1. Four practical approaches to managing a more effective device trial Blair Keagy, MD, CEO, Medical Products Analytics David Levin, Vice President, Clinipace June 10, 2009

2. Sponsors Commercial Feasibility Analysis | Clinical Development Digital Clinical Research Organization (dCRO)

6. FDA approval doesn’t guarantee reimbursement Pre-IDE meeting is very important

7. {Great} reimbursement ideas from the government Prospective Payment System Inpatient Outpatient

9. 2,800 Level II HCPCS Codes A Codes Miscellaneous services and supplies B Codes Enteral or parenteral treatment C Codes Drugs and biologics (pass-through) D Codes Dental codes E Codes Durable medical equipment H Codes Alcohol and drug abuse treatment J Codes Drugs that cannot be self-administered Q Codes Biologics such as dermagraft

13. AHRQ Analysis of Aortic Endografts

14. Hospitals make purchasing decisions

17. Technology is more efficient, but requires more planning Technology-Driven Trials [1997 - ] Design Conduct Analysis Low High Cost 30% Reduction

18. Successful technology deployment requires focus on process Management Operations Strategy & Planning Design Enrollment Data Capture/Mgt Analysis Regulatory Modeling/Simulation Site/Patient Recruitment Submission Protocol Design Electronic Data Capture [EDC] IVRS PRO Study/Project Management Reporting / Analytics CDM Clinical Trial Portfolio Management IIR / Grants Management

19. Visibility is king Management Operations Strategy & Planning Start - Up Conduct Close - Out Project Milestones Queries Patient Accrual CRF Status Monitoring Activities

20. Questions & Answers Commercial Feasibility Analysis | Clinical Development Blair Keagy, MD [email_address] www.mpanalytics.com Digital Clinical Research Organization (dCRO) David Levin [email_address] www.clinipace.com