ENGG1960. Introduction to Biomedical Engineering.

Biomedical Technology Lecture Notes

Professor Andrew Ruys. Director of Biomedical Engineering (Education). University of Sydney

ENGG1960. Course Outline.
4 of the fundamental aspects of biomedical engineering will be taught in parallel by 4 different experts, and a team of 6 tutors. The culmination of this is a
team design project.
Introduction to Biomedical Technology
Fundamentals of Human Biology
Fundamentals of Engineering Mechanics and Biomechanics
Fundamentals of Engineering Design and Drawing
Team project applying all you have learned into an applied biomechanics project
All the details are on CUSP (Faculty of Engineering courses and units of study portal) at http://cusp.sydney.edu.au/ lookup ENGG1960
ENGG1960. Teaching Team
Unit Coordinator. Dr Philip Boughton (Link room 242)
Biomedical Technology. Professor Andrew Ruys (Link room 217)
Biomechanics. Dr Philip Boughton (Link room 242)
Human Biology. Associate Professor Colin Dunstan (Mech room 313)
Engineering Design. Dr Paul Briozzo (Mech room 318)
Mechanics Tutors: Christine Poon, Benjamin Chow, Elizabeth Kolos
Engineering Design Tutors: Peter Lok, Edwin Soh, Jessica Houang
ENGG1960: Textbooks
All are invaluable reference resources required not only for ENGG1960 but also for later year units of study.All are available in the university coop
bookshop.
Required Books
Engineering Drawing Mechanical.McGraw Hill. ISBN 9781121838321 (required for first and third year).
Martini FH, Nath JL, Bartholomew EF, Fundamentals of Anatomy and Physiology, 9th Edition Pearson Education Inc. ISBN 978-0-321-50589-7
(required for first and second year).
Recommended (not required) Books
Engineering Mechanics: Statics, 7th Edition SI Version, J. L. Meriam, L. G. Kraige, ISBN 978-1-1183-8499-2, Wiley 2012. (Helpful in first and fourth year).
ENGG1960. Assessment
Biomechanics Quiz 1. 10%. Week 5 (Wednesday tutorial).
Human Biology Quiz. 10%. Week 6 (Tuesday lecture).
Biomechanics Quiz 2. 10%. Week 8 (Wednesday tutorial).
Assignment biomechanics.10%. Week 10 (Wednesday tutorial).
Assignment Engineering Drawing.5%. Assignment Box (Mech Eng Level 3) 5PM Friday week 13.
Team Seminar. 10% Week 9 (Wednesday Tutorial)
Team Report. 10% Week 9 (Wednesday Tutorial)
Final Exam. 35%. Exam Period. (Exam contains 3 sections, 15% Human Biology, 10% Medical Technology, 10% Engineering Drawing/Design).

Introduction to Biomedical Technology

Professor Andrew Ruys
Weeks 1 and 2: Biomedical Technology
Medical Devices
Biotechnology
Computational Biomedical Engineering
Industry Case Studies

Biomedical Technology is Assessed in final exam at end of semester.

What to study for the exam?
If it is in the pdf notes it could be in the exam.
If it is in the slides shown in the lecture, but NOT in the pdf notes it will NOT be in the exam, but still it is important knowledge.
Biomedical Engineering is booming
Fastest growing branch of Engineering in the world
Ranked in 2014 as Number 1 Best Job in America

Aging population, and the biotechnology boom

In Australia the manufacturing industry is shrinking. Areas for Engineering growth are Biomedical Engineering and Mining sector

THE GLOBAL BIOMEDICAL INDUSTRY

Biomedical Engineering: The application of engineering to Medical Science. It spans 4 principal areas, with biology and
engineering the two unifying themes:

Mechanical engineering (biomechanics and biomedical device design)

Mechatronic/Electrical Engineering (medical equipment and signal processing)

IT/Computer Engineering (Medical imaging, computational simulation)

Chemical Engineering /Biotechnology (biochemistry, bioprocessing, and pharmaceuticals)

Biotechnology:Any technological application that uses biological systems, living organisms, or derivatives thereof, to make or modify
products or processes for specific use. (biochemistry, bioprocessing, Biomaterials, tissue engineering, biomedical devices,
pharmaceuticals)

Pharmaceutical Industry: Industry dedicated to manufacture and distribution of legal therapeutic drugs. (drugs)

All content in the notes beyond this point is potentially in the exam.
Definition of a Medical Device:
A Medical Device has been defined by the Therapeutic Goods Administration as any technology, including devices, software or diagnostics, intended to be
used by human beings for the prevention, monitoring or treatment of a disease, injury or physiological process.
Implantable Medical Devices
The great majority of implantable medical devices are mechanical or mechatronic engineering technology
Implanted medical devices: one of the most profitable businesses of the Global Healthcare Industry
1: Load-Bearing Devices (Orthopaedic)
2. Implantable Bioelectronics
Moderate Risk
3: Blood-interfacing Devices (Cardiovascular).
High Risk
Biotechnology
The chemical engineering realm of biomedical engineering.
Pharmaceuticals
Genetically-modified (GM) technology
Bioreactors manufacturing compounds (eg insulin) from GM microorganisms.
Antibody diagnostics
Advanced cancer treatments
Tissue engineering
Biotechnology and Genetic Engineering
1978 Genentech first produced human insulin in genetically engineered Ecoli bacteria. Yeast is more commonly used now.Numerous drugs and
compounds are now being made by genetically engineered organisms in bioreactor.
The Global Pharmaceutical Industry
It is a huge industry. Globally one of the largest industries in the world. The major focus in Australia is on sales, marketing, and distribution. Drug
manufacture mainly happens offshore. However, much drug design work happens in Australia. Australias largest biomedical company is a pharmaceutical
and biotechnology company (CSL), with a market capitalisation of $32 billion.
Pharmaceutical IndustryKey skills required:
Molecular biology, especially proteomics.
Management and regulatory affairs
Marketing, marketing, marketing
The cost of developing a new drug and running it through clinical trials, and bringing it to market is now estimated at $800 million.

30 Major Breakthroughs that Underpin Biomedical Engineering:

A) Platform Technologies
1. Electron microscope. 1931 (Germany).
2. Microelectronics. 1947 (USA).

B) Biomedical-Mechanical Engineering Realm

3. Hip replacement. 1962 (UK)
4. The everlasting ceramic hip. 1972 (Australia)
5. Bioactive ceramics. 1960s/1970s (USA).
6. Dental Implant. 1965 (Sweden)
7. Bio-Hydrogels for Opthalmic Implants. 1959 (Czechoslovakia)
8. Prosthetic Heart Valve. 1952 (USA)
9. Vascular stent. 1986 (Germany)
10. LVAD (left ventricular assist device) turbocharger for the heart. 1988 (USA).
11. CPAP sleep apnea device. 1981 (Australia)
12. Catheter artery ablation (renal and heart) just coming on the market now.
13. Advanced navigation systems (catheter and cranial) just coming on the market now.
C) Bionics, Biomechatronics, and Bioelectronics
14. Heart Pacemaker and IPG concept (implantable pulse generator). 1958 (USA)
15. Cochlear bionic ear implant. 1978 (Australia)
16. Advanced Bionics (artificial pancreas, wearable AWAK artificial kidney, myoelectric contol of robotic limbs, thought control of robotic limbs, and
synthetic telepathy). Just coming on the market now.
17. Robotic exoskeleton. Just coming on the market now.
18. Functional electrical stimulation (FES) for paraplegics. Under development since the 1960s.
D) Biotechnology/Chemical Engineering
19. Monoclonal antibodies. 1975 (UK)
20. DNA sequencing machines.1980s (USA).
21. Biotechnology: Genetically engineered microbes. 1978 (USA).
22. Anti-bacterials: Antibiotics (1928 UK) and Bacteriophage viruses (USSR 1920s).
23. Drug delivery implants. Just coming on the market now.
E) Tissue Engineering
24. Stem cells.1960s (Canada).
25. Stem cell synthesis. 2006 (Japan)
26. Cloning 1952 (frogs); 1996 (Sheep); 1998 (Human).
27. 3D bioprinter. 2003.
F) IT and Computational Biomedical Engineering
28. Finite element software. 1980s.
29. Molecular simulation. 2000s
30. E-Medicine. 2000s
Breakthrough 1. Electron microscope. The electromagnetic lens was invented in 1926 by Hans Busch (Germany). Ernst Ruska and Max Knoll built the
first prototype electron microscope in 1931 (Germany). Development was slow but by the 1970s and 1980s a whole range of atomic-scale imaging
technology became widespread that has made possible so many biomedical breakthroughs.
Optical MicroscopesVery 19th Century. No Depth of Field. Practical Limit 100x, theoretical limit 1000x
Electron Microscopes: Invented in the 1930s. Two Types: Scanning and Transmission.
Atomic Resolution STM: Scanning Tunneling Microscope
AFM: Atomic Force Microscopy
Focussed Ion Beam Milling (FIB)
Breakthrough 2. Microelectronics. The invention of the transistor in 1947 by John Bardeen, Walter Brattain, and William Shockley (USA) initiated the
semiconductor microelectronics revolution: from pocket transistor radio (1950s), to personal computer (1970s), to smart phone (2000s). Biomedical
engineering benefitted in numerous ways from microelectronics, from the 1960s onward.
Breakthrough 3. The hip replacement. The first modern hip replacement was invented in 1962 by John Charnley (Leeds, UK) using
CobaltChrome/Polyethylene(CoCr/PE), which remains the standard and has revolutionised the field of joint replacement: 1 million hips and 1 million knees
are implanted a year, and smaller numbers of ankle, elbow, shoulder, finger, spinal disks, all using CoCr/PE.

Global Market for orthopaedic devices: $37 Billion (2012)

Hip replacement (~1,000,000 implants per year globally) ~$10B
Knee replacement (~1,000,000 implants per year globally) ~$10B
Spinal fusion, implant, nucleus ($11.5 Billion in 2012 globally)
Bone grafts (2.2 million bone grafts globally in 2012) ~$2.5B

Bone Trauma Devices IM nails, pins, wires, screws ~$4 Billion

Ankle, shoulder, elbow, wrist ($200 million globally)
Skull plates

Approximately 60% of joint replacements end up with revision surgery. US$1.5 billion per year.
1. Load-Bearing Implants Orthopaedics, Dental, Soft Tissue
Orthopaedics
Hip , knee, ankle, shoulder, elbow, wrist, spinal fusion, spinal disk implant/nucleus, bone grafts, bone trauma devices (IM nails, pins, wires,
screws), skull plates.
Approximately 60% of joint replacements end up with revision surgery.
Soft Tissue Repair
Ligaments
Hernia patches
Skin substitutes
Hip Replacement.
Modern hip replacement invented by Charnley in 1962
Only minor changes in the subsequent 50 years
Most common reason: ostearthritis
Fractured hip is also a common reason
Polyethylene-Metal bearings wear out in 5-10 years.
All the polyethylene wear particles end up in the joint.
Spinal Technology
Spinal fusion
(screws, cages)
Nucleus replacement
Prosthetic disks
Orthopaedic Repairs
Bone nails, pins, wires, screws
Skull plates
Wherever possible, titanium is used as it is the best metal in current use for structural load-bearing implants
4. The everlasting ceramic hip. Zirconia toughening was invented by Ron Garvie (Australia) in 1972. An unbreakable incredibly wear-resistant
ceramic originally called ceramic steel. However, pure zirconia proved unstable in the body. In the 1990s, Zirconia-toughened-alumina (ZTA) was
commercialised in Germany (Ceramtech) and has completely revolutionised the hip replacement in the 2000s.
It would be difficult to over-estimate the impact of the ceramics revolution in Orthopaedics.
10 years ago almost all hip replacement bearing joints were Cobalt-Chrome on Polyethylene, the rest were Cobalt-Chrome/Cobalt-Chrome.
By 2010 nearly 50% of all hip bearing joints were ceramic.
All the orthopaedic companies sell ceramic joints.
Since the 2010 De-Puy recall of the hip replacements with the Cobalt-Chrome/Cobalt-Chrome bearing system, Cobalt Chrome is falling from
favour.
By 2020 nearly 100% of hip joints may use ceramics
Breakthrough 5. Bioactive ceramics (discovered 1960s/1970s): hydroxyapatite and bioglass, synthetic ceramics capable of bioactivity (bonding to bone
and soft tissues in the body) revolutionisedorthopaedic implants and now tissue engineering.
Hydroxyapatite the Ultimate Bioceramic
Chemically similar to bone mineral.
Bioactive: Forms a chemical bond with bone in the body.
Long established use and pedigree.
Stable and durable for years in the body.
Used for plasma-sprayed coatings onto metal implants such as hip replacements, so that the implant will bond to the bone.
Bioglass: Bioactive Glass
Specific bioglass formulations are capable of forming a bioactive bond with soft tissue.
Bioglass is the only material known to humankind that can form a bioactive bond with soft tissue.
It was also recently discovered that bioglass-doped polymers could form a bioactive bond with soft tissue.
Bioglass bonds to bone 6 times Faster than Hydroxyapatite (HA)
Commercial Foamed Bioglass Bone Scaffolds Used as Synthetic Bone Graft for Non Union Fractures bone tumor filling, and any application

requiring bone graft.

Bone grafts are the second most common surgical procedure in the world today 2.2 million a year.
The gold standard is autograft bone harvested from the patients iliac crest (pelvic region). This is a finite source and requires a pelvic surgical
procedure.
Bioglass and tricalcium phosphate (TCP) are the synthetic bone graft materials.
The synthetic bioglass or TCP graft BECOMES bone within a few weeks in the body
This is known as bone tissue engineering
Bioglass becomes bone 6 times faster than TCP.
Breakthrough 6. The Dental Implant. Invented in 1965 by Per-Ingvar Branemark (Sweden) based on the (then) revolutionary metal titanium, and its
capability of osseointegration. Today over a million are implanted a year and the number is growing exponentially.
Dental implants are generally made from Titanium as it is the best metal in current use for structural load-bearing with its capability of osseointegration.
Other than dental implants, there are also:
Plates/wires/screws for maxillofacial reconstruction
Crowns/Bridges
Dental Pins
Fillings
Synthetic Scaffolds in Dentistry. Fill the hole left in the jaw after a tooth is removed with bone graft so the jaw regenerates and a dental implant can later be
fitted.
Breakthrough 7. Bio-Hydrogels for Opthalmic Implants. The hydrogel soft contact lens was invented by Otto Wichterle and Drahoslav Lm
(Czechoslovakia) in 1959. 150 million people use them today, a $6 billion market. Hydrogel intraocular lenses followed in the 1970s, and now 6 million are
implanted a year.
Opthalmological. Opthalmological technology is a large industry which utilises biopolymers, and shares common biomaterials origins as
orthopaedic implant technology.
Contact lenses
Corneal implants
Implants for Glaucoma
Intraocular lens implants
Implants for retinal detachment surgery
Surgical adhesives
Breakthrough 8. Prosthetic Heart Valve. Invented in 1952 by Charles Hufnagel (USA), hundreds of thousands are now implanted a year, a global market
of $1.5 billion. The heart has four valves, which can malfunction and need replacing.
Breakthrough 9. Vascular stent. Invented in 1986 by Ulrich Sigwart (Germany) 1990, it revolutionised coronary surgery, and led to many percutaneous
vascular implants: PFO plugs, DVT filters, heart valves. Also aneurism stents, ureteral stents, prostatic stents, esophegal stents, biliary stents, glaucomal
stents, duodenal stents, colonic stents, and pancreatic stents.
Blood-Interfacing Implants
Temporary Implants (External blood-interfacing devices):
Heart-lung machines
Kidney dialysers
Tubes and catheters
Blood bags
Long-term Implants Requiring Open Heart Surgery:
Vessel patches and vascular grafts (no percutaneous option)
Heart Valves
Total implantable artificial heart
Heart-assist pumps (left ventricular assist devices)

Percutaneous Implants Requiring Day Surgery:

Vascular stents for propping open blood vessels
Aneurism stents
Hole in the heart (PFO) plugs
Inferior vena cava deep vein thrombosis filters
Percutaneous heart valve

Vascular Graft Implants

No percutaneous option. Can only be done by open heart surgery.
Percutaneous cardiovascular medical technology that can be delivered via a catheter (usually via femoral vein) as day surgery. This is a big improvement
over open-heart surgery.,
Cardiovascular Percutaneous Innovations are having a huge impact on longevity.
Percutaneous Vascular Implants.Day Surgery! Avoids Open Heart Surgery
In 1990, the invention of the vascular stent, delivered by catheter, revolutionised heart surgery.
Pre-1990. blocked coronary arteries required open-heart surgery (6 months recovery). A vascular stent can be fitted by day surgery procedure.
Aneurism Stent
Patch for Hole in the Heart (PFO).Patent foramen ovale (PFO) is a hole in the wall that divides the right and left chambers of the heart. We all have a PFO
during before birth, but it usually closes before birth.
Deep-Vein Thrombosis Filters
The Latest Innovation: Percutaneous (Transcatheter) Heart Valve
Breakthrough 10. LVAD (left ventricular assist device) Heart Assist Pump: turbocharger for the heart. Invented in 1988 by William Bernhard (USA). The
only viable treatment for heart failure other than heart transplant.
Total Artificial Heart. Rarely used, because of the consequences of failure. Superseded by the much safer LVAD. Power failure to an LVAD simply means
the heart is continuing to pump but without the blood-pressure boost of the LVAD. The term heart failure means the heart is pumping more weakly than it
should. Power failure to a total artificial heart means no blood is pumped at all: cardiac arrest in effect.
Breakthrough 11. Catheter artery ablation (Renal and heart). St Jude Medical, just coming on the market now.
1 billion sufferers of Hypertension (high blood pressure) worldwide.
25% of hypertension sufferers do not respond to medication.
Renal ablation: systolic blood pressure reduction of up to 28 mm-Hg after 30 days.
Breakthrough 12. Advanced surgical navigation systems (catheter and cranial). Medtronic and St Jude Medical, just coming on the market now.
Atrial fibrillation (AF) is a chaotic atrial rhythm resulting in an atrial rate of 350-600 beats/min and a lack of effective atrial contraction.
700 million sufferers worldwide. 5% of over 65s, 10% of over 75s
Treatable by cardiac ablation using a catheter day surgery!
Breakthrough 13. Heart Pacemaker: IPG (implantable pulse generator). The pacemaker was invented in 1958 by Earl Bakken (USA) which began
Medtronic. The IPG concept later spawned many biomechatronic spin-offs: deep brain stimulator, spinal-cord electrode back pain therapy, sacral nerve
stimulator, etc.
IPG technology is known as neuromodulation
Global: Implantable Bioelectronics Market leaders

Medtronic

St. Jude Medical

Boston Scientific
Cyberonics
Medtronic dominates with 45% of the Neuromodulation devices market.
Medtronic dominates the 2 largest sectors of Neuromodulation: Pacing and Spinal Cord Stimulators.
Advances in Implantable Bioelectronics
Heart pacemaker.Regulates heartbeat.
Defibrillators can also shock the heart. Highly evolved technology - Pacemaker-defribrillator
Deep brain stimulator (approved for essential tremor, parkinsons, dystonia, and OCD)
Vagal nerve stimulator (approved for the treatment of epilepsy and depression).
Spinal cord stimulator for chronic back pain, by far the largest market sales of all IPGs other than the pacemaker
Breakthrough 14. Cochlear bionic ear implant. Invented in 1978 by Graeme Clark (Australia), now about 200,000 have been implanted worldwide, a
small fraction of the market. Cochlear leads the world and is Australias 2nd largest medical device company employing thousands. The Cochlear implant
has led to the bionic eye (in development now).
Cochlear bionic ear implant has 22 electrodes. More than enough for speech recognition.
Breakthrough 15. CPAP sleep apnea device. Invented by Colin Sullivan in 1981 (Sydney University, Australia) which led to mega company ResMed.
Australias largest medical device company employing thousands and a huge global industry.

More than 10% of the population suffers from sleep apnoea, and until 1981 no treatment existed. The market potential for CPAP is in the hundreds of
billions of dollar range.
Breakthrough 16. Advanced Bionics. The Medtronic artificial pancreas has just come onto the market. The wearable AWAK artificial kidney is soon to
come on the market.
Furthermore, in the advanced bionics realm, myoelectric contol of robotic limbs, thought control of robotic limbs, and synthetic telepathy, are taking bionics
from science fiction to reality.
Kidney Dialysis: Conventional Haemodyalysis 4 hours/day hospital ward. 1 litre per minute blood flow rate (250 litres in a typical session). Patients with
kidney failure currently have two options:
Live in a hospital dialysis ward - $20,000 per year per patient. 550,000 dialysis patients in the USA alone.
Donor kidney lifelong waiting list
AWAK 1kg portable Wearable Kidney
The peritoneal membrane serves the same function as the normal kidneys, selectively filter out impurities from the blood.
Awak patients change the disposable cartridge up to 3 times a day. It contains 750 ml of fluid solution, compared with 120 liters used for a four-hour
hemodialysis session.
Other advanced bionics rising to prominence:
Artificial Pancreas: Portable Insulin Delivery. Just Entered the Market.(Medtronic).
Brain-Computer Interface for Robotic Limb Control: Mind control or Myoelectric control of robotic limbs
The Bionic Eye.Bionic Vision Australia.
Synthetic telepathy
Breakthrough 17. Robotic exoskeleton. Just coming on the market now.commercial bionic walking assistance system that uses powered leg
attachments to enable paraplegics to stand upright, walk and climb stairs. Costing ~$100,000.
Breakthrough 18. Functional electrical stimulation (FES). A Paraplegic or Quadriplegic retains muscles and nerves in their limbs.Computer stimulation
of the nerves can enable controlled movement. Under development since the 1960s, FES cycling is now routine. FES walking is now becoming possible for
a paraplegic (with walking frame).

D) Biotechnology
Breakthrough 19. Monoclonal antibodies. Invented in 1975 by Georges Khler and Csar Milstein (UK) they have revolutionised the diagnostics industry
since the 1990s: disease diagnosis, cancer diagnosis and targeted treatments.
Breakthrough 20. DNA sequencing machines (invented 1980s by Applied Biosystems), and complete mapping of the human genome by 2003
revolutionised genomics, proteomics, drug design, hereditary disease diagnosis, and lead directly to the new field of pharmacogenomics: personalised
medicine.
Protein: Embodies Information giving biological functionality. Protein Sequence determines folded Structure, and therefore the Surface Morphology
which Determines the Functionality
Antibody: Example of Complex Information in Proteins Harnessed for Complex Function.
Millions of Antibodies Exist enabling targeting of millions of antigens (bacteria, viruses, poisons) thereby keeping us safe from pathogens.
Biotechnology and Cancer
Monoclonal antibodies are revolutionising cancer detection.
Monoclonal Antibody diagnostics by early detection of the first cancerous cells in the body.
Monoclonal Antibody smart-bomb tumor targeting.
Anti-angiogenesis drugs.
Total organ perfusion chemotherapy.
SIR-spheres.Selective internal radiation therapy. 30 microns in diameter beta-radiation emitting (1cm penetration) microspheres with a 1 week
half life delivered into liver tumours but NOT into healthy liver tissue.
Breakthrough 21. Biotechnology: Genetically engineered microbes. In 1978 Genentech first produced human insulin in genetically engineered Ecoli
bacteria. Yeast is more common now. Numerous drugs and compounds are now being made by genetically engineered organisms in bioreactor.
Biotechnology: The chemical engineering realm of biomedical engineering.
Pharmaceuticals
Genetically-modified (GM) technology
Bioreactors manufacturing compounds (eg insulin) from GM microorganisms.
Antibody diagnostics

Advanced cancer treatments

Tissue engineering

Biotechnology and Genetic Engineering

1978 Genentech first produced human insulin in genetically engineered Ecoli bacteria. Yeast is more commonly used now.
Numerous drugs and compounds are now being made by genetically engineered organisms in bioreactor.
Breakthrough 22. Anti-bacterials: Antibiotics (1928 UK) and Bacteriophage viruses (USSR 1920s).
Breakthrough 23. Drug delivery implants. Just coming on the market now.
Drug Delivery Implant
Slow release pills are long established.
Drug delivery implants are a long established research field, but commercialised quite recently.
E) Tissue Engineering
The Tissue-Engineering Revolution
No more donor organs.
No more immune rejection.
Organs and body parts made from your own cells.

Organ rejection occurs when the organ is from a donor, or if it is tissue engineered using stem cells from a donor. This is because
the immune system rejects foreign cells. Organs tissue engineered from your own cells will have no immune rejection.
Bone Tissue Engineering
Research field since 1980s.
Commercialised in the last decade, starting to become widely available to the general public.
Skin Tissue Engineering
Research field since 1990s.
Commercialised in the last decade, starting to become widely available to the general public.
Invented in Australia by Dr Fiona Wood an Australian plastic surgeon
Of the other key connective tissues, cartilage tissue engineering is close to commercial realisation. Ligaments are not, nor is muscle tissue or tendons.
Donor Organs
A Huge Biomedical Engineering and Sociopolitical Challenge
Huge global shortage of donor organs. Demand far outstrips supply and always will.
Donor organs cause immune rejection.
Tissue engineering is the most important biomedical challenge of the 21st century.

Organ
Biomedical Solution Portable Globally
Sufferers
Heart Failure
LVAD
Yes
175,000,000
Sufferers
Heart Vasculature Valves and Stents
Yes
20,000,000
Deaths/year
Diabetes
Medtronic Pancreas
Yes
250,000,000
Sufferers
Kidney Failure
Dialysis
Yes*
240,000,000
Sufferers
Liver Failure
NO
NO
10,000,000
Sufferers
*Invented but not yet approved for commercial use
While portable solutions exist for all key major organs other than liver, there are many inconveniences associated with portable bionic organs. Risk of
infection from catheters is the biggest problem. Taking a shower or a swim is problematic. There is also the maintenance issue and the need for constant
vigilance and access to technical support. It would be far preferable to have a tissue engineered organ.
Tissue Engineering: Foundations
Tissue engineering is a new field.It builds on the foundations of four medical discoveries that came before.
IVF (in vitro fertilisation) 1978 Worlds first Test-tube baby (4 million since)
Genome sequencing 2000 human genome first sequenced
Stem cells discovered 1960s. Controversy impedes technology advancement
Cloning First human mammal 1996
It also builds on the foundations of biomedical engineering
Biomaterial scaffolds

Bioreactors
3D printing
Decellulization

Tissue Engineered Organs???

Not yet technically feasible.
May never be technically feasible
Decades away if feasible
Huge international research focus
1. Stem-cell seeding of scaffold in a lab bioreactor.
2. Body as a bioreactor.
3. 3D Printing.
4. Decellularized donor organs seeded with stem cells
Tissue engineered organs is the biggest biomedical challenge in the 21st century. Two key obstacles:
1. Ethical
Adult stem cells are rare and of low potency.
Stem cells produced by therapeutic cloning are highly potent but ethical questions remain unresolved.
The discovery in 2010 that fetal stem cells can be synthesised by re-programming adult cells (rather than the controversial harvesting of fetal
tissue) could revolutionise tissue engineering, and remove all the controversy associated with stem cells.
2. Technological
Vascularisation is highly problematic in laboratory bioreactors.
3D printing?
De-cellularized organs doped with stem cells?
Success will bring huge humanitarian benefits to society and huge commercial benefits to the IP holders.
Breakthrough 24. Stem cells were discovered in the 1960s, and since the 1990s have heralded in the new field of tissue engineering.
Breakthrough 25. Stem cell synthesis. In 2006 Shinya Yamanaka (Japan) discovered that adult cells can be reprogrammed to become pluripotent stem
cells. He shared a 2012 Nobel Prize with John Gurdon for this. Rather than the traditional (controversial) approach of harvesting fetal tissue,
re-programming could revolutionise tissue engineering, and remove all the controversy associated with stem cells. Moreover, it prevents immune rejection
as harvested fetal cells are donor cells, unless produced by the VERY controversial process of therapeutic cloning.
Stem cells are undifferentiated biological cells that can differentiate into specialized cells and can divide to produce more stem cells. Why are
they Controversial? Adult stem cells are rare. Adult stem cells have low potency.
Stem cells were discovered in the 1960s, and since the 1990s have heralded in the new field of tissue engineering.
Stem cell synthesis. The discovery in 2010 that fetal stem cells can be synthesised by re-programming adult cells (rather than the
controversial harvesting of fetal tissue) could revolutionise tissue engineering, and remove all the controversy associated with stem cells.
Breakthrough 26. Cloning was first achieved in 1952 with frogs Robert Briggs and Thomas King (UK), but it was not until 1996 that a mammal was first
cloned: Dolly the Sheep by Steen Malte Willadsen (UK), and the first human embryo in 1998, opening up a whole range of therapeutic possibilities.
. Stem cells enable therapeutic cloning.
Breakthrough 27. 3D bioprinter. The 3D printer was invented In 1981 by Hideo Kodama (Japan) but bioprinting of living cells was not developed until
2003. Prototype (non functional) human organs have been bio-printed and the race is on to bio-print the first functional human organs. Tissue engineering
builds on many breakthroughs, from bioactive ceramics to stem cells, but 3D bioprinting was the big leap forward.
3D PrintingMay not require stem cells
De-cellularized Organs Doped with Stem Cells
F) IT and Computational Biomedical Engineering
Breakthrough 28. Finite element software. The finite element method is a long-established mathematical technique. It was not until the advent of the
personal computer that FEA software began to change the world. Strand7 was developed at Sydney University in the 1980s. The massive growth in
computing power in the last decade, has enabled sophisticated study and design of implants.
Breakthrough 29. Molecular simulation. Computational molecular simulation (developed since 2000) has enabled drugs to be designed from the atom
upward, and will one day enable complete simulation of the human body ultimately eliminating the need for human clinical trials.
Breakthrough 30. E-Medicine
Computational Biomedical Engineering
Advanced CFD (computational fluid dynamics).

Finite element modelling of entire body systems.

Molecular modelling drug design, proteomics, genetic engineering.

Virtual surgery
E-medicine
Computational Biomedical Engineering
The dream for the future
Constant wireless remote monitoring of bionic/bioelectronic implants.
Complete simulation of the human body from a molecular scale upwards, with no more necessity for human clinical trials.

The Australian Medical Device Industry

Australias Top Biotech Companies

Number 1. CSL Ltd Australias Leadingbiotechnology company
Number 2. ResMed. Australias Leading Medical Device manufacturer
Number 3. Cochlear
Number 4. Sirtex Medical
Number 5. Mesoblast
Number 6. Nanosonics
A small selection of leading Multinational Medical Device Companies
Medtronic. $80 Billion.50,000 Employees.(450 in Australia).Global leader in medical device technology.Pacemakers, deep brain stimulators,
spinal technology, artificial pancreas.
St Jude Medical: $20 Billion. 16,000 Employees (200 in Australia). Similar technology focus to Medtronic.
Johnson and Johnson: $280 Billion. 122,000 Employees (1500 in Australia). Worlds largest orthopaedics company (bought out $20 Billion De
Puy and in 2011 $20 Billion Synthes) and also produce a wide range of pharmaceuticals, therapeutics, and cosmetics.
The 5 largest orthopaedic medical device manufacturers:
Synthes/DePuy is ~$40 billion, which is the orthopaedics division of parent company Johnson and Johnson ($280 Billion)
Stryker - $21 Billion
Zimmer - $11.7 Billion
Biomet - $4.5 Billion
Smith & Nephew - $10 Billion
There are 650 Australian companies in the biomedical realm, and counting multinationals with operations in Australia, 1100 biomedical companies in
Australia. Globally, there is a huge number of large and small biomedical companies, in the three main realms of: medical devices, biotechnology, and
pharmaceuticals. This short introduction will not go into detail about them, this will be a focus in 3rd year.

Johnson&Johnson and Roche are both biomedical companies, ranked 6th and 7th largest companies in the world, respectively.
The Purpose of the Biomedical Technology Lectures
Give you an understanding of what Biomedical Engineering is your chosen profession.
Course orientation
Much science and engineering fundamentals lie ahead for you in 1st and 2nd year university.
Having been exposed to the Biomedical Engineering Applications early, the purpose and value of all the fundamentals will be clearer for you.
3rd year the focus is on your major or your combined degree.
You do not return to applications until fourth year
You should join and follow AusBiotech and AusMedtech
http://www.ausbiotech.org/default.asp
http://www.ausbiotech.org/content.asp?pageid=109