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Improving Medical Implant Performance Through 
Retrieval Information: Challenges and Opportunities

National Institutes of Health
NIH Technology Assessment Conference Summary
January 10-12, 2000

Conference artwork with a stylized human figure with dots depicting locations of medical implants.


Due to the cumulative nature of medical research, some of the information in this statement is likely to be out of date. For more current information on this and other health topics, please visit MedlinePlus, a service of the U.S. National Library of Medicine, National Institutes of Health.

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Abstract

Objective: To provide researchers, health care providers, patients, and the general public with a responsible assessment of the opportunities for and challenges of developing a framework for independent research on explanted medical implants. For the purpose of this conference, medical implants are defined as devices that have a minimum lifespan of three months; that penetrate and have a physiologic interaction with living tissue; and that can be retrieved.

Participants: A non-Federal, nonadvocate, 14-member panel representing the fields of health policy, engineering, internal medicine, materials science, cardiology, pathology, law, theology, pharmacy, statistics, women's health and the public. In addition, 31 experts from these same fields presented data to the panel and a conference audience of 215.

Evidence: The literature was searched through Medline, and an extensive bibliography of references was provided to the panel and the conference audience. Experts prepared abstracts with relevant citations from the literature. Scientific evidence was given precedence over clinical anecdotal experience.

Consensus Process: The panel, answering predefined questions, developed their conclusions based on the scientific evidence presented in open forum and the scientific literature. The panel composed a draft statement, which was read in its entirety and circulated to the experts and the audience for comment. Thereafter, the panel resolved conflicting recommendations and released a revised statement at the end of the conference. The panel finalized the revisions within a few weeks after the conference. The draft statement was made available on the World Wide Web immediately following its release at the conference and was updated with the panel's final revisions.

Introduction

Medical implant devices (MIDs) have been used widely for more than 40 years, and it is estimated that 8 percent to 10 percent of Americans (20-25 million people) currently have such a device. Although implant devices have produced great benefits, it must be recognized that all MIDs are subject to failure. They are in a continual state of development to improve their performance and extend their useful lifespan. Long-term data on the behavior of implanted devices and host response are essential inputs to the development process, yet there are no systematic programs for the retrieval and analysis of implants in this country. Independent data banks do exist. The contributions to implant design provided by retrieval and analysis will benefit patients through improvements in implant performance.

For the purpose of this conference, implants are defined as having a minimum lifespan of 3 months, as penetrating living tissue, as having a physiologic interaction, and as being retrievable.

A number of barriers exist to the establishment of an implant retrieval program. Major impediments are the costs associated with such a program and the fear of litigation affecting manufacturers, hospitals, physicians, and investigators.

This conference is therefore timely and important. The panel addressed the following key questions:

  1. What are the patient, health care provider, and societal expectations of the lifetime costs, risks, and benefits of medical implants?
  2. What are the legal, ethical, religious, cultural, public policy, and economic barriers to implant retrieval and reporting, and how can they be overcome?
  3. What information is necessary to evaluate and improve implant and material performance and device design?
  4. What can the role of information data systems be in educating the public, medical community, and policymakers about medical implants and retrieval?
  5. What future research and institutional support is necessary to ensure continuing advances in implantable devices?

Responses to these questions by an independent, non-Federal technology assessment panel are based on the study of pertinent written material from the medical/scientific literature and on 11/2 days of presentations by experts and audience discussion.

The primary sponsors of this conference were the National Heart, Lung, and Blood Institute (NHLBI) and the NIH Office of Medical Applications of Research (OMAR). Additional sponsors were the NIH Biomaterials and Medical Implant Science Coordinating Committee (which represents all of the NIH Institutes and Centers), the National Institute of Arthritis and Musculoskeletal and Skin Diseases, the National Institute of Dental and Craniofacial Research, the National Institute of Neurological Disorders and Stroke, the National Library of Medicine, and the National Institute of Standards and Technology.

1. What are the patient, health care provider, and societal expectations of the lifetime costs, risks, and benefits of medical implants?

Costs

The type or presence of health insurance and coverage provided likely modifies patient expectations of costs of implants. For life-saving devices that are not experimental or newly introduced, a patient should expect insurance coverage. Patient expectations of implant costs should include medications needed, if any, as well as coverage for explantation or revision, if necessary. Patients should not have to encounter unanticipated costs of revision, complications, or prescription drugs.

Health care provider expectations of the costs of medical implants are difficult to assess because many health care providers are insulated from costs of devices. However, hospitals or health care organizations may restrict the use of devices to certain manufacturers in order to contain costs, and physicians may feel constrained to choose less expensive devices if reimbursements are constant for the operative procedure.

Societal expectations of the costs of medical implants should conform to those of similar or alternative treatments, if available, and should factor in benefits provided by the implant, including recipients' increased productivity.

Benefits

Although quite variable, patient expectations of the benefits of medical implants are often unduly high, for a variety of reasons. Information presented to patients may be poorly understood, misleading, or inadequate. Expectations of medical implants vary according to the type of implant. Although there are gray areas and exceptions in individual cases, implants can be broadly categorized as form enhancing, life enhancing, or life saving. Expectations of the benefits of life-saving implants may be unduly high; for example, patients' perceptions of the benefits of artificial hearts and ventricular assist devices appear to exceed those of alternative therapies such as cardiac allografts (transplants). In general, patient expectations of life-enhancing or life-saving devices include survival, restoration of active lifestyle (function, quality of life, pain relief), gainful employment, and access to replacing the implant if necessary. The last expectation would also apply to form-enhancing implants.

Health care provider expectations of the benefits of medical implants are, and should be, similar to those of the patient. However, the patient's evaluation of the performance of an implant is different from that of the physician. For example, a patient may be satisfied by a hip replacement because of resolution of pain and enhanced range of motion. However, the physician may note x-ray abnormalities suggestive of imminent failure and not be satisfied. Whereas the patient will expect benefits to persist for his or her lifetime, the physician may be satisfied with immediate relief of the patient's disorder. Therefore, monitoring of implants needs to take into consideration perceptions of both physician and patient.

Risks

As with the expectations of costs and benefits, expectations of risks of implants are greatly affected by the type of implant. For life-enhancing and especially form-enhancing implants, patients and physicians expect no catastrophic risks. For life-saving devices, patients and physicians understand there are risks; expectations are significantly affected by pre-operative education and the nature of the informed consent. It is also likely that cultural, socioeconomic, and ethnic considerations affect expectations of medical implants, but there are few data to support this contention. Health care provider expectations of risks of medical implants may, as in the case of benefits, be somewhat more short term than those of the patient. However, with optimal patient-provider communication and informed consent, the expectations of the physician and patient should become closer.

2. What are the legal, ethical, religious, cultural, public policy, and economic barriers to implant retrieval and reporting, and how can they be overcome?

Implant retrieval and analysis is currently conducted on an ad hoc basis by implant manufacturers and academic health care institutions. Such analyses may provide the best opportunity to understand the long-term consequences of implantation and provide input to the evolutionary development of future implant technology.

A number of obstacles inhibit such studies, including limited availability of implants, concerns about tort liability, and costs. But inasmuch as studies are already being done, it is clear that these obstacles are not insurmountable. Why implant retrieval and analysis does not occur on a more widespread and routine basis is a matter that requires attention.

Legal

Commentators have identified a number of legal obstacles or disincentives to implant retrieval and analysis. First, uncertainties exist about who owns an implanted device. As with other questions about the bundle of rights protected by property law, a number of parties may assert an interest in a device, and the resolution of disputes about ownership will depend to some extent on the terms of contractual agreements among these parties. Ultimately, however, the issue has less to do with ownership, as such, than with custody and control of potentially relevant evidence.

If litigation is pending or reasonably can be anticipated, persons must preserve potentially relevant evidence so that parties not in possession may view it and, subject to court-ordered restrictions, engage in destructive testing. Even if litigation is not pending, entities in possession of an explant may avoid engaging in retrieval analysis because of fear of the prospect of subsequent litigation and charges of intentional destruction of evidence. The possibility of future litigation may also discourage attempts to retrieve devices in the first place. Because of the inapplicability of the "self-critical analysis" privilege, potential defendants will hesitate to generate internal documentation of implant performance that plaintiffs may then request during discovery and introduce as evidence. Finally, independent researchers may hesitate to undertake implant retrieval and analysis either because litigants may subpoena their work or manufacturers may threaten product disparagement lawsuits if unflattering results are published.

Several commentators have asserted that tort litigation stifles technological innovation and continues to cause unavailability of certain raw materials, and it may well create disincentives to more widespread implant retrieval and analysis. This subject deserves further research and possibly legislative attention. Notwithstanding the potential enormity of such an undertaking, health care practitioners and researchers have an important opportunity to influence some of these legal disincentives by defining the standard of care in a manner that may facilitate medical device research and improvement. Health care professionals already have an ethical obligation to report adverse events and device malfunctions, and explanting surgeons and facilities at least should not inhibit efforts at retrieval analysis.

Finally, regulatory requirements may impede or discourage implant retrieval and analysis. Although the FDA could mandate that manufacturers conduct such research as a condition of premarket approval or as an element of a postmarket surveillance order, it has exercised such authority only rarely. The FDA's quality system and medical device reporting requirements may negatively influence manufacturers' decisions about whether to conduct such research voluntarily. If reported to the FDA, manufacturers may fear that proprietary retrieval information may be disclosed to the public if it does not qualify as trade secret or confidential commercial data. On the other hand, the expansion of Federal and State privacy protections makes it difficult for independent researchers to link information about retrieved devices to the health records of patients.

Religious

Among Roman Catholics, mainstream Protestants, and Orthodox Christians, there are no magisterial or in principle objections to retrieval of medical devices from living or dead human bodies for purposes of analysis and assessment. However, some Christian sects strenuously oppose any mutilation of the body, either before or after death. If pre- or post-mortem retrieval procedures are done in a timely manner (i.e., anticipating a prompt burial) and if the wound is sutured and the corpse treated with respect as though it were a living patient, liberal Jews-mostly Reform, Reconstructionist, and Conservative-have no objection on the principle of "pikkuah nefesh," the obligation to save life or lives. Such an act is a "mitzvah." Some Orthodox Jews and traditionalists, as a non-negotiable halachic norm, object to any mutilation of a corpse, including autopsy and embalming. Other religious groups have similar diversity of opinion.

Economic

There are clear and impressive economic barriers to retrieval of devices for analysis and assessment. Not least among these are costs associated with the project itself, and despite cost variables for different devices, financing is problematic.

Academic health care institutions' submissions of study proposals to funding agencies are not typically funded. Joint industry-academic efforts have been undertaken, but these are the exception rather than the rule. The ability of manufacturers to conduct their own studies relates directly to their size and in-house capability; the reality is that most of the medical device industry consists of small entrepreneurial companies without such a capability. There currently exists no industrywide "superfund" to support implant retrieval and analysis, but even if it were feasible to establish such a fund, these monies would not likely be sufficient to secure retrieval and analysis of every implanted device.

Likewise, funding for implant registries is difficult to obtain and sustain. Institutions and professional societies have supported limited patient registries/databases, and manufacturers have established patient registries both voluntarily and when asked or ordered to do so by regulatory agencies. Moreover, third-party registries have been attempted. Provisioning a universal data bank-with components for tracking and adequate representation of device and patient experience over time-appears to be prohibitively expensive at this time.

Analysis and assessment of medical implants currently poses significant liability risks for physicians and hospitals as well as manufacturers, and fear of costly litigation is a major barrier to retrieval. Exemption of some life-saving devices, as innovative or experimental therapies, from risk of liability would diminish that anxiety. Further, a publicly funded shared cost-charged, for example, in part to basic research and in part to applied technology-could facilitate a retrieval and analysis project. We need to understand why, in other sectors, technology reduces cost and increases market availability.

Economic factors can result in a lack of accessibility to some high-tech tertiary interventions by substantial segments of American citizens, particularly the poor and ethnic minorities. As a result, the findings from an implant retrieval and analysis program may not be applicable to underrepresented groups.

There is a strong sense that academic health care institutions would conduct more and varied studies, either alone or in concert with Federal laboratories and/or manufacturers, were funding available. A continuation of an ad hoc approach, however, is not a viable means to meet the need for a coordinated implant retrieval and analysis system. Not only is funding needed, but that funding should be managed as part of an NIH/FDA joint program to develop uniform functional, quality-of-life, and analytical measures that would ensure intercomparability and sharing of data. Such an effort should also be in harmony with efforts globally.

An unexplored opportunity for funding is the third-party payer. As health maintenance organizations and other payers strive to contain costs while ensuring quality of health care, it becomes critical to conduct outcomes research. Implant retrieval and analysis, when coupled with information on the health status of patients at the time of explant, offers an opportunity to gather data in support of the cost-effectiveness of various implant technologies. The availability of chips that can monitor device performance, in ways similar to an airplane's "black box," suggests the possibility of obtaining implant performance data at a feasible cost.

3. What information is necessary to evaluate and improve implant and material performance and device design?

Technology progresses by facing its failures and learning from its successes. The goal of device research and development is to improve patient care through improvement of implants. A fundamental objective is to understand successful implants and assess failures through retrieval analysis. In addition, monitoring device performance in vivo may permit early corrective therapy. Explants will require specific analysis by qualified laboratories using appropriate protocols.

The information required to evaluate and improve implants is a combination of clinical data and device retrieval analysis.

At the Time of Implantation

The information should include (1) patient demographics, (2) primary diagnosis, (3) comorbidities, (4) patient-derived functional status if appropriate, and (5) date, location, surgeon, and specific implant data.

Following Implantation

The clinical status of the patient should be monitored by functional data, imaging, and internal monitoring via telemetry as appropriate.

At the Time of Explantation

Information needed at this time includes (1) patient demographics, (2) date, location, surgeon, and specific implant data, (3) clinical functional and imaging data acquired before explantation, (4) implant interrogation via internal monitoring/telemetry systems, (5) circumstances of explantation device failure or post-mortem retrieval of a well-functioning implant, and (6) device-specific information.

Explant Analysis

The explant analysis should begin with local pathological review followed by expert analysis by a qualified laboratory (manufacturer or independent). The appropriate studies of the implant should be done according to protocols, based on existing American Society for Testing and Materials (ASTM) and International Organization for Standardization (ISO) standards, where applicable, including biocompatability as judged by local and systemic (when available) tissue reaction.

4. What can the role of information data systems be in educating the public, medical community, and policymakers about medical implants and retrieval?

Many people understand that MIDs provide improvements in quality of life for their recipients. Less widely recognized is the importance of the retrieval and analysis of a medical implant when it has failed or when it is no longer useful. Information gained from such retrieval and analysis provides insight into the strengths and weaknesses of the design of the device and enables improvement in future product design. Moreover, for those devices that have serious design flaws, retrieval and examination can yield insight into how to monitor patients who currently have the implanted device.

Education about retrieval and analysis for the various constituencies should take different forms because the needs of the constituencies differ. Patients and families must understand the purpose of retrieval to motivate their willingness to allow retrieval and analysis of the device. Policymakers must learn about retrieval to help them formulate wise policy. The medical community, that is, practitioners, administrators, and medical societies, should be able to use education about retrieval to help them treat current and future patients more effectively. Finally, device manufacturers will find the information gained from the study of explanted devices useful in the improvement of the next generation of devices.

Patients need to understand their disease and the options they have in choosing whether to have an implantable device. To make informed choices, patients must receive interpretable information that will allow them to develop reasonable expectations about the immediate, short-term, and long-term risks, the functional benefits arising from the device, and the lifespan of the device. The process allowing a patient to give a truly informed consent should be complete and clear. A primer describing the function of the device and possible failure modes will help patients understand the experience they are about to undergo. Finally, part of the educational process should be an explanation of retrieval of the product if it fails or if the patient dies before it fails. A fully informed patient who appreciates the benefits and risks of the device may be more willing to allow retrieval than a person who has unreasonably optimistic expectations about lifelong success.

Policymakers must have all the information given to patients, as well as other data. They must understand that innovation is complex. They must appreciate the importance of analysis of explants, the economic impact of systems of retrieval and analysis, and the barriers to retrieval and analysis. Detailed, specific case histories of past failures of devices will help them understand how to establish policy.

The medical community should have all the information given to patients and policymakers, but they need still more information. Specifically, practicing physicians must decide which of the competing devices to use in a specific patient. To make that decision, they need comparative information about device models. Data on performance, with appropriate denominators, should help inform their choices. An educational program for physicians should stress that part of the standard of care should include retrieval of devices and return of retrieved devices to a laboratory along with the relevant medical history of the patient from whom the device was retrieved. A Web-based collaborative support system could facilitate and promote multi-site collaborative research and analysis.

Manufacturers, in their quest for improved devices, should have all the information available to the other stakeholders, in addition to their own proprietary information.

An effective educational program should be multifaceted. Books and pamphlets, brochures, packet inserts, and videos all should be available, each written at a level of sophistication appropriate to the audience for which it is designed.

In addition, a Web-based educational forum would allow rapid access to relevant data. The Web has a number of excellent medical sites with scientifically up-to-date information accessible both to professionals and the lay public. A Web site dealing with devices, modeled on one of these, would provide useful information. The portal page should have five themes. First, it should have a link to a section that educates the user about the fact that things in general eventually fail. This introduction should serve as a reminder that any medical device has a finite life. Second, it should link to a discussion of risk. This section should help patients understand how to assess the level of risk they personally are willing to assume. Third, it should link to a discussion of informed consent. Fourth, it should link to a section that describes the importance of retrieval and analysis. This part of the Web site should point out that the altruism of previous recipients of devices has contributed to the development of currently available devices, and it should encourage implant recipients to think about allowing retrieval when their devices are no longer of use to them.

The fifth and most extensive part of the portal page should be a set of links to more specialized Web sites that contain information about specific devices. The lay user will choose a body part (for example, a hip, an eye, a knee), which will link to a page containing all the patient-relevant information described earlier (for example, descriptions of the disease, the devices, and their lifespans). This page will also link to other relevant sites. Professional users may select by body system; their choices will include Web sites with more technical information.

Maintaining and updating the Web site will require considerable effort. The group responsible for the main site will need to provide critical appraisals of the linked sites so that the user will not be misled by raw data and biased selection. Cooperation between the FDA and NIH on developing and maintaining the Web site would be ideal.

Finally, an ongoing educational program should include support groups (both real and virtual), computer chat rooms, and list servers that allow patients and professionals to learn about the various devices.

5. What future research and institutional support is necessary to ensure continuing advances in implantable devices?

The NIH should develop an aggressive research and development program on sensors and other telemetry devices for early detection of potential problems.

The NIH has an exceptional opportunity to improve the care of patients with implants by providing support for state-of-the-art core laboratories for analysis of retrieved implants. This analysis would be done in full collaboration with and through participation of the medical specialty societies and medical device industry, which should identify areas of need for basic bioengineering analysis of implants.

For new or significantly altered MIDs, studies should be funded competitively by the NIH to follow recipients regularly for a prolonged time in order to collect data on clinical and implant function and patient satisfaction. Sampling methods should be used to ensure valid epidemiologic inference where appropriate. Persons admitted to the study should be required to permit retrieval of the implant when it is no longer of value.

An independent body commissioned by the NIH and FDA should examine current databases on devices for their completeness and their use in improving MIDs.

The field of medical implants is entering the exciting new phase of tissue engineering. The U.S. Government should prepare and plan to construct the regulatory protocols required by the nature of this new class of implants. For tissue engineered products, where there will be no implant to retrieve, alternate means of analysis of failures and successes need to be developed.

Medical societies should strive to educate their members about the importance of the informed consent process to medical device implantation. Informed consent documents should educate the patient before surgery regarding benefits, risks, potential complications, expected longevity of the device, need for follow-up, and possible future examination of the implant. The patient should be provided with copies of the informed consent document.

The NIH should sponsor technology assessment conferences on selected MIDs to assist patients, providers, and society in evaluating the clinical and economic outcomes associated with their use. The NIH also should fund multicenter studies with longer-term outcomes than those associated with pre-market approval. These studies should include relevant basic science aspects. Existing databases should be coordinated with each other and their funding continued.

Subspecialty medical societies should be involved in public education about devices, collaboration with the FDA, and dissemination of information to pathology laboratories and medical examiner's offices regarding the mechanism of forwarding the devices to the core laboratories.

Conclusions

Implant retrieval and analysis is of critical importance in the process of improving care of patients in need of implants.

Attention needs to be directed toward reducing various obstacles to implant retrieval and analysis, particularly legal and economic disincentives.

Society's and patients' expectations of the risks and benefits of medical implants are often unrealistic, especially as to the lifespan of the implant. An inadequate process for allowing patients to give truly informed consent is a significant source of patients' dissatisfaction with the outcome of implant procedures. Patients' dissatisfaction with the informed consent process may adversely affect their willingness to consent to implant retrieval and analysis.

The failure to appreciate the value of MID retrieval and analysis is a serious impediment to medical device research. A focused educational program aimed at obtaining patients' consent to medical implant retrieval will lead to the acquisition of information necessary to improve the quality of future devices.

Recommendations

  1. The NIH and FDA should sponsor a consensus development conference on the relationship between (and possible adverse effects of) litigation and medical innovation. A goal of this proposed conference would be to determine mechanisms for mitigating the effects of litigation on medical innovation.

     

  2. Patients should be provided with a card containing information about their implant(s), including date of implantation, make, model, and serial number. The card should also serve as an implant "donor" consent form, analogous to an organ donor card, to simplify post-mortem retrieval.

     

  3. The NIH and the FDA should be encouraged to develop an aggressive educational program for teaching patients, policymakers, the medical community, and device manufacturers about the importance of device retrieval and analysis. To support this activity, the NIH and the FDA should develop a Web site that links to databases of devices.

     

  4. The medical device industry should build on their existing strengths to enhance the process of implant retrieval and analysis by sharing information regarding adverse experiences with interested parties.

     

  5. Encourage national medical societies and other organizations to meet regularly to discuss medical device issues of mutual concern. The Orthopaedic Device Forum, a group comprised of representatives of the clinical and scientific orthopaedic community, orthopaedic industry, government agencies, and professional societies, provides a useful model for fostering device-specific communication among clinicians, scientists, government, and industry.

     

  6. The NIH should support training programs designed to develop expertise in analysis of retrieved MIDs.

     

  7. Health care practitioners and researchers should define a standard of care in medical implant retrieval and analysis to moderate some of the legal system's disincentives.

     

  8. Tissue engineering technologies are beginning to be applied to the development of medical implant devices. The U.S. Government should begin active preparation and planning to construct the regulatory protocols that this new class of implants likely will require.

Technology Assessment Panel

Panel Chairs:

Edward N. Brandt, Jr., M.D., Ph.D.
Regents Professor and Director
Center for Health Policy
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma
Julia R. Weertman, D.Sc.
Walter P. Murphy Professor Emerita
Department of Materials Science and Engineering
Northwestern University
Evanston, Illinois
F. Alan Andersen, Ph.D.
Director, Cosmetic Ingredient Review
Cosmetic, Toiletry, and Fragrance Association
Washington, DC
Allen P. Burke, M.D.
Associate Department Chair
Cardiovascular Pathology
Armed Forces Institute of Pathology
Washington, DC
Kenneth E. DeHaven, M.D.
Professor and Associate Chair
Director of Athletic Medicine
School of Medicine and Dentistry
University of Rochester
Rochester, New York
Robert Frye, M.D.
Professor
Cardiovascular Diseases and Internal Medicine
Mayo Clinic
Rochester, Minnesota
Phyllis Greenberger, M.S.W.
Executive Director
Society for Women's Health Research
Washington, DC
Arthur R. Kantrowitz, Ph.D., M.A.
Professor of Engineering
Thayer School of Engineering
Dartmouth College
Hanover, New Hampshire
Lars Noah, J.D.
Professor of Law
University of Florida College of Law
Gainesville, Florida
Miguel F. Refojo, D.Sc.
Senior Scientist Emeritus
The Schepens Eye Research Institute
Boston, Massachusetts
Harmon L. Smith, Jr., Ph.D.
Professor Emeritus
Professor of Moral Theology (Divinity)
Professor of Community and Family Medicine (Medicine)
School of Divinity
Duke University
Durham, North Carolina
David L. Veenstra, Pharm.D., Ph.D.
Assistant Professor
Department of Pharmacy
University of Washington
Seattle, Washington
Janet Wittes, Ph.D.
President
Statistics Collaborative, Inc.
Washington, DC
William A. Wulf, Ph.D.
President
National Academy of Engineering
Washington, DC

Speakers

James M. Anderson, M.D., Ph.D.
Professor of Pathology, Macromolecular Science, and Biomedical Engineering
Institute of Pathology
School of Medicine
Case Western Reserve University
Cleveland, Ohio
Robert E. Baier, Ph.D., P.E.
Professor and Executive Director
Industry/University Center for Biosurfaces
State University of New York at Buffalo
Buffalo, New York
Paul Citron
Vice President
Science and Technology
Medtronic, Inc.
Minneapolis, Minnesota
Terrie Cowley
The TMJ Association
Milwaukee, Wisconsin
Andrew Crosbie
Section Head
Implants and Materials Section
Medical Devices Agency
London, England
The Honorable David F. Durenberger
President
Public Policy Partners, LLC
Washington, DC
David W. Feigal, Jr., M.D., M.P.H.
Director
Center for Devices and Radiological Health
U.S. Food and Drug Administration
Rockville, Maryland
David Fleming
Group Senior Vice President
Diagnostic Products and Genetics
Genzyme Corporaton
Cambridge, Massachusetts
Susan Bartlett Foote, J.D., M.A.
Associate Professor
Health Services Research and Policy
University of Minnesota, Twin Cities
Minneapolis, Minnesota
Linda M. Graham, M.D.
Professor, Surgery Department
Professor, Vascular Surgery Section
University of Michigan Health System
Ann Arbor, Michigan
Bartley P. Griffith, M.D.
Professor of Surgery
University of Pittsburgh School of Medicine
Chief, Division of Cardiothoracic Surgery
University of Pittsburgh Medical Center Health System-Presbyterian
Pittsburgh, Pennsylvania
Robert Z. Gussin, Ph.D.
Vice President
Science and Technology
Johnson & Johnson
New Brunswick, New Jersey
Jeffrey O. Hollinger, D.D.S., Ph.D.
Professor of Surgery, Anatomy, and Developmental Biology
School of Medicine
Professor of Oral Molecular Biology
School of Dentistry
Oregon Health Sciences University
Portland, Oregon
Peter C. Johnson, M.D.
Chief Executive Officer
TissueInformatics, Inc.
Pittsburgh, Pennsylvania
Larry G. Kessler, Sc.D.
Director
Office of Surveillance and Biometrics
Center for Devices and Radiological Health
U.S. Food and Drug Administration
Rockville, Maryland
Jack E. Lemons, Ph.D.
Professor
School of Dentistry and Division of Orthopaedic Surgery
University of Alabama at Birmingham
Birmingham, Alabama
Jeffrey C. Lerner, Ph.D.
Vice President for Strategic Planning
ECRI
Plymouth Meeting, Pennsylvania
Dane A. Miller, Ph.D.
President and Chief Executive Officer
Biomet, Inc.
Warsaw, Indiana
Bernard F. Morrey, M.D.
Consultant, Department of Orthopaedic Surgery
Mayo Clinic
Rochester, Minnesota
Patricia A. Murphy, Ph.D., R.N.
Clinical Ethicist
University Hospital
University of Medicine and Dentistry of New Jersey
Newark, New Jersey
Pamela S. Noonan-Saraceni
Patient Representative
New Fairfield, Connecticut
D. Glenn Pennington, M.D.
Chair of Cardiothoracic Surgery
Wake Forest University School of Medicine
Winston-Salem, North Carolina
Victor L. Poirier, M.B.A.
President
Thermo Cardiosystems, Inc.
Woburn, Massachusetts
Michio Sato, Ph.D.
Division of Medical Devices
National Institute of Health Sciences
Tokyo, Japan
Ross F. Schmucki, Esq.
Corporate Counsel
E.I. du Pont de Nemours & Company
Wilmington, Delaware
Frederick J. Schoen, M.D., Ph.D.
Director of Cardiac Pathology and Vice Chair of Department of Pathology
Brigham and Women's Hospital
Harvard Medical School
Boston, Massachusetts
Bernard N. Stulberg, M.D.
Director
Cleveland Center for Joint Reconstruction
Cleveland, Ohio
Charles H. Swanson, Ph.D.
Vice President
Chief Quality and Regulatory Officer
Corporate Quality and Regulatory Affairs
Medtronic, Inc.
Minneapolis, Minnesota
Joseph P. Vacanti, M.D.
John Homans Professor of Surgery
Harvard Medical School
Massachusetts General Hospital
Boston, Massachusetts
Theodore M. Wendt, Ph.D.
Vice President
Global Regulatory and Clinical Affairs
Zimmer, Inc.
Warsaw, Indiana
Pamela G. Williams-Russo, M.D., M.P.H.
Associate Professor of Medicine
Outcomes Unit
Hospital for Special Surgery
Cornell University
New York, New York
Brian Williams
Patient Representative
Durham, North Carolina

Planning Committee

Planning Chair: John Watson, Ph.D.
Acting Deputy Director
National Heart, Lung, and Blood Institute
National Institutes of Health
Bethesda, Maryland
James M. Anderson, M.D., Ph.D.
Professor of Pathology, Macromolecular Science, and Biomedical Engineering
Institute of Pathology
School of Medicine
Case Western Reserve University
Cleveland, Ohio
Alan Berson, Ph.D.
Acting Leader
Bioengineering Research Group
National Heart, Lung, and Blood Institute
National Institutes of Health
Bethesda, Maryland
Ram Bhat, Ph.D.
Corporate Director
Corporate Office of Science and Technology
Johnson & Johnson
New Brunswick, New Jersey
Edward N. Brandt, Jr., M.D., Ph.D.
Panel and Conference Co-chair
Regents Professor and Director
Center for Health Policy
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma
Elsa A. Bray
Senior Analyst
Office of Medical Applications of Research
National Institutes of Health
Bethesda, Maryland
John H. Ferguson, M.D.
Director (Ret.)
Office of Medical Applications of Research
National Institutes of Health
Bethesda, Maryland
Susan Bartlett Foote, J.D., M.A.
Associate Professor
Health Services Research and Policy
University of Minnesota, Twin Cities
Minneapolis, Minnesota
F. Terry Hambrecht, M.D.
Head of Neural Prosthesis Program (Ret.)
Division of Fundamental Neurosciences
National Institute of Neurological Disorders and Stroke
National Institutes of Health
Bethesda, Maryland
William J. Heetderks, M.D., Ph.D.
Head of Neural Prosthesis Program
Division of Fundamental Neurosciences Medical Officer (Former)
National Institute of Neurological Disorders and Stroke
National Institutes of Health
Bethesda, Maryland
Christine A. Kelley, Ph.D.
Health Scientist Administrator
National Heart, Lung, and Blood Institute
Bethesda, Maryland
Eleni Kousvelari, D.D.S., D.Sc.
Director
Biomaterials, Biomimetics, and Tissue Engineering
Saliva and AIDS Program, Division of Extramural Research
National Institute of Dental and Craniofacial Research
National Institutes of Health
Bethesda, Maryland
Edward Mueller
Vice President
Bernard Technologies, Inc.
Chicago, Illinois
James Panagis, M.D., M.P.H.
Director, Orthopaedics Program
National Institute of Arthritis and Musculoskeletal and Skin Diseases
National Institutes of Health
Bethesda, Maryland
Jack E. Parr, Ph.D.
Executive Vice President, R&D
Wright Medical Technology
Arlington, Tennessee
William F. Regnault, Ph.D.
Director
Division of Mechanics and Materials Science
Center for Devices and Radiological Health
U.S. Food and Drug Administration
Rockville, Maryland
Nancy L. Shinowara, Ph.D.
Health Scientist Administrator
Center for Scientific Review
National Institutes of Health
Bethesda, Maryland
Bernard N. Stulberg, M.D.
Director
Cleveland Center for Joint Reconstruction
Cleveland, Ohio
John A. Tesk, Ph.D., F.A.D.M.
Coordinator, Biomaterials Program
Polymers Division
National Institute of Standards and Technology
Gaithersburg, Maryland
Julia R. Weertman, D.Sc.
Panel and Conference Co-chair
Walter P. Murphy Professor Emerita
Department of Materials Science and Engineering
Northwestern University
Evanston, Illinois
Timothy M. Wright, Ph.D.
Director
Biomechanics and Biomaterials
Hospital for Special Surgery
New York, New York
Additional Planner

Harvey S. Borovetz, Ph.D.

Professor
Departments of Bioengineering and Surgery
University of Pittsburgh
National Heart, Lung, and Blood Institute
Bethesda, Maryland

Conference Sponsors

National Heart, Lung, and Blood Institute (NHLBI)
Claude Lenfant, M.D.
Director
Office of Medical Applications of Research (OMAR)
Stephen C. Groft, Pharm.D.
Acting Director

Conference Co-sponsors

NIH Biomaterials and Medical Implant Science Coordinating Committee
John Watson, Ph.D.
Chair
National Institute of Arthritis and Musculoskeletal and Skin Diseases
Stephen I. Katz, M.D., Ph.D.
Director
National Institute of Dental and Craniofacial Research
Harold C. Slavkin, D.D.S.
Director
National Institute of Neurological Disorders and Stroke
Gerald D. Fischbach, M.D.
Director
National Library of Medicine
Donald A.B. Lindberg, M.D.
Director
National Institute of Standards and Technology
Raymond Kammer
Director

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