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Bioengineering Systems Research in the United States: An Overview Executive Summary There is no more exciting and challenging field of science and engineering today than the study of living organisms from the entire body through its subsystems down to cells and subcellular processes, and the application of this knowledge to the develop- ment of products and technologies for the benefit of mankind. Already, bioengineering is using the advances made by molecular biologists, geneticists, and biochemists to generate products rang- ing from simple molecules to complex proteins. Advances in our understanding of human physiological systems have led to entirely new technologies for diagnosing disease and repairing or replacing damaged systems. The potential of these technologies for enhanc- ing human health, food production, and environmental quality is enormous. Bioengineering encompasses those disciplines that seek to ap- ply engineering knowledge to (1) the development of new and improved devices for health care, (2) the advancement of our un- derstanding of living systems, and (3) the scale-up and production of new products derived from advances in biology. It includes the fields of biomedical and biochemical engineering. (The latter encompasses the engineering aspects of biotechnology, including 77

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78 DIRECTIONS IN ENGINEERING RESEARCH genetic engineering.) By its very nature, bioengineering is inter- disciplinary. It makes use of virtually every traditional engineering discipline as well as those sciences related to agriculture, biology, biochemistry, medicine, and public health. The uses of bioengineering research represent potentially sig- nificant economic opportunities for the United States. An esti- mated $4~$100 billion worth (in 1984 constant dollars) of bio- Togically derived products annually could be created by the year 2000 through biochemical engineering alone (National Academy of Sciences, 1984~. The overall market for biomedical engineer- ing devices and systems is estimated to be $11 billion for 1987. Because most engineering-intensive segments of that market have been growing at annual rates ranging from 10 to 25 percent, the potential size of the market by the end of the century is on the same order as that for biochemical engineering. To achieve the poten- tial that both fields offer, however, mere science and engineering research is required. American researchers have clearly established the United States as the world leader in the fundamental fields related to bio- engineering. Nevertheless, several European countries and Japan are currently devoting a significantly higher proportion of their na- tional resources to important elements of bioengineering research than is the United States. The economic stakes alone are consider- able. To assure U.S. leadership in this economically vital field, and to realize bioengineering's full potential for improving the quality of human life, more government support for research is needed. Support for bioengineering research is relatively small and scattered throughout the federal government. The National Sci- ence Foundation (NSF) and the National Institutes of Health (NTH) are the two principal agencies of the U.S. government that fund bioengineering research. Yet the National Bureau of Stan- dards (NBS), the National Aeronautics and Space Administration (NASA), and the Veterans Administration, among other agencies, also have programs or an interest in various aspects of bioengi- neering research. There is currently no interagency mechanism by which the programs of these various agencies are coordinated. Moreover, bioengineering research projects are typically spread among a va- riety of offices and programs within an agency. The NSF, for example, funds bioengineering research through its programs on biochemical and biomass engineering, biotechnology, and aid to

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BIOENGINEERING SYSTEMS 79 the handicapped. Other NSF programs also support bioengineer- ing as a part of larger research studies. As a result, it is difficult to determine with certainty how much NSF spends on bioengineering research alone; however, the research budgets of the NSF divisions that support bioengineering total more than $12 million, of which $2.2 million is earmarked for the newly established bioengineer- ing research center at the Massachusetts Institute of Technology (MIT). The lack of a specific focus on bioengineering is particularly evident at NTH, where only an estimated $11 million out of a $660 million intramural research budget currently supports projects with a significant bioengineering component. Whereas NSF has recently created an Office of Biotechnology Coordination, no such mechanism exists within NTH. As the principal agency of the U.S. government for biomedical research, NTH emphasizes projects that focus on fundamental biological or medical science. Although it is estimated that about one-fifth of NTH's extramural grants include bioengineering studies, usually as a minor component of larger projects, those studies account for only about 3 percent of the extramural research budget. Few engineers sit on the committees that rank and fund research proposals. More generally, there has been a shift in government policy in recent years with respect to research funding. As a result of budgetary restrictions, the philosophy has changed from one that viewed research as an investment in the future to one in which it is considered explicitly as a means to product development. Whereas this approach is beneficial in many ways, it tends to overlook imaginative but speculative research proposals that could achieve significant long-term results. Industry involvement in bioengineering has become consider- able, particularly in the burgeoning field of biotechnology. How- ever, the activity is mostly limited in scope and focused on near- term product development. Sponsorship of fundamental research at universities has not been either substantial or consistent, nor is this situation likely to change soon. In the biomedical field, the market for many devices (e.g., prostheses) is small, and fails within an area in which government has traditionally held responsibility. (The situation in this respect is analogous to that for "orphan drugs." ~ Consequently, federal support of both basic research and the fundamental engineering research needed to realize the useful

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80 DIRECTIONS IN ENGINEERING RESEARCH potential of basic discoveries in bioengineering will continue to be essential. This report identifies 11 areas within the field of bioengi- neering that could produce important research results in the years ahead. Eight areas involve biomedical engineering research. These are systems physiology and modeling, human rehabilita- tion and neural prostheses, biomechanics, biomaterials, biosensors, metabolic imaging, minimally invasive diagnostic procedures, and artificial organs. Three areas of biochemical engineering were also selected bioreactors and biocatalysis, separation and purifica- tion, and bioprocess instrumentation and control. These research areas illustrate the potential for bioengineer- ing research and point out where financial support is urgently needed to achieve significant results. They are not, however, the only research areas worthy of government support. In addition, the listing of eight biomedical engineering and three biochemical engineering topics does not signify any relative priority between the two subfields of bioengineering. Both subfields are essential. Although each of the research areas presents its own spe- cific needs and opportunities, certain ones are common to more than one area. For example, more research is needed to extend our knowledge of the physical and chemical properties of living tissues, cells, and subcellular components as well as their relationship to each other. Such research is of particular importance to our under- standing of systems physiology, but could also be applied to neural prostheses, biosensors, biomaterials, and artificial organs. More also needs to be known about the characteristics of materials used in biomedicine and how those materials interact with living tis- sue. This information would be important in developing both new prostheses for disabled persons and new minimally invasive tech- niques for diagnosis and treatment. In this regard, mathematical modeling is important for learning how to represent the properties and behavior of tissues, cells, and subcellular components so as to simulate the response of a living system. Certain topics hold special importance. Improved biosensors, for example, could convert biological signals more quickly and re- liably into electronic responses that can be processed and used for medical diagnoses, as well as providing the input needed for the control and optimization of industrial bioprocesses. Research on biosensors could also help scientists and physicians to better

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BIOENGINEERINrG SYSTEMS 81 understand the body's natural sensors. To be useful, however, biosensors must be compatible with the human body and its signal processing systems. Similarly, advances in metabolic imaging could also aid diag- nosis. This field has already produced positron emission tomog- raphy and nuclear magnetic resonance imaging, among other new technologies. Further developments, however, may depend on ba- sic research on tissue properties, both physical and biochemical, and on integrative systems analysis. A third area in which bioengineering research can make par- ticularly significant contributions is the development of artificial organs. Organ replacement is still in its infancy, and great strides can be expected in the future. At present, air-driven artificial hearts are the focus of attention; work is also progressing on elec- trically powered devices that would be implanted to assist the heart for several years rather than replace it. However, many of the body's organs besides the heart are potential candidates for replacement or assistance by engineered devices. Multidisciplinary efforts combining biochemical and biomedical engineering should eventually lead to synthetic systems able to replace a range of human organs and all the functions a single organ performs. In the expansion of biomedical technology, there is a promise of vastly improved health care delivery, possibly even at reduced costs (as illustrated in this report in connection with percuta- neous transTuminal angioplasty). Greater attention needs to be paid to the costs and benefits associated with the introduction of new technologies and new devices to encourage their elective and efficient use and to discourage costly and wasteful practices. To carry out these research programs and projects, more trained bioengineers will be needed. Although the total number of bioengineering students in U.S. graduate schools has increased significantly during the last decade, the number relative to all engi- neering graduate students has remained about the same (roughly 2 percent). Greater support for university programs from NSF and NTH would encourage more engineering graduate and post- graduate students to go into bioengineering. Studies indicate that there are not enough biochemical en- gineers in the United States today to meet existing needs. In addition, there is a shortage of the qualified faculty members needed to expand graduate enrollments and courses in the future.

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82 DIRECTIONS IN ENGINEERING RESEARCH Fewer than 20 U.S. colleges and universities now have meaning- ful biochemical engineering programs. In part, this is because biotechnology is still a relatively new field of study, and one that is highly interdisciplinary. In order to realize the vast potential of this field for improving the quality of life, and to meet the strong competitive challenge that other nations are mounting to capture the large market for products of biotechnology, it is imperative that we provide the incentives and the research programs needed to increase the cadre of research talent. RECOMMENDATIONS The following recommendations of the panel are excerpted from the section "Conclusions and Recommendations" at the end of this chapter. See that section for accompanying conclusions and rationale, which are in turn based on the report itself. 1. The panel recommends that the coordination of research programs in bioengineering throughout the federal government be improved and that the coordination include the relevant work of NTH, NSF, NBS, and other agencies interested or involved in bioengineering research. To ensure its effectiveness, it is essential that this interagency coordinating effort receive the full recognition and support of upper management in each of the participating agencies. 2. The coordination of bioengineering research within sup- porting agencies should also be improved. For example, NTH could create an "office of bioengineering research" to review and coordinate its investigations. Such an office would be one way of focusing attention on the careful development of this important field. 3. NIH should give careful attention to the need for large- scale, focused research in biomedical engineering. To achieve the required scale, NTH should consider creating a center for such research, comparable in concept and size to the Engineering Re- search Centers being created by NSF. Any such NTH center should encourage links between acadern~c research and clinical practice. 4. Both NTH and NSF should devote a greater share of their research budgets to supporting bioengineering programs at U.S. universities and colleges. NIH in particular should expand its pro- grarns that encourage medical students to go into research so as

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BIOENGINEERING SYSTEMS 83 to include bioengineers as well. Stipends awarded for postdoctoral study should be sufficiently high to offset the attractiveness of salaries offered by industry. 5. Those who rank and award grant proposals within NIH and NSF should consider funding research projects that have a great potential for significant results, but also a high risk of failure. The pane] applauds the strong current trend in this direction at NSF. 6. Bioengineering in all its aspects is advancing rapidly. To ensure the Tong-term health of this commercially important field, a permanent advisory body should be created within the Executive Branch. This body would assess bioengineering research opportu- nities and needs, review the relevant research programs of NIH, NSF, and other government agencies, and identify needs for new programs or changes in directions. Introduction RATIONALE FOR A STUDY Bioengineering is associated with questions that have gener- ated some of the most intense interest, excitement, apprehension, and debate ever seen in the context of American science and technology. Within the last decade, some of its newer and more revolutionary elements have captured the attention of the public fully as much as they have the interest of the research community. From heart transplants and reproductive technology to genetic engineering, these are topics that fascinate people because they deal so intimately with life itself. Apart from (or perhaps partly because of) its intrinsic interest to researchers and the public, bioengineering also has tremendous economic potential. It Is one of the fields on which our most forrn~dable international industrial rivals are placing great em- phasis; it is also a field that holds the promise of providing the new technologies needed to supply our increasingly sophisticated medical care at minimum costs for benefits received. Thus, the Engineering Research Board considered it to be essential to iden- tify research needs in this field and to assess the health of the environment within which it is conducted.

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84 DIRECTIONS IN ENGINEERING RESEARCH SCOPE OF THE STUDY The Pane] on Bioengineering Systems Research was formed to address the status of research in the bioengineering field.* In particular, it was charged with identifying new or emerging areas of research. To establish boundaries, the pane] defined three broad areas of research as falling within the scope of its study. These are . the application of engineering knowledge and concepts to understanding the human body and other biological systems and the interaction of humans, machines, and the environment; . new and improved biomedical devices for use in maintain- ing health and treating disease; and . the manufacture of products using the techniques of the so-called "new biology," including molecular and cellular biology. Because of the need to set boundaries, certain significant areas could not be addressed; agriculture and food processing and mili- tary bioengineering are examples of such areas. In addition, those areas falling primarily within the purview of other panels of the Engineering Research Board were not specifically addressed. It is worth noting that considerable confusion exists over the terms used to describe the field of engineering that seeks to apply the biological and medical sciences. ~Bioengineering,n Genetic engineering,n ~biotechnology," and ~biomedical" or ~biochemical" engineering all have their adherents; often the terms are used almost interchangeably. This report uses ~bioengineering" to encompass those disci- plines that seek to apply our understanding of living systems to the engineering of useful products. Bioengineering uses the knowI- edge gained through research to develop new and improved devices for use in maintaining health and treating disease as well as for the manufacture of products using the processes of modern biol- ogy. Thus, bioengineering can be said to include both biomedical and biochemical engineering. The latter terms are used, where appropriate, when referring to those specific areas. In the three areas listed previously as being within the scope of bioengineer- ing research, the second refers to biomedical engineering and the *The word "systems" is used here to denote, not "systems engineering," but the organismic, physiological, and hardware systems on which this research focuses. For a more detailed definition of this concept, see the report of the Engineering Research Board.

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BIOENGINEERING SYSTEMS 85 third refers to biochemical engineering. The first item on the list is relevant to both disciplines. Biomedical engineering research investigates (1) the structure and properties of cells, tissues, organs, and whole bodies; (2) the growth and repair of living tissues; (3) strength and tolerance; (4) the behavior of electrically excitable tissues; and (5) relevant surface and flow phenomena. All of these topics apply to the diagnosis and treatment of disease, as well as to rehabilitation, prostheses, artificial organs, aging, and trauma-related injuries. Biochemical engineering includes the engineering aspects of biotechnology. Biotechnology was cleaned in a recent study (Office of Technology Assessment, 1984) as the ruse of living organisms (or parts of organisms) to make or modify products, to improve plants or animals, or to develop microorganisms for specific uses." Thus, there is clearly a substantial overlap with the "new biology." By its nature, Bioengineering research is broadly interdisci- plinary in scope. It relies heavily on the life sciences: biochem- istry, biophysics, biology, medicine, public health, and agriculture. It makes use of virtually every branch of engineering, as well as subdisciplines within the various engineering fields, such as struc- tures, fluid mechanics, thermodynamics, circuit and field theory, and signal processing. Bioengineering also draws from mathemat- ics, chemistry, and physics. Probably no other field of engineering embraces so many spheres of human inquiry. BACKGROUND Bioengineering depends heavily on information gained from the biological and biomedical sciences. It differs from them by focusing on living organisms as systems that can be used for the benefit of mankind. Bioengineering research seeks to discover and organize the information needed to develop new products and processes. In this sense, Bioengineering is concerned with applying basic advances in our knowledge about the human body and other biological systems. To achieve its potential, more engineering research as well as scientific research is required. Processes in biology and medicine, however complicated, ul- timately obey the same basic principles as all the other natural sciences. Thus, an essential step in the engineering of biological processes is the development of mathematical models that describe

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86 DIRECTIONS IN ENGINEERING SEARCH and predict biological behavior. Historically, many important ad- vances in the natural sciences have been founded on models based on experimental data. The structure of DNA is perhaps the best known example. Others include cardiovascular flow, the tribology of synovial joints, and musculoskeletal modeling. Together these models have clarified understanding and led to practical develop- ments in diagnosis and therapy. Bioengineering seeks not only to make new devices, but also to understand them more fully. For example, the first artificial heart valve required engineering research. The development of heart valves designed to last a lifetime must be based solidly on the prin- ciples of fluid mechanics, physiology, and biomaterials research. Correspondingly, anatomy, physiology, and pathophysiology in- terpreted by bioengineers at the system and cellular level are being illuminated in new and important ways that lead to novel and less invasive diagnostic methods, replacement joints and or- gans, and other processes and products that improve medical care and enhance human health. Advances in basic science drive the engine of invention and improvement. Breakthroughs in computer science and information science, for example, with their attendant engineering advances in hardware and software, have many poten- tial applications in bioengineering. (See the report of the Pane} on Information, Communications, Computation, and Control Sys- tems Research for a discussion of breakthrough research areas in these fields.) These technologies oilier solutions to long-standing problems in biology, medicine, and health care delivery, as well as improvements to current practices. In addition to the basic capa- bility for computer modeling, promising examples would include the availability of Smart microprocessor-based analytic instru- ments in biology, expert systems in support of medical diagnosis, new imaging diagnostic technologies, and various clinical and med- ical information systems to enable effective and economical health care delivery. Similarly, there have been tremendous advances in the basic sciences relating to gene manipulation. Genetic engineering uses recombinant DNA and cell fusion techniques built on a strong science base in molecular and cellular biology, biochemistry, and microbiology to construct biocatalysts that can produce, under controlled conditions, seemingly limitless numbers of potentially useful products. The ability to make biological products has cre- ated many research needs in the area of bioprocess engineering.

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BIOENGINEERING SYSTEMS 87 However, in contrast to the long-standing relationship between chemistry and chemical engineering, no comparable association yet exists between biology and biochemical engineering. Such a relationship is absolutely necessary to extend the practical imple- mentation of genetic engineering. There are many potential uses for the products of biotech- nology. In the health field, new pharmaceuticals for humans and animals are being developed from naturally occurring molecules that are more effective and safer than the drugs they will replace. Monoclonal antibodies and genetically engineered enzymes are now being used to diagnose various diseases. In the area of food production, growth promoters can be used as a food supplement to improve animal nutrition. New crop varieties can be made that will be more resistant to adverse environmental conditions or disease. In addition, crop production will be more effectively controlled by the use of growth regulators. In the area of environ- mental quality, new and more effective ways can be designed to detoxify waste. Similarly, biocatalysis can be used to produce a wide range of chemicals now made from conventional feedstocks. Apart from their obvious benefit to mankind, the applica- tion of these concepts through bioengineering also presents sig- nificant economic opportunities for the United States. Biochemi- cal engineering could create an estunated $4~$100 billion worth of biologically derived products annually by the year 2000 (Na- tional Academy of Sciences, 1984~. The market for biomedical engineering devices (including diagnostic imaging, therapeutic de- vices, medical laboratory instruments, and medical information and other communication systems) is estimated at $11 billion for 1987 (Attinger, 1984), and is growing at an annual rate of 10-25 percent, so that the potential size of this market in the year 2000 is similarly large. However, considerable research is still needed in a variety of areas to take advantage of these vast opportunities. Especially Important or Emerging Areas of Bioengineering Systems Research The Pane! on Bioengineering Systems Research has identified 11 subjects, divided into two broad categories, that represent es-

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104 DIRECTIONS IN ENGINEERING RESEARCH . extending the length of grant awards to 5 or 7 years to en- sure stability and the opportunity to bring a project to a successful conclusion. INDUSTRY INVOLVEMENT BIOTECHNOLOGY The worldwide market for biologically derived products could be as high as $100 billion annually by the year 2000* (or about 15 percent of the estimated total annual market for chemicals) (National Academy of Sciences, 1984~. Since about 1978 there has been a virtual stampede of private investment in new, en- trepreneurial companies entering this field. Venture capital has been an important source of private capital, funding well over 100 biotechnology firmsmany of which have not survived in this highly speculative field in which few products have yet come to market. R&D limited partnerships, only one source of funds, to- taled $1.5 billion in 1984 alone (Office of Technology Assessment, 1984~. Many of these small entrepreneurial firms focus on producing one or a handful of products derived from academic research. As such, their challenge is to perform the engineering research necessary to make an idea commercially viable, because this is the type of research that is not often sponsored by federal agencies at universities. Because the work is limited in scope (and highly proprietary), it is not of great use in the overall advancement of the field. Of greater potential value in this regard is the engineering research performed by established industries. The pharmaceutical industry was the first to seek applications of the new biology on a large scale. Biologically engineered prod- ucts have traditionally accounted for roughly 23 percent of annual sales of pharmaceutical products (Drew, 1985~. With domestic expenditures for health care now exceeding 10 percent of the gross national product and the world market for human and animal drugs exceeding $35 billion, this is likely to remain one of the most active areas of research in biotechnology. The key problem for this and other industries involved in *In 1984 constant dollars.

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BIOENGINEERING SYSTEMS 105 biotechnology is likely to be performing the engineering research necessary to capitalize on the explosive growth in the biological sci- ences. According to Drew (1985), the current focus of engineering research on process development and scale-up to manufacture has kept pace with new product discovery, but the margin of comfort in completing process development before licensure has dwindled. The trend toward more complex product chemistries, higher prod- uct purities, and increased product stability will only worsen the problem and place process economics under greater constraints. BIOMEDICAL ENGINEERING Most of the research in biomedical engineering to date has been carried out within the academic research community through government funding, private philanthropy, and limited industrial cosponsorship. In recent years, as the commercial potential of a line of research has become clear, industrial research in some cases has brought the basic work beyond the proof-of-concept stage to product development. Yet, here again, the fundamental work leading to the proof-of-concept stage is the key. Despite efforts tc, increase industrial sponsorship of such research at universities, little additional support is anticipated. The nature of this industry dictates that investments in R&D are made only after the concept has been proven and the market potential shown to be adequate to provide a return on investment. One drawback to the advancement of this field appears to be a prevailing belief, on the part of the medical community, that in- dustry should be responsible for medical instrumentation R&D. In fact, industry does not support R&D on medical instrumentation or equipment that is used in research per se, but only that which is addressed to the clinical market. These factors will likely combine with a limited market for many types of instrumentation and devices (e.g., prostheses) to keep industry's investment in research small. Because the public health and welfare are traditionally a responsibility of govern- ment, an adequate research base in biomedical engineering should continue to be maintained through federal support of university researchers.

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106 DIRECTIONS IN ENGINEERING RESEARCH BIOENGINEERING IN OTHER COUNTRIES As part of its study, the Panel on Bioengineering Systems Research examined bioengineering research and education in the United States, Western Europe, and Japan. In particular, the analysis pointed up major differences in the magnitude and or- ganizationa] structure of government-supported research and de- velopment efforts in biochemical engineering. West Germany, Japan, and Great Britain each have three government institutes that support biotechnology exclusively. These nine institutes bring together academic and industrial investigators, feature cross- disciplinary activities, and have impressive operating budgets. In West Germany, for example, the Gesellschaft fur Biotech- nologische Forschung had an operating budget of $14 million in 1983 and the Institut fur Biotechnologie II in Julich had a budget of $4.3 million for biochemical engineering alone. The last fig- ure nearly equals the NSF's entire annual budget in biochemical engineering. West Germany also has nearly double the amount of space and equipment for bioengineering research found in the United States. In Japan, the Ministry of International Made and Industry 1~ year plans have strong R&D components in biotechnology. Three of the nine areas emphasized are bioreactors, animal cell culture, and membrane separations. The Japanese government budgeted $20 million in support of membrane separation research and devel- opment alone in 1983. NSF, by comparison, contributes less than $1 million for similar research in the United States. Thus, countries such as West Germany and Japan are lay- ing a foundation of research and trained personnel as part of their strategy for meeting the intense international competition in biotechnology. Given the potential size of the worldwide market described earlier, the economic rewards for success are likely to be very great. Getting into these markets first will be critically important in international competition. Major shares will be cam tured by countries that have the needed national capability in research and personnel. AVAILABILITY OF BIOENGINEERING RESEARCH MANPOWER IN THE UNITED STATES Because bioengineering ~ a relatively new field, and one with great potential for research breakthroughs and commercial devel-

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BIOENGINEERING SYSTEMS 107 opment, there is a clear need for training young engineers who understand the major principles of biology, medicine, and other relevant scientific disciplines, and who can communicate readily with researchers in those fields. This human resource will develop only with long-term support for bioengineering research. Funding from NIH, NSF, and other government agencies must be stable, continuous, and sufficiently large to train and support an adequate number of new investigators in bioengineering. BIOMEDICAL ENGINEERING Although the total number of biomedical engineering graduate students in U.S. colleges and universities has increased by about 50 percent during the last 10 years, the number relative to all engi- neering graduate students has remained about the same.* Over the past decade, biomedical engineering students have averaged less than 2 percent of all engineering students enrolled in both master's programs and doctoral programs. Recent trends in enrollment of graduate students in biomedical engineering specifically show a relative increase in master's and a decrease in doctoral students. The decline in Ph.D. candidates may reflect a loss of students to medical schools or other engineering disciplines with competitive popularity or better research funding. Although Ph.D. biomedical engineers are the primary resource for future research in this field, they are not the only resource. In- terdisciplinary doctoral programs in biomedical engineering are relatively new. Indeed, most of the current leaders in the field are doctoral-level researchers in another engineering field (e.g., electri- cal, mechanical, chemical, or even civil) or in a medical speciality who became interested in applying their expertise to developing new knowledge, techniques, or equipment in the biomedical field. Often pairs of Ph.D. researchers with complementary, in-depth knowledge of engineering and medicine can offer an especially powerful capability for creative research In biomedical engineering when they work together on research of mutual interest. For this reason, the ability to understand and communicate with investi- gators in related areas of science and engineering is as important as formal interdisciplinary education in producing a pool of highly qualified bioengineering researchers. *According to calculations made by the panel, based on data published by the American Association of Engineering Societies over the period 1975- 1985. (See, for example, Engineering Manpower Commission, 1985.)

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108 DIRECTIONS IN ENGINEERING RESEARCH BIOCHEMICAL ENGINEERING Studies indicate that there are not enough biochemical re- search engineers in the United States today to meet existing needs. The Office of Technology Assessment (OTA) and the Committee on National Needs for Biomedical and Behavioral Personnel of the TOM surveyed the biotechnology industry in 1983 (Office of Technology Assessment, 1984~. The OTA-IOM survey found that more than 80 percent of the existing firms began operations in 1978 or later. About one-third reported shortages of Ph.D.s in one or more specialities. In bioprocess engineering, for example, 80 Ph.D.s were employed in the 138 firms reporting. They ex- pected an increase of over 50 percent in the following 18 months. Fewer than 20 departments of chemical engineering at U.S. universities and colleges have meaningful biochemical/biotechnol- ogy programs. Collectively, they are graduating fewer than 60 doc- toral and master's students* annually (National Research Council, 1984~. The annual need for graduate-level biochemical engineers over the next decade will average two or three times that num- ber. Moreover, biochemical engineering students need to have better exposure to the biological sciences to Improve their ability to manipulate and control cellular biosynthesis. They must also be taught the techniques and methods of the life sciences for solv- ing critical, large-scale bioprocess problems. Learning the "new" biology is important to improving the relationship between the life sciences and biotechnology. There are likely also to be shortages in the faculty needed to train biochemical engineers. Given the powerful allure of indus- try research in biotechnology, it cannot be expected that a large percentage of the few new doctoral graduates will join university faculties. Yet these are precisely the people who are needed to train tomorrow's researchers, because older faculty are not as con- versant with the new technologies or as likely to produce new ideas in research. There is little reason to expect that this situation will solve itself. Demographic studies show that the overall number of sci- ence and engineering students will decrease by 25 percent over the next IS years. The loss of tuition that this reduction represents will pose a financial strain on already hard-pressed universities. Many will probably respond by curtailing hiring and laboratory *Few of these students terminate their studies at the master's level. Most go on to obtain the doctorate.

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BIOENGINEERING SYSTEMS 109 improvements. Already the proportion of science and engineering faculty who are recent graduates has decreased from 40 percent in 1968 to 20 percent by 1980. An expanding program of research support (particularly for young investigators) is urgently needed to ensure that university bioengineering research continues to keep the United States in the forefront of knowledge in this field. Conclusions and Recommendations Despite significant advances in the biological and biomedical sciences in recent years, much remains to be learned from bioengi- neering research. Our basic understanding of biological systems and our ability to use that knowledge to produce economically products that can enhance the quality of life and permit the deliv- ery of better health care can be greatly furthered by such research. However, the focus of attention and funding for bioengineer- ing as opposed to biomedical science research in the U.S. gov- ernment is scattered among several agencies, as well as among different divisions and programs within those agencies. To date, little effort has been made to coordinate the work of those agencies and programs. One coordinating body established in the past has not been very active and consequently has been relatively ineffec- tive because, in the panel's judgment, it has not received sufficient support and attention from upper-level management in the par- ticipating federal agencies. Thus, the Pane} on Bioengineering Systems Research recommends that: The coordination of research programs in bioengineering throughout the federal government be improved and that the co- ordination include the relevant work of the NIH, NSF, NBS, and other agencies interested or involved in bioengineering research. To ensure its effectiveness, it is essential that this interagency cm ordinating effort receive the full recognition and support of upper management in each of the participating agencies. Similarly, there is little coordination of bioengineering research within those agencies that support most of the relevant research programs within the U.S. government. This is particularly true of

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110 DIRECTIONS IN ENGINEERING RESEARCH NIH, which has primary responsibility for biomedical and related research in the government. Thus, the pane! recommends that: . The coordination of bioengineering research within su p- porting agencies should also be improved. For example, NIH could create an "office of bioengineering research" to review and coordi- nate its investigations. Such an office would be one way to focus attention on the need for careful development of this important field. NSF has recently created six ERCs to promote cros~disciplin- ary studies and to encourage the more rapid implementation of research results into commercial products. One ERC focuses ex- clusively on biotechnology. Although NTH supports that center, it has not established similar centers for biomedical engineering research. Thus, the pane! recommends that: . NTH should give careful attention to the need for large- scale, focused research in biomedical engineering. To achieve the required scale, NTH should consider creating a center for such research, comparable in concept and size to the NSF's ERCs. As is true of the ERCs, any such center created by NIH should encourage links between academic research and clinical practice. There is demand for a wide spectrum of researchers across the different specialties of biomedical and biochern~cal engineer- ing. Certainly the demand for doctoral biochemical engineers in particular is now large and will increase. Because bioengineering is a relatively new field with great potential for research break- throughs and commercial development, there is a clear need for training young research engineers who understand the principles of biology, medicine, and other relevant scientific disciplines, and who can communicate readily with researchers in those fields. Therefore: . NIH and NSF should devote a greater share of their re- search budgets to supporting bioengineering programs at U.S. universities and colleges. NTH, in particular, should expand its programs that encourage medical students to go into research so as to include bioengineers as well. Stipends awarded for postdoc- toral study should be sufficiently high to offset the attractiveness of salaries offered by industry. Although it is understandable, too often government and in- dustry support of research at universities aims at achieving prac- tical results that can be turned into commercial products. This is

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BIOENGINEERING SYSTEMS 111 not to be discouraged, because the U.S. economy and competitive- ness in international markets require such efforts. Nevertheless, there is also a need for basic research that does not necessar- iTy lead to commercial products but, in the aggregate, creates the basis for practical results by increasing our understanding of biological systems. Thus, the Pane] on Bioengineering Systems Research recommends that: Those who rank and award grant proposals within NTH and NSF should consider funding research projects that have a great potential for significant results, but also a high risk of failure. The panel applauds the strong current trend in this direction at NSF. The need for a continuing study of bioengineering research programs and issues will not end with this panel's report or the work of the Engineering Research Board. The subject will be with us for many years to come. Thus, the Panel on Bioengineering Systems Research recommends that: . To ensure the long-term health of this commercially impor- tant field, an authoritative and permanent advisory body should be created. This body would assess bioengineering research oh portunities and needs, review the relevant research programs of NIH, NSF, and other government agencies, and identify needs for new programs or changes in direction. References Attinger, E. O. Impacts of the technological revolution on healthcare. IEEE Okay'. Biomcd Eng. BME-31:736~743, 1984. Culliton, B. NIH's role in biotechnology debated. Scicnec 229~4709~: 147-148. Drew, S. Biotechnology and the health care industry. In: Thc Now Engi- necr~ng Research Ccnicr~: Plane, Goals, and Expectations. Washington, DC: National Academy Press, 1985. Engineering Manpower Commission. Engineering and Technology Degrees, 1984. Part III: By Curriculum. Engineering Manpower Commission of the American Association of Engineering Societies, Inc., 1985. Holliman, W. J. Data on NIH research grants, supplied by Chief, Research and Documentation Section, Statistics and Analysis Branch, Division of Research Grants, NIH. March 18, 1985. Institute of Electrical and Electronics Engineers. An IEEE Opinion on Research Needs for Biomedical Engineering Systems. (rev.) Report of an IEEE task force to the Engineering Research Board. IEEE, March 3, 1985.

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112 DIRECTIONS IN ENGINEERING RESEARCH National Academy of Sciences. Report of the Research Briefing Panel on Chemical and Process Engineering for Biotechnology. Prepared by the Committee on Science, Engineering, and Public Policy for the Office of Science and Technology Policy. Washington, DC: National Academy Press, 1984. National Academy of Sciences. Injury in America: A Continuing Public Health Problem. Committee on Trauma Research of the Commission on Life Sciences of the National Research Council and the Institute of Medicine. Washington, DC: National Academy Press, 1985. National Center for Health Statistics. Advance report of final mortality statistics, 1980. Monthly Vital Statistics Report (Suppl.) 32~4), 1983. Office of Technology Assessment. Commercial Biotechnology: An Interna- tional Analysis (OTA-BA-219~. Washington, DC: Office of Technology Assessment, January 1984.

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BIOENGINEERING SYSTEMS Appendix Responses to the Engineering Research Board's Request for Assistance from Universities, Professional Societies, and Federal Agencies and Laboratories 113 Requests for assistance were sent by the Engineering Research Board to a number of universities, recipients of Presidential Young Investigator Awards, professional societies, and federal agencies and laboratories in order to obtain a broader view of engineering research opportunities, research policy needs, and the health of the research community. Some of the responses included comments on engineering research aspects of bioengineering systems; these responses were reviewed by the panel to aid in its deliberations. The panel found the responses helpful and wishes that it were possible to individually thank all those who took the time to make their views known. Because that is not practical, we hope that this, albeit small, acknowledgment conveys our gratitude. Responses on aspects of bioengineering systems research were received from individuab representing 47 different organizations, which are listed in Table A-1: 28 universities (including 6 rep- resented by recipients of NSF Presidential Young Investigator Awards), 12 professional organizations, and 7 federal agencies or laboratories. Some comments covered specific aspects of the panel's scope of activities, whereas others provided input on a variety of subjects. Although most of the responses addressed priority research needs, several respondents did touch on policy issues. Many of the research needs and policy and health issues addressed by the respondents were similar to those noted by pane! members. The broadened perspective provided by the responses to the survey was most beneficial in the panelts deliberations.

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114 DIRECTIONS IN ENGINEERING RESEARCH TABLE A-1 Organizations Responding to Information Requests Relevant to Bioengineering Systems Research UNIVERSITIES California Institute of Technology Case Western Reserve University Cornell University Johns Hopkins University Lehigh University North Carolina State University Northwestern University Oregon State University Purdue University Rensselaer Polytechnic Institute Rutgers University San Diego State University Syracuse University Texas A&M University University of California, Davis University of California, Los Angeles University of Georgia University of Illinois University of IllinoisUrbana/ Champaign University of Kansas University of Michigan University of Minnesota University of Pennsylvania University of Pittsburgh University of Rochester University of Texas at Austin University of Utah Wayne State University PROFESSIONAL ORGANIZATIONS American Chemical Society American Institute of Chemical Engineers American Society of Agricultural Engineers American Society of Civil Engineers American Society of Mechanical Engineers Biomedical Engineering Society Council for Chemical Research Institute of Industrial Engineers Industrial Research Institute Society of Engineering Science, Inc. The Institute of Electrical and Electronic Engineers, Inc. U.S. National Committee for Biomechanics AGENCIES AND LABORATORIES Air Force Office of Scientific Research Army Research Office NASA Goddard Space Flight Center NASA Jet Propulsion Laboratory NASA Langley Research Center Naval Research Laboratory Oak Ridge National Laboratory