PROCEEDINGS FROM THE WORKSHOP ON BIOMEDICAL MATERIALS AT THE EDGE
Challenges in the Convergence of Technologies
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NOTICE: The project that is the subject of this report was approved by the Governing Board of the National Research Council, whose members are drawn from the councils of the National Academy of Sciences, the National Academy of Engineering, and the Institute of Medicine. The members of the committee responsible for the report were chosen for their special competences and with regard for appropriate balance.
Support for this project was provided by Alfred University, American Academy of Orthopaedic Surgeons, Bose Corporation, Boston Scientific Corporation, California State University Program for Education and Research in Biotechnology, Center for Integration of Medicine and Innovative Technology, DuPont Bio-Based Materials, Edwards Lifesciences Corporation, Genzyme Corporation, Medtronic, Inc., National Institutes of Health, National Science Foundation, University of Florida, and U.S. Food and Drug Administration. Any opinions, findings, conclusions, or recommendations expressed in this publication are those of the author(s) and do not necessarily reflect the views of the organizations or agencies that provided support for the project.
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THE NATIONAL ACADEMIES
Advisers to the Nation on Science, Engineering, and Medicine
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ROUNDTABLE ON BIOMEDICAL ENGINEERING MATERIALS AND APPLICATIONS
BUDDY D. RATNER, Chair,
University of Washington
CRYSTAL M. CUNANAN, Vice Chair,
ReVision Optics, Lake Forest, California
PAUL CITRON, NAE Liaison,
Medtronic, Inc. (retired), Minneapolis, Minnesota
SCOTT E. ANDERSON,
Bose Corporation, Minnetonka, Minnesota
REBECCA BERGMAN,
Medtronic, Inc., Minneapolis, Minnesota
JAMES W. BURNS,
Genzyme Corporation, Cambridge, Massachusetts
HENGCHU CAO,
Edwards Lifesciences Corporation, Irvine, California
A. STEPHEN DAHMS,
California State University Program for Education and Research in Biotechnology, San Diego
ROBERT R. DORSCH,
DuPont Bio-Based Materials, Wilmington, Delaware
ALAN GOLDSTEIN,
Alfred University, Alfred, New York
JOSHUA J. JACOBS,
American Academy of Orthopaedic Surgeons, Rosemont, Illinois
WINFRED M. PHILLIPS,
University of Florida, Gainesville
SOHI RASTEGAR,
National Science Foundation, Arlington, Virginia
JONATHAN JAY ROSEN,
Center for Integration of Medicine and Innovative Technology, Boston, Massachusetts
RONALD SAHATJIAN,
Boston Scientific Corporation, Natick, Massachusetts
RICHARD E. SWAJA,
National Institute of Biomedical Imaging and Bioengineering, Bethesda, Maryland
TERRY O. WOODS,
U.S. Food and Drug Administration, Rockville, Maryland
NRC Staff
BONNIE A. SCARBOROUGH, Program Officer
JAMIE L. OSTROHA, Research Associate
TERI THOROWGOOD, Administrative Coordinator
COLLEEN BRENNAN, Program Associate
LAURA TÓTH, Senior Project Assistant
NATIONAL MATERIALS ADVISORY BOARD
KATHARINE G. FRASE, Chair,
IBM, Hopewell Junction, New York
LYLE H. SCHWARTZ, Vice Chair, Consultant,
Chevy Chase, Maryland
JOHN E. ALLISON,
Ford Motor Company, Dearborn, Michigan
PAUL F. BECHER,
Oak Ridge National Laboratory, Oak Ridge, Tennessee
CHERYL R. BLANCHARD,
Zimmer, Inc., Warsaw, Indiana
EVERETT E. BLOOM,
Oak Ridge National Laboratory (retired), Oak Ridge, Tennessee
BARBARA D. BOYAN,
Georgia Institute of Technology, Atlanta
L. CATHERINE BRINSON,
Northwestern University, Evanston, Illinois
DIANNE CHONG,
The Boeing Company, Bellevue, Washington
PAUL CITRON,
Medtronic, Inc. (retired), Minneapolis, Minnesota
FIONA DOYLE,
University of California, Berkeley
SOSSINA M. HAILE,
California Institute of Technology, Pasadena
CAROL A. HANDWERKER,
Purdue University, West Lafayette, Indiana
ELIZABETH A. HOLM,
Sandia National Laboratories, Albuquerque, New Mexico
ANDREW T. HUNT,
nGimat Company, Atlanta, Georgia
DAVID W. JOHNSON, JR.,
Stevens Institute of Technology, Bedminster, New Jersey
FRANK E. KARASZ,
University of Massachusetts, Amherst
CONILEE G. KIRKPATRICK,
HRL Laboratories, Malibu, California
TERRY C. LOWE,
Los Alamos National Laboratory, Los Alamos, New Mexico
KENNETH H. SANDHAGE,
Georgia Institute of Technology, Atlanta
LINDA S. SCHADLER,
Rensselaer Polytechnic Institute, Troy, New York
ROBERT E. SCHAFRIK,
GE Aircraft Engines, Cincinnati, Ohio
JAMES C. SEFERIS,
University of Washington, Seattle
SHARON L. SMITH,
Lockheed Martin Corporation, Bethesda, Maryland
NRC Staff
GARY FISCHMAN, Director
DENNIS CHAMOT, Acting Director (October 2004 to March 2005)
TONI MARÉCHAUX, Director (to October 2004)
Preface
Recent advances in biomedical materials technology, such as the use of stem cells as biomaterials, the development of biomolecular materials composites, and supramolecular/nanoscale biomaterials engineering and design, hold the promise of a revolution in clinical medicine. Potential applications of these technologies include treatments for cancer, AIDS, congenital diseases, orthopedic problems, and cardiovascular disease. Despite their promise for clinical applications, however, there are many barriers to the development, manufacture, regulatory approval, and commercialization of these materials.
ROUNDTABLE ON BIOMEDICAL ENGINEERING MATERIALS AND APPLICATIONS
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. BEMA provides a forum for participants to identify opportunities for applying engineering principles to create and improve the clinical performance of medically useful materials and devices. In addition, the roundtable discusses strategies for overcoming the technical, legal, and cultural obstacles that impede the transition of new materials and devices to clinical application. BEMA achieves these objectives by three means:
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Providing a neutral setting for the exchange of information about issues related to biomaterials science, research, and practice;
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Identifying and discussing priority issues in the general area of biomaterials and their application in the development, manufacture, and use of medical devices; and
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Conducting problem-solving and issue-identification activities such as workshops that address these issues in greater depth.
WORKSHOP ON BIOMEDICAL MATERIALS AT THE EDGE
A workshop entitled “Biomedical Materials at the Edge: Challenges in the
Convergence of Technologies” was held on September 30 and October 1, 2004, at the National Academies in Washington, D.C. (the theme was identified in BEMA meetings held earlier that year). The purpose of the workshop was to discuss breakthrough biomedical materials technologies that could be used in the development of future treatments and the manufacture of future medical devices. To facilitate discussion, the workshop was organized into sessions on three emerging technologies: stem cells as biomaterials of the future, biomolecular materials composites, and supramolecular/nanoscale biomaterials engineering and design. Each session, and the resulting discussion, is summarized in this report, and abstracts of the individual presentations are offered. The agenda for the workshop is included as Appendix A and biographical sketches of the speakers are given in Appendix B. The viewgraphs presented by the speakers are reproduced, as originally supplied, on the accompanying CD-ROM.
NRC roundtables are established solely to provide open forums for discussion of emerging issues. They are prohibited by NRC policy from producing conclusions and recommendations or from offering advice to government agencies. As such, the primary purpose of this workshop was to educate the individuals who attended so that they might take this information back to their organizations and use it in their daily planning and decision making. This proceedings therefore serves primarily as a guide for those participants to remembering the content of the discussions. The abstracts of the workshop presentations and the unedited viewgraphs represent the viewpoints of the presenters only.
ACKNOWLEDGMENTS
The BEMA roundtable has no head and no foot. While prohibited from providing advice or recommendations, the BEMA roundtable was formed so that its members might learn, analyze, freely exchange ideas, identify challenges, suggest the need for more formal NRC meetings and publications, and publish workshop proceedings such as these. On behalf of BEMA, I would like to thank the speakers for their informative presentations, the session chairs for keeping the discussions focused and on time, and the workshop participants for taking the time to join with BEMA members for a day and a half of lively discussion.
I would also like to thank the BEMA members who volunteered their time to organize this workshop, especially Jim Burns, Alan Goldstein, Josh Jacobs, and Sohi Rastegar. Crystal Cunanan deserves special recognition for her role as program chair. She and Bonnie Scarborough did a terrific job of putting together the workshop summary. In addition, I would like to thank
the following NRC staff members for their assistance and support in making this workshop and proceedings possible: Jamie Ostroha, Colleen Brennan, Teri Thorowgood, and Laura Tóth.
Thanks are extended to the following individuals, who reviewed the contents of this proceedings volume: Ray A. Gsell, Zimmer, Inc.; Jack E. Lemons, University of Alabama; Martha S. Lundberg, National Heart, Lung, and Blood Institute; and Scott G. McNamee, U.S. Food and Drug Administration. The review of this proceedings was overseen by Howard Freese, Allvac Incorporated. Appointed by the National Research Council, he was responsible for making certain that an independent examination of this proceedings volume was carried out in accordance with institutional procedures and that all review comments were carefully considered. The individual presenters and the summary authors are responsible for the substance of this proceedings.
Buddy D. Ratner, Chair
Roundtable on Biomedical Engineering Materials and Applications
Contents
National Nanotechnology Initiative, |
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Nanotechnology and Biomaterials: Venture Capital Investment and Emerging Business Issues, |
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Globalization: Challenges for Trade Organizations, |
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Engineering Biocompatible Nanostructures, |
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Bioconjugated Nanotubes for Biosensing and Bioseparations, |
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Metal Nanoshells: Diagnostic and Therapeutic Applications of Nanotechnology, |
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