1. Innovation and the US: A Perspective
Active Clinician Inventor-Entrepreneur
Aaron V. Kaplan, M.D., F.A.C.C. Professor of Medicine (Cardiology)
Dartmouth Medical School
Dartmouth-Hitchcock Medical Center
7 Feb: 8:35 – 8:45

2. Disclosures Founder and Director Grant Support Off-Label Use:
Tryton Medical, Inc.
Grant Support
Medtronic, ABT Vascular, Boston Scientific, Edwards Lifesciences
Off-Label Use:
This talk will be limited to off-label
Interventional Cardiologist 2011: >2 meters of stent delivered
AV Kaplan MD: Perspective

3. Agenda The Worst/?Best of Times Examining the Causes
What does the future look like?
AV Kaplan MD: Perspective

4. Medical Device Start-up Perspective
Uncertainty in U.S.
Regulatory Reform
Health Care Reform
Efficient Congress
DES undersiege
Financial Crisis
Large Co.’s In Transition
VC Funding Scarce
Tropical Storm Irene
August 2011
AV Kaplan MD: Perspective

5. Uncertainty in U.S. Market
Regulatory Reform
510K
IOM Report
Re-examination ongoing
PMA
Health Care Reform
DES Market In decline
AV Kaplan MD: Perspective

6. Large Strategic Companies: In Transition
Medtronic: New CEO-Omar Ishrak
Boston Scientific: New-CEO Michael Mahoney
Abbott Labs: Restructuring
Cordis/JnJ: Exiting Coronary Stents
AV Kaplan MD: Perspective

7. Venture Capital: ‘Consolidating’
VC Firms
Three Arch Partners Exiting
Versant Reducing Raise
Morganthaler-ATV Merge
Focus on Current Investments
PricewaterhouseCoopers (PwC)
2 Feb 2012-MD+DI
AV Kaplan MD: Perspective

8. Medical Device Success: Cause for Optimism Driven by meeting unmet clinical needs
AV Kaplan MD: Perspective

9. Medical Device Success: Cause for Optimism Driven by meeting unmet clinical needs
AV Kaplan MD: Perspective

10. Outlook Moving Forward
FDA Reform: Moving Forward?
Large Companies: New Leadership/Structure in place
Financial Markets?
New Innovation success
addressing unmet needs
In a changing globally focused environment
AV Kaplan MD: Perspective

11. AV Kaplan MD: Early Device Evaluation
Thank You
AV Kaplan MD: Early Device Evaluation