1. Innovation: A Priority for FDA
William H. Maisel, MD, MPH
Deputy Center Director for Science
Chief Scientist
Center for Devices and Radiological Health
February 7, 2012

2. CRT 2012 William H. Maisel, MD, MPH
NOTHING to DISCLOSE

3. FDA Regulates a Wide Variety of Products
William H. Maisel, MD, MPH – CRT 2012

4. FDA on Innovation
The United States is the global leader in medical device innovation.
FDA wants American patients to have timely access to safe, important new technologies and next generation products.
We want to bring MORE safe and effective products to market FASTER.
William H. Maisel, MD, MPH – CRT 2012

5. Health Care Delivery is Changing
Home
Mobile
Wireless
William H. Maisel, MD, MPH – CRT 2012

6. Emerging Technology Trends
Robotics
Miniaturized Devices (including nanotechnology)
Home Use
Combination Products
Sophisticated, Computer-Related Technologies
Organ Replacements and Assist Devices
Personalized Medicine
Wireless Systems
William H. Maisel, MD, MPH – CRT 2012

7. U.S. Medical Device Manufacturing Companies by Number of Employees
Total Number of Device Manufacturing Companies = 15,952
Source: Dun and Bradstreet, Inc.
Date: June 2009

8. Device Development
William H. Maisel, MD, MPH – CRT 2012

9. CDRH Innovation Initiative
Strengthen the U.S. research infrastructure and promote high-quality regulatory science
Facilitate the development and regulatory evaluation of innovative medical devices
Prepare for and respond to transformative innovative technologies and scientific breakthroughs
William H. Maisel, MD, MPH – CRT 2012

10. Regulatory Science
The science of developing new tools, standards and approaches to assess the safety, efficacy, quality and performance of FDA-regulated products.
William H. Maisel, MD, MPH – CRT 2012

11. Computational Modeling and Simulation
Lochner D, Takai E, Carroll J, Chen J, Hansgen A, Salcedo E.
Morrison T, Fillinger M, Mitchell M, Fairman R, Glickman M

12. Innovative Methods for Device Evaluation
Bench‐top testing methods are often based on poor understanding of actual in vivo conditions.
Animal testing is suboptimal because animals do not typically present with diseased pathologies (atherosclerosis, aneurysms, …).
Human testing is limited by ethical issues and plagued by difficulties in determining failure mechanisms.
William H. Maisel, MD, MPH – CRT 2012

13. William H. Maisel, MD, MPH – CRT 2012

14. Leverage External Expertise
Innovation
Leverage External Expertise
Advisory Panels with SGE’s
SGE’s Complete Homework Assignments
Scientific Literature/Scientific Meetings
Public Workshops that Include Scientific Experts
Speak 1-on-1 with Outside Experts
Reach Out to Other Federal Scientists
NETWORK OF EXPERTS
William H. Maisel, MD, MPH – CRT 2012

15. Synergistic Collaborations
Multiple stakeholders (other government agencies, academia, industry, professional societies.
Leverage available expertise and resources.
Formal agreements or Public-Private Partnership.
William H. Maisel, MD, MPH – CRT 2012

16. Conclusions FDA is committed to facilitating medical device innovation
Science and technology are rapidly evolving
Need to strengthen the U.S. research infrastructure and promote high-quality regulatory science
Shared responsibility
William H. Maisel, MD, MPH – CRt 2012

17. Innovation: A Priority for FDA
William H. Maisel, MD, MPH
Deputy Center Director for Science
Chief Scientist
Center for Devices and Radiological Health
February 7, 2012