The document discusses challenges and opportunities in the medical innovation process. It notes that while regulatory approval and reimbursement processes can be slow, improvements are being made. Medical device innovation requires collaboration between physicians, engineers, and industry. The future includes more implanted diagnostics to better manage diseases and promote wellness. Overall, the field remains promising for new technologies despite barriers that can be further addressed.

1. What’s the Idea? University of Toronto LifeScience Career Day June 23, 2009 Debra Chanda

5. New Product Innovation Process Technology R&D IDEA Proof of Concept Concept Development Preliminary Clinical Evaluation Product Development Clinical Trials Regulatory Clearance Commercial Phase Feasibility Next Generation Product 3 to 15 years Breakthrough

6. Pharma or Devices?

8. OR Both: Novel Drug Delivery Platforms Unmet Needs/Indications Hep C MS ALS Chronic pain Depression Inflammatory disease Advantages Decreased dosage Increased efficacy Decreased side effects Compliance Site specific delivery

12. Expenditures on Health Research in Canada by Source of Funding, 1988 and 2004 Source: Statistics Canada, Catalogue 88-001-XIE, July 2005, and Economics Division, Library of Parliament.

13. Federal Funding for Health Research by Sector of Performance, 2004 Source: Statistics Canada, “Estimates of Total Spending on Research and Development in the Health Field in Canada, 1988 to 2004,” Science Statistics , Catalogue 88-001-XIE, Vol. 29, No. 5, July 2005. Sector of Millions of Performance Dollars Federal Government 195 Higher Education 890 Industry 13 Non-governmental Organizations 3 Total 1,101

14. Source: Canada Foundation for Innovation, On-line Database, and Library of Parliament. Canada Foundation for Innovation Funding in Health Research Infrastructure by Program (As of 28 April 2006)

18. Other Barriers to Entry Regulation Reimbursement Product Liability

21. ~ ~ ~ ~ Biocor Stented Ht Valve Activa Parkinsons Acculink Carotid Stent Contak Ht Failure Pacer Regent Ht Valve HeartMate II LVAD 5/97 CE 4/98 CE 2/99 CE 11/99 CE 10/01 CE 11/05 CE 8/05 FDA 1/02 FDA 5/02 FDA 3/02 FDA 8/04 FDA 4/08 FDA 99 Months 44 Months 37 Months 30 Months 30 Months 29 Months Regulatory Approval Lag Time: CE Mark vs. FDA PMA Implications for patients and innovation? Biocor® St. Jude Medical; Activa® Medtronic; Regent® St. Jude Medical; Contak® Boston Scientific; Acculink™ Abbott Laboratories; Heartmate® Thoratec Corporation Trademarks: © Paul Citron 2008

23. Medical device innovation process is on-going, highly dynamic, highly technical, multidisciplinary, collaborative, and interdependent. Scenario #1 Physician identifies unmet need engineers implement solution Scenario #2 Engineer identifies opportunity physician applies to patient In most instances, physicians and industry share a co-dependence: -- Physicians can’t independently implement technology -- Industry relies on physicians for patient access and care -- Industry biomedical engineers hold peer status

30. Expansion of Neurological Indications Vision Locomotion Blood pressure Inflammatory diseases Spinal cord repair Etc, etc +