Proceedings from the workshop on science-based assessment : accelerating product development of combination medical devices / Bonnie A. Scarborough, Editor.

Format:

Book

Government document

Contributor:

Scarborough, Bonnie A.

National Research Council (U.S.). Roundtable on Biomedical Engineering.

Language:

English

Subjects (All):

Medical instruments and apparatus.

Medicine--Research.

Medicine.

Physical Description:

1 online resource (48 p.)

Edition:

1st ed.

Place of Publication:

Washington, D.C. : The Academy, 2004.

Language Note:

English

Contents:

""Front Matter""; ""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""

Notes:

Description based upon print version of record.

ISBN:

0-309-53964-1

OCLC:

560257212