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Science-Based Assessment: Accelerating Product Development of
Combination Medical Devices The
Roundtable on Biomedical Engineering Materials and Applications (BEMA) is an
activity of the National Research Council (NRC) convened with the objective of
bringing together government officials, industry representatives, academics,
and others to discuss research, development, applications, and regulation of
biomedical materials and devices. On April 22-23, 2003, a workshop titled
“Science-Based Assessment: Accelerating Product Development of Combination
Medical Devices” was held at the National Academies’ Constitution Avenue
building in Washington, D.C., to discuss how science-based assessment can be
used effectively to evaluate biomedical materials and combination devices. This CD
contains the viewgraphs (reproduced as originally supplied) presented by the
speakers at the workshop, with the exception of a small number of slides that
were deleted due to copyright issues, proprietary business issues, and/or
ethical issues; a list of previously published figures for which permission to
reprint was obtained; and the text of the booklet that accompanies this CD, Proceedings from the Workshop on Science-Based
Assessment: Accelerating Product Development of Combination Medical Devices,
which contains abstracts of the presentations given at the workshop. Booklet of Abstracts
from the Science-Based Assessment Workshop Presentations: Setting the Context Use of
Science-Based Assessment in the Development of Standards John T. Watson, National Institutes of Health Setting the Context:
Clinician Renu
Virmani, Armed Forces Institute of Pathology Science-Based Testing:
Balancing Risk and Reward Paul
Citron, Medtronic, Inc. William
Costerton, Testing for
Safety and Efficacy: An Ethicist’s Perspective Leonard
J. Weber, Science-Based Assessment and
Experimental Design Science-Based Testing for
Combination Devices Aric
Science-Based
Testing for Biologics Darin
J. 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, Cell-Matrix Cartilage Implants Cell-Matrix
Cartilage Implants: A Clinician’s Perspective Richard
D. Coutts, 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. Credits for Reprinted Material
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