from the Cooper ligament to the neal space in the midline (Figure 3,4). Dis- attempt should be made to reduce a com-
ASIS dividing the myopectineal orifice section of the extraperitoneal space begins plete sac as excessive traction causes severe
into superior and inferior compartments. in the midline. The aim is to identify the postoperative testicular oedema and pain.
The superior compartment has the inferior pubic bone. Dissection then proceeds in- Such a sac should be separated from the
epigastric artery which divides the inguinal feriorly and laterally and the Cooper’s liga- cord, transected and ligated using a catgut
hernias into direct (medial) and Indirect ment is identified. The direct hernial sac is endoloop. Complete reduction of the peri-
(lateral). Below the iliopubic tract lie the visible immediately and is reduced by trac- toneal extrusion is ensured by stripping
external iliac vessels. The medial most com- tion on the peritoneal extrusion and counter the peritoneum over the cord till it is no
partment of the femoral sheath houses the
femoral canal which is a potential space oc-
cupied by a femoral hernia.
Endoscopic repair requires exposure of
the entire myopectineal orifice, from the
midline to the ASIS, so as to cover all the
potential sites of hernias with a single large
mesh.

Indications
Endoscopic hernia repair is the procedure of
choice in patients with bilateral and recur-
rent hernias.
Anterior repair of a recurrent hernia is a
technically demanding operation and is as-
sociated with a much higher risk of regional
nerve injury and testicular ischemia. Endo-
scopic herniorrhaphy provides a posterior
approach so that the previously dissected
tissue is avoided, thereby reducing the
chance of regional nerve injury and vascular
compromise of the testis.
Bilateral inguinal hernias are an ideal
indication for endoscopic repairs. The abil-
ity to avoid bilateral inguinal incisions,
dissection and postoperative disability is
a significant advantage that should not be
minimised.
Laparoscopic hernia repair is performed
for primary unilateral hernia as well.

Technique of TEP
Here we undertake to describe the technique
of TEP in brief followed at our institute.
The patient is positioned in supine position Figure 2: OT layout for TEP
with the surgeon and the assistant standing
as shown in (Figure.2). Repair can be done
in either regional or general anaesthesia. Ex-
traperitoneal access is achieved through an

18 Asian Hospital & Healthcare Management ISSUE-13 2007


SURGICAL SPECIALITY

Figure 3 & 4: Port sites


more visible proximally. Adequate space has
to be created lateral to the cord structures as
the lateral extent of the mesh would lie in
this space. The inferior extent of dissection
in this space is the psoas muscle.
The minimum size of the polypropyl-
ene mesh to be used on either side should
not be less than 15 x 12 cm. The mesh is
laid from the midline and extended over
the cord structures till the lateral abdominal
wall. The free margin of the mesh is pushed
into the retropubic space medially and lies
over the psoas muscle laterally. The mesh is
then fixed at two places – the pubic bone
Figure 3
and Cooper ligament using a 5mm fixation
device, Protack TM (Autosuture). No fixa-
tion should be done laterally for fear of cu-
taneous nerve entrapment. The mesh is then
unrolled to lie within the extraperitoneal
space and CO2 is exsufflated ensuring that
none of the edges of the mesh is partially
rolled as this may lead to further rolling and
the likelihood of future recurrence.

Contraindications
The absolute contraindication is a stran-
gulated hernia. Patients with history of ex-
tensive intra-abdominal pelvic infections,
history of pelvic irradiation, surgery in the
Figure 4
space of Retzius are not suitable for lapa-
roscopic herniorrhaphy. Similarly, patients
with severe cardiopulmonary insufficiency has fewer complications and equivalent if advantage in this regard as both sides can be
are not suitable for laparoscopic approach. not superior recurrence rates. repaired with the same approach
The relative contraindications based on A large series of randomised controlled
the experience of the surgeons are obstruct- TEP vs Conventional repairs trials conducted all around the world have
ed hernia, complete irreducible hernia, pa- The TEP repairs began at a time when Li- confirmed clearly the advantages of endo-
tients who are obese and those with a his- chtenstein repair had become the standard scopic inguinal hernia repair compared to
tory of previous lower abdominal surgery. of care with reported recurrence rates of less the open technique in terms of operative
than 1%. The advantages of laparoscopic complication, discomfort, analgesic use and
TAPP vs TEP repair over open repair are: return to work. In a study by Liem et al, us-
The TAPP method is simpler to learn and 1) Reduced postoperative incisional pain ing a validated quality of life measurement
therefore more frequently performed. How- and disability instrument, the endoscopic patient group
ever, we do not agree in principle to a trans- 2) The greater availability of space by the ex- was found to have a significantly improved
abdominal approach routinely for groin traperitoneal approach facilitates the inser- quality of life at 1 and 6 weeks after surgery.
hernia repair as it necessitates violation of tion of a much bigger mesh as compared to a
the peritoneal cavity. For over a decade we smaller mesh when performing an open repair Conclusion
have been following the TEP technique for 3) In recurrent hernia, the dissection pro- Primary inguinal hernia is a heterogeneous
repair of groin hernias and a TAPP repair is ceeds through a virgin area which was not disease which with the increasing age of the
performed only in patients who have had ex- previously operated upon thus reducing the patient, shows a rising incidence and also a
tensive lower abdominal surgery. In a study chances of nerve injury and vascular injury tendency to bilaterality. The optimal surgi-
by Sergio Roll et al from Brazil comparing 4) The entire myopectineal orifice can cal approach must be selected individually.
TAPP and TEP, it was observed that TEP be inspected bilaterally and repaired. Though no true gold standard exists, the
repair was associated with the lowest risk of The reported incidence of a contra TEP procedure is the main pillar of opera-
intraoperative and postoperative complica- lateral hernia in a patient presenting tive treatment which synergises the advan-
tion related to the male genitalia. Similarly, clinically with a unilateral hernia is up tages of minimal access surgery, tension free
a study by Felix et al. has shown that TEP to 50%. TEP approach presents a major mesh repair and the Stoppa’s repair.

w w w . a s i a n h h m . c o m 19
DIAGNOSTICS

Rapid Diagnostics
Fighting emerging diseases

Hospitals must learn to incorporate new technologies for diagnosis for the simple reason
that vaccination, drug treatment and other containment efforts cannot be maximised unless
emerging diseases are quickly identified.

become difficult to treat due to drug re- emerging diseases. They are at a high risk of
Albert Cheung-Hoi Yu sistance. More and more germs that were acquiring the infection because patients do
Chairman & CEO once easily controlled now defy treatment. not display obvious symptoms or in most
This is due to the indiscriminate and exten- cases, the symptoms are unknown. During
Lok Ting Lau
sive use of treatments. Doctors cite diagnos- the first few weeks of the SARS outbreak,
COO & General Manager
tic uncertainty, time pressure on physicians Hong Kong, Singapore, Vietnam and Can-
Hai Kang Life Corporation
and patient demand as the main reasons for ada witnessed a large number of healthcare
Hong Kong
over-prescription of antibiotic. associated infections. Cases were either not
Southeast Asia has experienced several identified quickly due to vague respiratory
emerging diseases in the past decade, e.g. the symptoms or inexperience in dealing with
avian flu (H5N1) in Hong Kong in 1997, known SARS cases. In Hong Kong, 25% of

D
espite impressive advances in the Nipah virus encephalitis in Malaysia in patients with SARS were healthcare work-
field of antimicrobials and vacci- 1998, the SARS outbreak in Southern Chi- ers. Consequently, rapid diagnostic tests are
nation, the world is still facing the na in 2002, dengue fever in India in 2005 of great importance for the management of
threat of emerging diseases. A new disease followed by chickungunya outbreak in India emerging diseases in the future.
makes headlines almost every year. Are we in 2006. Currently, H5N1 poses the greatest Molecular diagnostic tools have been
witnessing more diseases now than any time danger to humans because of its increased around for years and are advancing with
in the past? host range, rapid mutation, resistance to an- time. They have allowed us to discover dis-
From the plague to the 1918 influenza tiviral drugs and absence of vaccination. eases that may appear new but have been
pandemic, infectious diseases have always Dengue fever, first recognised in 1950s, loitering around for some time. One exam-
played havoc. Several factors have played a is the leading cause of childhood mortality ple is Helicobacter pylori, the bacteria re-
role in the rise of emerging diseases, includ- in South Asia. Before 1970, only nine coun- sponsible for stomach ulcers. A few decades
ing genetic variation in hosts and pathogens, tries had experienced dengue fever but by ago, the very idea of bacteria causing ulcers
environmental changes and population 1995, the number had increased four fold. It seemed far-fetched. But now, it is a proven
pressures. Furthermore, air travel has com- is re-emerging in the tropics and had reached fact, thanks to diagnostic tools available to
pounded the problem. People are traveling epidemic levels in India last year. Rapid test for Helicobacter pylori infection. The
more often and so are germs. Travellers may growth of cities in tropical countries has led infection has not changed, but the only
be exposed to germs they do not have im- to overcrowding and decrease in sanitation, thing that has is our knowledge and percep-
munity to and hence have a higher chance allowing more mosquitoes to live closer to tion of it.
of contracting an infectious disease, bring- more people. Many of the affected countries Hospitals must learn to incorporate
ing it home and spreading to others. Dur- are some of the poorest. new technologies for diagnosis for the
ing the Severe Acute Respiratory Syndrome The Nipah virus caused a severe out- simple reason that vaccination, drug treat-
(SARS) outbreak, infected travellers carried break of viral encephalitis in Malaysia in ment and other containment efforts cannot
SARS around China to Hong Kong, Singa- 1998-1999. It affects pigs and people. Large be maximised unless emerging diseases are
pore, Vietnam and Canada. Therefore, every scale production of live stock e.g high con- quickly identified. Vaccination cannot pro-
serious infectious disease today is of global centration of pigs in limited space, have lead tect against the rapidly changing viruses of
importance, not restricted to the country of to the spread of Nipah virus. Recent out- tomorrow and drug treatment cannot limit
origin. breaks have occurred in India in 2001. the spread. In the case of bird flu, drug
Emerging diseases can also result from treatment is effective only if administered
re-emerging old infections, new infections Tackling the challenges within 48 hours after the onset of the
like SARS or infectious diseases which Hospital workers are at the frontline battling symptoms.

20 Asian Hospital & Healthcare Management ISSUE-13 2007


w w w . a s i a n h h m . c o m 21
DIAGNOSTICS

Conventional methods vs rapid molecular Immunosorbent Assay (ELISA). Although They face problems in executing sample
diagnostics these tests cost less, they are easy to operate collection schemes for disease surveillance.
Most traditional or conventional microbio- and provide results within hours, they are Overall, the smaller hospitals have been
logical and immunological approaches for prone to co-reactivity between proteins, af- slow to adapt to new technologies due to
identifying diseases work best when high fecting results. These methods are also less the lack of capital and clinicians' enthusi-
concentrations of the pathogens are present, sensitive than Polymerase Chain Reaction asm for them. It is important to support the
i.e. when the patient is already critically ill. (PCR), described below, and their sensitivity development of tests that are quick, sensi-
They are also limited by the time required is inferior to virus/cultural isolation. tive and inexpensive.
to obtain a satisfactory answer. Even with The third type of tests, NATs, give re- Peking University has initiated a low
these concerns, they still remain as the most sults within a few hours. This type of testing cost project to help eliminate the need for
widely used method for identifying a broad helps provide convenient and fast automat- expensive machines for diagnosis in remote
range of biological agents. There are two ed result analysis, achieve higher sensitivity areas. A mobile unit based on the NASBA
reasons for this. Firstly, people have become as compared to virus isolation, and higher technology has been set up to conduct di-
accustomed to this method and are hesitant specificity than the traditional immuno- agnosis on site. This saves time as it cancels
to adopt any changes. Secondly, these are logical testing. NAT tests include PCR and the need to send results to one of the few
well established methods and do not require Nucleic Acid Sequence-Based Amplification designated laboratories for confirmation, in
significant investment in new technology (NASBA). NASBA offers advantage over case of an outbreak. The mobile unit will be
or equipment and can be put into opera- other testing methods in that it requires no able to make the rounds of villages during
tion in a broad range of private and public expensive machines for the whole process. any season, facilitating early diagnosis and
laboratories. However, traditional methods treatment.
tend to be labour and resource intensive and Cost effectiveness of rapid Prompt recognition and identification
require sufficient expertise. diagnosis of emerging diseases is the first and vital step in confronting any
Molecular diagnostics, on the other Developed countries have the facilities to disease, regardless of whether it is a preva-
hand, are sensitive, can be performed more conduct diagnosis but the on-going chal- lent, a newly emerging one or deliberately
rapidly with high throughput and at a lower lenge is to bring cost-effective and efficient released. It is important to develop and im-
cost. However, molecular diagnostic tests diagnosis to highly affected developing re- plement non-traditional methods for public
are not commonly used and virus culture gions with minimal resources. Asia has been health surveillance and a system that allows
still remains the method of choice. Also, the epicenter of many emerging diseases. a wide and immediate dissemination of in-
most technicians in developing countries are Considering that 60% of the world’s popu- formation.
not well trained to use molecular diagnostic lation resides in Asia, emerging diseases are
tests. At the moment, microarray technol- an important cause of death in developing
BOOK Shelf
ogy is developing rapidly but it still lacks the countries, it is vital to make these rapid di-
sensitivity for direct application to clinical agnostic tests available at rural healthcare Medical Infrared Imaging
specimens. Nevertheless, these new technol- centres because the vast movement of people
Authors : Nicholas A.
ogies are an option and through the avail- between cities and rural areas will continue
Diakides
ability of portable machines for conducting to introduce emerging microbes.
Joseph D.
tests, they may change the face of diagnosis Advantages of employing rapid diagnostic Bronzino
of emerging diseases in the future. methods
Year of Publication: 2007
Routine methods in use today for There are several clinical and financial ben-
Pages: 448
diagnosis of emerging diseases can be efits of rapid diagnostic methods. They re-
divided into three categories: duce the number of tests required and their Description:
1) Culture method, conventional method associated charges, reduce casual antibiotic Medical Infrared Imaging presents many of
2) Laboratory antigen detection tests, rap- use, side effects, the length of stay in the the new ideas, concepts, and technologies
id test hospital, and increase appropriate antiviral that are key to the wider acceptance of
infrared imaging as a revolutionary new
3) Tests using Nucleic acid Amplification usage. They also allow community surveil-
standard. Beginning with the worldwide
Techniques (NATs), rapid test lance by informing physicians quickly about
advances and their medical applications
Virus/bacterial culture is considered what agents are in the community. Rapid from a historical perspective, the book
as the ‘gold standard’ for identification of diagnosis also prevents physicians from us- provides detailed and comprehensive
viral/bacterial infections. However, in an ing drugs on wrong indications, possibly information on the technology and
outbreak, time is the limiting factor and the delaying proper treatment of other infec- hardware resulting from these innovative
sooner the disease is diagnosed, sooner the tions and thus enabling doctors to prescribe breakthroughs that will make currently
contributory infrared information even more
control measures can be put into place. more effective drugs to patients.
pertinent.
The second type of tests are the antigen Diagnostic laboratories in developing
detection tests and they have to be carried countries are confronted with several chal-
For more books, visit Knowledge Bank
out in a laboratory. These include the Immu- lenges including financial constraints to section of www.asianhhm.com
nofluorescence Assay and Enzyme-Linked purchase equipment, supplies and reagents.

22 Asian Hospital & Healthcare Management ISSUE-13 2007


COVER STORY

The lab-to-market place transition of genomics seems to have begun. The whole healthcare continuum
is likely to be influenced by this. Genetic tests, personalised medicines, therapies, are all set to
change the way healthcare is provided. The unique combination of interviews and articles provide
unique perspectives on genetic testing and how personalised medicine can transform Cancer and
Cardiovascular care. The cover story also presents a perspective on the convergence in the life sciences
industry. This convergence is also most likely to be influenced by genomics in the future.

w w w . a s i a n h h m . c o m 23
Interview

Genetic Tests
All about interpreting
Profiling can be inherently valuable, but
we must keep it in the perspective of the
entire picture of a person’s health, lifestyle,
environmental factors, and the like.

Stephen M Sammut person may mitigate risk suggested by other


Senior Fellow genetic factors.
Wharton Health Care Systems Each of us is heir to the genetics of our
University of Pennsylvania
and
parents, grandparents and so forth, as well
Venture Partner as their health and intervention histories.
Burrill & Company Profiling can be inherently valuable,
USA of course, but we must keep it in the per-
spective of the entire picture of a person’s
health, lifestyle, environmental factors, and
the like. So is it “hype?” I wouldn’t go that
far by any means. It is legitimate enthusi-
asm provided that scientists, clinicians and
Christopher McLeod, President of 454 the matter before us. At the present time people bear in mind the real limitations of
Life Sciences was quoted as saying, "It's we really do not know the full range of what we really understand in 2007, and
the dawn of a new era when you can look genetic markers that might suggest a where we will inevitably go as we learn
at not just all the genes, but all the ge- predisposition to Alzheimers. more and integrate the knowledge with
netic information that an individual has. What does “predisposition” really preventive care and response to disease.
We're just on the cusp of making that means, or what factors will trigger onset
economically feasible." Is the hype asso- of the disease (if it ever presents itself at This is a highly knowledge-depend-
ciated with Genetic-testing justified? all), and at what point will the disease, if ent sector. With each company carry-
To get started, we really have to define what ever, appear. The implications of most ing out its own research, will they be
we mean by “all the genetic information diseases are most grave when they ap- ready to share their valuable knowl-
that an individual has.” While it is the case pear in the presence of other diseases. In edge? If not, how will this affect the
that at some given cost, which is rapidly the United States for example, according industry?
dropping, individuals will be able to have to a study prepared by the Bloomberg You raise a critical issue here. There are
their genome sequenced in much the same School of Public Health at Johns Hopkins companies with proprietary instrumenta-
way that James Watson, co-discoverer of University, about two-thirds of all health- tion that allow for rapid reading, and pre-
the structure of DNA with Francis Crick care costs are absorbed by people with five sumably cheaper reading, of a sequence.
and Rosalind Franklin, recently did with or more chronic diseases. Studies in Japan These companies can compete based on
454 Life Sciences, a division of Roche. But have come up with similar results for their what is unique to their own equipment
what is it that Dr. Watson really knows af- society. This makes for a murky picture platform. There may be cases where they
ter his profiling? At the age of 78, he did and suggests that any genetic profile of a mutually infringe some aspect of the
decide to exclude information that might person will require hundreds of statisti- equipment. There may be cross-licensing
indicate a predisposition to Alzheimers, if cally verifiable correlations before anyone resolution of these issues, or even down
present, there was no real meaningful in- can draw a definitive conclusion. Moreo- and dirty infringement suits. These are
tervention. This, however, is the crux of ver, some genetic factors in any given generally engineering problems that can be

24 Asian Hospital & Healthcare Management ISSUE-13 2007


MEDICAL SCIENCES

circumvented by clever scientists and en- with an enormous patent thicket the reso- counselors that can appraise the risk and
gineers. A good IP attorney doesn’t hurt, lution of which will take many years and assist families in making decisions. This
either. significant layering of royalties. Regardless long-standing clinical practice is not nec-
The real question with the interde- of the engineering efficiency of given in- essarily analogous to the interpretation of
pendence of knowledge has more to do strumentation, this will impact costs and results for most diseases based on genomic
with “ownership” of genes, and we have delay entry thus driving up the required profiling, and certainly not in the case of
to be clear what “ownership” really means, investment capital. the enormous amount of data that will
and the true limitations. This is still an have to be interpreted. Counselors will be
open area of intellectual property in the What could prove to be the hurdles to aided by software to be sure, but ultimately
United States at least, but I suspect that the growth of the industry? advice will have to be rendered. There is, of
we will converge on international princi- Beyond the IP issues that I’ve just outlined, course, a business implication of interpre-
ples related to genomic-related patents. At I suspect that the major challenges to the tation of the genome as a whole and com-
the end of the day, however, some level of industry will be a combination of clinical prehensive counseling based on that. The
proprietary rights will attach to the discov- and social issues. On the clinical side, we implication is one of cost. Even supposing
ery and description of the role of the gene, have many unresolved problems in the that good engineering can get the cost of
that is to say, the role of proteins expressed interpretation of results. For many years, a profile down to, say US$ 1000, it may
(in patent-speak, “utility”). Therein rests there has been testing available to counsel require many thousands beyond that to
the problem. In almost all diseases, there aspiring parents as to risk for Tay-Sachs, derive an accurate interpretation and set of
will be multiple genes or mutations impli- cystic fibrosis, sickle cell anemia and other recommendations. Myriad Genetics, how-
cated in either predisposition to a disease diseases. These are specific and testing of ever, has a business model that anticipates
or the disease itself. At the present time, the parents is generally a solid indicator these issues and focuses on specific diseases
the portfolio of genes apparently related to of risk for their offspring. In most cases, and can provide a comprehensive set of
a disease condition are “owned” by many the would-be parents are working under services, interpretations, recommenda-
parties. A company interested in develop- a “hypothesis of risk” based on family tions and access to reimbursement. Their
ing the profiles as a business, and then pro- history or related factors. The results of approach may well be the best interim
viding interpretation, may have to contend the testing can be interpreted by genetic business model.

w w w . a s i a n h h m . c o m 25
The bigger issues, however, will be so- by physicians as well as quality time with want to be along the spectrum of interpre-
cial and ethical. At the moment, I really their patients before and after the testing. tation. There is enormous liability risk for
would not want a prospective employer At least in the US, this is running coun- these laboratories, not because they will get
or insurer knowing (or thinking that they ter to the trends in care over the last two the genome wrong, but they will inevitably
know) something about my predisposi- decades during which physicians have get the interpretation wrong more often
tion to a disease (Note “thinking that they been forced by reimbursement policies that getting it right. Clearly, they will have
know”). As I submitted above, we really to process patients through a gauntlet of to figure out where they can safely play in
are not knowledgeable enough yet to un- allied health professionals prior to spend- the value chain.
derstand the full picture of disease impli- ing ten or so minutes with their patients.
cations. Drawing conclusions that might How can the industry address issues re-
result in discriminative action is clearly The industry is yet to come up with a lated to Ethics and data security in the
not in the interest of society or people. In proper business model, are the ones be- future? Is it too early to start worrying?
times to come when we have a fuller un- ing tried out by companies like Genomic It is not too early to start worrying, in fact
derstanding, viable interventions, privacy Testing, 23andMe and DeCode likely to the debate started even before the Human
safeguards, and the clinical care settings for survive over the long run? Genome Project was approved and under-
administration, then the testing will make You’ve actually lumped three companies way. As I commented earlier, data security
incontrovertible good sense. It is fair to say, with entirely different business models will be a major hurdle for acceptance of
however, that for selected risks where we do together. I’ve already described Myriad this technology. If insurance companies
understand the genetic underpinnings of a Genetics and their well-structured model. pay for the testing, they will likely want
disease, that those patients with the emo- DeCode’s primary business is discovery of the results. To what extent can I trust a
tional and psychological make-up to han- drug targets and interventions in collabo- lab or an organisation that does the inter-
dle and act upon the information would be ration with academic health centers, such pretation? Any company can establish a
better off having it. Again, of course, that as Massachusetts General Hospital, and sound protocol for patient protection, but
their privacy is protected. pharmaceutical companies. The model is mistakes happen even under the most dili-
One other area worth mentioning is essentially sound, but the economic rents gent of circumstances, witness the recent
the role of genetic testing as it relates to the that can be extracted for any given prod- enormous breech of patient data in the
testing or use of a particular pharmaceu- ucts or services that result from their data Japanese health care system.
tical agent during clinical trials or general are not clear to me. Nevertheless, when I
use. It is the case that roughly one-third first learned of DeCode, I was enthusiastic How much longer is it likely to be before
of all pharmaceuticals have no effect or about their mission and approach and that it becomes economically feasible to pro-
adverse effects on people. Genetic testing enthusiasm has not waned despite some vide genetic-tests?
may well identify those people who will setbacks. Allow me to summarise a few of the points
benefit and those who will not. The clini- 23andMe hypothetically addresses that I’ve already made. The actual labora-
cal benefits of such technology are obvi- some of the issues I identified previously. tory costs of testing are not the issue. They
ous. Genentech’s breast cancer products, Google, its investor, has other extraordi- will inevitably drop, even to the point
Herceptin and Her-2, are already a good nary initiatives underway in knowledge where the cost is trivial relative to other
example of how a drug and diagnostic can management and data mining, and ge- costs in the healthcare system.
marry. This concept is one of the founda- nomic interpretation is an interesting The fundamental economic issues are
tions of “personalised medicine” which will manifestation of their activity. The strategy the costs associated with interpretation,
become a clinical reality rapidly. of 23andMe still begs the questions as to the massive time-shifts that are likely to
In the interim, we will have to rely on sufficiency of data and reliable insight into result from how this data is communi-
“early adopters” or pioneers to participate the relationship of specific genes or sets of cated to patients, and the paradigm shift
in the testing and provide the social frame- genes to disease, but the concept is based that will have to occur in changing medi-
work for going forward. on filling the interpretation gap. cal care philosophy from one of reacting
With respect to the company to disease to preventing disease. For many
How has been the initial response from Genomic Testing, I would rather address decades people have cavalierly said that
the medical community to genetic test- the model of companies doing genomic the medical community does not promote
ing products? testing (the lower case “g” and “t”) gener- preventive medicine because there is no
With respect to specific, well established ally as opposed to this company specifical- money in it for anyone, except perhaps the
tests for specific diseases, testing has ly, Several companies have entered or will nutritional supplement companies and the
largely been embraced by clinicians, es- enter the service area of running genomes, manufacturers of exercise equipment. I am
pecially when they know that they can especially as laboratory costs drop. These deliberately cynical here in order to make a
provide their patients with viable advice are the companies that may have the big- point. Genomic testing performed to iden-
or intervention. Let’s keep in mind that gest challenge operationally, especially in tify disease predisposition for the purpose
this is a new area of medicine that will marketing their services, assuring people of of early intervention will not be cheap. Yes,
demand an enormous amount of learning confidentiality, and figuring out where they sometimes it will be merely a matter of

26 Asian Hospital & Healthcare Management ISSUE-13 2007


MEDICAL SCIENCES

exercise and better diets, but in most cases of the industry to address directly. The over-thinking the issues. I would say in
the options will be expensive intervention companies and their advocates—and the response, so are a lot of people inside and
with life-long medicines, gene-therapy (yet advocates, including myself, are many outside of medicine.
another set of issues), or frequent monitor- and include influential politicians, busi- The direct benefits to consumers, i.e.,
ing, e.g., annual colonoscopy. Most of these ness leaders and celebrities, many of an intervention for a specific predisposi-
preventive measures will essentially shift whom are “putting their money where tion, are not on the immediate horizon.
the cost from treating disease to prevent- their mouths are”—have the challenge That is so reason not to move ahead with
ing it. It is not simply a matter of “pay me of convincing the political and medi- alacrity. The potential mass of data—if
now or pay me later.” Unless our predictive cal communities that despite the sea- we solve the privacy issues—will be of
skills are near-perfect, we will spend scarce change that will follow in the costs and enormous benefit in the discovery of
money preventing diseases that might practice of medicine that there is the drugs and other interventions to address
never have occurred, and possibly doing so potential of revolutionary advance in the very same predispositions that will
over a life time. I have said elsewhere that the progress of humankind. We all have be found with a basis of confidence. And
if a woman has a predisposition for breast the moral obligation to assure that this the discoveries may come as fast as the
cancer, do you start intervention at pu- new care will not be an option for only visionaries suggest.
berty, in her twenties, or after childbirth. the “haves” to the exclusion of the “have Society and those of us in the busi-
We will eventually know the answer. Per- nots.” This worries me because most of ness of healthcare will, for the foresee-
sonally, we are unanimously in favour of humanity is still awaiting access to essen- able future, be in a period of vast ex-
prevention, but let’s not delude ourselves tial medicines, vaccines and basic care. perimentation seeking optimal modes of
to the economic implications. This will be the technology, the most productive and
a new world of medicine and a new world Amidst all this, where do the patients/ sustainable business models, and sensible
of healthcare costs. consumers stand currently and what approaches to integrating this unprec-
does the future hold for them? edented knowledge into healthcare and
What does the industry need to do to en- If consumers think the way I do, they are our lifestyles. It is an interesting time to
sure that this happens? also in a state of shock and awe. My com- be alive, and the younger among us may
Frankly, this goes beyond the capacity ments probably suggest that I might be live longer than ever imagined.

w w w . a s i a n h h m . c o m 27
Interview

Genetic Testing
The ethics side

The industry should be addressing these issues


right now. Ethics is the biggest obstacle to the
future success of genetic testing.

Arthur Caplan What could prove to be the hurdles to the


Emanuel & Robert Hart Professor of growth of the industry?
Bioethics
The information given out must be accurate
Chair
Department of Medical Ethics and we don’t have good international stand-
and ards for genetic testing. Nor do we have agreed
Director Center for Bioethics upon standards for counselling consumers.
University of Pennsylvania
There will be liability issues surrounding false
USA
negatives and positives as well as misunder-
standing by consumers of complex probabil-
istic information. There are also issues about
the need for privacy protection which is not
firmly in place and the handling of 'genetic
Christopher McLeod, president of Con- records'. The stigmatization of racial, ethnic
necticut-based 454 Life Sciences was or family groups by testing is also a danger.
quoted as saying, "It's the dawn of a
new era when you can look at not just The information given How can the industry address issues related
all the genes, but all the genetic infor- out must be accurate to Ethics and data security in the future? Is
mation that an individual has. We're just and we don’t have good it too early to start worrying?
on the cusp of making that economically The industry should be addressing these is-
feasible." Is the hype associated with Ge-
international standards for sues right now. Ethics is the biggest obstacle
netic-testing justified? genetic testing. to the future success of genetic testing.
There is some hype. The chance of seeing
any real commercially viable gene testing Amidst all this, where do the patients/con-
in doctors' office or home kits in the next sumers stand currently and what does the
two years is slim. But the future of testing future hold for them?
is very bright. As more diseases and condi- share their valuable knowledge? If not, Patients will in the short run rely on their
tions are reliably correlated with predictive how will this affect the growth of the in- doctors for advice about all this, but direct to
accuracy and more information is obtained dustry? consumer advertising will begin and then it
about who will and will not respond well Not much sharing likely in this highly will be a free-for-all while the good drives the
to medications this field will become huge competitive industry. I think it will mean a bad out of the marketplace.
in medicine. I think we are still five or six proliferation of tests, test kits and different
years away however. testing locations. Not sure how this will Any other comments?
all sort out but it will stand in the way of See my book Smart Mice Not So Smart
This is a highly knowledge-dependent efficient testing and may undermine con- People (Rowman Littlefield) which came out
sector. With each company carrying out sumer interest if there are too many com- six months ago for more on genetic testing
its own research, will they be ready to petitors with small test niches. and ethics!

28 Asian Hospital & Healthcare Management ISSUE-13 2007


w w w . a s i a n h h m . c o m 29
Interview
Genetic Testing
All set for growth

Julian Awad
CEO & Co-Founder
Smart Genetics LLC
HIVmirror LLC
USA

Photograph by William West


Technology and the worldwide coordination of efforts to
push discovery in genetics has exacerbated the growth
of opportunity in this sector.

What are your thoughts on the growth formation are now driving ethical and ef- ucts independently will be competitive and
potential of the sector? ficiency questions. less effective than if the markers were com-
We believe this sector has tremendous bined and used/sold collectively. Addition-
growth potential and is poised to explode This is a highly knowledge-dependent ally, the competitive marketing efforts will
over the next five to ten years. Technol- sector. With each company carrying out confuse consumers and potentially reduce
ogy and the world wide coordination of its own research, will they be ready to uptake overall. What will be interesting is
efforts to push discovery in genetics has share their valuable knowledge? If not, to see if /how the patentability of genomic
exacerbated the growth of opportunity in how will this affect the growth of the in- information will remain unchallenged by
this sector pushing market issues prema- dustry? the world community at large.
turely to the forefront. These issues may Sharing of knowledge will become essen-
be the factors that slow conversion of the tial for industry at large but also for joint- What could prove to be the hurdles to
opportunities more than the technological ventures where the big plays will happen in the growth of the industry?
restrictions. Distribution and the after ef- a rapidly developing marketplace. If there End users (patients and consumers) of the
fects of the "disruption" to consumers are multiple markers being developed for products and services will need to go through
current access to personalised medical in- risk scenarios of the same disease, the prod- a large learning curve. The information is

30 Asian Hospital & Healthcare Management ISSUE-13 2007


MEDICAL SCIENCES

complex and must be diluted to the essen- The industry is yet to come up with a How much longer is it likely to be be-
tial components and delivered in a man- proper business model, are the ones be- fore it becomes economically feasible to
ner the end user can understand and value. ing tried out by companies like Genomic provide genetic tests?
There are addition challenges with an in- Testing, 23andMe and Decode likely to We are already there. A subsidiary of
dustry that is constantly discovering, new survive over the long run? Smart Genetics, HIVmirror LLC offers
products (markers) are being discovered I'm not aware that 23andMe's model has the HIVmirror genetic test for US$ 99.
on a regular basis. A new and potentially been declared but they are consumer-fo- Several of our customers have commented
more relevant marker could threaten cur- cussed according to their website. Decode they are shocked by how affordable our
rent products and all the capital invested is a research organisation. Both have differ- tests are. Genetics test have been offered
to develop and bring it to market. ent models and are in different businesses. for years.
It may be too early to make assumptions
How has been the initial response from on their survival. More interesting will be 8. Amidst all this, where do the pa-
the medical community to genetic test- their ability to adapt to how this sector will tients/consumers stand currently and
ing products? be changing. what does the future hold for them?
Mixed depending on the disease category Patients/Consumers will be forced to
and the test. Some tests have been embraced How can the industry address issues re- become educated with the issues, ben-
and others have been shunned. But as more lated to Ethics and data security in the efits and limitations of genetics. It will
products become available more demand is future? Is it too early to start worrying? have such a personal impact on each of
placed on front line clinicians to be aware Ethics and data security should be ad- us in how we live our lives, how we are
and incorporate genetic testing into their dressed now and not later. Good standards, treated for diseases and ailments (person-
practice. Our company has had numerous industry best practices and guidance is alised medicine), and potentially to our
calls from customers with very positive and needed quickly to help new organisations treatment of one another that we have to
thankful feedback telling us that their doc- develop in this space. Organisations such embrace this change and quickly.
tors have directed them to our site. Some as the Genetic Alliance that Smart Genet-
For more information, visit: www.smartgenetics.
customers are being directed to us by ge- ics is a member of acts as a focal point for com, www.hivmirror.com
neticists and hospital workers as well. these types of issues.

w w w . a s i a n h h m . c o m 31
Personalised Medicine
Future architecture

The standard “one size fits all” approach of treating many individuals may soon
become obsolete. More targeted approaches promise to improve outcomes while
reducing toxicity and medical costs.

able to assess the expression of ~30,000 matching” was developed, which is a clear
Timothy Yeatman genes in a single day across numerous tu- departure from our standard means of iden-
Executive Vice President mours, a quantum leap in the technology of tifying patients for therapeutic clinical trials.
Translational Research mRNA-based gene expression profiling. This With a large database composed of molecular
H. Lee Moffitt Cancer Center & Research technological advance has made it possible to fingerprints from thousands of patients (with
Institute
University of South Florida develop large data sets containing both gene metastatic disease), it was clear that it might
and expression data as well as clinical outcome be feasible to match the right patient to the
President & CSO and response data. right drug in an expedient fashion. And not
M2Gen Initial studies clearly demonstrated the only would the trial be completed in record
USA
potential to predict diagnosis and prognosis time, we hypothesise the response rates will
for a number of tumour types more compre- climb due to the selective process for the iden-
hensively than had been possible with previ- tification of patient candidates. So, the future
ously available semi-quantitative immunohis- of clinical trials will be much like organ trans-

C
ancer is a molecularly heterogeneous tochemical tools. It has become clear that no plantation where large sophisticated comput-
disease. Simply put, not all cancers, two tumours are precisely identical, with a erised data systems and networks are used to
even when derived from an organ significant amount of biological heterogene- find the right organ donor for the right trans-
site such as colon or lung, are alike. Despite ity between and within tumours. Correlative plant recipient.
this recently determined finding, treatments studies at multiple sites have found that the The H. Lee Moffitt Cancer Center has
are assigned to tumour types primarily based biological variability from one tumour to the begun to collaborate with multiple partners,
on their site of origin. Thus, while there may next exceeds the inherent variability or repro- both in academia and in industry, to develop
be many different molecular subtypes of ducibility of the test. Moreover, the potential a clinical and gene expression database for sci-
lung cancer, all adenocarcinomas of the lung to predict response or non-response to che- entific research and for translational research.
are treated with the same chemotherapeutic motherapy has been recently demonstrated This database is part of a larger initiative at the
agents. by a number of investigators, suggesting that Moffitt Cancer Center called “Total Cancer
Cancer therapy as we know is effective there could be a clinical application for this Care”. Total Cancer Care is a Center-wide
for some patients, but for others it can be tox- technology. Collectively, the data suggested and State-wide initiative to improve the qual-
ic and has no survival benefits. Despite many that there might be a long-term benefit in ity of medicine and the standard of care by
therapeutic choices, still very few patients evaluating every tumour possible using mi- developing personalised approaches to cancer
with metastatic disease are cured. Couple this croarray technology (“one tumour, one chip”) care whereby the best therapeutics are deliv-
fact with the clear reduction in the availability to fully characterise the tumours' individual ered to the patients who might benefit the
of new drugs for testing and it becomes obvi- signatures. most. In Total Cancer Care, we will scrutinise
ous that a radical change in the drug develop- It was then not a stretch to start to envi- outcomes and survivorship. We will try to de-
ment process is necessary in order to improve sion a data repository for tumour and clinical termine what barriers are there to clinical trial
outcomes. We believe the standard “one size data that might be useful for a host of op- accrual. We will also try to actually deliver
fits all” approach of treating many individu- portunities from target and pathway iden- personalised cancer care back to the patient
als may soon become obsolete. More targeted tification, to signature generation. Think- through population-based trial matching.
approaches promise to improve outcomes ing that a database might be more valuable This is truly an enterprise project that spans
while reducing toxicity and medical costs. with data from both primary tumour and the State of Florida and beyond, attempt-
We and others have answered the chal- metastases, we began to devise a mecha- ing to bring new value to the participating
lenge that human tumours might be clas- nism by which patients with metastatic dis- patients, physicians and hospitals.
sified using a new molecular tool—the eases might draw value from this project. We have overlaid an all digital IT
microarray. With this tool, we are now The concept of “population-based trial approach to collecting and sorting the

32 Asian Hospital & Healthcare Management ISSUE-13 2007


MEDICAL SCIENCES

clinical data that will be collected for the life For example, because we plan to acquire potential to measure the response of a
of the patient on top of a sophisticated data thousands of tumour and blood samples, tumour to a drug or to radiotherapy
warehouse that can collect, sort and relate we will be able to interrogate these samples within minutes of delivery. This would
data from many different electronic feeds with other novel technologies as they are be a radical change from current prac-
and types. The data warehouse will contain developed. We fully anticipate the potential tice where drug responses are evaluated
data from gene expression experiments to evaluate thousands of tumour samples only after ~3 months of therapy using
and will link this data by unique identifiers for somatic gene mutations in the very near Response Evaluation Criteria in Solid Tu-
to clinical outcomes data such as overall future. This will permit the development mours (RECIST) that physically measure
survival and disease recurrence. of new dimensions to the data warehouse, tumour diameters with CT scans. Such an
While initial pilot projects have been ultimately allowing scientists to better un- approach, when integrated into a person-
successful, the real challenges lie ahead when derstand the relationships between gene ex- alised medicine paradigm, might allow a
we begin to build the front end to the ware- pression and the underlying genetic codes rapid, iterative, reevaluation/reassignment
house that will enable patients, physicians and associated mutational flaws. of therapy following initial therapeutic
and basic researchers to access the data and Beyond the development of a data selection and delivery.
process it. Thus, the future of personalised warehouse and trial matching capabili- The path to personalised medicine is
cancer care depends on our ability to opera- ties, we believe there is a great need to neither short nor straight. We believe,
tionalise a network of hospitals, physicians develop molecular imaging technologies. however, that we have outlined a rational
and nurses to collect the tissues and associ- The capacity to image the metabolic activi- roadmap to deliver personalised cancer
ated clinical data longitudinally over time. ties in a tumour is now becoming a reality. care to patients within 5-10 years. This
More importantly, our capacity to reach While currently we can examine the glu- roadmap requires precise execution of a large
out to the patients with metastatic disease cose metabolism of a tumour using 64 slice translational research project we call “Total
and align them with the best trial opportu- PET-CT scanners, we plan to develop im- Cancer Care”, that will build a research data
nity through gene profiling is critical to the aging tools based on tumour biological end- warehouse relating clinical and molecu-
success of this project. points such as apoptosis, proliferation, and lar data in a format useful to patients,
There is more to the personalised medi- angiogenesis. This sort of technol- physicians and scientists.
cine project than gene expression data sets. ogy would permit, for the first time, the

w w w . a s i a n h h m . c o m 33
Personalised Medicine
An idea whose time is approaching

DNA sequencing of human genes could provide the 21st century with the ultimate in
evidence-based medicine allowing us to tackle not only cardiovascular disease,
but many other life threatening diseases.

nent. We need to identify genetic risk factors resistant to aspirin. The dose of warfarin
before we can implement a comprehensive required to be effective to prevent throm-
Robert Roberts
genetic screening and prevention program. bosis in patients also varies markedly. It de-
President & CEO & CSO
The evidence about genetics’ role in car- pends upon the influence of the gene that
University of Ottawa Heart Institute
USA diovascular disease is compelling. In a study encodes for Vitamin K Epoxide Reductase,
of premature Coronary Artery Disease responsible for 25% of the variation in the
(CAD), only 38% of patients had abnormal dose. In the future, we will likely screen
lipid values. It is reasonable to suspect that patients for the 10 forms of this gene to
the remainder of CAD patients were influ- determine the effective dosage. Already,
enced by family history, as several studies of genetic screening across ethnic groups has

I
n half a century, advances in cardiol- the Utah population suggest. led to the following recommendations:
ogy have revolutionised the approach In the Framingham study, a family his- African Americans require a high dose of
and treatment of the once-deadly dis- tory of CAD, cerebral vascular accidents warfarin, Asian Americans a low dose and
eases. In the last 30 years, we have cut the or peripheral arterial disease was associ- European Americans a medium dose.
cardiac mortality rate in North America ated with 2.4-fold increased risk of CAD in Genotyping is already an established
by half. Cardiovascular disease remains men, and 2.2 in women. More than 50% of practice before administering chemo-
the No. 1 killer, however, and by 2010 it a person’s predisposition to coronary artery therapy for some forms of cancer. 20% of
will have earned that dubious distinction disease is genetic, although the quantifica- breast cancer patients, for example, exhibit
worldwide. tion of the genetic versus environmental the gene that encodes for HER2 protein.
DNA sequencing of human genes component awaits more precise definition. Herceptin is given to block HER2 protein.
could provide the 21st century with the ul- Until recently, it was not possible to If the protein is not present, the therapy
timate in evidence-based medicine allowing identify the genes involved in coronary will not be effective. The Food & Drug
us to tackle not only cardiovascular disease, artery disease and other common multi- Administration (FDA) is also convinced
but the many other life threatening diseases. gene disorders. The introduction, of 500K of the importance of pharmacogenet-
For the first time, we have the technology DNA markers on a microarray chip and ics; recently, the drug regulator approved
and the basic science to personalise therapy the multi-slice Fast Computed Tomography BiDil only for use in heart failure in African
based on an individual’s genetic makeup (CT), which permits non-invasive coronary Americans. The drug was shown to reduce
and variants. “Personalised Medicine,” com- angiograms, has made it possible to search mortality and hospitalisation in African
bined with prevention, offers us the chance for the responsible genes. Americans with heart failure by 43%, while
to defeat coronary artery disease. having no effect in the Caucasian popula-
We can, in large part, prevent coronary Current and future applications tion.
artery disease by attacking its major risk In 2004, adverse drug reactions caused
factors: hypercholesterolemia (elevated cho- more than 100,000 deaths and 2 million Genetic screening: A prerequisite
lesterol levels), obesity, hypertension and hospitalisations in the United States. Our for preventing Sudden Cardiac
diabetes. The advent of statin therapy and increasing knowledge of pharmacogenet- Death
the use of Angiotensin-Converting Enzyme ics suggests that patients’ variable response Below age 35, most Sudden Cardiac Death
(ACE) inhibitors to treat heart failure have to drug therapy is, in large part, genetically (SCD) is attributable to familial diseases.
reduced the mortality rate. However, not all determined. Genetic screening for those More than 40% of SCD is due to hypertro-
patients respond to treatment with statins. responses can eliminate such death and phic cardiomyopathy, followed by familial
All these risk factors have a genetic compo- morbidity. For example, 20% of people are arrhythmias such as long QT syndrome or

34 Asian Hospital & Healthcare Management ISSUE-13 2007


MEDICAL SCIENCES

Brugada syndrome. Most individuals are inherited cardiovascular disorders has been The initial population, estimated to
otherwise asymptomatic, and SCD occurs successful largely in the field of single-gene be 2,000 (1,000 affected individuals and
without any warning. Approximately 5% of disorders, in which a single gene induces 1,000 controls) was genotyped to detect
the 13 million people with cardiovascular the phenotype. It is estimated that there are association having a p-value of 0.001 or
disease in the United States are significantly 6,000 single-gene disorders, of which we more significant. Those markers showing
predisposed to SCD, which accounts for have identified more than 2,000. Hyper- an association in the initial population were
more than 50% of deaths in patients with trophic cardiomyopathy was the first such genotyped in a second independent popula-
heart failure. In patients over age 35, SCD disorder identified in cardiology. There are tion to ascertain the degree of replication.
is predominantly due to coronary artery dis- more than 1,200 mutations recognised as A second sample size of 12,000 (8,000
ease and usually occurs within the first 60 responsible for single-gene disorders that affected and 4,000 controls) would, we
minutes of symptoms, often precluding the induce cardiovascular disease. estimated, detect SNPs showing a stronger
availability of medical help. Multiple genes, however, confer sus- association at p-values such as 10-8 or great-
Genetic screening and prevention ceptibility to CAD. We expect hundreds er. As far as we know, this is the first study
through therapy, such as the use of a defi- of SNPs to contribute only 5% to 10% of to utilise the 500K as a genome-wide scan
brillator, is the only hope these individuals increased risk each. But in combination, for CAD, with the latter documented by
have, because drug therapy for arrhythmias they are responsible for the phenotype. coronary arteriography.
is relatively ineffective. But cardiac defibril- In genome-wide studies, searching
lators cost more than $75,000. If we can for these SNPs would require a DNA Results of Ottawa Heart Genomics
determine through early screening which marker every 6,000 base pairs, amount- Study
patients have familial cardiomyopathies and ing to 500,000 markers that would need At the Canadian Cardiovascular Genet-
arrhythmias and so are vulnerable to SCD, to be genotyped for each DNA sample. ics Centre, established at the University of
we could determine who would benefit Such high-throughput genotyping has un- Ottawa Heart Institute in 2004, we perform
from a defibrillator. til recently been prohibitively expensive. more than 10,000 angiograms per year,
A study would require samples from sev- providing the necessary high-throughput
Sudden Death phenotype exhibits eral thousand individuals to detect a single phenotyping. The Institute, which serves
genetic predisposition SNP. 1.8 million people, has more than 100,000
Hundreds of mutations have been identi- coronary angiograms available on patients.
fied in the sarcomeric proteins responsi- New technology enables genome- To date, we have completed more than
ble for cardiomyopathies and SCD. The wide genotyping for case control 900 million genotypes on 1,800 individuals.
increased risk associated with family history association studies We expect to complete Phase I (n = 2,000)
provides a second indication of genetic in- Case control association studies are the shortly. Unfiltered analysis of the first 500
volvement. In cohorts of SCD, Friedlander most sensitive and appropriate mechanism controls and 500 affected cases indicates that
et al. and Jouvin et al. have shown there is a to identify genes for coronary artery dis- we have found several thousand SNPs with
1.6-1.8-fold increase in SCD susceptibility ease. These studies collect samples from p-values of 0.001 or greater, and more than
among offspring of parents who died from thousands of unrelated individuals with 130 clusters with p-values ranging from 10-3
SCD. Although the sample size is small, CAD and thousands of controls without to 10-12. We will analyse the second popula-
the relative risk in offspring from fami- CAD. Then investigators compare the tion (n = 12,000) to determine replication,
lies where both parents experienced SCD SNP frequency in controls versus cases (af- coupled with further customised SNP geno-
increased by 9-fold. Thirdly, variations in fected individuals). typing. We recognise that many of these as-
DNA sequences known as Single Nucle- Today, microarray chips contain- sociations are false positives. We don’t expect
otide Polymorphisms, or SNPs, of the he- ing 500,000 SNPs and 1 million SNPS to confirm them all.
patic P450 clearance pathways increase the are available. They provide, on average, a Completing the initial phase, however,
risk of ventricular (Torsades-de-pointes) marker at intervals of 6,000 bps or 3,000 provides us with a population with an all-in-
arrhythmias. Fourthly, a single SNP variant bps respectively. Studies by Hinds, et al. clusive set of SNPs exhibiting strong associa-
in the SCN5A sodium channel gene found and that of the International HapMap tions to the phenotype of CAD. We hope to
in African Americans, affecting 4 million project indicate a minimum of 375,000 collaborate with investigators in Canada and
people , is associated with an increased properly placed markers to genotype an other countries to identify and analyse the
incidence of arrhythmias, particularly in American-European population. genes contributing the most risk for CAD.
individuals receiving proarrhythmic drugs Using the 500K microarray, in Au- It is a unique opportunity to provide
that prolong the QT interval. Over the gust 2005 we initiated a study at the the armamentarium for comprehensive
next 10 years, several predisposing SNPs University of Ottawa Heart Institute (the genetic screening to help prevent this deadly
will likely be identified. Ottawa Heart Genomics Study). The condition. Subsequent to completing the
sample size was calculated assuming 90% replication studies, researchers can compare
Research delayed in identifying power, a gene frequency of ≥ 5%, odds ratio these genes to those involved in specific risk
genes for CAD of ≥ 1.3 and ≥ 0.2 size differences between cohorts, such as hypertension, obesity or
The application of molecular genetics to controls and cases. hyperlipidemia.

w w w . a s i a n h h m . c o m 35
Convergence
in the Life
Sciences Industry
Combination products
show the way

Driven by market forces, a need for new growth


avenues and an ever more conscious consumer,
medical device, pharma and diagnostics companies
are coming together to deliver innovative solutions.

Akhil Tandulwadikar
Healthcare Editorial Team

T
raditionally, the medical devices and pharmaceutical sectors have represent-
ed two different facets of the life sciences industry. Both the sectors have
charted their own paths to growth on a similar terrain. Therefore, ‘conver-
gence’ between the two never quite went beyond basic drug delivery instruments
such as injections. That was, of course, before the introduction of Drug Eluting
Stents (DESs)—the most successful combination product so far with a market size of
US$ 5.5 billion worldwide. Meant to treat coronary disease, the stents proved to
be a huge success as they allowed delivery of drugs directly and in low doses to
targeted areas unlike oral consumption that would require higher quantities to be
consumed. The DES had proved that combination products could play a major role
in improving patient care—and provide new areas of growth for the companies.
The early and huge success of DESs sparked a sort of frenzy in both the sec-
tors to collaborate and create a whole new line of products. This was evident from
the fact that the number of applications for combination products with the FDA
increased from less than 100 in 2003 to 275 by 2005. Today, this convergence
stretches across device makers, pharma, biotechs and diagnostics. This convergence
has already resulted in the creation of many combination products (Table 1) and
with further research and development, the horizon for combination products is
only likely to get wider. Market figures too indicate the same. According to Chris
Cramer, Principal, Life Sciences Practice, PRTM Management Consultants, the
market for combination products is currently estimated to be around US$ 40-50
billion and growing at 14% annually.
However, this area is still in its early stages. Several questions will have to be
answered and challenges that convergence presents will have to be overcome to
ensure that the products are innovative and safe. As products get smaller in size
and are implanted in the patient’s body to reach the targeted area, their safety will
be of utmost importance. Hence, regulatory agencies like the US Food and Drug
Administration (FDA) will play a crucial role in the development of the combina-
tion products market.

36 Asian Hospital & Healthcare Management ISSUE-13 2007


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The need to converge the hospitals to manage their operations


Device – Drug
Both device and pharma companies are better. While companies might have their
looking for new avenues of growth. Phar- Drug-eluting stent that opens and prevents own business motives behind this, the big-
ma is struggling to cope with pipeline restenosis in coronary and peripheral gest beneficiary of this convergence will be
shortages, high R&D costs resulting in low arteries the patient. Says Go, “by bringing more
returns and increasing competition from Bone grafting scaffold/sponge coated self-administered healthcare solutions to
generics. The blockbuster model seems no with a growth protein that promotes bone the market and enabling remote patient
regeneration
longer sustainable. For biotechs this con- Implantable, programmable pump that
monitoring by physicians, convergence
vergence brings in access to better funding delivers a drug or biologic in small, timely may reduce the number of care visits that
and sharing of resources. For device mak- doses are needed, potentially resulting in services
ers, integrating devices with drugs is help- Implantable polymer wafer that releases a that are more cost-effective.” Combination
ing them develop new products, something chemotherapy agent to a specific site products are also helping to reduce the
that was much needed given the fact that Implantable neuromodulator that enables side-effects that only add to the patient's
they were finding it increasingly difficult the targeted, regulated delivery of a drug or woes and expenses.
electrical stimulation
to come up with innovative products un- Transdermal patch that transports drugs
Several combination products have
til recently. The initial push for developing locally and systematically through the skin received the FDA's nod in the recent past
combination products did therefore come Pre-filled, metered dose syringe, injector (see box item). Further down the line,
from them. pen, or inhaler these devices will get smaller in size, in-
The diagnostics sector is perhaps the novative and more effective. Says Cramer,
best placed sector in terms of perform- Diagnostic – Drug “Miniaturisation will change the way we
ance over the last few years thanks to the use medical devices as manufacturers will
Screening test for the presence of a specific
emergence of in-vivo and in-vitro diagnos- be able to create implantable devices for
gene or protein coupled with targeted drug
tics market size for the latter is expected to therapy diagnostic and therapeutic delivery at the
reach US$ 40 billion by 2010 according to Use of passive pharmaceuticals and micro to nano level.”
a research report by Business Insights. As radiopharmaceutical tracers as contrast
a result, device manufacturers have shown agents for positron emission tomography Regulation – The key
keen interest in diagnostics makers. A key (PET) scanners The coming together of hitherto mostly
example of this being the big acquisition independent industries presents a unique
of Bayer Diagnostics for US$ 5.7 bil- Diagnostic – Device – Drug challenge for the regulatory agencies like
lion by Siemens Healthcare and Abbott’s Glucose monitor with an insulin pump the FDA. Medical devices typically take
diagnostics arm by GE Healthcare for shorter times to get approvals from FDA
US$ 8.13 billion last year (although it was Source: Managing Pathways to Convergence in the Life than a drug which has to under go sev-
Sciences Industry, Deloitte Research
recently). Diagnostics companies can gain eral stages of trials and might take many
by collaborating in development of patient years. FDA was the first regulatory body to
monitoring equipment for chronic diseases with timely, controlled release of insulin, recognise a need to develop guidelines to
that have become highly prevalent around providing diabetes patients with a less in- regulate combination products. FDA’s Of-
the world among the ageing population. vasive and more effective treatment alter- fice of Combination Products was set up to
In recent years, there has been a re- native, says Robert Go, Managing Direc- manage the review of these products. Cur-
markable improvement in the technologies tor, Global Life Sciences and Health Care, rently, three centres of the FDA namely,
that support the R&D and manufacturing Deloitte Touche Tohmatsu. Center for Biologics Evaluation and Re-
processes in life sciences. As a result, sci- These factors have shown the way to search (CBER), Center Devices and Radi-
entific advances such as genetic tests, stem convergence within the life sciences in- ological Health (CDRH) and Center Drug
cells and genomics are helping companies dustry. Cramer sums it up when he says, Evaluation and Research (CDER) take care
to develop better tests to identify and treat “combining drugs, devices and biologics of the regulatory function. Depending on
diseases. appears to be the logical next step.” the primary mode of action the product is
Apart from this, rising healthcare allocated to the respective centre and will
costs and a more informed customer have All for the patient be under its jurisdiction.
played their part as well. Aided by better The consumer is slowly but surely becom- Defining the primary mode of action
knowledge about the options available, ing the centre of the healthcare universe for a product though is not that easy. If a
consumers are demanding better treatment and as a result, treatments too are be- disagreement arises over this, it results in
at lower costs. And it is safe to say that con- coming patient-centric in nature. Ageing lengthy disputes over who’ll get the juris-
vergence has enabled companies deliver population all over the world has meant diction over the product. Given the rate
such solutions. In the case of patients with that technologies have to become more at which the number of applications from
diabetes, for example, blood glucose moni- patient-friendly, so that they not only help combination product makers for approval
tors combined with implanted insulin in patient monitoring but also help the is growing, this could prove to be a ma-
pumps offer round-the-clock monitoring doctors in taking the right decisions and jor hurdle to the growth of the industry.

w w w . a s i a n h h m . c o m 37
Opines Go, “regulators need to develop a
strong understanding of the technologies Recently approved combination products
that are involved and how exactly they are
integrated.” Schwarz Bioscience’s transdermal patch
Neupro Patch, used for the treatment of symptoms of Parkinson's disease,
It will be some time before a compre-
combines a new dopamine agonist, rotigotine, with the convenience of a
hensive approach to regulate combination transdermal patch delivery system.
is in place. “Till then”, says Cramer, “com-
panies looking to bring new products to Medtronic’s absorbable collagen sponge with genetically
market should take a proactive approach engineered human protein
INFUSE® Bone Graft used in the Anterior Lumbar Interbody Fusion (ALIF) surgical
to working with the FDA on pre-market procedure in combination with an interbody fusion device.
review/approvals”
Orthovita Inc.’s biological product gel for surgical hemostasis
Vitagel™ Surgical Hemostat contains an enzyme that assists in the clotting of blood.
Issues involved in converging
Vitagel is intended to assist in clotting when conventional means fail or are impractical.
As attractive as the rewards might be, mak-
ing a convergence successful is easier said Alza Corporation’s Iontophoretic transdermal system
than done. This will be a first time experi- IONSYS™ is a patient-controlled iontophoretic transdermal system providing on-
demand systemic delivery of fentanyl, an opioid agonist.
ence for many of the companies involved,
as they have never worked together. Says Shire US. Inc.’s transdermal patch for attention deficit
Cramer, “most device manufacturers have hyperactive disorder
little or no experience working with the Daytrana is a treatment containing the drug methylphenidate, a central nervous system
drug that will be included in the device or (CNS) stimulant for treating Attention Deficit Hyperactivity Disorder (ADHD) in children.
its coating. They not only have to decide Somerset Pharmaceuticals, Inc.’s transdermal patch for
how to select, modify and incorporate the depression
drug into the product, but also demon- Emsam transdermal patch used for treating major depression, delivers selegiline, a
strate its acceptable toxicity and shelf life monoamine oxidase inhibitor or MAOI, through the skin and into the bloodstream.
and characterise its release into the body.” Pfizer’s inhaled insulin combination product for diabetes
Finding a suitable convergence partner Exubera is an inhaled powder form of recombinant human insulin (rDNA) for the
could, itself, prove to be the biggest hurdle. treatment of adult patients with type 1 and type 2 diabetes.
The companies need to identify specific op-
portunities with respect to each others ex-
pertise while making sure that technological
support needed to integrate the two or more
Source: FDA
products exist and that the venture would
be profitable. They have to understand the sector and hence offers better opportunities. safety and efficacy issues that might arise.”
various risks that come along with the con- This has made several industry observers Therefore, initial convergence has occurred
vergence path they choose. While there is doubt the interest level a pharma company at the later stages of product development.
a growing demand for combination prod- would show in a convergence effort. “Gen- But this is changing, observes Go, “con-
ucts, industry dynamics make it tough for erally speaking, pharma opportunities and vergence is now increasingly occurring at
the companies to make these decisions, and therefore pharma deals tend to be much earlier stages of research and development,
when made, to stick to them and go the larger than those of devices.” says David and companies in all sectors are forming
distance. Cassak, Managing Partner at Windhover alliances and co-creating technologies and
Risks, of course, are not just external. Information, a healthcare industry analysis products from the earliest phases of R&D
When coming together, companies need to firm based in the US. He further adds, “the through clinical validation, manufacturing,
address issues related to knowledge sharing whole drug-eluting stent market, which and product commercialisation.”
and creating teams that will not just work will be shared by a number of companies In conclusion, it is fair to say that the
together but cooperate in all the aspects of is now pegged at around US$ 5-5.5 billion, convergence within the life sciences sector
product development. In addition to this, which just about qualifies as one blockbust- presents a unique opportunity to all the
says Cramer, “the people aspect should not er drug and isn’t even the size of Plavix by players involved to develop solutions that
be overlooked; i.e., the difficulty in bringing itself.” Thus, he says, a biotech firm would will have a long lasting impact on patient
together the various viewpoints, practices, see much bigger incentive in licensing its care, which in turn will provide growth in
and experiences from the different worlds of products to a pharma company than a de- the long run. However, the key to this will
drug, biologic, and device development.” vice company. Further, device companies be innovation. And innovation can only re-
Device companies have been the proac- have tended to target existing drugs to be sult when companies work together. As Go
tive partners in this convergence—which used in the combination products. By do- observers, “success will depend on the level
has been attributed to the fact that pharma ing so, says Cassak, “device companies hope and intensity of participation from all the
sector is many times bigger than the device to avoid their own extensive trials and the sectors of the life sciences industry.”

38 Asian Hospital & Healthcare Management ISSUE-13 2007


T E C H N O L O G Y, E Q U I P M E N T & D E V I C E S

Interview
Life Sciences
Industry
Converging for better care
Combination products have the potential to respond
to the increase in patient needs in a way that may be
more affordable, easier to use, less expensive,
or more effective than current solutions.

Robert Go
Managing Director
Global Life Sciences and Health Care
Deloitte Touche Tohmatsu patient monitoring by physicians, conver-
USA
gence may reduce the number of care visits
that are needed, resulting in services that
are more cost-effective.

What are the legal ethical issues involved


What are the forces driving this generally in the convergence between in the convergence?
convergence? industry sectors, particularly between The regulation of combination products is
Many factors are driving and influenc- pharmaceutical and biotech sectors, one of the biggest hurdles for both compa-
ing convergence in today’s life sciences which are often now combined in a single nies and regulators. This is largely because
industry. Recent scientific advances and reference to “drugs” in spite of their funda- drugs and devices are subject to different
improvements in enabling technologies mental scientific differences. regulatory requirements—when they are
have opened new avenues for convergence combined, regulators must determine
among drugs, diagnostics, and devices. How is this convergence changing which set or sets of regulations apply. To
Aging populations and rising consum- patient care? provide guidance and ensure that combina-
erism are increasing demand for health There is a general shift in patient needs as tion products are tested and validated suffi-
care products that offer greater effective- a result of the overall demographic shift to- ciently, regulators need to develop a strong
ness and convenience. Shifting industry ward older populations and larger popula- understanding of the technologies that are
and market conditions are also creating tions of patients with one or more chronic involved and how exactly they are integrat-
pressures and new opportunities. ailments that require regular monitoring, ed. Companies may be able to facilitate the
Each of the life sciences sectors—phar- prolonged treatment, and pain manage- validation and approval process and avoid
ma, biotech, devices, and diagnos- ment (cardiovascular conditions and dia- delays by working in close collaboration
tics—faces somewhat different in- betes, for instance). This shift is putting with regulators during the R&D phase.
dustry and market circumstances, upward pressure on health care costs and Variation in regulatory requirements across
but convergence is presenting a new increasing the demands on existing health- different regions of the world also remains
avenue for business growth for all of them. care resources. Combination products an issue. Greater harmonisation of product
For instance, by acquiring and partner- (ones that offer remote and continuous testing requirements, quality standards,
ing with firms in other life science sectors, monitoring, provide controlled drug thera- acceptance norms, technology protocols,
pharmaceutical firms are filling product py, are less invasive and painful, are simple and certifications could lead to faster mar-
pipelines, extending product lifecycles, to use, and require minimal intervention ket introduction of combination products.
and expanding product portfolios, while by healthcare providers) have the potential Yet another issue may be the potential
device companies are achieving product to respond to the increase in patient needs increase in battles over the ownership of
differentiation and expanding product in a way that may be more affordable, eas- intellectual property as convergence leads
applications by developing platforms ier to use, less expensive, or more effective to the formation of partnerships and alli-
that have multiple uses. Convergence is than current solutions. Also, by bringing ances. Companies will need to evolve new
reflected specifically in the develop- more self-administered healthcare solu- models of licensing and profit sharing with
ment of combination products, but also tions to the market and enabling remote alliance partners.

w w w . a s i a n h h m . c o m 39
Apart from the huge success of Drug specific protein - human epidermal growth part in the clinical validation and approval
Eluting Stents, has the response to factor receptor-2 (HER2). processes together. This may help each gain
other combination products been Examples for device-drug-diagnostic technology-product insights and speed up
good/satisfactory? combinations are also plentiful. Blood clinical approvals. Similarly, alliances in
Drug eluting stents (DES) are, indeed, one glucose monitors, for example, when com- manufacturing may help companies un-
of the most prominent examples of con- bined with implanted insulin pumps, offer derstand the nuances of manufacturing in-
vergence. However, there are many other round-the-clock monitoring with timely, dividual products vs. converged solutions.
combination products thriving in the mar- controlled release of insulin, and provides
ketplace today. Examples include spinal diabetes patients with a less invasive and Any other comments you would like to
cage fusion solutions and implantable drug more effective treatment alternative. make?
delivery devices that provide controlled There are two things that are vital for the
and timely release of chemotherapy agents Are the two sectors doing enough to cre- success of convergence in life sciences.
for the treatment of certain cancers. ate a platform for knowledge sharing that First, convergence is a cross-sector and in-
Another category includes combina- would drive the innovations in the future? ter-disciplinary activity. Therefore, success
tions that integrate diagnostics with drugs. Knowledge sharing occurs naturally hap- will depend on the level and intensity of
Consider the example of positron emission pening during the convergence process. participation from all the sectors of the life
tomography (PET) scanners that are used Given that companies are not easily able sciences industry. Second, convergence will
in combination with pharmaceutical con- to create and commercialize a convergent impact all the stakeholders of the health-
trast agents and radiopharmaceutical trac- product alone, alliances and joint ventures care industry – providers, regulators, gov-
ers to be able to diagnose cancers at ear- have become key paths to product crea- ernments, payers and patients. They will
lier stages and less invasively than through tion. And, since the majority of alliances all have to work together, along with the
surgery. Similar is the case of Herceptin (a require end-to-end participation from col- innovators, to facilitate the development,
genetically engineered humanized mono- laborating partners, the degree of knowl- introduction, and adoption of innovative
clonal antibody) which is used only for edge sharing may be quite high. Alliance combination products.
breast cancer patients for whom a diag- partners may not only be expected to be For more information on convergence, please read
our new Deloitte Research report, Managing Pathways to
nostic test has detected the presence of a involved jointly in R&D, but also to take Convergence in the Life Sciences Industry.

40 Asian Hospital & Healthcare Management ISSUE-13 2007


T E C H N O L O G Y, E Q U I P M E N T & D E V I C E S

Interview
Combination
Products
Enabling localised care
Combination products will enable healthcare
providers to treat diseases with localised
drug delivery and fewer side effects.

Chris Cramer
Principal
Life Sciences Practice
PRTM Management Consultants
USA

Finally, technology improvements of the retina, systemic treatments may be


have fundamentally enabled this conver- ineffective or potentially harmful. Combi-
gence. Recently, drug-eluting coatings have nation products will enable healthcare pro-
played a big role in cardiovascular stent- viders to treat diseases with localised drug
ing and implantable orthopaedics. In the delivery and fewer/less severe side effects.
future, we'll see more use of gene therapies,
human growth factors, and pharmaceuti- What are the legal, ethical issues
cals where devices will serve as a vehicle involved in the convergence?
to deliver the therapeutic agent or as a As more combination products reach
What are the forces driving this scaffold to encourage the body to actu- the market, the difference between prod-
convergence? ally heal itself. Miniaturisation will also ucts may come down to the drug/bio-
Healthcare in general is moving away from change the way we use medical devices as logic component. As a result, I think,
"one size fits all" / systemic approaches to manufacturers will be able to create you will begin to see new ways of market-
more targeted treatments. Patients are de- implantable devices for diagnostic and ing combination products. In the past,
manding better therapies with fewer side therapeutic delivery at the micro to devices were marketed exclusively to phy-
effects, and combination products offer a nano level. sician, surgeons and hospitals as surgical
safe and effective solution. tools. In the future, companies will look to
Increasing competitive pressures are How is this convergence changing create consumer demand for their prod-
playing a role in driving convergence too. patient care? ucts. This will be especially true with drug-
Until recently, the rate of innovation ap- Simply put, the convergence is leading delivery systems. Combination product
peared to be slowing in the medical device to better products and better outcomes manufacturers will need to deal with the di-
and pharmaceutical industries. There were for patients. To give you a few examples, rect to consumer marketing and patient edu-
a lot of incremental improvements, line coronary stents and orthopaedic implants cation issues that the pharma industry faced.
extensions, and "me-too" offerings, but have benefited from improved efficacy; the
very few breakthroughs. Today, you see former for the treatment of cardiovascular Apart from the huge success of Drug
more companies adopting an open innova- artery disease and the latter for improved Eluting Stents, has the response to other
tion model for developing products. They acceptance of things like joint replace- combination products been good / sat-
are looking outside their organisation for ments. Pacing leads and glucose sensors isfactory?
new ideas and partnership opportunities. could benefit from better biocompatibility Depending on whom you talk to, the
Combining drugs, devices, and biologics and a lower risk of inflammation and rejec- exact numbers may vary. But the overall
appears to be the logical next step. tion. In cases such as cancer and diseases market for combination products is large

w w w . a s i a n h h m . c o m 41
and growing. Initial estimates put the industry players and regulatory bodies
total value in the range of US$ 40-50 work together to develop a consolidated
billion and it’s growing at a rate of about set of requirements and guidelines for
14% annually. This growth is being led combination products.
primarily by inhalation devices, includ-
ing intranasal and pulmonary systemic Any other comments you would like to
therapies. Transdermal delivery will also starting to pay attention to combination make?
contribute significantly. Drug-enhanced products. For example, there are now It’s good to see that the FDA is putting
technologies—like stents, orthopedics, conferences focused exclusively on more focus on combination products by
and electrodes—are also expected to combination products. Several large com- establishing the Office of Combination
contribute as well. It’s important to point panies have even created combination prod- Products (OCP). It is responsible for the
out that these numbers do not include uct 'centers of excellence' to consolidate les- prompt assignment of a new combina-
regenerative medicine products (wound sons-learned and to help match the needs of tion product to the lead FDA agency (i.e.
management, dermal substitutes, artificial combination product development - CDRH, CDER, or CBER) and coordi-
organs, etc.) that hold tremendous programs with the right resources and nating the cross-agency review process.
potential. expertise. However, the regulatory oversight model
However, one of the biggest and requirements for combination prod-
Are the two sectors doing enough to cre- challenges—and opportunities for ucts are still evolving. This trend is likely to
ate a platform for knowledge sharing knowledge sharing—is in the regulatory continue for the next few years. As a result,
that would drive the innovations in the environment. There are still no specific companies looking to bring new products
future? regulations or regulatory submissions to market should take a proactive approach
A tremendous amount of learning that are unique to combination products. to working with the FDA on pre-market
has taken place and the industry is It would be great to see the leading review/approvals.

42 Asian Hospital & Healthcare Management ISSUE-13 2007


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Operating Room of the Future


Emerging technologies

RFID, UIP and VoIP are technologies that will ultimately increase patient safety while
resulting in cost savings through improved workflow efficiency. However, careful
planning should take place prior to installation in order to avoid incompatibilities and
overload of existing local area networks.

(RTLS = Real-Time Location System) of switches the tag mode to passive or vice ver-
patients, staff and equipment. Voice over IP sa. Active tags are more expensive, use more
Olivier Wenker (VoIP) takes advantage of existing wireless bandwidth, and have shorter battery times.
Professor of Anesthesiology networks in hospitals for delay-free commu- Passive tags usually require special readers.
Division of Anesthesiology, Critical Care,
nication within the institutions. An increas- No electromagnetic interference with medi-
and Pain Medicine
and ing number of hospitals are now testing such cal equipment has been reported to date
Director of Technology Discovery systems for various purposes. The following when using 2.4 GHz or 802.11 networks.
Office of Translational Research overview will describe and compare some of St. Vincent’s Hospital in Birmingham,
M. D. Anderson Cancer Center
the emerging technologies and summarise Alabama, conducted a pilot study on the
University of Texas
USA initial experiences. benefits of using an RFID indoor position-
ing solution in the hospital. They mainly
RFID measured real-time patient location, and
It is known from other industries that by doing so, they were able to improve
knowledge about location and movements admission, transfer, and discharge times by

T
he Operating Room of the Future of relevant people and items can help maxi- 85%. Discharges by noon, a key through-
(ORF) or the Intensive Care Unit mise productivity. Over the past few years, put metric in many hospitals, could be
of the Future (ICUF) are environ- several hospitals around the world have improved by 21%. Patient satisfaction im-
ments that are becoming more digitised, started to use RFID technology for real- proved as a result of shorter waiting times,
complex and integrated into the overall time tracking. The systems consist of tags, improved resource availability, and faster
hospital operations. Tracking of patients, readers, hospital local area networks (wired transport times. Staff satisfaction improved
staff and equipment on a real-time basis or wireless), central computer/server and because of decrease of unnecessary trips
will allow for better patient identification, software. Tags can be active (constantly or and patient searches as well as a decrease in
resource management and work flow im- almost constantly emitting signals) or pas- answering pages.
provements. Digitalisation of the work- sive (only emitting signal when activated by An RFID tracking system was also in-
place will reduce time requirements for reader). Depending on the task, the appro- stalled in the “Operating room of the Fu-
charting, enable more accurate patient data priate technology should be used. Some tags ture” at Massachusetts General Hospital to
recording and archiving, provide better have a hybrid function and act as active tags measure work flow efficiency in the operat-
imaging, allow integration between clini- until they pass a certain detector which then ing room when combining the technology
cal and administrative tasks, enable remote
monitoring, and result in reduced medical Active vs Passive RFID
errors by avoiding unreadable handwrit- Active RFID Passive RFID
ing or incorrect patient identification. The Tag Power Source Internal to Tag Energy Transferred from Reader
ultimate goal is to achieve enhanced pa- Tag Battery Yes No
tient safety and to obtain cost/time savings Availability of Tag Power Continuous Only Within Proximity of Reader
through better work flows.
Required Signal Strength from Low High - Required to Power Tag
New technologies such as Radio Reader to Tag
Frequency Identification (RFID) or Ul- Communication Range Long Range (100m or more) Short (3m or less)
trasound Indoor Positioning Systems Sensor Capability Continuously monitor and record Only able to read and transfer data when
(UIP) enable real-time location tracking timestamp data tag is powered by reader

w w w . a s i a n h h m . c o m 43
T E C H N O L O G Y, E Q U I P M E N T & D E V I C E S

with other work flow improvements. The Ultrasound tags attached to patient charts
and displayed together with other relevant
pilot study included 45 patients and the information stored on the tags. Ultrasound
results were impressive. Pre-surgical wait- signals are confined to the room where
ing time could be reduced to 12.1 minutes they originate and don’t “bleed” through
(vs. 29.9 minutes for standard OR times). walls, floors and ceilings. Therefore, they
Emergence time was 8.3 minutes vs. 15.6 allow for room-level accuracy. Since ul-
minutes prior to the changes. This allowed trasound waves are not radiofrequency
for four additional cases per day in that dependent, they don’t interfere with sensi-
operating room. Additional benefits were tive hospital instruments and equipment.
increased patient safety through positive The bandwidth requirements are minimal
RFID versus ultrasound
patient tracking and identification prior to (less than 200 bytes per signal) and local
surgery. area networks (wired or wireless) of hospi-
Optimally, positive patient identifica- tals are not being overloaded with excess
tion should be combined with the display transmission information.
of the patient’s photo on the display screens The benefits of UIP are similar to the
of the appropriate pre-operative room and ones of RFID and RTLS systems that
operating room for absolute positive iden- include:
tification, with automatic opening of the • Enhanced patient safety due to bet-
electronic patient chart on the appropriate ter patient identification, availability
screens such as anaesthesia work station of real-time patient data, and location
and nursing station in the OR, and with of items such as location of sponges
crosschecking of intended surgery and oth- during surgery
er relevant data such as preexisting medica- • Time saving by real-time locating of
tion and allergies. patients, charts, staff and equipment
Computer screen examples
• Reduced equipment shrinkage costs
UIP • Better utilisation of staff and equip-
Another technology enabling RTLS is ment
based on ultrasound. The system consists • Improved patient flow with better uti-
of tags, detectors, hospital local area net- lisation of resources
works (wired or wireless), central com- • Improved room, bed and staff manage-
puter/server and some software. Small, ment
wireless transmission tags are attached to • Improved patient and staff satisfaction
objects such as equipment, patient charts, • Better inventory management and
staff, or patients. They can be tracked improved supply chain
via detectors using special digital signal • Overall cost reduction in the hospital
processing algorithms. The detector trans-
mits the data via the hospital network to a VoIP
central computer where the exact location At the 2003 annual meeting of American
and movement of the objects are tracked Society of Anaesthesiologists (ASA) a survey

Comparison of various RFID tags


Technology Deployment Options Benefits Frequency Range Strengths Weaknesses

Passive RFID Passive Patient Tags Positive Patient 13.56 KHz or 900 MHz Low Cost, ease of Supports fixed reading only in
Identification deployment, flexible form line of sight usage model
factor
Active RFID (Non-802.11) Active Patient, Asset, Positive Patient 400 MHz//900MHz with Low Tag Cost, Long Requires additional network
Low Frequency Staff Tags Identification, Asset/ Infrared technology Battery Life, Lower (Access Point Infrastructure),
Person tracking frequency band Non-Standard proprietary
protocol
Active RFID (Non- Active Patient, Asset, Positive Patient 5751 - 7001 MHz Requires additional network
802.11) Ultra Wide Band Staff Tags Identification, Asset/ (Access Point Infrastructure),
Frequency Person tracking Non-Standard proprietary
protocol
Active RFID (802.11 Active Patient, Asset, Positive Patient 2.4 GHz Utilises existing 802.11 High Tag Cost , lower battery
Based) Staff Tags Identification, Asset/ infrastructure, aligned life for frequent real-time
Person tracking with general wireless tracking, additional 802.11
networking standards access points

44 Asian Hospital & Healthcare Management ISSUE-13 2007


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was conducted. The five-question survey phones for staff and visitors alike. It can be instant two-way voice conversation without
polled the anaesthesiologists about modes concluded that newer technologies could the need to remember a phone number or
of communication in operating rooms, decrease or eliminate unnecessary delays manipulate a handset. The badge is con-
ICUs, and hospitals in general. 65% of the in emergency-related communication trolled using natural spoken commands.
over 4,000 respondents indicated that pag- and therefore increase patient safety. Also, To initiate a conversation with Jim and
er systems were their primary tool for com- direct communication without delays Mary, for example, the user would simply
munication while 15% used their wireless could result in improved work efficiency say, "Conference Jim Anderson and Mary
mobile phones. 20% used other tools such and cost savings. Smith." In addition, when a live conver-
as regular telephones or overhead systems A relatively new technology, VoIP sation is not necessary, text messages and
or had no preference for a single commu- enables instant voice conversations alerts can be sent to the LCD screen on the
nication solution. 45% of the pager users among team members, across groups, and back of the Communications Badge.
reported significant delays and 35% of throughout an organisation of mobile It was shown that nursing groups in
those had observed medical errors or inju- professionals. The systems are made up hospital units can wait a total of 2,100
ry as result of the delays. Only 31% of the of three elements: the wireless network hours per year on the phone while trying
mobile phone users experienced significant within an organisation, the system soft- to reach physicians, pharmacists, or other
delays and 38% of those reported having ware, and the communications badge. healthcare professionals. It is expected that
observed medical errors or injury. Mo- One such commercially available solution direct communication via VoIP can sig-
bile telephone users were 1.6 times more in the US runs on a standard Microsoft nificantly reduce these waiting times. This
likely to report interference with medical Windows server and houses the central- was shown in Blacktown Hospital in Aus-
equipment, but this finding was not sig- ised system intelligence: the call manager, tralia. While past methods of locating staff
nificant. Overall, the results suggested that user manager and connection manager within hospitals including mobile phones,
the use of mobile telephones decreases the programmes as well as speech recognition pagers and physically searching were ineffi-
risk of errors which needs to be weighed software and various databases. The com- cient, the VoIP solution resulted in an esti-
against the potential risk of interference munications badge is a wearable device that mated 6,000 hours per year in time savings
with medical equipment. Most of the hos- weighs less than two ounces and can eas- for staff, leading to potential cost sav-
pitals prohibit or limit the use of mobile ily be clipped to a shirt pocket. It enables ings of more than US$ 105,000 per year.

w w w . a s i a n h h m . c o m 45
T E C H N O L O G Y, E Q U I P M E N T & D E V I C E S

A pilot study in Regions Hospital, Min-


nesota, with about 100 staff members
across shifts in a trauma unit and a medi-
cal surgery unit supported expectations of
increased productivity of mobile personnel
and showed a decrease of overtime hours
by as much as 67% when using VoIP. Re-
cently, M. D. Anderson Cancer Center in
Houston, Texas, implemented the use of
VoIP as their primary tool for resuscitation
alarms and as the primary communication
tool amongst a selected group of healthcare
professionals within the hospital.

In summary
While most of the emerging technologies
are still being evaluated and implemented
as stand-alone tools, one can easily imag-
ine that they will soon be integrated in
overall solutions within the hospitals. As
more hospitals become wireless-enabled- while resulting in cost savings through Communication and coordination
enterprises combination of different tech- work flow efficiency improvements. Prior during planning and implementation be-
nologies will become reality and lead to to installing these systems, however, care- tween clinical operation, administration
“wireless convergence.” ful planning should take place in order to and information technology departments
RFID, UIP and VoIP are technologies avoid incompatibilities and overload of ex- are imperative in order to take full advan-
that will ultimately increase patient safety isting local area networks. tage of these new emerging technologies.

46 Asian Hospital & Healthcare Management ISSUE-13 2007


T E C H N O L O G Y, E Q U I P M E N T & D E V I C E S

Medical Devices
Going the generic way

With the application of the generic pharmaceutical model to off-patent devices, the
availability of generic alternatives to branded medical devices presents an opportunity
for a drastic reduction in healthcare costs.

alternatives as long as they offer the same in the United States and been submitted for
Richard Kuntz safety and efficacy as their branded coun- CE-Marketing in Europe; and the GMD
President & CEO terparts. By introducing these lower cost Universal Circumcision Clamp, which has
Generic Medical Devices, Inc. alternatives, drug manufacturers gravitate been granted both FDA 510(k) clearance
USA
towards innovation in healthcare for newer, and CE Marking. Several additional ge-
cutting edge pharmaceuticals. neric devices focussed on pelvic health are
Surprisingly, and despite the success of in the product pipeline. Each generic medi-

O
ver the last two decades, tech- generic pharmaceuticals across the globe, cal device will be offered at approximately
nical improvements in the de- the generic pharmaceuticals model has two-thirds the cost of brand name devices,
velopment of medical devices never been applied to the burgeoning medi- providing enormous cost savings to purchas-
have helped create a thriving US$ 100 bil- cal device market, where large manufactur- ers—which can translate into direct savings
lion-a-year global industry. The expansion ers continue to benefit from price increases for patients and healthcare systems.
of innovative and original medical device on patent-protected surgical devices. These To be clear, GMD is not setting its
manufacturing techniques has yielded re- patents create barriers to entry for new com- sights on devices that are considered life-
markable biotechnological progress that petitors, enabling prices to continue to rise critical, highly complex from a technology
has prolonged the life expectancy for with little regulatory control and often with stand point, consistently being improved
patients and provided access to new life- few, if any, additional innovations or im- upon or regularly replaced by new itera-
saving procedures; but throughout this provements on those devices. This, in turn, tions. New medical devices that require
growth, standard-of-care devices have creates financial problems for hospitals, am- years of engineering and development are
largely been ignored given their maturity bulatory surgical centers and independent not products for which generics should be
in the product life cycle. As a result, the physicians seeking to provide their patients manufactured. Instead, GMD is focussed
price of these devices has risen on pace with the best in medical care; rising costs for on devices considered standard-of-care in
with the rest of the healthcare industry, devices mean either a direct rise in costs to their respective categories, devices that have
but without acquiring any new features healthcare systems, insurance providers and undergone little, if any, innovation since
or improvements. Now, with the applica- patients in a privatised system, or else a re- first being introduced to the market, and
tion of the generic pharmaceutical model duction in the number of patients who can devices which are easily replicated and for
to off-patent devices, the availability of gain access to care in socialised systems. which the company can dramatically reduce
generic alternatives to branded medical de- However, as patents expire, competi- costs. By some estimates, the first GMD
vices presents an opportunity for a drastic tors are allowed to enter markets originally products could save the healthcare system
reduction in healthcare costs in Asia and dominated by brand names. Generic Medi- in excess of US$ 360 million per year in the
internationally. cal Devices (GMD), Inc. is the first such United States alone.
company to capitalise on these allowances
Generic pharmaceuticals––Laying by developing generic versions of standard- A new era of medical device
the groundwork for generic of-care surgical products no longer under manufacturing
devices patent protection. The first generic medical As more generic alternatives become avail-
For years, consumers have widely used ge- devices are already available: the GMD Uni- able in 2007, the impact on Original Equip-
neric drugs offered by the pharmaceutical versal Surgical Mesh, a Class II, non-active ment Manufacturers (OEMs)—and conse-
industry. The idea is simple: once the patent implantable medical device intended to sup- quently, the healthcare system—is likely to
on a brand name drug expires (usually after port tissue growth in open or laparoscopic be immediate and encompassing. By offer-
approximately 17 years), competitors are procedures (common for hernia repair), ing efficacious products costing significantly
allowed to develop, market and sell generic which has received 510(k) clearance for use less than brand name counterparts, the

w w w . a s i a n h h m . c o m 47
T E C H N O L O G Y, E Q U I P M E N T & D E V I C E S

market for generic surgical devices is likely medical devices is ever-increasing. The highest levels of safety and efficacy. Sup-
to grow quickly and steadily. increase in elderly patients will necessar- ported by deregulation programs in coun-
Hospitals, surgical centres, and third- ily create a higher burden on the various tries such as Japan intended to increased fo-
party payers are limited in procurement healthcare systems––many of which have cus on innovation and thus on partnerships
based on strict fiscal budgets. However, already ceased to provide sufficient govern- with foreign companies, GMD is beginning
with generic device prices estimated at ap- mental support for the general population. to establish partnerships with manufactur-
proximately two-thirds of the current mar- As a result of such conditions as widespread ers and hospital customers throughout
ket price, these organisations will now have deregulation in the healthcare sector in Ja- Asia; the potential for widespread systemic
access to high-quality, lower cost alterna- pan and the fact that much of the cost for change and savings is immense.
tives and benefit from an escalation in pur- healthcare falls to the individual in priva- Generic products will drive down the
chasing power, allowing them greater access tised environments like China and Taiwan, cost of standard-of-care devices, make room
to devices and the ability to provide services generic pharmaceuticals have been widely in a burdened global healthcare system for
to a wider number of patients—whether accepted in Asia. innovation, and, most importantly, give
through lowered direct costs or, in a so- According to The Asia Generic Phar- more patients access to cutting-edge treat-
cialised environment, through the ability maceuticals Forecast Report published in ments by correcting decades of unregulated
to purchase more devices within the same 2006, Japan will be Asia's biggest branded price inflation worldwide. GMD’s entry into
fixed budget. generics market by the end of the decade as the device industry has opened the doors to
As a result of the increased purchas- the government continues to cut drug costs a whole new market opportunity for OEMs
ing power of hospitals, surgical centres, and make hospitals and consumers more and new generic device manufactures––and
and third-party payers, it is predicted that price-aware, and China's generics market the potential impact on the market is just
OEMs will experience greater demand for will continue to expand strongly, although now being defined. Ultimately, hospitals,
surgical devices and increasing production success will depend on brand strength as the third-party payers and patients will drive
quantity––in short, opening the door to a population remains reliant on basic drugs. the industry shift by choosing brand name
new “generic” revenue stream influenced This trend demonstrates a willingness quality at generic prices.
and created by the demand from the health- among consumers and the healthcare in-
care system itself. Brand name companies dustry to accept products that do not carry
BOOK Shelf
will face the greatest challenge in choosing a brand name––it is expected that generic
how to contend with this new competition. medical devices will follow suit. Medical Devices and
To protect their market share, brand name, This prediction is further supported by Systems
manufacturers will need to respond by in- the fact that many Asian countries, includ- Authors : Joseph D
troducing lower cost alternatives of their ing Taiwan, South Korea and Singapore, Bronzino
own or adjusting to the new market prices. import more than twice as much in medi- Year of Publication: 2006
Either way, the healthcare industry will cal devices as they export—in many cases, Pages: 1376
win as brand name companies compete to Asian countries are importing more than
match their generic counterparts and overall US$ 0.5 Billion in foreign medical devices Description:
prices on expensive, standard-of-care surgi- each year in order to serve their ageing and
Over the last century, medicine has come
cal devices drop. expanding populations. With governmental out of the "black bag" and emerged as one
Ideally, this will benefit Asian countries programmes in place urging reduction in of the most dynamic and advanced fields
in several ways; Asian countries are already healthcare costs in several Southeast Asian of development in science and technology.
emerging as prime arenas for manufacturing countries and a program directed at raising Today, biomedical engineering plays a
low-cost medical devices, so, not only will the standards of medical devices and equip- critical role in patient diagnosis, care, and
rehabilitation. More than ever, biomedical
hospitals and patients gain access to qual- ment used in government-owned hospitals
engineers face the challenge of making
ity devices at lowered costs, but OEMs and in Malaysia, there is clearly a place for high-
sure that medical devices and systems are
materials manufacturers based in China, quality generic medical devices in the Asian safe, effective, and cost-efficient. Offering
Singapore, Korea and elsewhere will expe- market. an overview of the tools of the biomedical
rience a rise in the ability to partner with engineering trade, Medical Devices and
American and international companies to GMD: A market of one Systems reviews the currently available
produce the devices. Currently, GMD occupies an industry of technologies and lays a foundation for
the next generation of medical devices.
one, but with thousands of surgical devices
Beginning with biomedical signal analysis,
The market for generic devices in in production for which generic models
renowned experts from around the world
Asia could be developed, there is considerable share their experience in imaging, sensing
A 2001 United Nations population study room for emerging generic manufacturers technologies, medical instruments and
predicted that Asia’s over-65 population that could similarly benefit Asia and the devices, clinical engineering, and ethics.
will increase by 314% by 2050. With world. Ideally, each company would focus
one quarter of Asia’s population now over on a unique device segment in order to best For more books, visit Knowledge Bank
section of www.asianhhm.com
the age of 55, the demand for lower cost meet increasing demand and maintain the

48 Asian Hospital & Healthcare Management ISSUE-13 2007


FA C I L I T I E S & O P E R AT I O N S M A N A G E M E N T

Patient Safety
The next level
James B Battles
Senior Service Fellow
There is growing acceptance of the newer methods in Patient Safety
patient safety and a call to combine both retrospective Center for Quality Improvement and
Patient Safety (CQuIPS)
and prospective methods in order to gain a complete Agency for Healthcare Research and
Quality (AHRQ)
picture of the patient safety challenge. United States Department of Health &
Human Services
USA

I
t has been seven years since patient action directed at the identification of risks Significant progress has been made at
safety became recognised as a ma- and hazards to patient from healthcare as- implementing reporting systems at the
jor international healthcare issue. sociated injury or harm. We are now just institutional, regional and even the na-
Eisenberg’s analogy of patient safety having beginning to actively move to stage two of tional level. There is growing recognition
the characteristics of an epidemic of world- the cycle—the design and implementation of the importance of using administra-
wide portions provides a framework of but we are no where near reaching stage tive or billing data in patient safety. The
examining patient safety with three stages. three. In examining new approaches to pa- medical record continues to be a source
• Identify the risks and hazards that cause tient safety, it is important to review what of patient safety information but chart
or have the potential to cause healthcare we have learned in the past seven years at auditing is labour intensive. However
associated injury or harm stage one to determine the directions for newer approaches that use triggers with
• Design, implement and evaluate patient stage two. Electronic Health Records (EHR) are
safety practices that eliminate known showing promise. When it comes to iden-
hazards, reduce the risk of injury to pa- Stage One: Identification of risk tifying risks and hazards retrospectively,
tients and create a positive safety culture and hazards we should apply a principle of maritime
• Maintain vigilance to ensure that a safe Retrospective and prospective navigation which states that you can never
environment continues and patient safe- Battles and Lilford noted that there are truly know where you are without a three
ty cultures remain in place three primary sources of identifying risks point fix of your position. Thus all three
For most of the past seven years patient and hazards that can be used 1) sponta- of these approaches are required to gain a
safety movement has focussed on stage one neous active event reporting, 2) adminis- complete picture of risks and hazards to
in the epidemic cycle with the primary trate data and 3) patient charts or records. patient safety.

w w w . a s i a n h h m . c o m 49
FA C I L I T I E S & O P E R AT I O N S M A N A G E M E N T

Healthcare has relied almost exclusively


on retrospective methods for risk assess-
ment. This traditional epidemiologically
based approach has been useful; however
there is a growing need for more prospec-
tive or proactive approach to assessing risk
and hazards in patient safety. Proactive risk The Nested Model of
assessment has been extensively used in a Critical Design Elements of
Structure and Process
number of high hazard industries such as
aerospace and nuclear power. The methods
include Root Cause Analysis (RCA), process
mapping, Failure Modes Effects Analysis specially intended to eliminate or mitigate HIT to care for the object of the system i.e
(FMEA) and Probabilistic Risk Assessment known risks and hazards is the challenge the patient. The concept that work can be
(PRA). There is growing acceptance of the of stage two. Using the data collected in designed is not new. In healthcare, there
newer methods in patient safety and a call stage one, we need to move to a more risk has been a reluctance to shift away from
to combine both retrospective and prospec- - informed design approach to use proven the myth of the independent professional
tive methods in order to gain a complete design methods involving a number of pro- model of work to embrace the reality of in-
picture of the patient safety challenge. fessions outside of healthcare so that one terconnected clinical work systems. Clinical
Sensemaking could actually design out system failure and work can and should be designed for quality
In order for organisations to become learn- design in safety and quality of care. and safety.
ing organisations, they must make sense of Battles and Lilford have provided a Ineffective teamwork and communica-
their environment and learn from safety modification of the Donnabedian model tions continue to be listed as the main under-
events. Sensemaking, as described by Weick, to serve patient safety which uses a nested lying cause of failure in patient safety events.
literally means making sense of events. True approach of structure surrounding process This growing awareness of the importance
sensemaking in patient safety must use both with human behaviour at the core. This of team work has led to the development
retrospective and prospective approach to framework of structure and process can help of a number of successful programmes in
learning. Sensemaking is an essential part of determine what to design for the healthcare teamwork training designed to improve the
the design process leading to risk - informed system. Figure 1 is a graphic representation process of care. In addition to teamwork,
design. The results of these separate or com- of the nested model of the critical elements the use of simulation as an implementation
bined approaches are most effective when of structure and process that must be de- strategy that is showing great promise both
end users in conversation-based meetings signed. This design model shares similar as an intervention strategy and as a means to
add their expertise and knowledge to the characteristics with Ferlie and Shortell’s improve skills and performance across the
data produced by, FMEA, and/or PRA in model of the healthcare system and with continuum of care.
order to make sense of the risks and haz- Morey’s onion model of human factors de-
ards. Without ownership engendered by sign elements. Conclusion
such conversations, the possibility of effec- Clinical work is increasingly being There is no simple quick fix or easy solution
tive action to eliminate or minimise them is supported and shaped by technology in to the problems of patient safety. It requires
greatly reduced. the form of tools, devices and Health In- hard work and commitment by everyone.
Safety culture assessment formation Technology (HIT). Technology There are a growing number of individual
Safety culture assessment is an essential ele- represents a range of sophistication from advances in patient safety that are and will
ment at stage one of the epidemic cycle. Sig- automated laboratory testing and pharma- continue to have an impact on the quality
nificant progress has been made in health- ceutical dispensing equipment to robotic and safety of care. These advances must be
care in measuring the culture of safety at surgery devices to simple mistake-proofing looked at as a part of holistic or systems im-
the institutional and even the national level. devices. The fact is that the tools of work are provement rather than as a single solution
The results: safety culture assessment can embedded into the process of care and are to a very complex interconnected problem.
serve as a powerful starting point for organi- connected directly to the built environment. Unless there is a shared ownership of the
sations to implement patient safety projects They must be designed in coordination with risks and hazards associated with healthcare
in a positive atmosphere of improvement both the built environment and work itself. little progress will be made. This shared
as well as measure progress of patient safety Automating broken work/clinical processes ownership of risk involves all levels of or-
activities. can and often do make matters worse rather ganisations from the Chief Executive Of-
than bring promised improvements. ficers and the Board to all care givers and
Stage two - Safety by design The process of care can also be thought even to the janitors. It also includes govern-
The real challenge to patient safety is acting of as clinical work systems. Clinical work is ment officials, those who pay for care and,
on the information obtained once the risk an interaction of teams of healthcare pro- of course, patients. When risks are known
and hazards are identified. The design and viders working in micro systems within a and fully understood, dealing with them is
implementation of interventions that are built environment, using tools, devices and possible in a culture of safety.

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Cardiovascular Medicine
Integrating IT for better care

New interventions are urgently needed to update cardiovascular practice to the level of fast
pace in the other areas. The rapid and efficient cardiovascular services provided by these
new paradigms will improve standard of care and cut cost by eliminating communication
gaps, treatment errors and redundant diagnostic testing.

and money. Furthermore, efficiency of care nor found in medical textbooks. This is
could be significantly improved. “experiential knowledge,” how to survive
Ravi Komatireddy and thrive in the medical environment,
Resident in Internal Medicine Exchange of medical information how to anticipate problems, make tough
Dartmouth-Hitchcock Medical School
and medical education medical decisions based on scanty data,
Hanumanth K Reddy Rapid transmission of patient information etc. We sometimes refer to these as medi-
Adjunct Clinical Professor and treatment strategies are critical to op- cal “pearls” of wisdom. Anyone who has
Medicine/Cardiology timal disease management. To assure con- made the transition from medical school to
University of Arkansas for Medical sistent excellence of cardiovascular care, a graduate medical training can attest to how
Sciences
and well-informed team approach is needed. important this type of information can be
Clinical Professor The team members need to believe in on- to successful patient care. Some of this
Medicine St. Louis University Medical going medical education. Unfortunately, knowledge can only be learned through
School antiquated medical education systems exist experience, through trial and error; how-
USA in many parts of the world. ever, a significant portion is learned by
Medical education at all levels must emulating our peers and superiors. This
undergo a significant change. We cannot knowledge is essential to the practice of
expect to demand excellence from our efficacious medicine and is just as valu-
peers when we are not given the tools or able as factual knowledge. While we have
any formal training on how to effectively a plethora of electronic references that can

I
n the last half a century, unprec- teach them critical information needed to provide easily synthesised factual informa-
edented cardiovascular progress has practice medicine , tion there are virtually no central clearing
occurred. With advances ranging Perhaps one of the reasons we failed houses of this experiential, “how to prac-
from the human genome project to heart to develop a consistent, evidence-based tice” class of information. By leveraging
transplantation, cardiovascular medicine model of medical education is that we the power of the internet and social net-
has seen tremendous growth throughout consider mastery of didactic knowledge working, the creation of digital resources
the spectrum of both basic research and as “adequate.” However, the rapid change that enable physicians to share this type of
clinical practice. At the current pace, more of medical information makes this type of information could prove to be a very pow-
exciting advances such as prophylactic car- “memorisation-recall” focused education erful tool towards preparing physicians to
diovascular vaccines, genetic and stem cell model increasingly futile as the growing practice more efficient and safe medicine.
treatments may soon be realised. Unfortu- fund of medical knowledge grossly out-
nately, there are still serious infrastructural weighs any one individual’s ability to suc- Harnessing electronic power for
pitfalls in the coordination, communica- cessfully recall it. Current guidelines for cardiovascular care
tion and the delivery of medical care to recertification and CME are consistent With the prompt availability of recent
patients. With prompt and effective digital with this idea. Instead, we should focus on developments and techniques via elec-
communication, a well-coordinated and giving physicians the skills to enable them tronic media, prompt diagnosis and
comprehensive medical care could be of- to seek out and integrate new medical treatment of cardiovascular problems are
fered to patients. This approach would data as needed. Furthermore, and perhaps expected in 2007. It is puzzling that the
mitigate medical errors and duplication of more importantly, there is a large subset of cardiovascular field has not fully utilised
medical testing and treatment saving lives knowledge that is neither formally taught the power of networked technology and

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simulation to facilitate medical training as utilise various public databases of medical of healthcare delivery within that field.
fully as other industries such as the aero- information to learn about their illnesses. We can expect to see similar changes to
space industry. Practice simulations have This presents a very challenging situation other medical specialties where diagnostic
long been shown to increase efficiency, de- to physicians, as our role must evolve to data can be acquired and sent for analysis
crease response time and improve decision educate and reconcile often inaccurate and at remote locations via the internet (i.e.
making in various settings including ones incomplete medical information that is of- echocardiography, cardiac catheterisation,
that require urgent decision-making. ten gleaned from unreliable sources from CT angiograms, EKG, EEG, colonoscopy,
With physical distance no longer a the Internet. etc.). Tele-medicine could easily be inte-
limiting factor and intensive graphical and Information can also flow the other grated into such a platform. Although cur-
computing availability to the general pub- direction, from doctor to patient as we rent tele-medicine initiatives are being used
lic, the use of simulation software/hardware have the potential to leverage technol- to showcase specific procedures or to treat
or other complex tasks such as surgery, ogy in order to facilitate patient teaching; underserved areas in fields such as radiol-
ACLS, cardiac catheterisation, bronchos- this information, in the form of interac- ogy and dermatology, these tools are still
copy, etc. could be simulated by teams of tive displays, distributable computer pro- relatively in their infancy, the future holds
physicians working together connected via grams, or interactive simulations, can act tremendous potential for these platforms to
internet. This would enable practice and as supplementary material to face-to-face evolve for real time healthcare delivery and
learning of new techniques as well as the doctor-patient discussion. This promises teaching. Imagine surgeons at several dif-
ability to simulate problems and compli- to keep doctor-patient encounters more ferent locations working together on a case
cations periprocedure or intraprocedure informative for patients. using robotic surgical technology, or, rou-
without any real world consequences to a tine on-demand video conferencing and
patient. Medical Communication consultation from an underserved clinic
For surgical procedures this would act Top-notch healthcare will always critically to medical specialists at larger academic
as an additional, effective learning step depend upon an organised, efficient system centres.
placed between reviewing a text book one of communication between physicians, an- As such a system grows, it could po-
day, and expecting to perform in the OR cillary medical professionals and patients. tentially foster patient-doctor, as well as
during the procedure the next day. While Unfortunately, the mostly outdated means doctor-doctor communication. One pow-
several rudimentary simulation packages of technology currently used by the health- erful result would be the ability to facilitate
are currently in use, especially for endo- care industry; phone, fax, etc., results in a patient triage by enabling the acquisition
scopic technique, CPR and central venous haphazard array of communication styles of vital data or hemodynamic parameters
access, this technology has incredible room that are inadequate to handle the workload from home for a patient with a pacemaker
to grow before it reaches its full potential as of a modern healthcare workplace. There is or special monitoring device, possibly given
a ubiquitous medical training tool. no centrally accessible database or platform to patients with advanced illness, thereby
Multidisciplinary education is also an for physicians in the United States to col- helping to decide whether they will require
underutilised methodology for medical laborate or communicate with each other hospital admission or an adjustment of
education. Physicians spend a significant let alone with their patients. This problem their medication. This technology exists
portion of their lives working along side commonly manifests, with respect to doc- in very early phases; patient’s can already
other medical professionals whom they’ve tor-patient interaction, with the “lost to have their pacemakers interrogated over the
never met, know nothing about, and are follow up” phenomenon and has shown to phone.
totally unfamiliar with in terms of the ex- result in non-trivial mortality and morbid- Several studies have examined the use
tent of their education. In light of this fact ity. Collaboration is not only essential to of internet based monitoring for children
the physician workplace demands a seam- medical practice, it is in fact intrinsic to it. with asthma. The hardware necessary for
less integration with nurses, clinical re- Medical care delivery depends upon this type of monitoring is in development,
searchers, pharmacy etc. Working with or the combined efforts and analysis of mul- “smart” clothing, apparel containing em-
learning about ancillary medical staff, even tiple medical specialities; it would not be bedded sensors that can measure vital signs
briefly, during the process of medical edu- unreasonable to see the development of and transmit them to a remote site has
cation may increase long-term efficiency in an internet based solutions to foster this already reached the marketplace. With re-
the physician workplace. Medical schools collaboration by networking physicians; spect to electronic networking, precedents
are at the beginning stages of incorporating giving them a consistent and unified plat- already exist outside the medical field in
this type of interdisciplinary education, at form to communicate and share data. An the form of various “social networking
least on a small scale. And, there are several internet based network that connects phy- sites” which currently serve not only en-
examples of organised multidisciplinary sicians opens doors to a staggering number tertainment purposes but also to foster
cooperation within specific hospital envi- of possibilities for teaching physicians and important communication between con-
ronments i.e. intensive care units. patients, collaboration, consultation, re- tacts as well as facilitating the formation
Another shifting pattern of practice is search and healthcare delivery. The ability of new contacts. The medical community
becoming evident with the development of to remotely view diagnostic data, in radiol- could readily adapt this existing technol-
growing demographics of the patients who ogy for example, are changing the system ogy to at least create the initial version of a

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physician network, thereby bringing social As physician-patient load, clinical respon- primarily upon physicians. However, with
networking to physicians. At the time of sibility and patient expectations of physi- efficient use of information technology to
this writing several companies are bringing cian performance continue to increase, collect and collate data such as history and
such networks to market. For example, in medical errors will continue to be a topic at physical examination lab data, results of
a given geographic area of practice, all the the forefront of any conversation. In depth studies, and by using non-invasive moni-
participating healthcare professionals can analyses of these adverse medical events toring, remote monitoring, and decision
sign in to a secure medical intranet. always reveal a very complex sequence of support tools, we can free our time to
The patients in the system are provided events that eventually lead to a bad out- focus on problem solving and analysis,
with modern tools to appropriately com- come. Clearly, current attitudes toward rather than information collection, there-
municate with their healthcare. All the medical adverse events must change; a fo- by potentially increasing our diagnostic
relevant information of these patients in- cus on systems-based thinking and analysis and therapeutic acumen. For this to occur,
cluding history and physical examination of events that lead to medical errors could however, requires a fundamental shift in
as well as laboratory information should result in the streamlining of complex med- our attitudes toward the role of technology
automatically be sent to that intranet and ical systems, increased usability of current in medicine. We must assuage fears of tech-
the concerned healthcare professionals medical technology by improving human- nology replacing the human touch, physi-
should be able access this through a secure machine interaction, and finding new roles cian experience, or the ability to diagnose
site on their hand held digital device and for technology to act as decision support and form therapeutic plans for patients.
laptop. If they desire, healthcare providers and fail safes within the medical environ- This evolving role of technology in deci-
may be alerted through their hand held or ment. The potential to take “humans out sion support and information collection
their digital beepers. of the loop” for data gathering and phar- areas of medicine will represent one of the
Sick patients admitted to cardiac ICU maceutical drug delivery has the potential greatest paradigm shifts in the medicine.
may be fitted with sensor laden health vests to reduce human error in these areas that
so that cardiac ultrasound, ECG, oxygen could directly result in a significant de-
saturation and hemodynamic informa- crease in patient harm. For example, some BOOK Shelf
tion could be transmitted to the nurses electronic medical record systems and de-
station or other monitoring stations via cision support systems already warn practi-
wireless (Wi-FI, blue tooth etc) technol- tioners of potential adverse drug combina- Information Systems and
Healthcare Enterprises
ogy. This information could be fed into a tions or wrong doses.
pre-programmed computer (a computer We currently know that the efficacy Authors : Roy Rada
programmed with protocols, diagnos- of different medications depends upon an Year of Publication: 2007
tic and therapeutic information gleaned individuals metabolic polymorphisms as
Pages: 380
on line through world’s latest literature). determined by his/her genes. In some cas-
This computer would have artificial intel- es, whole drug classes work better within
Description:
ligence and together with the information certain ethnic populations for e.g., calcium
provided as described above, will come up channel blockers and African Americans The healthcare industry in the United
States consumes roughly 20% of the
promptly with the most appropriate care with hypertension. The ability to custom-
gross national product per year. This
plan for the patient and this plan could be tailor specific drugs to patients with specif- huge expenditure not only represents a
further altered by the patient’s physician as ic metabolic patterns could greatly increase large portion of the country's collective
deemed necessary. the efficacy of our treatment regimes. Fu- interests, but also an enormous amount of
With the development of comprehen- ture decision support systems could utilise medical information. Information intensive
sive medical records, there is no doubt that this data by recommending the most effica- healthcare enterprises have unique issues
they will become the dominant platform cious and appropriate class of medicine for related to the collection, disbursement,
and integration of various data within the
for medical documentation and commu- a specific patient.
healthcare system. Information Systems
nication in the future. Current systems, and Healthcare Enterprises provides
however, can vary in their power and abil- Role of technology: Information insight on the challenges arising from the
ity to facilitate efficiency in the workplace. gathering vs. information analysis adaptation of information systems to the
In the near future, we can expect continu- The recurring theme of advances and new healthcare industry, including development,
ing refinements to these systems that actu- paradigms within the context of medical design, usage, adoption, expansion, and
ally result in time savings, reduced redun- communication and education, as well as compliance with industry regulations.
Highlights the role of healthcare information
dancy of documentation and improved diagnostic and therapeutic clinical medi-
systems in fighting healthcare fraud and
patient care. cine, is the efficacious use of technology. the role of information technology and
Effective healthcare delivery and prompt vendors.
Medical errors and adverse events medical decision-making depend upon an
A great deal of research has been performed ever-increasing burden of both objective
For more books, visit Knowledge Bank
over the least 20 years detailing the magni- and subjective patient data. Traditionally,
section of www.asianhhm.com
tude of medical errors in the United States. the burden of collecting this data has fallen

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I N F O R M AT I O N T E C H N O L O G Y

Connected Healthcare
What next?

Healthcare in the 21st century will require a much higher degree of connectedness and
mobility of information, knowledge, processes, devices and people.

complex, the movement to care in non- care generated by an ageing, chronically ill
traditional environments like the home or population. Further, the power of the new
Kevin Dean
workplace, both introduce a risk of more technological capabilities will enable new
Managing Director
“unconnected” journeys. To make matters ways of working rather than automating
Connected Health
Internet Business Solutions Group (IBSG) worse, in the wider world outside health- current practices—changing the gover-
Europe care, technological advances are accelerat- nance, control and distribution rules for
Cisco Systems Inc. ing, offering more opportunities and also information and knowledge in healthcare.
UK
a greater need to coordinate and connect The next generation of internet solu-
John Grant processes, information, knowledge and tions is enabling a “human network” to
Managing Director patient journeys. evolve, rather than computer to computer
Connected Health transactions.
Cisco Internet Business Solutions Group The technology avalanche
(IBSG) Asia
Cisco Systems Inc. The rate of technology advancements— The impact of the human network
Hong Kong storage, processing, communications, and on connected health
connectedness of information—is exponen- While healthcare is facing huge challenges
tial and will have a profound impact on the influenced by ageing populations increas-
way people work, live, learn and play in the ingly suffering from chronic disease, the
next 20 years. Consider the progress made rules for interactions between organisa-

F
or many years, IT in healthcare has in wireless technology for example. In the tions and especially between individuals are
been treated as a poor investment in 1980s, a mobile phone was considered in- changing dramatically. Traditional produc-
relation to other investments with novative if it was smaller than a car battery. ers of content—from hospital performance
budgets frequently cut to fund treatments In 2001, the first telephone call was made information to health knowledge—are fac-
or pay rises or increased demand for care. from space when shuttle astronauts used a ing new competition from sources that as
However, there are emerging signs that the Cisco® IP SoftPhone communications ap- little as three years ago did not exist. Patients
value that IT can deliver in health & care plication (a software programme used on a now find it easy to create websites them-
is being recognised, though the difference PC or laptop) to call home instead of using selves (such as www.patientopinion.org.uk)
between standalone “e” health applications a radio. Today, phone calls are increasingly to capture information about a disease or a
and those that support the patient’s jour- made from computer devices for free over hospital’s performance.
ney through care is also being recognised, the Internet. Such content usually has little of the
and the value of truly Connected Health The scale of the technology avalanche traditional quality-assurance process ap-
solutions is becoming apparent. The con- is staggering. For instance, in 2003 alone plied to it but is accessible and quickly up-
nections must bridge time, organisations, 6.5 exabytes of data was created worldwide, dated. Large organisations, especially those
clinical disciplines and the yawning gap be- enough to fill the U.S Library of Congress in the public sector, can take years to cre-
tween health and social care, especially for 500,000 times over. ate a new service for patients, yet patients
ageing populations suffering from chronic Profound implications for the world or small private organisations can use in-
diseases. While healthcare industry is in of healthcare arise from the power of the novative Internet tools to design online ser-
the process of recognising the potential new communications enabled by advancing vices in a matter of days. “Mashups,” which
of IT, other factors are driving potentially storage, infrastructure and computing pow- combine content from multiple sources,
greater divisions in the patient’s journey— er. These new capabilities might be one of are powerful examples of these new services
for instance the fragmentation of medical the only ways in which we can collectively (see http://whoissick.org/sickness/). Simi-
specialities as treatments become more deal with the rapidly growing demand for larly, modes of distribution are being

54 Asian Hospital & Healthcare Management ISSUE-13 2007


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multiplied by the increasing number of con- patients at their homes using remote medi- critical resources. In addition, finding the
nected devices, and by delivery technologies cal devices and video monitoring. Patients right resources is also a significant challenge.
such as WiMAX, YouTube, wikis and blogs. leave the hospital up to 10 days earlier than For example, paramedics and nurses sitting
These content avenues are making an abun- normal, but as soon as they are discharged, in the back of an ambulance with a patient
dance of health information and services the hospital ceases to be paid for the showing unusual symptoms often have to
widely and easily available to patients and patient’s treatment. resort to paper-based lists of specialists and
citizens. Yet, the very flexibility and freedom Furthermore, the healthcare system phone numbers when calling for help. As an
that create these choices also make it hard to will not be able to afford to treat all dis- example of how Connected Health might
assess the quality, competence and reliability eases from which the ageing population address this problem, the Map of Medicine
of such services and knowledge. might suffer. Prevention must become the is being further developed to contain an
The impact of this technological norm—not only through preventive treat- Expert Network capability that will po-
change, combined with healthcare’s need to ments, but also through education to help tentially address both problems: locating
respond to sociological change with more people change unhealthy lifestyles, such as resources and scaling their expertise. The
prevention, efficiency, higher-quality care, smoking, that lead to disease. These changes Expert Network, accessed via the Map of
and delivery of more complex treatments, are fundamental to the organisation of care Medicine on PC or mobile device, has the
is leading to four emerging themes in many and to the information tools used to help potential to link clinicians across organisa-
healthcare systems: citizens take responsibility of their health. tions and professional boundaries so that the
e-health becomes connected health Consumerisation right skills are available for a given patient at
The term “e-health” emerged in the late Increasingly, as we focus on health and pre- the right time. Such developments will not
1990s as healthcare organisations noticed vention, the degree to which individuals can only improve access to care, but will also re-
that the advent of Internet technologies avoid disease will be driven by the services duce the cost of care, stretching the impact
added new information technology tools for available to them, or that they can afford. of skilled resources beyond the normal geo-
sharing data and communications. E-health In the future, more and more devices and graphic or organisational boundaries.
is still very much a part of the healthcare information-based services will become The future potential of the human net-
industry’s language and culture because it available to help people avoid or manage work and Connected Health is vast. How-
helps ensure that important tools are periph- disease, including wearable or implantable ever, the biggest challenges will occur not
eral to care, rather than intrinsic. Healthcare devices and smart clothing to monitor body at a technical level, but in supporting the
in the 21st century, however, is evolving; it functions. process, cultural and behavioural changes
is no longer just about e-health but more The availability of services to health required to take advantage of these techno-
about connecting healthcare—creating a consumers will again change expectations logical possibilities.
collaborative industry among clinicians regarding service levels people should re-
who have multiple specialties and cooperat- ceive from their care organisations when
ing across professional, organisational, and they move from health to care. This will dra- BOOK Shelf
budgetary boundaries. Unless a plan arises matically increase the pool of available data
for connected health, the opportunities cur- on which their care can be planned. There Paper Kills - Transforming
rently available will pass, as will the benefits. will be far reaching implications, however, Health and Healthcare with
New tools are beginning to offer true con- for having so much information about an Information Technology
nected health capabilities, such as the Map individual’s health. For example, today, if
of Medicine (www.mapofmedicine.com), someone suffers a sudden heart attack on the Authors : David Merritt
developed in the United Kingdom, which street, the ambulance and hospital do their Year of Publication: 2007
combines best practice patient journeys, best, on very short notice, to treat and save Pages: 150
clinical evidence and public and private the patient. In the future, however, caregiv-
health knowledge. ers may have four to six hours notice of an Description:
impending heart attack—and, as a result, Paper Kills addresses the most pressing
The divorce of health and care
issues in the drive to modernize and
As the world’s population ages and chronic expectations of success will be significantly
improve healthcare through health
or long-term disease becomes more preva- higher. The systems for notification, coor-
information technology. This unique
lent, traditional models of health and social dination of professionals, communications book guides the reader on a tour of the
care will need to change. Today, all too often with the patient, and liability for failure in evolving health information technology
the responsibilities for chronically ill people the care chain are still to be explored. and health policy landscape, covering
moving in and out of hospitals are split Virtualisation topics from protecting privacy and
between local government, social care and A lack of young people to care for the el- advancing research to building health
information exchanges and achieving
healthcare organisations. At the boundaries derly is a major concern among healthcare
interoperability.
of this infrastructure lie significant prob- organisations in much of the developed
lems with continuity of care, funding, and world. This concern, combined with the
For more books, visit Knowledge Bank
case management. For example, in Europe, increasing cost of healthcare continues
section of www.asianhhm.com
a hospital has discovered a way to support to erode the gap that already exists for

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I N F O R M AT I O N T E C H N O L O G Y

e-Health and
Healthcare Practice
The use of e-health can positively impact doctor-patient relationship promoting the mutual
participation model of medicine, which implies that, e-health can promote a shared
responsibility in decision making and problem solving.

Sisira Edirippulige
Coordinator e-Healthcare Programs

Anthony C Smith
Senior Research Fellow

Centre for Online Health


University of Queensland
Australia

H
ealth systems around the world
are facing numerous challenges,
including the rapid increase in
the prevalence of certain chronic diseases,
limited funds and the pressure of an ever-
ageing population. The shortage of health
professionals to provide essential services is
an important issue which both developed
and developing countries are struggling to
cope with. The rising costs of healthcare
makes the situation even more complicat-
ed. Governments and international organ- other spheres of the human society, such (pre-recorded). A common example of a
isations worldwide are seeking solutions. as online banking and online shopping real-time e-health application is commu-
Among others, e-health has been identified —the health sector has been slow to adopt nication via telephone. The use of the tel-
as one such solution that may help alleviate e-health. Nonetheless, hope for e-health ephone has become commonplace around
some of the challenges described. to play its role is still there. A number of the world and we can tend to forget the
In general terms, e-health may be used governments have implemented national value of it. Videoconferencing is another
to describe the delivery of healthcare and e-health strategies. National initiatives such example—however much more expen-
exchange of healthcare information across as National e-Health Transition Authority sive and generally less accessible than tel-
distances using Information and Com- (Australia), the Health and Human Servic- ephone services. Alternatively, e-health can
munication Technologies (ICT). Synony- es (United States) and the NHS Moderni- be achieved using pre-recorded techniques,
mous with e-health, other terms such as sation Program (United Kingdom) can be for example, the ordinary email. Whilst
telemedicine, telehealth and mobile health few such examples. It has been recognised considered a relatively inexpensive form of
are often used interchangeably. Despite the that the use of online communication e-health, this modality gives participants
high expectations raised in the early 1990s, techniques may be the key to improving the opportunity to access information and
e-health has not been widely adopted and quality, safety and patient outcomes. communicate at their own convenience.
integrated as a mainstream service interna- In principle, e-health can be catego- e-Health can be used for clinical,
tionally. Unlike the use of ‘e methods’ in rised as real-time and store-and-forward educational and administrative purposes.

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For example, the access of clinical data at to children who otherwise would have to easily make a referral by contacting the
distance can be useful for diagnoses and travel hundred or thousands of kilome- service instead of automatically sending
making important decisions regarding tres to the specialist hospital. Paediatric patients to Brisbane to see the special-
patient management. The growing use of sub-specialities offered by the telepaediat- ist in person. Once a referral is made to
technology-enhanced learning (e-learn- ric service include post-acute burns care, the telepaediatric service, a response is
ing) in medical/health education is a good cardiology, diabetes, neurology, oncology, guaranteed within 24hrs. Telepaediatric
example of e-health for educational pur- orthopaedics, psychiatry and surgery. Both coordinators liaise between the referer and
poses. In terms of administrative value of patients and providers have reported high specialist, and coordinate the response
e-health, studies have shown that the use levels of satisfaction with the service. Rou- subject to the urgency of each case. It is
of electronic tools and medium (for exam- tine telepaediatric clinics are now sched- also the responsibility of the coordinator to
ple, computers, PDAs, Internet) can ease uled 12 months in advance and managed manage the technology during each con-
the administrative process in healthcare in a very similar way to the conventional sultation. Upon the specialist’s arrival, the
settings. outpatient service. coordinators ensure that an adequate (vid-
It may be argued that the use of e- An important factor in the success eoconference) link is made to the regional
health can positively impact doctor-patient of the telepaediatric service is the unique site, that the sessions run smoothly and ac-
relationship promoting the mutual partici- referral model developed by the research curate usage records are maintained.
pation model of medicine. This means e- team. Firstly, a centralised referral centre Telepaediatric clinics are conducted
health can promote a shared responsibility has been developed which gives selected using standard videoconferencing equip-
in decision making and problem solving. regional hospitals direct access to a telepae- ment available in the hospitals. Since the
In Australia, the integration of elec- diatric coordinator via a dedicated toll-free service was established, project designers
tronic technologies in routine clinical number. Staff in regional hospitals could have set up dedicated videoconferencing
practice has been most prominent in the
field of general practice. A recent survey re-
ported by the Australian Medical Associa-
tion (AMA) indicates that a well over 90%
of the Australian general practitioners are
utilising computer technologies such as
electronic prescribing and communica-
tions systems. Another area where e-health
has been making some progress is the use
of the Internet as a source of health infor-
mation. A number of web-based health in-
formation sites are growing rapidly, and so
too are the number of respective users.

Some success stories


Telepaediatrics
One of the successful e-health projects re-
ported in the literature is the telepaediatric
service in Queensland. The service com-
menced in November 2000 as a research
trial through the University of Queensland’s
Centre for Online Health (COH) in col-
laboration with the Royal Children’s Hos-
pital (RCH) in Brisbane, and in time has
emerged as a routine service. The telepae-
diatric service provides specialist consulta-
tions to children and their families living
in rural and remote areas of Queensland.
About 90% of telepaediatric consultations
provided through the service are done via
videoconference. More than 5000 consul-
tations have been conducted since the serv-
ice began, benefiting thousands of families
statewide. Specialists at the RCH are now
using this service to provide consultations

w w w . a s i a n h h m . c o m 57
I N F O R M AT I O N T E C H N O L O G Y

from around the world have volunteered to


provide advices. The growing use of this sys-
tem is an indication of the usefulness of an
email-based e-health application.

Health information
The use of the Internet for accessing health
and medical information has rapidly in-
creased for the last few years. Both clinicians
and health consumers are relying on the In-
ternet as a useful information source. For
example, in a survey conducted in 2002,
80% of adult Internet users, or almost half
of Americans over the age of 18 (about 93
million), said they have researched health
topics on the Internet. 30% of email users
have sent or received health-related email.
Online health information sources al-
low consumers to become informed about
diagnoses, surgery or health promoting be-
haviours, prepare for a visit to their doctor
or hospital, share information and give or
receive support. From the perspective of a
rooms (studios) in selected remote sites. In addition to standard studio-based healthcare professional, the Internet may
The specialists use videoconference videoconferencing units, the telepaediatric be useful for continuing medical education,
studios at the COH. However, at both service has developed a mobile videocon- conducting online peer review research and
regional and Brisbane sites, technology ference system for use in the clinical areas. access to the latest evidence-based informa-
handling of clinicians has been kept to a In 2004, the COH introduced a videocon- tion. The Internet has also become useful
minimum. Basic training is offered to all ferencing unit dressed up in the shape of a tool for health communication. Online
clinicians, but the majority of responsi- robot in a regional hospital which lacked discussion lists and news groups, email chat
bility for operating the equipment is a full-time paediatrician. “Roy the Robot” rooms are becoming popular tool for health
maintained by the telepaediatric coordi- (named after Royal Children’s Hospital) has communication.
nators. Videoconference calls are made been used for ward rounds where specialist
using digital telephone lines (ISDN) at paediatricians from Brisbane could offer re- Conclusion
a preferred minimum bandwidth of 384 mote consultations directly at the bedside. With the growing pressures on health serv-
kbit/s. Roy has won the hearts and minds of the ices around the world, there is potential for
The acceptance of this system from children in the hospital while nurses and e-health to be used more widely. Despite
both patients and clinicians has been doctors find him clinically useful. Indicat- predictions and high hopes that telehealth
highly satisfactory. For patients, telepae- ing the success of this method, four new (e-health) would become commonplace
diatric service has resulted in savings robots are now being launched in different in the 1990’s, evidence suggests that wide-
for the family who are saved the incon- distant sites in Queensland. spread integration has not occurred. De-
venience and need for extensive visiters Low-cost telemedicine in developing countries spite this, the potential of e-health should
to Brisbane for follow up consultations Technologies involved in e-health are not not be ignored. Instead, important lessons
with specialists. The telepaediatric serv- always need to be expensive. A low cost e- (both successful and failed) should be con-
ice has resulted in substantial cost sav- health project run by the COH in collabo- sidered before and during the development
ings for the health service in Queensland ration with the Swinfen Charitable Trust of e-health within an organisation.
which is responsible for subsidising a pa- (SCT) has proven that inexpensive methods
Further information
tient travel scheme. From the specialists’ such as email can be useful for the delivery The Centre for Online Health (COH) is one of very few
perspective, it has become obvious that of health related services. This charitable research and teaching centres in the world which focus
on the evaluation of telehealth for the delivery of health
a substantial proportion of sub-special- service provides free medical advice to doc-
services. The COH is responsible for a broad range of col-
ist outpatient appointments can be done tors in developing countries using ordinary laborative projects which explore and evaluate innovative
at a distance. One of the leading exam- email and attached digital images where ap- methods of providing clinical services in metropolitan
and regional environments, including telehealth, health
ples of telepaediatrics is in the area of propriate. The SCT has been running for
information systems and health education.
post-acute burns care where about 17% eight years and has facilitated a specialist Centre for Online Health, University of Queensland,
of all outpatient services are now done response to more than 1000 clinical ques- Australia
through the telepaediatric service. tions. More than 200 specialist consultants Web site: http://www.uq.edu.au/coh/

58 Asian Hospital & Healthcare Management ISSUE-13 2007


I N F O R M AT I O N T E C H N O L O G Y

Intelligent Health Networking


Changing our way of healthcare

The fundamental reason for the healthcare IT gap, and the lack of impact of ICT
in healthcare relative to other industries, is that we are attempting to use an ICT
framework that is mismatched to the new models of care.

However, while many healthcare pro- In such a business environment, there


viders now have clinical desktops and are three keys to success: (1) the knowledge
Michael Georgeff
other computer systems, these cannot enterprise, (2) connectivity and (3) open
CEO
communicate with each other. Doc- networks of businesses and users.
Precedence Health Care
and tors often do not know what medications
Director and tests have been given to patients by The knowledge enterprise
e-Health Research Unit other doctors, even when they are mem- The knowledge enterprise is one in which
Monash University
bers of the same care team. It is even more the key resource is knowledge, compared
Australia
difficult to bring relevant medical knowl- to an industrial enterprise where the key
edge to the point-of-care, to create integrated resources are physical assets and labour.
care plans, to monitor a patient’s prog- As is clear from the rapid emergence of
ress against the care plan, or to alert care companies like Google and Amazon, and
providers when a patient’s condition the transformation of the music and retail

M
eeting the complex needs of requires intervention. The Economist has industries, knowledge enterprises are driv-
patients with chronic illness is referred to this as “Health Care’s Outrageous ing quite profound structural and qualita-
one of the greatest challenges IT Gap”. tive changes in the way we live and work.
facing medical practice. If we are to im- My view is that the fundamental reason However, despite the knowledge-in-
prove outcomes for these patients, the evi- for this gap, and the lack of impact of ICT tensive nature of healthcare, the business
dence strongly suggests that we rethink our in healthcare relative to other industries, is model we use in healthcare organisations
approach to ambulatory care. that we are attempting to use an ICT frame- is still based on the industrial enterprise.
With better disease management, hos- work that is mismatched to the new models This is characterised by a focus on physical
pital admissions for chronically ill patients of care. components, big players to get economies
could be reduced by 50%, with consequen- There are two key characteristics of of scale, detailed planning, standardisa-
tial improvements in quality of care and re- healthcare that should drive the type of tion, stability, and locked-down, tightly
ductions in mortality and morbidity. Infor- ICT solution we consider. First, we need to integrated computer systems.
mation and Communications Technology take seriously that the fundamental busi- The aim has largely been to move
(ICT) focussed on better sharing and utili- ness of healthcare is knowledge: knowledge from what is seen by many from an
sation of knowledge is the key to achieving of the patient, knowledge of medical treat- inefficient “cottage industry” to a more
this change. ments and practice, knowledge of the health- efficient industrial enterprise. This
In Australia, for example, it is estimated care system and knowledge of the prevailing approach may be suitable for running
that improved knowledge sharing and care environment. This knowledge is extensive and hospitals but it will not work for manag-
plan management for patients with chronic complex, is continuously changing, must be ing and preventing chronic illness across
disease would produce direct healthcare shared among many providers and consumers, the continuum of care. Here, the organi-
savings of over US$ 1.5 billion a year. The and must be brought to bear at the right time, sations and people involved use different
savings in non-healthcare costs (such as in the right context, at the point-of-care. Sec- systems, different practices, different data
travel, special foods and carer expenses) are ond, we need to be fully aware of the inherent and different processes. The type of care is
estimated to be the same order of magni- complexity of healthcare: it is composed of a also different: it requires continuous care
tude. And increases in workforce participa- variety of participants, highly heterogeneous surveillance, with reminders and alerts
tion and productivity could add a further systems and practices, highly autonomous sent to the right people and followed
US$ 4 billion per year in benefits to the and independent agents, and highly up with the right intervention at the
economy. distributed information sources and services. right time.

w w w . a s i a n h h m . c o m 59
I N F O R M AT I O N T E C H N O L O G Y

The organisations and information agreements and standards, continuously The Internet was also designed from
technologies used in healthcare must adapt increasing the value of the data in an evo- the beginning to have no central au-
to match this business environment. Instead lutionary way. The need to understand the thority and to operate “while in tatters”.
of the industrial model, which may work flow of information will drive faster adop- While initial government investment was
within a hospital setting, we need business tion of standards, in a virtuous cycle of in- essential to provide the core infrastruc-
models and technologies that are typical creased information flow, improving stan- ture, the Internet’s huge growth has cost
of knowledge enterprises such as Google, dards and increasing value. the taxpayer little or nothing, as each
Amazon and Skype. However, this is not where we have fo- node is independent and has to manage
These knowledge enterprises are char- cussed in healthcare. Instead, most invest- its own financing and its own technical
acterised by networked information, sup- ment has been directed at the development requirements. This allowed a mix of
port for autonomy and personalisation, and of large, closed monolithic systems. The government and private investment, new
use of information systems that are open, Electronic Health Record (EHR) is almost applications and services to “plug in” and
adaptive and distributed. universally seen as the key to better knowl- add value, and new and innovative tech-
Not many are thinking this way in edge sharing in healthcare, but instead it is nologies and business models to rapidly
healthcare. We are still planning, standardis- the connectivity of the players that is the evolve.
ing, and “locking in” the big, centralised in- key. It is the information flow that is impor- These three key factors—the knowledge
formation systems. These kinds of systems, tant, because from that everything else de- enterprise, connectivity and open networks
such as being rolled out in the UK, require rives. Without it—without the connectivity of businesses and users—have transformed
massive investments between 5-10% of to populate and to access health data—an the retail, finance and music industries,
annual healthcare expenditure. EHR is very difficult to build, maintain, and are starting to transform film and
and operate. television.
Connectivity We need to do the same in health-
The second key is connectivity. In the pe- Open networks care. We can begin by connecting provid-
riod of the information economy (1970 to Thirdly, we need to design our systems to ers and consumers across the continuum
1995), competitive advantage lay with in- accommodate the heterogeneity and in- of care and making existing systems
vesting in crunching power: large applica- completeness of information, the distrib- interoperable using Internet technologies.
tions that could process Moore's Law: the uted and diverse nature of the information We can begin by sharing what we have.
performance to price ratio of computing sources and users, and the various forms We can begin by living with existing
doubles every eighteen months. of autonomous and governed institutions business processes, without impinging
But for the knowledge economy (from and businesses that are part of healthcare. on the time or practices of healthcare
1995 forwards), raw computing power and Instead, the conventional approach in practitioners.
large monolithic applications are not the healthcare can largely be characterised as an Once connected, and with the right
keys to success. Here competitive advantage attempt to remove the heterogeneity and financial incentives in the right places, in-
accrues to those who invest in connecting autonomy from the system, so that it can dividual value propositions will then drive
power: connecting to more people and better run like a well organised bank. greater electronic data entry, agreed data
more systems to share knowledge faster and The prominent example of a system models, and an increasing diversity of care
farther. The prevailing law is Metcalf's Law: built to accommodate heterogeneity and management and decision-support ser-
the value of a computer is proportional to autonomy is the Internet, and there are two vices. Consumers, together with profes-
the square of the number of connections it keys to its success: (1) connecting anything, sional healthcare organisations, will drive
makes. The key message: don’t spend time anybody, anywhere, and (2) divesting in- evidence-based care and practice change.
getting agreement on the data, don’t spend vestment and control of the network (and And this in turn will create new business
time ensuring all the systems conform—get its services) from a central authority to sup- models and opportunities for hospitals, in-
connected. pliers and users. surers, employers, healthcare providers and
In businesses today, most high priority If we go back to the beginning of the businesses.
and high volume communications are han- Internet, in the early 1990s, we see that It will take money and partner-
dled electronically. Yet in healthcare, these it was radically different from the prevail- ships between government and indus-
high importance communications—such ing information systems at that time. As try to get started. It will take different
as referrals and hospital discharge summa- Tim Berners Lee, the founding father of ways of collaborating with and building
ries—are usually transmitted using paper the World Wide Web, said in 1991: “Its on the conventional operational systems
and pen, fax, letter and hand delivery. This universality is essential: the fact that a of government-run health departments.
state of affairs would be inconceivable in al- hypertext link can point to anything, be But with the right conceptual frame-
most any other industry, let alone one that it personal, local or global, be it draft or work—by taking seriously the knowl-
rests so fundamentally on knowledge and its highly polished.” This was highly radical edge enterprise and the autonomy and
sharing across the supply network. at the time, where uniformity, accuracy heterogeneity of care providers and consum-
Once connected, individual value and completeness of information were ers—we can start to transform our health
propositions will drive stakeholders towards considered an essential part of computing. practices.

60 Asian Hospital & Healthcare Management ISSUE-13 2007


w w w . a s i a n h h m . c o m 61
I N F O R M AT I O N T E C H N O L O G Y

Interview
Healthcare
IT in India
This changing scenario of the healthcare industry
has drastically changed the IT requirements of
hospitals. There are clear challenges within the current
healthcare ecosystem that must be overcome before
the healthcare revolution is realised.

Ajay Shankar Sharma


CEO
Srishti Software Applications Pvt. Ltd.
India

Over the last few years, the Indian before the healthcare revolution is realised. to other countries in Asia/Rest of the
healthcare sector has been rapidly evolv- The challenges are: world?
ing. How has this affected the software/ • Low reach / inaccessibility as well as insuf- The structure within which healthcare
IT needs of hospitals? ficiency (where available) of quality care is carried out varies from country to
Healthcare is undergoing a distinct move- to the most economically backward areas country—and sometimes even within
ment along a logical trajectory from its his- • Presence of specialist doctors is restrict- national boundaries.
torical focus on acute care i.e. dealing with ed to the metro and class-A cities The most fundamental property af-
immediate and severe outbreaks of illness, • High focus / risk of under-utilization of fecting the Indian healthcare sector is the
to chronic care, continuous care for long capacity (beds, doctors, nurses) multi-faceted demographic and socio-eco-
term illness that may reduce acute cases to • Fragmentation of isolated bits of patient nomic profile of the country.
preventive care, i.e. care focussed on early and medical know-how across entities The emergence of corporate hospitals
detection and treatment of illness, includ- in the ecosystem on a larger scale is another important devel-
ing immunisation, ultimately leading to • Lack of a one-point complete patient opment. The corporate entry into health-
predictive care, i.e. not waiting for early record care is important for the professionalism of
signs of illness but predicting and thwart- • High Cost / Low Productivity due to hospital management. Till recently, mod-
ing it before the illness has the chance to bottom-up re-creation of diagnosis/ ern management systems had not penetrat-
take root. This revolution would move us analysis for every instance ed most healthcare institutions, with some
away from a curative drug based healthcare notable exceptions. Most hospitals would
towards consulting/service based health- How have the suppliers handled this? organise their resources and manpower
care with focus on lifestyle, and adapting Business models are currently focussed on within structures that had evolved rather
behaviour to prevent and cut out the roots Acute Care across healthcare ecosystem. than been designed. The processes would
of any instance of illness. Models catering to Chronic, and more ad- be structured to ensure multiple points of
This changing scenario of the health- vanced Preventive care need to be explored control rather than patient convenience.
care industry has drastically changed the by insurance companies and healthcare Information capture would be rudimen-
IT requirements of hospitals. There are service providers alike. tary and information rarely integrated be-
clear challenges within the current health- The hospitals and the suppliers will yond that required for reporting purposes,
care ecosystem that must be overcome now have to start looking at the following: because of which any data-based quality
1. Alternative delivery model to multiply control would not be possible.
reach With corporate entities entering the
2. Chronic
Care 2. Integrated health records - A complete, up- healthcare sector, they are introducing man-
dated / accurate one point patient database agerial practices and tools, which they had
1. Acute 3. Preventive
Care Care 3. Alternative transaction models been using for long, in the hospitals that
they are promoting. To understand the In-
4. Predictive How have Indian hospitals fared in terms dian hospital landscape, given below is the
Care
of healthcare IT adoptation as compared classification of various types of hospitals:

62 Asian Hospital & Healthcare Management ISSUE-13 2007


I N F O R M AT I O N T E C H N O L O G Y

Care Beds / Population of 1000


Primary hospitals
These are the hospitals that are in the village
8.00
or the local locality level. The concept of Germany
2.50
Delhi
7.00
these hospitals is “Everything for Everybody” 6.00 2.00
5.00
Secondary hospitals France 1.50
4.00
These are the hospitals that run on the con- 3.00 USA Spain
1.00 India
cept “Everything for Everybody, but at a 2.00 UK
0.50
UP
1.00 India
Higher Level”.
0.00 0.00
Tertiary care hospitals
These are the hospitals that give “Expert Care
for Everything”. These can be corporate or
Government. On the government side these Srishti's integrated Healthcare solu- 1. The quality of service has gone up
are the hospitals with the Medical Colleges. tions provide the ability to support mod- and hospitals have turned more effi-
Super speciality hospital (One speciality) ern healthcare services, additionally future- cient in terms of reach and delivery of
These are the hospitals where only one type proofing initiatives, delivery models and service.
of vertical or speciality is handled. emerging trends that would soon domi- 2. Integrated electronic medical records
An important and positive development nate this sector. Built on the philosophies facilitate research as data is made
taking place in the Indian healthcare sec- of integration of the entire spectrum of available in structured manner, which
tor is the use of information technology for healthcare technology enablers plus Srish- helps in studying trends, identifying
purposes such as computerization of medical ti's powerful tool-kit approach (that makes disease outbreaks etc.
records, networking of various departments healthcare services avoid constraints from 3. By means of creation of electronic
in a hospital, and providing of tele-medicine technology limitations), PARAS is the an- patient record, each patient’s blood
services. swer to the need for a one-stop technology group, known allergies etc. would
With advent of Information Technology for healthcare. be documented and available, hence,
in Indian healthcare, disintermediation has Srishti software offers a complete preventing manual errors.
occurred in such a way that the primary & healthcare information management sys- 4. It also facilitates remote diagnosis of
secondary level hospitals can have a direct ac- tem (HIMS) which involves implementa- patients. As a result, people in rural
cess to the Super Speciality Hospitals, in a col- tion of clinical system for managing EPR areas can also have access to consulta-
laborative way. The new organisation model and development of clinical care pathways. tion from speciality doctors.
not only removes the intermediate layers but This clinical system can be integrated 5. It has enabled Customer Relationship
also provides a conducive atmosphere for pri- seamlessly with the hospital administra- Management (CRM), as this is a very
mary level hospitals, to work symbiotically tion system important facet for Speciality hospi-
with the Super Speciality hospitals. This will Integrated electronic patient record tals and chain hospitals, in terms of
be a win-win situation for both partners. system (EPR) - This gives the complete patient loyalty.
This graph depicts the ratio of number demographic information of the patient 6. IT also helps patients move seam-
of beds to number of patients of a few de- i.e. age, name, sex, etc., patient’s present lessly across different geographical
veloped countries against that of India. As of illness information which includes details locations.
now India is very low on this ratio, with just on present illness, history, medication, 7. IT provides the flexibility to procur-
0.75 bed per 1000 population, as compared consultant notes, etc. ing and billing.
to the other countries. PARAS toolkit facilitates remote diag- 8. IT also provides accounting frame-
nosis or tele-medicine. This separates point work hence help with entire billing,
What developments are likely to occur of care and diagnostic resources, hence en- inventory management, store man-
in the healthcare IT landscape in India abling healthcare providers to extend their agement, laboratory management,
in the near future, how are you prepar- reach to geographies where such resources etc.
ing for it? are not available to patients. Thus IT helps in maximising returns on
The following developments will have to every penny spent.
necessarily take place in healthcare: How has IT changed the patient care
a. Alternative delivery model to multiply landscape in India? As a software company what are your
reach With the help of IT, patient care has im- views on the potential of the health-
b. Integrated electronic patient record sys- proved drastically. In IT enabled hospitals, care IT sector in India?
tem (EPR) - This helps in capturing of the bed turnaround ratio has increased by Healthcare is an emerging industry
information and maintaining continu- as much as 10%, which is a big advantage. where the scope is unlimited. We have
ity and granularity. Hence, the investment towards enabling a vision and that’s what we aim to sell.
c. Alternative transaction models IT gets recovered in a few months. Our differentiator lies in the fact that
d. Remote diagnosis or Tele-medicine and Enumerated below are the advantages we don’t just sell functionality, but func-
follow-up procedures of enabling IT in hospitals: tionality with a vision.

w w w . a s i a n h h m . c o m 63
Products & Services

Company Page No. Company Page No.

Diagnostics Synthes Asia Pacific OBC OBC3


AsiaGen Corporation 31 Unomedical Pty Ltd. IBC2
Hanlab Co., Ltd. 46 ZOLL Medical Corporation 4
Inverness Medical Innovations, Inc. 21
Synthes Asia Pacific OBC3 Surgical Specialty
APS Medical 27
Facilities & Operations Management Shimadzu (Asia Pacific) Pte Ltd. 29
APS Medical 27 Synthes Asia Pacific OBC3
Synthes Asia Pacific OBC3
Unomedical Pty Ltd. IBC2 Technology, Equipment & Devices
APS Medical 27
Healthcare Management AsiaGen Corporation 31
1st India Health Summit 14 Bloodline SpA 25
B. E. Smith 10 Electrolux Professional 2
Hospital India 40 Fotona d.d. IFC1
Gouri Engineering Pvt. Ltd. 45
Information Technology
Hanlab Co., Ltd. 46
ZOLL Medical Corporation 4
Hospital India 40
Medical Sciences Inverness Medical Innovations, Inc. 21
APS Medical 27 Monomedi Korea Co. Ltd. 42
AsiaGen Corporation 31 Shimadzu (Asia Pacific) Pte Ltd. 29
Bloodline SpA 25 Synthes Asia Pacific OBC3
Mediaid (Singapore) Pte Ltd. 33 Unomedical Pty Ltd. IBC2
Shimadzu (Asia Pacific) Pte Ltd. 29 ZOLL Medical Corporation 4

Suppliers Guide
Company Page No. Company Page No.

1st India Health Summit 14 Hospital India 40


www.ihs.in www.hospital-india.com
APS Medical 27 Inverness Medical Innovations, Inc. 21
www.apsmedical.com.au
www.determinetest.com/print
AsiaGen Corporation 31
www.asiagen.com.tw Monomedi Korea Co. Ltd. 42
www.monomedi.com
B. E. Smith, Inc. 10
www.besmith.com Mediaid (Singapore) Pte Ltd. 33
Bloodline S.p.A. 25 www.optosystems.com.sg
www.bloodline.it Shimadzu (Asia Pacific) Pte Ltd. 29
Electrolux Professional 2 www.shimadzu.com
www.electrolux.com
Synthes Asia Pacific OBC3
Fotona d.d. IFC1 www.synthes.com
www.fotona.si
Unomedical Pty Ltd. IBC2
Gouri Engineering Pvt. Ltd. 45
www.gouriengg.com www.unomedical.com

Hanlab 46 ZOLL Medical Corporation 4


www.hanlab.co.kr www.zoll.com

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