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

FrontMatter -- Preface -- Contents -- ABSTRACTS -- Setting the Context -- USE OF SCIENCE-BASED ASSESSMENT IN THE DEVELOPMENT OF STANDARDS John T. Watson National Heart, Lung, and Blood Institute National Institutes of Health -- SETTING THE CONTEXT: CLINICIAN Renu Virmani Department of Cardiovascular Pathology Armed Forces Institute of Pathology -- SCIENCE-BASED TESTING: BALANCING RISK AND REWARD Paul Citron Medtronic, Inc. -- BIOFILMS AND MEDICAL DEVICES William Costerton Center for Biofilm Engineering Montana State University -- TESTING FOR SAFETY AND EFFICACY: AN ETHICIST'S PERSPECTIVE Leonard J. Weber University of Detroit Mercy -- Science-Based Assessment and Experimental Design -- SCIENCE-BASED TESTING FOR COMBINATION DEVICES Aric Kaiser Center for Devices and Radiological Health U.S. Food and Drug Administration -- SCIENCE-BASED TESTING FOR BIOLOGICS Darin J. Weber Center for Biologics Evaluation and Research U.S. Food and Drug Administration -- USING DESIGN OF EXPERIMENT METHODS IN THE INNOVATION PROCESS James Rutledge DataVision Statistical Consulting and Training, LLC -- MAKING IT FLY: CURRENT BOEING CERTIFICATION PROCESSES Stephen G. LaRiviere Boeing Commercial Airplanes -- Bone Morphogenetic Proteins and Orthopedic Repair -- THE BASIC SCIENCE OF BONE MORPHOGENETIC PROTEINS AND THE IMPORTANCE OF TEST METHODS Barbara D. Boyan Georgia Institute of Technology -- BONE MORPHOGENETIC PROTEIN COMBINATION PRODUCTS AND ORTHOPEDIC REPAIR Amy J. LaForte Stryker Biotech -- PRODUCT DEVELOPMENT PROCESS FOR A BONE MORPHOGENETIC PROTEIN COMBINATION PRODUCT William McKay Medtronic Sofamor Danek -- Drug-Eluting Stents -- DRUG-ELUTING STENTS: CURRENT CLINICAL STATUS Robert S. Schwartz Minneapolis Heart Institute -- DRUG-ELUTING STENTS: PRECLINICAL TESTING CHALLENGES H. Semih Oktay CardioMed Device Consultants, LLC.

TAXUS: A POLYMER-BASED PACLITAXEL-ELUTING STENT Ronald A. Sahatjian Boston Scientific Corporation -- Cell-Matrix Cartilage Implants -- CELL-MATRIX CARTILAGE IMPLANTS: A CLINICIAN'S PERSPECTIVE Richard D. Coutts University of California at San Diego -- CELL THERAPY FOR CARTILAGE REPAIR: PRESENT AND FUTURE James W. Burns Genzyme -- CELL-MATRIX CARTILAGE IMPLANTS FOR ARTICULAR REPAIR AND REPLACEMENT Anthony Ratcliffe Synthasome, Inc. -- APPENDIXES -- APPENDIX A WORKSHOP AGENDA -- APPENDIX B BIOGRAPHIES OF SPEAKERS AND SESSION CHAIRS.

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Electronic reproduction. Ann Arbor, Michigan : ProQuest Ebook Central, 2024. Available via World Wide Web. Access may be limited to ProQuest Ebook Central affiliated libraries.