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Clinical Applications of Biomaterials

National Institutes of Health
Consensus Development Conference Statement
November 1-3, 1982

Conference artwork, an astract dot pattern in red black and white with the title above.

This statement is more than five years old and is provided solely for historical purposes. Due to the cumulative nature of medical research, new knowledge has inevitably accumulated in this subject area in the time since the statement was initially prepared. Thus some of the material is likely to be out of date, and at worst simply wrong. For reliable, current information on this and other health topics, we recommend consulting the National Institutes of Health's MedlinePlus http://www.nlm.nih.gov/medlineplus/.

This statement was originally published as: Clinical Applications of Biomaterials. NIH Consens Statement 1982 Nov 1-3; 4(5):1-19.

For making bibliographic reference to the statement in the electronic form displayed here, it is recommended that the following format be used: Clinical Applications of Biomaterials. NIH Consens Statement Online 1982 Nov 1-3 [cited year month day]; 4(5):1-19.

Introduction

A Consensus Development Conference on the Clinical Applications of Biomaterials was held at the National Institutes of Health on November 1-3, 1982.

NIH Consensus Development Conferences bring together biomedical researchers, practicing physicians, consumers, representatives of industry, and public interest groups and others to conduct scientific evaluations on the safety and efficacy of medical technologies. Those technologies may be drugs, devices, or procedures.

During this conference, medical uses of biomaterials, the process by which biomaterials are introduced into the health care system, and the safety and effectiveness of biomaterials presently used in the practice of medicine were evaluated.

Since the early 1950s devices made with synthetic or natural biomaterials have been introduced into the human body at an ever- increasing rate. Initially focused on life-threatening situations, the clinical use of biomaterials has been extended progressively to treatment or support of a vast array of bodily functions. Biomaterials are now employed to address needs that the patient perceives in terms of rehabilitation, comfort, convenience, and aesthetics.

The number of biomaterial implants is estimated to be several million per year in the United States alone, for devices as varied as vascular grafts, intraocular lenses, cardiac pacemakers, hip prostheses, fracture plates, breast augmentations, and dental implants. "Spare parts medicine," first made possible by the availability of materials of industrial origin and presented as a therapeutic approach in end-stage disease, is now shifting toward elective restoration of chronically damaged structures, and may some day be considered for preventive maintenance in early-stage disease.

This consensus conference provided an opportunity to assess advances, opportunities and challenges in cardiovascular surgery, plastic surgery, orthopedics, dentistry, neurosurgery, ophthalmology, otolaryngology, nephrology, and urology, with particular focus on implants and extracorporeal devices. It provided the viewpoint of the material scientist, surface chemist, biochemist and bioengineer, coupled with the definition of medical problems as seen by surgeons, dentists, internists, pathologists, and microbiologists. It included considerations stemming from industrial research, product development, quality control, safety assessment, and regulatory affairs.

For the purpose of this conference, a biomaterial was defined as any substance (other than a drug) or combination of substances, synthetic or natural in origin, which can be used for any period of time, as a whole or as a part of a system which treats, augments, or replaces any tissue, organ, or function of the body. Materials science was defined as the science which relates structure to function of materials. Device was defined by the 1976 amendment to the Food, Drug, and Cosmetic Act to mean:

"an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, which is ... intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, ... and which does not achieve any of its principal intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its principal intended purposes."

The Consensus Development Panel and the members of the audience considered evidence in addressing the following questions:

  1. How safe and effective are biomaterials currently in clinical use?
  2. How well can we predict biological performance of materials in the human body: host response, biomaterials response?
  3. What results of ongoing research in materials science would potentially be applicable to clinical care?
  4. Are the ways for introducing biomaterials into medical use responsive to current clinical needs? Which elements in the process are amenable to improvements?
  5. What are the areas of greatest clinical need for new biomaterials?
 How Safe and Effective Are Biomaterials Currently in Clinical Use?

Virtually every individual will have contact with biomaterials at some time during his or her life. This contact may occur in several ways: (1) permanent implantation (e.g., heart valves, total joint replacement, dental restoration, intraocular lenses), (2) long-term application (e.g., fracture fixation devices, contact lenses, removable dental prostheses, hemodialysis systems), and (3) transient application (e.g., needles for vaccination or phlebotomy, wound healing devices, cardiopulmonary bypass and cardiac assist systems).

In evaluating safety and effectiveness of biomaterials, the material cannot be divorced from the device. Effectiveness must be considered in relation to the specific device and the indications for its use. There are three general situations in which biomaterials are used: (l) to sustain life or limb viability, (2) to restore or improve function, and (3) to restore or improve contour.

Most cardiovascular and neurosurgical implants are in the first category, e.g., cardiac valves, vascular grafts, pacemakers, and hydrocephalus shunts. These implants have allowed major advances in treatment, and, although significant improvements still can be made, they are generally effective.

The second category includes biomaterials intended to restore function, such as joint replacement, fracture fixation devices, and dental implants. The success rates vary significantly in this category, ranging from excellent results in total hip replacement to lesser success rates in other joints. The biomaterials used in these devices have been improved through an increased understanding of the relevant properties, and are a key to further progress.

Facial reconstruction and breast augmentation and reconstruction are procedures representative of the third category (restore or improve contour). Even though these types of devices are not employed in life-threatening situations, they play an important role in restoring and preserving psychological and social well-being. If used properly, they have a high degree of effectiveness.

In order to consider the safety of biomaterials, a balance of risk to benefit must be recognized. Biomaterials in devices used to maintain life can carry some degree of risk in terms of time to failure and still be considered relatively safe. On the other hand, devices used to restore function or contour must have a higher degree of safety to justify their use. Overall, currently used biomaterials have been found to be safe, causing little difficulty with local tissue reaction or systemic toxicity. There have been some reports of immune responses. They are being addressed in attempts to find less sensitizing materials. Although extensive surveys are unavailable, at present there is no apparent evidence of a carcinogenic response associated with the use of implants. Few of these factors have been evaluated over extended periods of time, however, and we strongly encourage the acquisition of additional data to evaluate the long-term safety of implanted biomaterials.

In short, significant improvements have been made in biomaterials and their utilization over the past 20 years, providing the patient the benefits of increased longevity and improved quality of life. The medical profession and the public have accepted biomaterials as a part of established medical treatment.  

How Well Can We Predict Biological Performance of Materials in the Human Body: Host Response, Biomaterials Response?

While functional aspects of the performance of materials in the human body can be predicted with some reliability, forecasting the biological performance of implants is difficult. There is limited fundamental information on the subtle variations of the host response to the different classes, types and forms of materials. There is also a lack of understanding of the effects of the host tissue on the implant. The breadth and depth of knowledge regarding the host and biomaterials responses are inadequate because of the wide variety of implant materials, devices, anatomic sites, and duration of implantation.

Likewise, little is known about the correlation between the in vivo response and the in vitro test methods that are used initially to characterize the material biologically. To predict biological performance in the human, we must obtain a fundamental understanding of the dynamic biological changes occurring at the material/tissue interface. These include in vivo and in vitro cell and molecular biology approaches to acute and chronic inflammatory responses, and the relationship of these responses to the long-term sequelae that may determine biomaterial success or failure. At the present time, an implant which becomes infected must be removed in order to clear up the infection with antibiotic therapy. In some ways as yet unknown, the implant surface appears to protect the infecting agent against local or systemic attack. Thus, as part of our fundamental knowledge we will need to develop a more comprehensive appreciation of poorly understood areas such as infection, immune responses, and the characteristics of the tissue reaction at blood/gas and blood/liquid interfaces.

There also is limited knowledge of the host response in different animal models. Criteria for choosing specific animal models prior to clinical testing in humans need to be defined. Variations in the response mechanisms among animal species (e.g., coagulation, thrombus formation, inflammation, immune responses, fibrosis) and their similarities and dissimilarities with the human must be understood if animal experiments are to be appropriately interpreted.

The subtleties that can be exhibited in the host response are exemplified by recent studies involving metallic implants and the response of the immune system. It is suspected that some nickel, cobalt, and chromium salts commonly encountered in normal life are sensitizers and can contribute to the rare problem of hypersensitivity reactions to metallic implants. In considering the promise of porous metallic implants, this potential problem must be studied carefully, since such materials present markedly increased surface areas in contact with tissues.

Potential causes of device failure encompass the material, the material processing, the device design, the fabrication and/or assembly of the implant, the surgical technique, the postoperative followup, and the patient's condition. Little has been done to identify correctly the etiology of failure and the role that a material may or may not have played. Such efforts must be increased markedly if the biomaterial response is to be understood. Comprehensive implant retrieval and evaluation programs, and well-designed clinical epidemiology studies would make important contributions to elucidating the individual contributions of the various aspects of implant failure. Testing and characterization techniques on the retrieved biomaterial, including particulates and residues derived from implants, should address known and/or hypothesized host responses. The methods used to analyze materials subjected to host responses should be sensitive, reliable, reproducible, and quantitative if we expect to obtain meaningful information. This is especially important if we wish to understand the dynamic events occurring at the tissue/materials interface and use the information for the further development of biomaterials.

Each biomaterial considered for potential clinical application has unique chemical, physical, and mechanical properties. In addition, the surface and bulk properties may differ, yielding variations in host response and material response. Evaluating biological performance also depends on the unique biological characteristics of the anatomic site of implantation. All these factors suggest that the failure of a material in a particular application may not preclude it from consideration in a different setting. Conversely, the success of a material in a given application does not guarantee its universal acceptance. In fact, the mechanism of failure in one application may provide the key to success in another application. Only improved communication among scientists can promote the best use of all available data. Diverse groups such as cell and molecular biologists, veterinarians, neurophysiologists, and others must be involved in this enterprise.  

What Results of Ongoing Research in Materials Science Would Potentially Be Applicable to Clinical Care?

The field of biomaterials is first and foremost a materials science. Thus it is appropriate to ask whether there are new developments in the larger sphere of materials science that could be expected to influence future clinical performance of synthetic and natural biomaterials. It is clear that there is a definite gap between the state-of-the-art in the field of materials science and the use of materials in the practice of medicine. To date, most biomaterials applications rely on industrial substances that were initially developed by industry for non-medical purposes. However, we can point to several areas where current materials technology has the potential to improve host and biomaterial response in clinical applications.

Metals

  • New processing techniques that maximize the mechanical properties of present alloys, such as hot isostatic pressing and powder metallurgy, should be explored to a greater degree.
  • Coating processes, such as reactive flame spraying, carbon coating, and nitrating, offer another possibility for reducing corrosion rates and thus reducing local and systemic host response. Rapid biological qualification and utilization of the more promising of these techniques are recommended.

Polymers

  • New polyurethane elastomers are now entering clinical use and are expected to have a positive impact on cardiovascular devices.
  • The role of solvents in determining both bulk and surface morphology and thus, to a degree, host response, is now becoming recognized. Improved polymer processing incorporating this understanding should be introduced into the manufacture of polymeric components of biomedical devices.
  • Surfaces of polymers modified by chemical and physical means can lead to improved cell response.
  • New high-compliance, elastic polymers as well as synthetic and natural absorbable materials have the potential to provide further design freedom in biomedical devices.
  • Various tissues from human or animal sources can be treated chemically to yield clinically useful devices.

Ceramics and Carbons

  • Ceramics, both inert and bioactive, have found useful roles in a variety of clinical situations. However, the generic brittleness of these materials tends to limit their clinical application to areas where stresses are predominantly compressive.
  • The advent of newer, higher strength carbon and graphite materials may permit broadening of their range of application.
  • Carbon surfaces have exhibited a high degree of tissue compatibility in a variety of applications (e.g., heart valves, percutaneous access devices, dental implants, bone plates, finger joints).

Porous Materials

  • Porous and nonporous organic and inorganic materials have found increasing acceptance in applications where tissue in growth is required for optimal device performance.

Composites

 

  • Recognizing that all natural tissues are composite, composite biomaterials appear to offer attractive possibilities in terms of flexibility and adaptation to special requirements. Of specific promise are polymeric composites for blood contacting devices and polymer- carbon structural composites for musculoskeletal augmentation.
  • Composites in which one or more phases are absorbable offer considerable promise for applications where healing processes can gradually replace the implant with natural tissue.

Characterization

  • The recent advances in spectroscopic techniques for materials science promise a new era of understanding of the nature of biomaterial surfaces and the biomaterial/tissue interface in the clinical setting as well as the laboratory. These techniques, including Fourier transform infrared spectroscopy (FTIR) and electron spectroscopy for chemical analyses (ESCA), could be beneficial in both manufacturing and clinical followup, but the cost of the required equipment is a significant problem.

Advanced technologies that are expected to have a positive impact on the development of new biomedical devices are those pertinent to synthetic polymers with controlled absorption profiles, as well as polymers for sustained release of conventional and macromolecular drugs.  

Are the Ways for Introducing Biomaterials Into Medical Use Responsive to Current Clinical Needs? Which Elements in the Process Are Amenable to Improvements?

In view of the number of successful clinical devices in use today, the overall process by which biomaterials are introduced into medical use has clearly been responding to clinical needs. An evolving environment, however, has created additional demands that must be met. This new environment is developing because:

  1. Most of the materials now applied to medical needs were originally developed for industrial purposes. New materials specifically designed for medical use are now needed to permit significant advances.
  2. The process of applying materials to medical devices has become more complex and costly.

 

Unfortunately the net result of these trends is that in the future the process for introducing biomaterials into medical use can be expected to be applied more selectively, and thus may restrict clinical progress.

In particular, the Panel sees the following trends:

  • The near-term development of devices will favor the use of existing materials with previous clinical history.
  • The longer term search for new materials will require the modification of both bulk and surface properties, a goal which will not be easy to achieve.
  • New materials developed for specific medical applications are likely to be proprietary, which could slow the rate of application to other areas of medicine.
  • The increased cost of developing new biomaterials and obtaining premarket approval can be expected to restrict experimentation and with it the probability of fortuitous discoveries.
  • The growing potential for product liability associated with the introduction of medical devices utilizing new biomaterials may limit the enthusiasm of clinicians and manufacturers toward developing new products.

 

A number of elements of this evolving process are amenable to improvement:

  • The development of a better fundamental understanding of the behavior of biomaterials in vivo can enhance the ability to design new materials for the intended application.
  • The closer involvement of the various medical and scientific disciplines, especially in cell and molecular biology, is needed to fully address the technical problems faced.
  • A careful evaluation of the regulatory and voluntary standard process is needed to ensure that unnecessary costs and time loss are not incurred through the requirement of preclinical and clinical tests for which there is no clearly established relevance.
  • Improvement and general acceptance of testing methodology could help shorten the preclinical and clinical evaluation phases and assure greater clinical safety and efficacy.
  • A more effective way of sharing the current state of knowledge and applications of biomaterials would assist practicing physicians, physicians-in-training, and the public in the understanding and clinical use of these biomaterials.

 

In order to continue the scientific advancement of biomaterials, there needs to be an ongoing, well-constructed collection of epidemiologic information. This might include demographic data, clinical indications, procedure and materials used, pathologic findings, and short- and long-term followup in a manner that is acceptable to both the scientific and clinical community.  

What Are the Areas of Greatest Clinical Need for New Biomaterials?

The consensus conference emphasized the considerable progress that has been made in modern medicine as a result of the current use of biomaterials. Nevertheless, improved materials with specific properties are needed. For instance, materials that can be used as permanent transdermal or transmucosal implants without risk of infection, and materials that can be implanted within the cardiovascular system without risk of blood clot formation, would have immediate application to clinical problems. Materials able to duplicate both the physical and biological properties of native tissue would be able to replace skin, muscle, tendon, etc. Elastomers with extremely good flexure life and resistance to biodegradation might serve to replace those components of the body that undergo repeated bending. Special materials that are unlike any biological counterpart but that promise to play an increasingly important role in patient care include controlled biodegradable materials for use as sutures; blood vessel frameworks; and materials with controlled physicochemical properties for use as drug delivery systems.

Biomaterials and devices have reached varying levels of sophistication and reliability, but none sufficiently mimics normal tissues and organs to negate the need for improvement.

Improved biomaterials will find applications in every branch of medicine. As examples, several specific applications could have an important impact on medical care:

  • Coronary artery disease--A small but definite percentage of the 120,000 patients who undergo coronary artery bypass grafting each year have unsuitable arterial vessel substitutes. There is an urgent need for a small (3 mm to 4 mm) blood vessel substitute having the compliance (stiffness) of the normal vessel, ease of suturing, freedom from kinking, and the likelihood of remaining patent for many years.
  • Soft tissue contoural and functional deformities--Currently several soft tissue substitutes are available to restore or augment the shape on silhouette of body parts. None can preserve their softness reliably and consistently and still retain the complex features and contours of the defective area. A significant percentage of implants (30% to 60%) are deformed and hardened by the contracting scar capsule. Little is understood about the tissue/prosthesis interface that produces such varying results in seemingly identical prostheses. To date, soft tissue augmentation is successful only in the face, breast, and anterior chest. Contoural deformities in the rest of the trunk and limbs remain untreatable with biomaterials. Soft tissue substitutes for muscles, tendons, and ligaments are often unable to provide the solid tissue-prosthesis fixation needed to withstand the loads required for function.
  • Chronic disease--Advances in biomaterials promise to have an impact on patients who are required to take medications over long periods of time. Implantable drug delivery systems, which range from miniature pumps to polymer-encapsulated, sustained-release drug pellets, are being developed. Specific polymer properties are required for these devices and complete feedback loop systems are desirable.
  • Urinary incontinence--One of the biggest problems in medicine today, seen especially in the chronically ill and the elderly, is urinary incontinence. The potential for improved long-term indwelling catheters and prosthetic sphincters and bladders should be developed.
  • Dental alveolar ridge process--A significant nutritional, physical, and emotional problem in the elderly population is the inability to achieve proper mastication with dentures. Implants may help to prevent the loss of the alveolar ridge which is critical in such situations.
 Conclusion

Biomaterials have made an important contribution to modern health care. Their field of application, already much more extensive than generally appreciated by the public, is likely to expand even further as chronic, debilitating disease becomes a dominant concern in an aging population.

The implantation of biomaterials can result in some complications, but in most cases it is difficult to discern whether the problems are related to background disease, faulty implantation techniques, improper device design, or inadequate material properties. It is important that the source of such problems be identified, since failure related to implanted devices can threaten the life of the patient.

Continuing attention must be paid to the conditions under which biomaterials are prepared, evaluated, and implanted. Follow-up clinical studies constitute the best approach to the assessment of long-term safety and reliability. Device retrieval programs must be encouraged, together with the evaluation of materials that have been exposed to the body environment for prolonged periods. Prospective epidemiological surveillance of selected devices ought to be expanded to ascertain the interactions between disease states and biomaterial alterations.

The biomaterials field is in transition from a cottage industry to an integrated research and product development effort. There is a distinct problem of technology transfer, with clinical application often considerably ahead of fundamental science. There is no uniform set of principles in biomaterials research. Rather, each participating discipline has been bringing its own precepts to bear on it in an empirical fashion. In the future, an interdisciplinary approach should be taken to answer critical questions related to material compatibility with living tissues. One approach will be to bring together the various participants in the process of developing biomaterials (government, industry, academia, and the medical profession) in periodic scientific gatherings. The most difficult task may be to assemble a critical number of investigators into a hybrid discipline--biomaterials science--when the primary allegiance of these investigators is commonly to a specialty field.

Although building biomaterials science is an inescapable necessity, it will take time. In the interval, the key question is, "How do we best utilize the technology available today?" One approach is to educate the public as well as the medical profession on the promise and limitations of biomaterial implants. A biomaterials information center could provide a focus for such communication. Finally, there may well be a need to reexamine, in the light of accumulated experience, the process under which devices (and, thus, biomaterials) are regulated according to the 1976 amendment to the Food, Drug, and Cosmetic Act.

While this report for the main part is appropriately charged with addressing the areas of greatest clinical need in which the state of the art today is feasible and practical, there should be a more distant projection of clinical need in which the state of the art is just emerging. The field of prevention, early detection, and screening for disease is one in which biomaterials and the technology they make possible are extremely important if we are indeed to make any meaningful impact on the overall morbidity and mortality of our major chronic disease processes.

This conference was sponsored by the Biomedical Engineering and Instrumentation Branch, Division of Research Services. The NIH Office for Medical Applications of Research provided assistance in the planning and conduct of the meeting.  

Consensus Development Panel

Pierre M. Galletti, M.D., Ph.D.
(Panel Chairman)
Professor of Medical Science
Vice President (Biology and Medicine)
Division of Biology and Medicine
Brown University
Providence, Rhode Island
James M. Anderson, M.D., Ph.D.
Associate Professor of Pathology and Macromolecular Science
Department of Pathology
Case Western Reserve University
Cleveland, Ohio
Denes I. Bardos, Ph.D.
Director, Research Services
Zimmer, Inc.
Warsaw, Indiana
Jonathan Black, Ph.D.
Professor, Department of Orthopedic Surgery and Department of Bioengineering
University of Pennsylvania
Philadelphia, Pennsylvania
Garry S. Brody, M.D.
Clinical Associate Professor of Surgery (Plastic)
Chief, Division of Plastic and Reconstructive Surgery
Rancho Los Amigos/University of Southern California Medical Center
Downey, California
Lorraine Day, M.D.
Associate Professor
Department of Orthopedic Surgery
University of California at San Francisco
San Francisco General Hospital
San Francisco, California
Manville G. Duncanson, Jr., D.D.S., Ph.D.
Associate Professor and Chairman
Department of Dental Materials
College of Dentistry
University of Oklahoma
Oklahoma City, Oklahoma
James Grizzle, Ph.D.
Professor and Chairman
Department of Biostatistics
School of Public Health
University of North Carolina
Chapel Hill, North Carolina
Edward J. Kowalewski, M.D.
Professor and Chairman
Department of Family Medicine
University of Maryland Hospital and School of Medicine
Baltimore, Maryland
Katharine Merritt, Ph.D.
Associate Professor of Microbiology in Orthopedics
Orthopedic Research
University of California at Davis
Davis, California
William S. Pierce, M.D.
Professor, Department of Surgery
Division of Cardiovascular and Thoracic Surgery
College of Medicine
Milton S. Hershey Medical Center
Pennsylvania State University
Hershey, Pennsylvania
Frank E. Samuel, Jr., Esq.
Dickstein, Shapiro, and Morin
Washington, D.C.
Shalaby W. Shalaby, Ph.D.
Manager, Polymer Research Section
Ethicon, Inc.
Somerville, New Jersey
Edmund E. Spaeth, Ph.D.
Vice President, Planning and Business Development
Medical Specialties Business
American Hospital Supply Corporation
Irvine, California
Mary K. Stallo
Alexandria, Virginia
I. V. Yannas, Ph.D.
Professor of Polymer Science and Engineering
Department of Mechanical Engineering
Massachusetts Institute of Technology
Cambridge, Massachusetts

Speakers

John Autian, Ph.D.
"The Value of Primary Toxicological Testing as a Means of Safeguarding the Patient"
Professor and Director
Materials Science Toxicology Laboratories
Dean of the College of Pharmacy
University of Tennessee Center for the Health Sciences
Memphis, Tennessee
Robert E. Baier, Ph.D.
"Surface Phenomena Associated With In Vivo Behavior of Biomaterials"
Research Professor
Departments of Biophysics and Dental Materials
State University of New York at Buffalo
Staff Scientist
Advanced Technology Center
Calspan Corporation
Buffalo, New York
Arthur C. Beall, Jr., M.D.
"Biomaterials: Magnitude of the Need"
Professor of Surgery
Baylor College of Medicine
Houston, Texas
John W. Boretos
"Development and Introduction of Biomaterials"
Chemical Engineering Section
Biomedical Engineering and Instrumentation Branch
Division of Research Services
National Institutes of Health
Bethesda, Maryland
Richard E. Clark, M.D.
"Identification of Contemporary Practice"
Professor of Surgery and Biomedical Engineering
Department of Surgery
Washington University School of Medicine
St. Louis, Missouri
Pierre Comte, Ph.D.
"Clinical Performance Analysis Based on Metallurgical Observations"
Head of Research and Development
Institut Straumann AG
Waldenburg SWITZERLAND
Klaas de Groot, Ph.D.
"Biocompatible Ceramics"
Professor of Materials Science
Department of Biomaterials
Schools of Dentistry and Medicine
Free University
Amsterdam
THE NETHERLANDS
Paul Didisheim, M.D.
"Animal Models Useful for Predicting Clinical Performance of Biomaterials"
Professor of Laboratory Medicine (Hematology)
Department of Laboratory Medicine
Director, Thrombosis Research Laboratory
Mayo Clinic
Rochester, Minnesota
John L. Ely, M.S.
"FDA Regulations and Policy Relative to Biomaterials"
Chief, Surgical Devices Branch
Division of Cardiovascular Devices
Bureau of Medical Devices (HFK-450)
Food and Drug Administration
Silver Spring, Maryland
Eldon E. Frisch
"The Dilemma of High Cost and Low Volume for Biomaterials Applications"
Associate Medical Device Consultant
Dow Corning Corporation
Hemlock, Michigan
Jorge O. Galante, M.D., D.M.Sc.
"Orthopedic Applications of Biomaterials"
Professor and Chairman
Department of Orthopedic Surgery
Rush-Presbyterian-St. Luke's Medical Center
Chicago, Illinois
Christian C. Haudenschild, M.D.
"Predicting Tissue Response"
Professor of Pathology
Mallory Institute of Pathology
Boston University School of Medicine
Boston, Massachusetts
Kozaburo Hayashi, Ph.D.
"Mechanical Properties of Biomaterials"
Director, Department of Biomedical Engineering
National Cardiovascular Center Research Institute
Fujishiro-Dai, Suita Osaka JAPAN
Larry L. Hench, Ph.D.
"Emerging Technology"
Professor of Materials Science and Engineering
Department of Materials Science and Engineering
University of Florida
Gainesville, Florida
Peter Barton Hutt, Esq.
"Practical Legal Considerations Facing Industry in the Introduction of New Biomaterials to the Market"
Covington & Burling
Washington, D.C.
J. Lawrence Katz, Ph.D.
"Present and Potential Contributions of Composite Materials Technology to Medicine"
Professor of Biophysics and Biomedical Engineering
Director, Center for Biomedical Engineering
Rensselaer Polytechnic Institute
Troy, New York
John N. Kent, D.D.S.
Professor and Head
Louisiana State University Department of Oral and Maxillofacial Surgery
Chief, Oral and Maxillofacial Surgery
Charity Hospital of New Orleans
New Orleans, Louisiana
Richard L. Kronenthal, Ph.D.
"Introduction and Use of Biomaterials"
Director of Research
Ethicon, Inc.
Somerville, New Jersey
Robert S. Langer, Sc.D.
"Macromolecular Delivery System for Therapeutic Applications of controlled Drug Release"
Associate Professor of Biochemical Engineering
Department of Nutrition and Food Science
Massachusetts Institute of Technology
Cambridge, Massachusetts
Robert M. Lindsay, M.D.
"Interrelationship Between Biomaterials Behavior and the Living Organism"
Associate Professor of Medicine
University of Western Ontario
Director of the Renal Unit
Victoria Hospital
London, Ontario
CANADA
Geoffrey H. Lord, D.V.M., Ph.D.
"Safety and Risk: Limits of Predictability for Biomaterials"
Consultant
Johnson and Johnson Products, Inc.
North Brunswick, New Jersey
Edward W. Merrill, Ph.D.
"Influence of Physico-Chemical Properties on Material Response: Morphology, Structure and Interaction"
C. P. Dubbs Professor of Chemical Engineering
Department of Chemical Engineering
Massachusetts Institute of Technology
Cambridge, Massachusetts
Francis J. Meyer, Ph.D.
"Quality Control and Good Manufacturing Practices as an Essential Element for Consistent Performance of Biomaterials"
Vice President
Medical and Regulatory Affairs
Extracorporeal, Inc.
King of Prussia, Pennsylvania
Alan S. Michaels, Sc.D.
"Predicting Performance of Materials"
Adjunct Professor
Chemical Engineering
Massachusetts Institute of Technology and Lehigh University
New York, New York
Kazuo Ota, M.D. "Dr. Ota"
"Biomaterials as Critical Components for Therapeutic Applications"
Professor of Surgery
Director of Kidney Center
Tokyo Women's Medical College
Tokyo, JAPAN
Buddy D. Ratner, Ph.D.
"Evaluation of the Blood Compatibility of Synthetic Polymers: Consensus and Significance"
Research Associate Professor
Department of Chemical Engineering, BF-10
University of Washington
Seattle, Washington
Richard C. Schultz, M.D.
"Biomaterials for Reconstruction and Augmentation"
Chief, Division of Plastic and Reconstructive
Surgery
Department of Surgery
University of Illinois Hospital
Abraham Lincoln Medical College
Chicago, Illinois
Michael Szycher, Ph.D.
"The Use of Porous Biomaterials for Tissue Ingrowth"
Adjunct Professor of Surgery
Tufts Medical School
Adjunct Professor of Bioengineering
University of Miami
Director, Biomaterials Research
Biomedical Systems Division
Thermo Electron Corporation
Waltham, Massachusetts
Sidney Weisman, M.S.
"Voluntary Standards and Their Potential Contribution to the Quality of Clinical Care"
Director, Corporate Professional Relations
Howmedica, Inc.
Rutherford, New Jersey
Creighton B. Wright, M.D.
"Biomaterials for Cardiovascular Applications"
Professor of Clinical Surgery
Uniformed Services University of the Health Sciences
Department of Cardiac Surgery
Christ Hospital
Cincinnati, Ohio

Conference Coordinator

John W. Boretos
Chemical Engineering Section
Biomedical Engineering and Instrumentation Branch
Division of Research Services
National Institutes of Health
Bethesda, Maryland

Conference Sponsors

Division of Research Sciences, Biomedical Engineering and Instrumentation Branch

Office of Medical Applications of Research

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