Introduction to

Healthcare Technology
Management
KUEU4135 Biomedical Engineering
2018/2019
Professor Ng Kwan Hoong, PhD
University of Malaya
ngkh@ummc.edu.my
 Overview
 Definition
 History & Evolution of Healthcare Technology
 Medical Device
 Regulatory Bodies
 Technology Diffusion
 Summary
 Healthcare Technology through cartoons
 References & Further Readings
 Definition
Healthcare technology includes the
devices, equipment, systems, software,
supplies, pharmaceuticals,
biotechnologies, and medical and surgical
procedures used in the prevention,
diagnosis, and treatment of disease in
humans; for their rehabilitation; and for
assistive purposes.
Perspectives in Healthcare Technology - Ir. Gnana Sakaran. R
http://geocities.com/kbeb3234/IrGnanaNotes/topic1.doc
 Definition
Management –

1. the act or art of managing : the

conducting or supervising of something
(as a business)
2. judicious use of means to accomplish an
end

 Merriam-Webster Dictionary
History of Medical Technology
Before about 1800, physicians
primarily depended on the
history as given by the patient,
the appearance of the patient
and perhaps feeling the pulse
and touching the forehead to
check for a fever. Some would
visually examine the urine. A
few would taste it. In the case
of diabetes the urine was very
sweet from the excreted
glucoses.
The Anatomy Lesson of Dr Tulp
Rembrandt 1606-69

Christmas set of 14th century paintings from

prayerbook of Robert De Lisle. Includes “The
Circumcision.” Cook Islands, 1970
Health Technology during Renaissance
 Sphygmomanometer
1582

1620 Sanctorious improved

on the idea and called
it a pulsilogium.

When only seventeen, Galileo

timed the swinging of a lamp in
the Cathedral of Pisa by his pulse
and thus discovered the law upon
which pendulum clocks are built.
The instrument now universally used
to measure blood pressure called a
sphygmomanometer.
 Listening to sounds from the body
In 1761 a Viennese physician, Leopold
Auenbrugger, published a small book
describing the use of percussion to
diagnose disease. It depended on the
different sounds heard when you tap the
body.

1819
stethoscope invented
by Rene' Laennec

The word stethoscope in

Latin means "I view the
chest."
 Evolution of Stethoscope
Bartlett's Laennec Early stethoscope
Stethoscope - with diaphragm
Used metal ear-
tubes with the silk
covered rubber
tubes leading to a
Laennec’s stethoscope wooden chest
piece
Ist binaural
stethoscope
1816 1855 1882 1930 ------
Monaural stethoscopes Binaural stethoscopes 20th Century
1885
1828 1863 Latest Models

Piorry add
a removable
ivory earpiece Charles Ford's Bell chest
and chest piece. Denison – piece -
Welch Allyn Littmann
3 chest Funneled sound
electronic Cardiology III
Scott Alison’s differential stethoscope - pieces into two tubes,
stethoscope stethoscope
2 independent chest pieces, to allow the for hearing usually made of
listener to compare the sounds of two different types rubber, which led
areas of the chest. of sounds to the earpieces
Impractical because it muffled certain From: http://www.geocities.com/kbeb3234/present.htm
sounds. Nahrizul Adib Kadri, Raha Mat Ghazali
 Instruments For Visual Inspection of The Body
1851 Hermnn von Helmholtz invented
ophthalmoscope.
He later developed an
instrument to measure the
curvature of the cornea called
the ophthalmometer.

The ophthalmometer was later

simplified and called a
“keratometer”, which is very
important for fitting of contact
lenses.

Transilluminator effective for detecting hydrocephalus

before the ultrasound and CT imaging methods
became available.
 Electrocardiography or ECG

Willem Einthoven
developed a very
sensitive
galvanometer to
detect the extremely
small electrical events
generated by the
heart.
 1872 - Gabriel Lippmann invented
capillary galvanoscope using the capillary electrometer

"corrected curve,"

using Einthoven's string galvanometer

Evolution of the electrocardiogram

1889 - capillary galvanoscope from the electrometer.

Einthoven's string galvanometer

String electrometer
manufactured by
Leeds & Northrup, Philadelphia

Modern ECG machines

 Medical Device

Medical devices use electrical,

mechanical, chemical, or radiation
energy to achieve a desired
therapeutic purpose, maintaining
physiologic functions, or assisting
a patient’s healing process.
 Regulatory
US Food and Drug Administration (FDA)
 Responsible for regulating medical devices under
Medical Device Amendment of 1976.
 Established a three-tiered system of controls:
 Class I, General Controls
 low-risk devices that are not used to support or sustain human
health
 Class II, Performance Standards
 Devices are those for which general controls alone are judged
insufficient and about which sufficient information exists or
could be developed to establish performance standards.
 Class III, Premarket Approval.
 devices are those devices that are life-sustaining,life-
supporting, implanted, or present a potential unreasonable risk
of illness or injury.

From: Factors Affecting the Development, Diffusion, and Use of Medical Technologies
http://www.wws.princeton.edu/cgi-bin/byteserv.prl/~ota/disk3/1982/8227/822708.PDF
 Standards and Regulatory Bodies
 International Organization of Standardization (ISO)
 Quality System (QS)
 European CE (Conformite Europene) Mark
 European Medical Devices Directives
 Good Manufacturing Practice (GMP)
 Standards & Industrial Research Institute of Malaysia
(SIRIM)
 Medical Devices Authority, Ministry of Health Malaysia
Importance of Standards
Why regulation is important
 Key Regulatory Issues in Malaysia

 Very few trade barriers or regulations for imported

medical equipment in Malaysia. Existing regulations are
general and fairly broad.
 Example: it is government policy not to buy used/refurbished
medical equipment or allow experimental products into the
country without U.S. FDA or other international standard
approvals.

 The Ministry of Health and the Association of Malaysian

Medical Industries, drafted a more comprehensive
regulatory framework for medical devices (Acts 737)

From: Ames Gross, Asia: Medical Device Regulatory Issues

http://www.pacificbridgemedical.com/publications/Asia_MedDev_Regulatory_HIMA_2000.pdf
https://www.mdb.gov.my/mdb/
 Technology Diffusion
Oxford Dictionary
The spreading of something more widely.

e.g. the rapid diffusion of ideas and

technology
 Technology Diffusion
The process by which a technology is spread
over time in a social system.

 Stages of technology diffusion are as follows:

 Emerging – in the applied research stage, about the
time initial clinical testing.
 New – past the stage of clinical trials but not yet in
widespread use
 Established – considered by providers to be a
standard approach to a particular condition and
diffused into general use.
 Obsolete/outmoded – superseded by another
technology and/or demonstrated to be ineffective or
harmful.
Diffusion of EHR Innovation
Rice Univ, Dept of Bioengeering
 Technology Diffusion : Costs and Benefits

Benefit Cost
 Technology saves life  Some new technologies are
ineffective or redundant and
 Improve health does not improve health
outcomes outcomes.
 Improve quality of  It is not easy to

care discriminate effective &

ineffective technologies at
the time of their
introduction.
 Escalation of medical costs!!

From: Neumann PJ et al., The Diffusion of New Technology:Costs and Benefits to Health Care
 Factors Influencing the Development
and Diffusion of Medical Technologies
 Improvement in quality of care*
 Improvement in access to care*
 Reduction in cost of care*
 Acceptance by physicians and patients*
 Case reports in the scientific literature
 Career advancement by technology proponents
 Marketing advantages by owners of technologies
 Use of technologies to attract patients
 Desire to be portrayed on the leading edge of medicine
 Financial gain by those developing and employing technologies
 Pressure for referring physicians and patients
 Protection of imaging “turf”
* Criteria identified by the National Academy of Sciences’ Institute of Medicine as legitimate measures for assessment of the added
value of medical technologies.
From Institute of Medicine, Field MJ (ed): Telemedicine: A Guide to Assessing Telecommunications in Health Care. Washington,
DC, National Academy Press, 1996.
From: Hendee WR. – New Imaging Techniques
 Factors Influencing the Development
and Diffusion of Medical Technologies
 Improvement in quality of care*
 Improvement in access to care*
 Reduction in cost of care*
 Acceptance by physicians and patients*
 Case reports in the scientific literature
 Career advancement by technology
proponents

* Criteria identified by the National Academy of Sciences’ Institute of Medicine as legitimate measures for assessment of the added
value of medical technologies.
From Institute of Medicine, Field MJ (ed): Telemedicine: A Guide to Assessing Telecommunications in Health Care. Washington,
DC, National Academy Press, 1996.
From: Hendee WR. – New Imaging Techniques
 Factors Influencing the Development
and Diffusion of Medical Technologies
 Marketing advantages by owners of
technologies
 Use of technologies to attract patients
 Desire to be portrayed on the leading edge of
medicine
 Financial gain by those developing and
employing technologies
 Pressure for referring physicians and patients
 Protection of imaging “turf”
* Criteria identified by the National Academy of Sciences’ Institute of Medicine as legitimate measures for assessment of the added
value of medical technologies.
From Institute of Medicine, Field MJ (ed): Telemedicine: A Guide to Assessing Telecommunications in Health Care. Washington,
DC, National Academy Press, 1996.
From: Hendee WR. – New Imaging Techniques
 Control of Medical Technology Diffusion
in U.S.
Mid-1970s
 Establish state-based health systems agencies & utilization of
review panels to review applications for acquisition of a certificate of
need to purchase new medical technologies.
 Add bureaucracy but did little to suppress the
diffusion of technologies.

Mid-1980s
 Tax Equity & Fiscal Responsibility Act (TEFRA)

 Establish Diagnostic Related Groups (DRGs) to limit the level of

reimbursement of hospital & physician charges paid by the
government-sponsored Medicare program.

1990s
 “Era of Accountability”
From: Hendee WR. – New Imaging Techniques
 Accountability in Health Care

 ‘‘Doing the right things right.’

Determine What to do

Outcomes What Effect HEALTH CARE Medical

Research Get it Done Procedures
Did It Have? ACCOUNTABILITY

Was it Done? Do it Right

From: Hendee WR. – New Imaging Techniques

Schematic of health care accountability. (Courtesy of D. Eddy)
 References & Further Readings
 Bronzino J D (ed.) (1992) Management of Medical
Technology: A Primer for Clinical Engineers,
Butterworth-Heinemann
 Bronzino J D (ed.) (2000) The Biomedical Engineering
Handbook, 2nd edit., CRC Press.
 Enderle J D, Blanchard S M, Bronzino J D (1999)
Introduction to Biomedical Engineering, Academic
Press
 Reiser S J (1978) Medicine and the Reign of
Technology, Cambridge University Press
 KBEB3234 Perspectives in Healthcare Technology
(http://www.geocities.com/kbeb3234/)
 The Museum of Questionable
Medical Devices Online

Foot Operated
Breast Enlarger Pump 1976 Gas Grill Igniters: 1996
The Stimulator and Crystaldyne Pain Reliever

ACU-DOTS, 1979
Magnetic Analgesic Patches
Media Focus
Sep 2014
Media Focus
Sep 2014
 Quiz
 What is a Medical Device?

 What is Healthcare Technology?

 Explain Healthcare Technology

Diffusion.
Give an example.
 Healthcare Technology
- Learning from cartoons’
perspective
Perspective
Describe the engineering development and assessment
of technologies to address the following clinical needs:
A. Prevention of infectious diseases
Disease causing microorganisms
Immunity
How do vaccines work?
Pathophysiology of HIV infection
HIV Vaccine Development
Gene therapy for prevention of HIV infection
Clinical trials of HIV vaccines
Costs of HIV vaccines
Cost-effectiveness of HIV vaccines
Rice Univ, Dept of Bioengeering
Describe the engineering development and assessment
of technologies to address the following clinical needs:

B. Early detection of cancer

Pre-cancer and cancer transformation
Detection of morphologic changes
Pap smear - world impact, sensitivity and
specificity
New optical technologies for cancer imaging
Molecular biology of cancer
Detection of molecular changes - serum
biomarkers of cancer
PSA - patient outcomes
CA125 - patient outcomes
Describe the engineering development and assessment
of technologies to address the following clinical needs:

C. Treatments for atherosclerosis

CABG - Patient outcomes
PTCA - Additive costs
Laser Angioplasty - Moving target problem
Heart failure
Treatment for heart failure
Transplant
Total artificial heart
LVAD