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NATIONAL INSTITUTES OF HEALTH
Bioengineering Consortium |
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Support for Bioengineering Research DEPARTMENT OF HEALTH AND HUMAN SERVICESPublic Health ServiceNational Institutes of HealthTable of ContentsExecutive SummaryIntroduction Public and Private Funding of Bioengineering Research Evaluation of Bioengineering Innovation U.S. Uncertainties Affecting Innovation. Public and Private Sector Coordination Recommendations Executive SummaryThe NIH conducted a detailed inventory of sources and amounts of public and private funding for basic bioengineering research for fiscal year 1993. Within the Federal government, the NIH is the largest source of support for bioengineering research. The Whitaker Foundation is the largest nonprofit private source of funding. Support for basic bioengineering research constitutes approximately one-third of all Federal support for bioengineering. In contrast, an average of 60 percent of the overall NIH extramural research budget supports basic research. Industrial support for bioengineering is at least six to ten times greater than that of the Federal government; support for basic bioengineering research by industry, however, is virtually nonexistent. To assist in understanding how innovation in bioengineering proceeds, a case study was conducted in a representative field of bioengineering. Implantable prostheses were studied because the United States has a long history of success and leadership in this field. Data were collected on three stages of the innovation process: the science base, which is essential to the innovation process; patents, which are fundamental to technology transfer and investment; and new health care products, which are the ultimate objective of the investment in research and the innovation process. One of the most important findings of the effort was that relevant data are inadequate to assess this with confidence. Recommendations: Based on results of this study and the advice that was provided, the following four recommendations are made:
IntroductionThe ActPublic Law 103-43, the National Institutes of Health Revitalization Act of 1993, Section 1912, contained provisions for a study of support for bioengineering research. According to the statutory language:
BackgroundBioengineering is a broad, dynamic field that applies engineering principles and methods to medicine, biology, agriculture, and the environment. The estimated 20,000 practitioners of bioengineering are trained in many disciplines, including the life sciences, the physical sciences, clinical medicine, and engineering.Basic research in bioengineering covers a wide range of medical and disease areas, including occupational health and injury prevention, as well as the physical and life sciences, engineering, and mathematics. Research in biomaterials science, for example, expands our knowledge of how synthetic materials interact with body tissues. That knowledge can lead to development of improved implantable devices, such as joint prostheses and heart valves; improved therapeutic procedures, such as angioplasty for coronary occlusive disease; and more accurate delivery of drugs to particular body sites. Research on accurate delivery of drugs to particular body sites. Research on acoustic, electric, and magnetic field effects and how they can be used to produce images has lead to developments in ultrasound, magnetic resonance, and computer tomography imaging that have revolutionized diagnostic procedures. These methods allow internal organs to be viewed without the need for exploratory surgery, and they make it possible for radiation therapy to be administered with greater precision than has previously been possible. Research in optics has led to improved eyeglasses, contact lenses, and implantable intraocular lenses for patients with cataracts. People affected by heart failure and heart rhythm disturbances have benefited from basic bioengineering research focusing on biomaterials, flow mechanics, energy transmission, and electric energy conversion that have led to development of ventricular assist systems, pacemakers, heart valves, and the automatic implantable defibrillator. The status and future of bioengineering have been addressed in a number of reports since 1967, when an international conference was held in Washington, D.C., to assess the interactions between the engineering sciences and biology and medicine. Most recently, an ad hoc review committee for the National Center for Research Resources, NIH, produced a report . Observations and recommendations for the future of bioengineering have remained remarkably consistent. They have stressed the need for a central extramural bioengineering focus at the NIH, a strong intramural bioengineering program at the NIH, and increased coordination of bioengineering activities among the various Federal agencies. This ReportThis report was prepared by the NIH Bioengineering Working Group composed of representatives from all NIH Institutes and Centers and the Division of Research Grants. The Working Group was advised by a steering Committee of senior NIH officials, and received input from representatives of other Federal agencies that support bioengineering research, and focus groups from academia and industry. Representatives from academia, bioengineering societies and foundations, and industry were appointed to an External Consultants Committee, which produced its own report. NIH evaluation funds were secured to address the innovation provisions of the legislation.An evaluation workshop held April 21-23, 1994, in Rockville, Maryland, allowed all interested parties to exchange information, comment on study findings, and provide specific recommendations for consideration by the External Consultants Committee. Approximately 150 academic, private sector, and Federal experts participated in development of this study. Particular attention was directed toward determining Federal and private support for basic bioengineering research. The inventory of public and private sector funding for bioengineering research support is the first inventory to document contributions of individual Federal agencies and of the NIH components. With this framework now available, it will be possible to obtain more detailed information--such as data on specific funding levels for research in biomaterials sciences, cellular processing, and tissues and rehabilitation engineering--in the future. This study s short time-line limited the evaluation of bioengineering innovation to one case study of implantable prostheses. This report explores the current state of the Nation s bioengineering
research in its efforts to enhance the health of its people and retain
the innovative edge of American bioengineering businesses. Because the
NIH is the major supporter of bioengineering research and promoter of health
research policy in the United States, the report generally discusses issues
pertaining to bioengineering in the context of the NIH.
Public and Private Funding of Bioengineering ResearchDefinitionsThe Steering Committee formulated the following definition of bioengineering research in medicine and health, recognizing that no definition could completely eliminate overlap with other research disciplines or preclude variations in interpretation by different individuals and agencies:Bioengineering is an interdisciplinary field that applies engineering principles and quantitative methods to the advancement of knowledge at the genetic, molecular, cellular, tissue, organ, and system levels; to the development of new and novel biologicals, materials, processes, devices, and systems for prevention, diagnosis, and treatment of disease; for patient rehabilitation; and for improving health.Bioengineering research was subclassified according to the following schema: BASIC RESEARCH: Original study to gain fuller understanding the fundamental aspects of phenomena with any specific application. This broad base of findings will form the foundation for solving known or unrecognized issues. (Note: Basic bioengineering refers to the use of engineering principles and quantitative methods as a central focus in a basic research project; it may also refer to the study of new bioengineering principles.) APPLIED RESEARCH: Original investigation undertaken in order to acquire new knowledge and directed primarily toward specific practical aims or objectives, such as determining possible uses for findings of basic research or solving recognized problems. DEVELOPMENTAL RESEARCH: The systematic use of the knowledge or understanding gained from research as directed toward the production of useful materials (including molecules, cells, and tissues), devices, systems, or methods, including the design and fabrication of prototypes and processes. ResultsPublic SectorOne of the primary sources of Federal government support for bioengineering research is NIH. NIH funding components reviewed their portfolios to identify research projects supported in fiscal year 1993 that met the definition and to classify each as basic, applied, or developmental bioengineering research. The NIH determined that 1,781 research projects had a primary bioengineering emphasis (>75 percent), supported at a level of just over $300 million. Of that amount, about $80 million was devoted to basic bioengineering research. The vast majority of the NIH bioengineering research effort is conducted through its extramural research program; only 88 intramural projects were identified, for a total of about $20 million. Presently, the only organized intramural biomedical engineering activity is the Biomedical Engineering and Instrumentation Program of the National Center for Research Resources, and it is an outgrowth of what has been primarily a service activity. Other Federal agencies and departments that were considered to be likely to support bioengineering programs were asked to compile their inventories using the same definitions. The following organizations reported support for bioengineering during fiscal year 1993: Centers for Disease Control and Prevention, Department of Defense, Department of Energy, Department of Education, Department of Transportation, Food and Drug Administration (FDA), National Aeronautics and Space Administration, National Institute of Standards and Technology, National Science Foundation, and Department of Veterans Affairs. In total, they reported support for 592 projects at a level of about $180 million. The majority of the support came from the Department of Defense. Both the Environmental Protection Agency and the Advanced Research Projects Agency (ARPA) reported no support for bioengineering projects in fiscal year 1993. However, the ARPA expects to support bioengineering research in fiscal year 1994. Overall, Federal support for bioengineering research totaled $484 million in fiscal year 1993, of which $158 million funded basic bioengineering research. Local government support for bioengineering was not included because of difficulties in obtaining such data. Discussions with State agencies suggested that they fund little basic bioengineering research. Private Sector Estimates of industry support of bioengineering research were obtained from Standard and Poor s Compustat and Business Week. Research and Development expenditures were estimated at seven to ten percent of sales, for a total of $3 to $5 billion in 1993. Because the health care technology companies registered with the FDA number more than 10,000, and 72 percent have fewer than 50 employees, it was not possible to inventory all industrial sources of bioengineering support. Industry data are not available on the distribution of projects according to basic, applied, and developmental research. Discussions with many industry representatives made it clear that they support virtually no basic research, and that the total level of support could be prorated at 25 percent for applied research and 75 percent for developmental research. Nonprofit private-sector support for bioengineering research is provided almost totally by the Whitaker Foundation, which has contributed more than $112 million to universities and medical schools in the United States and Canada since its inception in 1975. In 1993, 366 projects were supported by the Foundation for a total of $23 million. The great majority of their engineering grant awards were for research, and more than 10 percent of them were for fellowships. Summary of Findings
Evaluation of Bioengineering InnovationOne of the most important findings of the effort was that relevant data are limited. Consequently, the following conclusions of the study concerning the level of innovation the area and the role of the public and private sectors in supporting related research and development must be view as preliminary:
Science BaseData were obtained on the references to articles in scientific journals that were included in implantable prosthesis patents issued in the United States between 1981 and 1991 to examine the extent to which Federal research funding contributed to implantable prosthesis inventions. The level of journal references per implantable prosthesis patent (1.2) was higher than that found in studies of some other areas of technology, which suggests that implantable prostheses inventions may be more closely linked to scientific research than are other areas of invention. However, only 27 percent of the patents had journal references, so no firm conclusions on this issue can be drawn.Attempts to identify funding sources for those articles were even more difficult. Funding sources could be identified for only 23 percent of the patents with journal references. Thus, overall only 6 percent of the patents in the area could be related to a funding source for the underlying science. Although no firm conclusions can be drawn from such extremely limited data, it is worth noting that non-Federal organizations were cited as a funding source (76 percent) about as often as the U.S. government (63 percent). Within the Federal government, the Public Health Service was by far the single most frequent source of research funding (58 percent). The work of the top U.S. firms appears to be more closely tied to the science base than that of the top foreign firms. The top U.S. firms appear to be drawing on the science base more rapidly than most firms in this technology, with an average journal reference age of 7.7 years. The top foreign firms by contrast are not only citing fewer journal references in this technology, but the age of those journal references averaged 9.3 years. PatentsBased on implantable prosthesis patent applications filed in some 30 countries for the years 1981 through 1994 (a measure of technology activity intended for international exploitation), it appears that U.S. companies have maintained a competitive international patent position. Interestingly, Small Business Innovation Research (SBIR) companies had international patent families equal to the leading U.S. and foreign firms. However, in 1987 the technological activity of top U.S. firms began a decline that led to a drop below the activity level of top foreign companies. If this trend continues, the United States may lose dominance in the field as new inventions are exploited by top foreign firms. A similar trend is apparent in the broader field of medical devices as reflected by U.S. patents granted from 1980 through 1993. U.S. origin for those patents decreased incrementally from 81 percent in 1980, to 76 percent in 1986, and to 74 percent in 1993.New ProductsApproximately 160 new implantable prosthesis products were introduced from 1980 to early 1994. The number introduce per year followed a generally increasing trend until 1991, when it peaked at 40, a figure that was more than twice as high as in any previous year. Especially active areas were cardiovascular technology, including pacemakers, defibrillators, artificial heart valves, and cardiac assist devices; artificial joints (especially knee and hip replacement systems); skin substitutes; implantable drug infusion systems; and cochlear implants.The products were introduced by 74 companies, 61 of which appear to be based in the United States. During the period of analysis, companies of foreign origin generally introduced their products outside the United States, and U.S. companies generally introduced theirs domestically. Although 85 percent of the new products were introduced first in the United States, the figure probably overstates the percentage of the products that were U.S. developed because products may be introduced into the U.S. market by subsidiaries of foreign companies. Unfortunately, there was no way to link these product data to patents
and, therefore, to research funding sources. Future innovation studies
would benefit from a data base that identified patents with new product
introductions.
U.S. Uncertainties Affecting InnovationBiomaterials AvailabilityUncertainty over the future availability of commercial-grade biomaterials is a major factor affecting bioengineering research and development. Over the next two years, U.S. manufacturers will remove from the market a number of biomaterials that are widely used for long-term medical implantation because of concerns over product liability. The pending withdrawal from the market will have an immediate and significant adverse impact on health care and may eventually shift basic biomaterials research overseas.Medical implants that may be affected include artificial joints, ligaments, urinary sphincters and blood vessels, bone fixation devices, intraocular lens implants, pacemakers, mechanical heart valves, ear vent tubes, silicone implants, catheters, ventricular shunts (to relieve hydrocephalus), dental implants, and infusions pumps. Unless corrective action is taken, this condition could spell the end of the American medical implant industry; that industry has benefited some eight to ten percent of U.S. citizens who have implants. The NIH supported biomaterials research at a level of $86 million in fiscal year 1993, but little effort was directed at research into new biomaterials. In addition to product liability concerns, other innovation uncertainties include regulation, health care financing and reform, and tax incentives. Each of these factors could influence the innovation process significantly. Reducing uncertainties in these areas would be expected to stimulate innovation and aid Federally funded bioengineering research, as well as private sector efforts. Overseas Products Testing and IntroductionIndustrial representations noted a U.S. trend toward increased planning for the introduction of new health care products overseas. This trend has accelerated during the last 10 years and has serious implications for basic bioengineering research.Overseas manufacturing leads to increased overseas research requirements, including applied and developmental research and training, that are filled by local medical centers and universities. These industrial needs result in hiring appropriate faculty who obtain support for basic research. Thus, the potential exists for movement of basic bioengineering research overseas. Overseas testing spawns the development of competition and the rapid introduction of second-generation technologies overseas; these foreign technologies are based on the principles of a U.S.-generated technology, As a result of overseas testing, the most advanced technologies in some areas of the U.S. bioengineering industry are available only outside the United States. Some U.S. companies have even lost their competitive edge to second-generation technologies developed overseas. The further movement of testing and introduction of new products overseas
should continue to be monitored. Two measures that could potentially be
used to assess the effects of these trends are increased overseas manufacturing
and greater availability of more advanced generations of original U.S.
technology in countries outside the United States.
Public and Private Sector CoordinationTechnology TransferImproved coordination in biomedical research and development between the public and private sectors can be expected to lead to improved innovations and, thus, competitiveness for bioengineering health care products. Several activities initiated by the Federal government over the past 10 to 15 years address this need. The Cooperative Research and Development Agreement (CRADA) mechanism and the SBIR program have succeeded in transferring technology from Federal and academic laboratories to commercialization in the private sector. Additional Federal initiatives such as the Small Business Technology Transfer (STTR) program, should lead to further competitive technology transfer.SBIR Omnibus SolicitationThe study participants agreed that the SBIR program could benefit from a regular process through which the private sector was given the opportunity to suggest precompetitive research topics that would have broad application to the bioengineering industry in general. This could enhance the innovation process by expanding the research base, while improving the U.S. competitive position and speeding technology transfer.Federal Organizational CommitmentThe advantages of close cooperation among Federal agencies were noted by various committees, including the External Consultants Committee. Collaborations (both formal and informal) already exit in some areas. The Federal focus group convened during the April 1994 workshop discussed ways to improve cooperation. A principal recommendation was to improve communications, possibly through the Internet or an electronic bulletin board, so that program announcements would be available to all agencies. It was also suggested that the National Science and Technology Council establish a subcommittee focused on bioengineering.Standards and GuidelinesActivities in the development of standards and guidelines for bioengineering have steadily increased since 1976, when the FDA was directed to regulate medical devices. U.S. standards and technical guidelines have been developed almost solely by voluntary organizations. Although compliance with such guidance is voluntary, the FDA has made it clear that it uses the guidance to verify labeling practices and to conduct regulatory processes. Several international organizations are simultaneously developing medical device standards with participation of U.S. representatives, including some from the Federal government.These activities should be encouraged and supported by Federal agencies
to the extent possible, particularly by provision of scientific and technical
expertise. Efforts would be continued by appropriate Federal agencies,
such as the FDA and the National Institute of Standards and Technology,
to harmonize U.S. and international standards to benefit U.S. competitiveness,
while at the same time ensuring that safety and efficacy are not compromised.
RecommendationsRecommendations I and II address support of basic bioengineering research and an organizational commitment to optimize investment in bioengineering research. These recommendations can also be expected to enhance innovation and cooperation within the NIH and between the public and private sectors. Recommendation III encourages private sector advice on precompetitive research topics for small business research projects. Recommendations IV should benefit future studies by providing information linking Federal research support with patents and new medical and health care products. The NIH should establish an Interagency Bioengineering Coordination Committee. Bioengineering is an important trans-NIH and trans-Federal research activity that should be promoted in accord with the missions of the various agencies. Bioengineering research would benefit from improved Federal coordination and an interface with the extramural community. The proposed coordinating committee, structured through a memorandum of understanding among participating agencies, would seek ad hoc advice from the extramural community; coordinate trans-NIH, Federal, and industry discussions as necessary; and provide a focus for generating information and reports. The NIH Institutes and Centers should include basic bioengineering research with appropriate intramural programs. The NIH intramural program benefits from the orientation and interdisciplinary nature of basic bioengineering research. The revitalization of the NIH intramural program provides the opportunity to include basic bioengineering components within the appropriate Institutes and Centers The NIH, using the Federal Register, should provide a comment period notice to solicit research topics suggested for inclusion in the annual SBIR Omnibus Solicitation. The research topics within the annual PHS SBIR Omnibus Solicitation could be expanded to include topics suggested by the private sector, particularly those companies not eligible for the SBIR program--that is, those companies with more than 500 employees. The NIH could solicit precompetitive research topics by publishing a Notice of Period for Public Comment in the Federal Register. The anticipated benefit is identification of research topics with potential for rapid transfer to the private sector.. Analysis of the bioengineering innovation process would benefit from improved documentation in patents, research publications, and new product introductions. Patents are the acknowledged currency of technology transfer and new health care products. The link between patented inventions and the science base could be more easily traced if the Patent and Trademark Office enforced existing policy [35 U.S.C 202(c) (6)] requiring a statement of government support, if appropriate, using complete literature citations in a standard format. A global data base devoted to new product introductions and their patents could link innovations to their research funding sources and help define the relative competitive position of U.S. health care technology companies.
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