APPENDIXES



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Proceedings from the Workshop on Science-Based Assessment: Accelerating Product Development of Combination Medical Devices APPENDIXES

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Proceedings from the Workshop on Science-Based Assessment: Accelerating Product Development of Combination Medical Devices APPENDIX A WORKSHOP AGENDA Tuesday, April 22, 2003 7:45 AM Continental Breakfast 8:30 AM Welcome and Introduction Robert Nerem, BEMA Chair 8:35 AM Setting the Context: Scientist/Engineer John Watson, NIH 8:55 AM Setting the Context: Clinician Renu Virmani, Armed Forces Institute of Pathology 9:15 AM Setting the Context: Risk/Benefit Ratio Paul Citron, Medtronic, Inc. 9:35 AM Discussion All 10:00 AM Break 10:30 AM Science-Based Testing for Devices Aric Kaiser, FDA 10:45 AM Science-Based Testing for Biologics Darin Weber, FDA 11:00 AM Experimental Design Technologies Jim Rutledge, DataVision 11:30 AM Discussion All 12 NOON Lunch 1:00 PM Scientific and Process Design Steve LaRiviere, Boeing 1:30 PM Discussion All 1:45 PM BMP-Orthopedic Repair Session Chair: Joshua Jacobs, Rush Medical College 1:45 PM Overview of Science and Test Methods Barbara Boyan, Georgia Institute of Technology

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Proceedings from the Workshop on Science-Based Assessment: Accelerating Product Development of Combination Medical Devices 2:05 PM Industry Presentation Amy LaForte, Stryker Biotech 2:25 PM Industry Presentation Bill McKay, Medtronic Sofamor Danek 2:45 PM Discussion All 3:15 PM Break 3:45 PM Drug-Eluting Stents Session Chair: Terry Woods, FDA 3:45 PM Clinician Presentation Robert Schwartz, Minneapolis Heart Institute 4:05 PM Industry Presentation Semih Oktay, CardioMed 4:25 PM Industry Presentation Ronald Sahatjian, Boston Scientific Corporation 4:45 PM Discussion All 5:15 PM Break 5:30 PM Biofilms and Medical Devices William Costerton, Montana State University 6:15 PM Reception Great Hall, NAS Building 7:15 PM Adjourn Wednesday, April 23, 2003 7:45 AM Continental Breakfast All 8:30 AM Ethics Presentation Leonard Weber, University of Detroit 9:00 AM Cell-Matrix Cartilage Implants Session Chair: Crystal Cunanan, Edwards Lifesciences

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Proceedings from the Workshop on Science-Based Assessment: Accelerating Product Development of Combination Medical Devices 9:00 AM Clinician Presentation Richard Coutts, University of California at San Diego 9:20 AM Industry Presentation Jim Burns, Genzyme 9:40 AM Industry Presentation Anthony Ratcliffe, Synthasome, Inc. 10:00 AM Discussion All 10:30 AM Break 11:00 AM General Discussion All 12 NOON Adjourn