Fostering Innovation on the Critical Path to Medical Device Development

1. Fostering Innovation on the Critical Path to Medical Device Development BME-IDEA Workshop, September 28, 2005 Donna-Bea Tillman, Ph.D Director, Office of Device Evaluation Center for Devices and Radiological Health

2. FDA Mission: Historical Basis • Protect the public from unsafe products

4. FDA Mission Today Promote Protect

5. The world today… • Technological changes occur at lightning speed • Medical devices are more complex than ever • The Internet is the new “snake oil” salesman • The American public is demanding great control over healthcare decisions • The global marketplace means global regulation

6. Technology trends • Miniaturization • Smart devices • Minimally invasive • Biotechnology revolution • Combination Products • Home use • Special Populations

7. Disruptive Technologies • That change the nature of medical devices • That change how medical care is delivered • That change health outcomes, hopefully for the better …that change how the industry and FDA do business.

8. Challenges to Innovation Basic biomedical science investment & progress has surpassed medical product development investment and progress

9. Challenges to Innovation We are using the evaluation tools and infrastructure of the last century… to develop this century’s advances.

10. Challenges to Innovation This has resulted in a bottleneck at the “critical path” for delivering new products to patients

11. Critical Path Research • Leverages basic science knowledge • Leverages cumulative research experiences Does not compromise safety and effectiveness evaluations

12. Critical Path for Medical Devices Market Application Approval Basic Research Prototype Design or Discovery Preclinical Development Clinical Development FDA Filing/ Approval & Launch Preparation Critical Path The journey from medical product candidate to full-scale production and marketing

13. Why is FDA interested? • Because of the significant benefit of bringing innovative products to the public faster • Because of our unique perspective on product development -- we see success, failure and missed opportunities • Because it will help us to develop guidance and standards that foster innovation and improve chances of success

14. What does FDA want to accomplish? Work together with industry, academia and patient care advocates to modernize, develop and disseminate solutions (tools) to address scientific hurdles impacting industry-wide product development.

15. What are the Critical Path tools? The methods and techniques used for: • Assessment of Safety – how to predict if a potential product will be harmful? • Proof of Efficacy - how to determine if a potential product will have medical benefit? • Industrialization – how to manufacture a product at commercial scale with consistent quality?

16. Devices are not drugs!

17. Drugs Yesterday Drugs Today Drugs Tomorrow

18. HHS/FDA/CDRH Devices

19. Devices are Different: Development • Devices • Complex components • Designed • Drugs • Pure molecules • Discovered

20. Devices are Different: Life-cycle • Devices • Short product life-cycle • Durable equipment • Drugs • Long market life • Short half-life

21. Devices are Different: Adverse Events • Drugs • Drug interactions • Wrong drug/wrong dose • Devices • Malfunction • User error

22. Devices are Different: Regulatory Requirements • Drugs • Clinical trial • Clinical endpoints • Devices • Risk-based • Surrogate endpoints

23. Risk-Based Classification of Medical Devices • Class I: simple, low risk devices • General controls • Most exempt from premarket submission

24. Risk-Based Classification of Medical Devices • Class II: more complex, higher risk • Special controls • Premarket Notification [510(k)] • Substantial equivalence • 10-15% require clinical data • Performance testing

25. Risk-Based Classification of Medical Devices • Class III: most complex, highest risk • Data “soup to nuts” • Premarket Application [PMA] • Establish safety and effectiveness • Bench - Animal - Human • May include post-approval study requirements

26. Critical Path is Different for Devices • Device Regulation • Least Burdensome Provision of FDAMA • Quality Systems and Design Controls • Device Innovation Process • Biocompatibility • Iterative Process • User learning curve • Performance and durability • Device Industry is Represented by Small Manufacturers

27. Some Critical Path Tools… • Biomarkers • Bayesian statistics • Animal models biomarkers • Clinical trials design • Computer simulations • Quality assessment protocols • Post-market reporting • Suggestions???

28. Medical Device Critical Path Projects of Interest • Validation of biomarkers • Blood panel to assess sensitivity and specificity • Peripheral vascular stents • Computer models of human physiology to test and predict failure (before animal and human studies) • Intrapartum fetal diagnostic devices • Clear “Regulatory Path” -- with consensus from the Obstetrics community)

29. Medical Device Critical Path Projects of Interest • Permanently implanted devices • Practice guidelines for appropriate monitoring -- with medical specialty organizations • Neural tissue contacting materials • Extent of neurotoxicity testing

30. Are you interested? • Web Address http://www.fda.gov/oc/initiatives/criticalpath • Open Docket http://www.fda.gov/dockets/ecomments Docket # 2004N-0181 • CDRH webpage (under news and events) provides links to the critical path white paper and docket http://www.fda.gov/cdrh

31. Questions? One does what one is; one becomes what one does. Robert von Musil