Medical Devices The Picture of Health in Convergent

Technologies

Clay Braziller Clay@braziller.com

April 14, 2004

Agenda •  Introduction

–  Definition of device –  Size of industry in BC –  Why the Growth –  BC examples

•  Convergence: Today •  Convergence: Future •  Resources

What is a Device

–  A medical device means any instrument, apparatus, appliance, material or other article, whether used alone or in combination, including the software necessary for its proper application intended by the manufacturer to be used for human beings for the purpose of:

•  diagnosis, prevention, monitoring, treatment or alleviation of disease, •  diagnosis, monitoring, treatment, alleviation of or compensation for an

injury or handicap, •  investigation, replacement or modification of the anatomy or of a

physiological process, control of conception, •  and which does not achieve its principal intended action in or on the

human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means.

Size of Industry

–  World $147 –  Europe $39.6 –  US $62.3 –  Japan $20.4 –  Massachusetts $7.2 –  Canada $4.3 –  BC $270 million

employee 3000+ 200-400 companies depending on def’n

»  All in billion US, 1998

Japan16%

Europe31% US

50%

Canada3%

Size of Industry in BC

•  130 companies in Medical Devices •  Over 300 including health informatics, and related

technologies •  Maturing entrepreneurs – ALI, Mitroflow, MDS

Devices from BC

–  Generation II orthotics: Knee Braces –  Millenium Technology: MRI –  Sulzer Mitroflow: Heart Valves –  VSM Medtech MEG Brain Imaging –  Delphi Portable Tourniquet

Character of Industry in BC

•  Over half the companies established from technology developed by the founder

•  Strong R&D infrastructure allows for development of new technologies and products

•  ¼ of companies are spin-offs from universities, hospitals and other research organizations

Export

•  Over 60% of sales are exported outside of BC •  40% of these are exported outside of Canada •  The United States is the prime export market,

followed by Europe and Asia

Strengths

•  Specialty, niche products •  Diagnostic, Stent •  Strong R&D infrastructure •  Government support •  Flexible and responsive •  Strong export potential

Strengths •  Specialty, niche products, for example…

–  Fluorescence imaging –  Heart valves –  Biomedical test instrumentation

Strengths

•  Strong R&D infrastructure –  Medical Device Development Centre –  BC Advanced Systems Institute –  UBC,SFU,UVic,BCIT –  Neil Squire Foundation –  i-cord

Strengths

•  Strong provincial and federal support for: –  Commitment to many development initiatives/

organizations (WestLink, BC MeDIA, SCBC, NCE’s, …)

–  Research and development (NRC- IRAP, CFI, MSFHR, CIHR, Canada Innovation Strategy…)

–  SR&ED tax credits –  ITI Initiative

Well represented disciplines

–  Assistive Devices – 10 –  Cardiology/Cardiovascular Medicine – 13 –  Diagnostics – 10 –  General Hospital & Personal Use – 12 –  Home health/Homecare – 11 –  Imaging & Ultrasound – 9

A wide breadth of other disciplines •  Anaesthesiology & Pulmonary Medicine - Opthalmic •  Biotechnology - Orthopaedic & Orthotics •  Clinical Medicine - Paediatrics •  Critical Care - Physical Medicine •  Dental - Physiotherapy/Orthopaedic •  Ear/Nose/Throat - Radiology •  Emergency Medicine - Surgery •  Healthcare Outcomes - Gastro Enterology •  Infection Control - Urology •  Laboratory & Testing Services - Women’s Health •  Managed Care - Wound Care, Ostomy & Continence •  Neurology •  Obstetrics & Gynaecology •  Occupational Health & Wellness

BC Snapshot –  World $142 Billion –  US $ 61 Billion –  Massachusetts $7.2 Billion –  Canada $1.6 Billion in 2000 –  BC $200 million???

BC Medices Devices by Field of Study

Hematology1%

Diagnostics7%

Dermatology2%

Dental2%

Cardiology / Cardiovascular

14%

Biotechnology / Biomedical

12%

Anaesthesiology / Pulmonary

6%

Urology3%Sports Medicine

2%

Rehabilitation Sciences

5%

Radiology (Imaging)11%

Ophthamology5%

Orthopaedics4%

Paediatrics1%

Surgery7%

Obstetrics & Gynecology

5% Neurology4%

Management2%

Ear Nose Throat3%

Gastroeneterology3%

Emergency Medicine

4%

Furniture6%

Infection Control1%

Informatics3%

MRI2%

Managed Care1%

Measure & Test Equipment6%

Mechanical Design 8%

Molds, Moulding, Plastics 4%

Needle & Syringes3%

Physical Medicine 1%

Prosthetics2%

Prototyping5%

Sterilization3%

Women's Health2%

Product Development14%

Long Term Care4%

Laboratory & Testing Service8%

Kits / Trays8%

Facilities2%

Assisted Devices14%

BC Medical Devices By Specialization

BC companies in development mode

–  Contract Design & Development – 11 –  Research & Development – 22 –  Product Development – 21 –  Commercialization – 11

Summary

•  Heavily involved in R&D •  Heavily into manufacturing 43/130 •  Huge exporters •  Already had successes (second generation of

entrepreneurs)

Strong Industry Association

•  President: Barry Allen Ventures West Management Inc., •  Matt Ferguson Technology Manager, UILO SFU •  Daryl Wisdahl Director of Regulatory Affairs, VSM MedTech Ltd. •  Mark Thomson President, MDX Medical Inc. •  Scott Phillips StarFish Product Engineering •  Clay Braziller Partner Cientis Technologies

Paul Geyer President & CEO, Medical Ventures Corp. •  Roger Kuypers Lawyer, Fasken, Martineau, DuMoulin LLP •  Jim McEwen President, Western Clinical Engineering Ltd

Trend is Convergence

Where wireless, biotech, mechanical engineering, software all meet

–  Angiotech –  Epic Biosonics –  Medtronic

Angiotech: www.angiotech.com

–  Paclitaxel Stent Coatings –  Used to treat arteries being narrowed by plaque –  Alternative to Balloon Angioplasty

•  In general made of Titanium->advanced materials •  Needs to go up through your leg into your artery •  Coated with a drug for local delivery •  Biotech + advanced materials + mechanical engineering •  Stock is at $56 •  www.angiotech.com

Convergence Today: Medical Device + Biotech

Epic Biosonics: www.epicbiosonics.com

-  Totally implantable cochlear implant -  Estimated to be a $900 million US by 2005 -  Needs to interface with nerves -  Needs to be miniaturized -  micro-molded fluoropolymer encapsulated

platinum circuitry -  Some serious challenges for those who are so

inclined

Convergence Today: Medical Device + Advanced Materials

Medtronic: www.medtronic.com

–  Baclofen Pump:Controls spasticity •  Mechanical device runs on a battery •  Placed in stomach wall •  Pumps Baclofen directly into spine •  Wirelessly adjusted by a handheld connected to a laptop •  Biotech + mechanical engineering + wireless

–  Deep brain stimulation: Controls symptoms of Parkinson §  pacers placed into chest cavity §  Leads placed “deep” in brain §  Imaging + mechanical engineering + electronics design

Convergence Today: Medical Device + Biotech+ Wireless

POD: www.medtronic.com

–  Portable Handheld Corneal Pachymeter •  used by optometrists and

ophthalmologists to measure the thickness of the cornea and to screen for glaucoma

•  first device of its kind to include a touch screen, IR printing, built-in pressure correction formulas, a computer interface and a small portable size.

Convergence Today: Medical Diagnostic + Handheld

Seven Engineering Challenges

1.  Biocompatibility - Effect of device on the body, including heat build-up from active devices. Will the presence of the device upset the ionic flow associated with nervous response?

2.  Bioresistivity- Survival of the device in the body 3.  Physical constraints of implant - What can the body tolerate? What are

the realities of surgery? What are the fabrication constraints?

4.  Longevity of the tissue – Is the remaining that is exploited by these devices ultimately susceptible to these diseases?

5.  Power - what are the requirements of the device. How can you keep the power usage as low as possible

6.  Range- Will the device provide the range that the a normal person can expect

7.  Flexibility / Stability - The prosthesis must adapt to the needs of different users, as well as compensate for as yet undefined changes in the body over time, to maintain stable performance.

Convergence: Future

-  Nanotechnology -  Micro Fuel Cells -  Brain Computer Interfaces -  Advanced Power Technologies

Nano Robots in Your Body

–  Devices on the nanoscale - 1 to 100 billionths of a meter

–  Microscopic robots clearing plaque from arteries. –  Microencapsulated cells treating diabetes

•  Ex: Carbon nanotubes—tubular molecules that are good electrical conductors—to deliver electricity to bone-forming rat cells deposited on a piece of polymer.

–  Peptide rings form nanotubes •  punch lethal holes in a bacterium's cell wall.

Convergence: Future

A Fuel Cell that Runs on Blood

–  Churns out 300 microvolts for two hours –  Next-generation heart pacemakers or tiny

implantable pumps that can deliver pain drugs for cancer patients or insulin for diabetics.

–  Wristwatch-sized sensor that can be used by soldiers to detect biological weapons such as nerve gas.

–  Fuel is fermented Glucose from the blood stream to produce electrons and protons from the hydrogen in it. By product is water and carbon dioxide

Convergence: Future

Brain Computer Interface -  A method to detect user-generated patterns in the

user’s EEG (brain signals) related to imagined movements

-  Applications in high spinal cord injured -  Neuro muscular disorders -  www.neilsquire.ca

Multiple Outputs

Multiple Actions

I am hungry I am thirsty I am sleepy I am cold

GO! Single Output

Brain Switch

Convergence: Future

Advanced Power Technologies -  LION -  DMFC -  New Polymers

-  Drivers -  Need for increased power in mobile applications -  The increased use of portable devices in OR, EMR -  Military -  Robotic Suits (Applications in high spinal cord injured -  Drug pumps -  BCI

Convergence: Future

Convergence Its not Fantastic Voyage but it is getting there!

To Learn More •  FDA www.fda.gov/cder/guidance/index.htm

•  BC Medtech www.bcmedtech.ca •  BC Biotech www.bcbiotech.ca •  Device link www.devicelink.com •  MIT www.technologyreview.com •  NRC Institute for Biodiagnostics www.ibd.nrc-cnrc.gc.ca/english/home_e.htm •  Cientis Technologies www.cientis.com •  MEDEC www.medec.com •  www.millennium.ca/ •  www.genii-orthotics.com •  Heath Canada Therapeutic Products Directorate www.hc-sc.gc.ca/hpb-dgps/therapeut •  ITI www.techinit.ca •  Fuel Cell Institute www.nrc.ca •  Clay Braziller clay.braziller@cientis.com 604-961-6360

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