Capturing the Full Power of Biomaterials for Military Medicine

Report of a Workshop

Committee on Capturing the Full Power of Biomaterials for Military Medical Needs

Board on Manufacturing and Engineering Design

National Materials Advisory Board

Division on Engineering and Physical Sciences

NATIONAL RESEARCH COUNCIL OF THE NATIONAL ACADEMIES

THE NATIONAL ACADEMIES PRESS
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Capturing the Full Power of Biomaterials for Military Medicine: Report of a Workshop Capturing the Full Power of Biomaterials for Military Medicine Report of a Workshop Committee on Capturing the Full Power of Biomaterials for Military Medical Needs Board on Manufacturing and Engineering Design National Materials Advisory Board Division on Engineering and Physical Sciences NATIONAL RESEARCH COUNCIL OF THE NATIONAL ACADEMIES THE NATIONAL ACADEMIES PRESS Washington, D.C. www.nap.edu

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Capturing the Full Power of Biomaterials for Military Medicine: Report of a Workshop THE NATIONAL ACADEMIES PRESS 500 Fifth Street, N.W. Washington, DC 20001 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. This study was supported by Contract DOD-4996 between the National Academy of Sciences and the Department of Defense. Any opinions, findings, conclusions, or recommendations expressed in this publication are those of the authors and do not necessarily reflect the views of the organizations or agencies that provided support for the project. International Standard Book Number 0-309-09283-3 (POD) Available in limited supply from: National Materials Advisory Board 500 Fifth Street, N.W. Washington, DC 20001 nmab@nas.edu http://www.nas.edu/nmab Additional copies of this report are available from the National Academies Press, 500 Fifth Street, N.W., Lockbox 285, Washington, DC 20055; (800) 624-6242 or (202) 334-3313 (in the Washington metropolitan area); Internet, http://www.nap.edu Copyright 2004 by the National Academy of Sciences. All rights reserved. Printed in the United States of America

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Capturing the Full Power of Biomaterials for Military Medicine: Report of a Workshop THE NATIONAL ACADEMIES Advisers to the Nation on Science, Engineering, and Medicine The National Academy of Sciences is a private, nonprofit, self-perpetuating society of distinguished scholars engaged in scientific and engineering research, dedicated to the furtherance of science and technology and to their use for the general welfare. Upon the authority of the charter granted to it by the Congress in 1863, the Academy has a mandate that requires it to advise the federal government on scientific and technical matters. Dr. Bruce M. Alberts is president of the National Academy of Sciences. The National Academy of Engineering was established in 1964, under the charter of the National Academy of Sciences, as a parallel organization of outstanding engineers. It is autonomous in its administration and in the selection of its members, sharing with the National Academy of Sciences the responsibility for advising the federal government. The National Academy of Engineering also sponsors engineering programs aimed at meeting national needs, encourages education and research, and recognizes the superior achievements of engineers. Dr. Wm. A. Wulf is president of the National Academy of Engineering. The Institute of Medicine was established in 1970 by the National Academy of Sciences to secure the services of eminent members of appropriate professions in the examination of policy matters pertaining to the health of the public. The Institute acts under the responsibility given to the National Academy of Sciences by its congressional charter to be an adviser to the federal government and, upon its own initiative, to identify issues of medical care, research, and education. Dr. Harvey V. Fineberg is president of the Institute of Medicine. The National Research Council was organized by the National Academy of Sciences in 1916 to associate the broad community of science and technology with the Academy's purposes of furthering knowledge and advising the federal government. Functioning in accordance with general policies determined by the Academy, the Council has become the principal operating agency of both the National Academy of Sciences and the National Academy of Engineering in providing services to the government, the public, and the scientific and engineering communities. The Council is administered jointly by both Academies and the Institute of Medicine. Dr. Bruce M. Alberts and Dr. Wm. A. Wulf are chair and vice chair, respectively, of the National Research Council. www.national-academies.org

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Capturing the Full Power of Biomaterials for Military Medicine: Report of a Workshop COMMITTEE ON CAPTURING THE FULL POWER OF BIOMATERIALS FOR MILITARY MEDICAL NEEDS JAMES M. ANDERSON, Case Western Reserve University, Cleveland, Ohio, Chair GARY W. CLEARY, Corium International, Inc., Redwood City, California ERIK A. HENCHAL, U.S. Army Medical Research Institute of Infectious Disease, Ft. Detrick, Maryland JOHN B. HOLCOMB, U.S. Army Institute for Surgical Research, Ft. Sam Houston, Texas JEFFREY O. HOLLINGER, Carnegie Mellon University, Pittsburgh, Pennsylvania ALAN LETTON, Polymerix Corp., Piscataway, New Jersey ARUNA NATHAN, Ethicon, Inc., Somerville, New Jersey JAQUES REIFMAN, U.S. Army Medical Research and Materiel Command, Ft. Detrick, Maryland JAMES SCHEIRER, Robert Wood Johnson Medical School, New Brunswick, New Jersey PETER P. TOLIAS, Ortho-Clinical Diagnostics, a Johnson and Johnson company, Raritan, New Jersey ROBERT H. VANDRE, U.S. Army Medical Research and Materiel Command, Ft. Detrick, Maryland Staff TONI MARECHAUX, Study Director MARTA VORNBROCK, Research Assistant

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Capturing the Full Power of Biomaterials for Military Medicine: Report of a Workshop BOARD ON MANUFACTURING AND ENGINEERING DESIGN PAMELA A. DREW, The Boeing Company, Seattle, Washington, Chair CAROL L.J. ADKINS, Sandia National Laboratories, Albuquerque, New Mexico GREGORY AUNER, Wayne State University, Detroit, Michigan THOMAS W. EAGAR, Massachusetts Institute of Technology, Cambridge ROBERT E. FONTANA, JR., Hitachi Global Storage Technologies, San Jose, California PAUL B. GERMERAAD, Intellectual Assets, Inc., Saratoga, California ROBERT M. HATHAWAY, Oshkosh Truck Corporation, Oshkosh, Wisconsin RICHARD L. KEGG, Milacron, Inc. (retired), Cincinnati, Ohio PRADEEP K. KHOSLA, Carnegie Mellon University, Pittsburgh, Pennsylvania JAY LEE, University of Wisconsin, Milwaukee DIANA L. LONG, Robert C. Byrd Institute for Flexible Manufacturing, South Charleston, West Virginia JAMES MATTICE, Universal Technology Corporation, Dayton, Ohio MANISH MEHTA, National Center for Manufacturing Sciences, Ann Arbor, Michigan ANGELO M. NINIVAGGI, JR., Plexus, Nampa, Idaho JAMES B. O'DWYER, PPG Industries, Allison Park, Pennsylvania HERSCHEL H. REESE, Dow Corning Corporation, Midland, Michigan H.M. REININGA, Rockwell Collins, Cedar Rapids, Iowa LAWRENCE RHOADES, Extrude Hone Corporation, Irwin, Pennsylvania JAMES B. RICE, JR., Massachusetts Institute of Technology, Cambridge ALFONSO VELOSA III, Gartner, Inc., Tucson, Arizona JACK WHITE, Altarum, Ann Arbor, Michigan JOEL SAMUEL YUDKEN, AFL-CIO, Washington, D.C. Staff TONI MARECHAUX, Director

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Capturing the Full Power of Biomaterials for Military Medicine: Report of a Workshop NATIONAL MATERIALS ADVISORY BOARD JULIA M. PHILLIPS, Sandia National Laboratories, Albuquerque, New Mexico, Chair JOHN ALLISON, Ford Research Laboratories, Dearborn, Michigan PAUL BECHER, Oak Ridge National Laboratory, Tennessee BARBARA D. BOYAN, Georgia Institute of Technology, Atlanta DIANNE CHONG, The Boeing Company, St. Louis, Missouri FIONA DOYLE, University of California, Berkeley GARY FISCHMAN, Biomedical Applications of Materials Consultant, Palatine, Illinois KATHARINE G. FRASE, IBM, Hopewell Junction, New York HAMISH L. FRASER, Ohio State University, Columbus JOHN J. GASSNER, U.S. Army Natick Soldier Center, Massachusetts THOMAS S. HARTWICK, TRW (retired), Snohomish, Washington ARTHUR H. HEUER, Case Western Reserve University, Cleveland, Ohio ELIZABETH HOLM, Sandia National Laboratories, Albuquerque, New Mexico FRANK E. KARASZ, University of Massachusetts, Amherst SHEILA F. KIA, General Motors Research and Development Center, Warren, Michigan CONILEE G. KIRKPATRICK, HRL Laboratories, Malibu, California ENRIQUE J. LAVERNIA, University of California, Davis TERRY LOWE, Los Alamos National Laboratory, New Mexico HENRY J. RACK, Clemson University, Clemson, South Carolina LINDA SCHADLER, Rensselaer Polytechnic Institute, Troy, New York JAMES C. SEFERIS, University of Washington, Seattle T.S. SUDARSHAN, Materials Modification, Inc., Fairfax, Virginia JULIA WEERTMAN, Northwestern University, Evanston, Illinois Staff TONI MARECHAUX, Director

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Capturing the Full Power of Biomaterials for Military Medicine: Report of a Workshop Preface This document is the result of a technology planning process undertaken by the new Center for Military Biomaterials Research and the National Academies to begin closing the gap between available biomaterials-related technologies and the military’s needs. The critical first step in this process was the organization of a workshop, held in Iselin, New Jersey, on February 2-4, 2004. To ensure that the directions taken would be aligned with the military’s needs, participants included 15 senior U.S. Army officers and scientists who are experts in the health care needs of warfighters. Participants also included 27 industrial scientists and business leaders who provided the state of the art in commercial biomaterial product developments. The third constituency was the 40 academicians who presented the most recent basic and applied research concepts in the field. The principal goal of the workshop was to explore a comprehensive approach to bringing new biomaterials technologies into service to fulfill the military's medical needs as early as possible. The workshop was intended to involve scientific, clinical, and business leaders from the field of medical biomaterials as knowledge sources and guides interacting with military scientists, clinicians, and program planners. The content was intended to address both the science contributing to biomaterials-based products and the corporate culture of technology companies working in biomaterials areas. The technology development roadmap that is detailed here is the first step for enabling the military to modify and enhance its existing research and development programs in order to take best advantage of academic-based and corporate advances in biomaterials technology. A near-term benefit of implementing this roadmap will be advances in combat casualty care through focused attention on targeted modification of emerging industrial products to increase their suitability for use on the battlefield. Through the implementation of the technology development plan articulated in this roadmap, the Army’s interests will be connected with a comprehensive network of scientific leaders, core competency laboratories, and innovative companies. This report has been reviewed in draft form by individuals chosen for their diverse perspectives and technical expertise, in accordance with procedures approved by the National Research Council's (NRC's) Report Review Committee. The purpose of this independent review is to provide candid and critical comments that will assist the institution in making its published report as sound as possible and to ensure that the report meets institutional standards for objectivity, evidence, and responsiveness to the study charge. The review comments and draft manuscript remain confidential to protect the integrity of the deliberative process. The authors wish to thank the following individuals for their participation in the review of this report: Pat Black, Picatinny Arsenal, U.S. Army Gary Fischman, consultant to the biomaterials industry Michael Helmus, Boston Scientific Corporation Joshua Jacobs, Rush Medical College Julie Swain, consultant to the Food and Drug Administration Ranji Vaidyanathan, Advanced Ceramics Research, Inc.

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Capturing the Full Power of Biomaterials for Military Medicine: Report of a Workshop Although the reviewers listed above have provided many constructive comments and suggestions, they were not asked to endorse the views expressed, nor did they see the final draft of the report before its release. The review of this report was overseen by Robert Frosch of Harvard University. Appointed by the NRC, Dr. Frosch was responsible for making certain that an independent examination of this report was carried out in accordance with institutional procedures and that all review comments were carefully considered. Responsibility for the final content of this report rests entirely with the authoring committee and the institution. The committee also acknowledges the invaluable contributions of Pablo Whaley, Michele Iacoletti, and Shara Williams, interns at the National Academies, in the preparation of this report. Barbara M. Boyan also greatly assisted the work of the committee through her participation in many of the committee's activities as liaison to the National Materials Advisory Board. James M. Anderson, Chair Committee on Capturing the Full Power of Biomaterials for Military Medical Needs

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Capturing the Full Power of Biomaterials for Military Medicine: Report of a Workshop Contents     SUMMARY   1 1   BIOMATERIALS AND THEIR IMPORTANCE TO MILITARY MEDICINE   3      The Process of Biotechnology Adaptation to Military Needs,   4      The Status of Biomaterials Research and Development,   5      Science and Technology Roadmaps—Precedents,   7      Finding a Path Forward,   8 2   BIOMATERIALS TECHNOLOGY ASSESSMENT AND ROADMAPPING   10      Far-Forward Wound Care,   10      Tissue Engineering,   12      Drug Delivery,   18      Physiological Sensors and Diagnostics,   22      Technology Integration,   27 3   ENABLING BIOMATERIALS DEVELOPMENT   28      Evaluation Protocols,   28      Near-term Crosscutting and Enabling Technologies,   29      Nontechnical Considerations,   29      Measures of Success,   30     APPENDIXES         Appendix A  Biographical Sketches of Committee Members   34     Appendix B  Workshop Agenda and Attendees   38     Appendix C  Roadmapping Process   43

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