1. Leadership and Advocacy for Medical and Biological Engineering La Raison d’etre pour AIMBE Raphael C. Lee, MD, ScD, DSc(Hon), FACS President, AIMBE

2. Leadership and Advocacy for Medical and Biological Engineering What is AIMBE? Provides leadership and advocacy in medical and biological engineering for the benefit of society. Founded in 1991 282 Founding Fellows (1992-1993) Current membership includes: College of Fellows Academic Council Council of Societies Industry Council AIMBE Represents – 50,000 Biomedical Engineers

3. Leadership and Advocacy for Medical and Biological Engineering What does AIMBE Do? A vehicle for input of biomedical engineering expertise into public policy making process: AIMBE: Promotes awareness of medical and biological engineering as a resource to solve common problems Works with lawmakers, government agencies, and other professional groups to support public policy impacting research and development Promotes the national interest in education, science, and engineering

4. Leadership and Advocacy for Medical and Biological Engineering MBE and the Quality of Life of Americans

5. Leadership and Advocacy for Medical and Biological Engineering AIMBE: Fostering Innovation Collaboration among Industrial, Academic, and Entrepreneurial members of AIMBE’s Industry Council and Government guides science and technology translation from the medical and biological engineering community. Industry Academia Entrepreneur FDA NIH Legislative Branch Executive Branch CDC NSF

6. 1991199219931994199519961997199819992000 Dr. Shu Chien letter in Science Signed into Law Passes Senate Passes House HR 1795 introduced AIMBE & ARRS form Coalition AIMBE Resolution NIH Report: Support for Bioengineering Research NIH Revitalization Bill AIMBE Founded Legislative Failures Timeline

7. NIH Budget vs FDA approvals

8. Leadership and Advocacy for Medical and Biological Engineering Productivity of the Pharmaceutical Industry 10 20 30 40 5060 40 30 20 10 19952000 2005 50 NMEs and Biologics Approved R&D Spending (US$ Billions) R&D Expenditures Approvals Sources: FDA/CDER, PhRMA, PricewaterhouseCoopers Note: R&D spending from non-PhRMA companies not available

9. Leadership and Advocacy for Medical and Biological Engineering Spiraling R&D costs coupled with decreased productivity Demand for safety and post-marketing surveillance Expectation of personalized medicine Reimbursement driven by medical and economic outcomes Proliferation and redistribution of healthcare outcomes information Five Public Policy Issues Affecting Biomedical Engineering

10. Leadership and Advocacy for Medical and Biological Engineering Asia Pacific Rim Success In Technology Industrialization People with strong sense of national purpose Strong investments in education and training Strategy to move rapidly up value chain Effective requirements for training and tech transfer Critical mass in R&D is beginning to be deployed to generate autonomous sources of innovation & growth Government goal is to acquire technological capabilities both to grow and to maintain national autonomy. Focused, Committed, and Willing to Spend Modified from C. Dahlman, Georgetown University

11. Leadership and Advocacy for Medical and Biological Engineering Why is advocacy important?

12. Leadership and Advocacy for Medical and Biological Engineering Why must INFORMED scientists be involved in legislation ? Congress BME

13. Leadership and Advocacy for Medical and Biological Engineering Federal Agencies with AIMBE Links

14. Leadership and Advocacy for Medical and Biological Engineering MBE’s Impact on the U.S. Economy 10.3% growth in net sales in 2008 compared to 5.9% growth in sales for the rest of the economy 2008: health care and social assistance industries increased GDP by 4.6% Total GDP attributed to health care expenditures: $2.3 trillion (2008) MBE-specific exports lead imports, which increases national income

15. Leadership and Advocacy for Medical and Biological Engineering Grand Challenges for Mankind from Nobel Laureate Richard Smalley: 1943-2005 1.ENERGY 2.WATER 3.FOOD 4.ENVIRONMENT 5.POVERTY 6.TERRORISM & WAR 7.DISEASE 8.EDUCATION 9.DEMOCRACY 10.POPULATION 2004 6.5 Billion People 2050 ~ 10 Billion People Bioengineering related

16. Leadership and Advocacy for Medical and Biological Engineering AIMBE American Institute for Medical and Biological Engineering 1701 K St., NW, Suite 510 Washington, DC 20006 Phone: 202-496-9660

17. Leadership and Advocacy for Medical and Biological Engineering The Valley Of Death Valley of Death Existing Commercialization Resources Existing Research Resources Idea Research Fuzzy Front End Product Development Commercialization From: The PDMA ToolBook 1 for New Product Development

18. Leadership and Advocacy for Medical and Biological Engineering “It is not the strongest of the species that survives, nor the most intelligent, but the one most responsive to change.” Charles Darwin (1809-1882) Illustration from The World Is Flat, Thomas L. Friedman, Farrar, Straus & Giroux, publisher Re-engineering Pharmaceutical R&D

19. Leadership and Advocacy for Medical and Biological Engineering The Cycle of Innovation and Translational Research