PROCEEDINGS of the NATIONAL WORKSHOP ON BIOENGINEERING RESEARCH AND MANPOWER | DOCUMENTS DEPARTMENT CER 25 {gg ) LIBRARY {lo Me] 2 UNIVERSITY OF CALIFORNIA 1p] [el] 13 CHEMISTRY PHYSIOLOGY EIJI {d PHYSICS Th gn J bd MATHEMATICS SoRiC Ca BT: USPHS. Le. = U.S. DEPARTMENT OF HEALTH, EDUCATION, AND WELFARE US Public Health Service PHS pub#iess, For the past decade or more scientists trained in the analytical techniques of bioengineering have been making their colleagues in the medical and related biological sciences progressively more aware of the importance of systems analysis as a final stage in the exploration of any research area. The National Institutes of Health has watched this innovation with keen interest from the beginning, testified to by various adaptive decisions, from time to time, by one or another of the Institutes or Divisions. The Division of Research Grants, NIH, is happy to have played a part in bringing about the National Workshop on Bioengineering Research and Manpower, whose proceedings are covered in the following pages. by A. Confrey, «Ds Director, Division of Research Grants National Institutes of Health April 27, 1967 PROCEEDINGS of the NATIONAL WORKSHOP ON BIOENGINEERING RESEARCH AND MANPOWER Sponsored by the Division of Research Grants National Institutes of Health Bethesda, Maryland Philadelphia, Pennsylvania RICHARD J. GOWEN, Ph.D., CAPT., USAF Tenure Associate Professor Department of Electrical Engineering United States Air Force Academy Colorado 80840 Held at November 9, 1965 CO-EDITORS ERRETT C. ALBRITTON, M.D. Scientific Evaluation Section Division of Research Grants National Institutes of Health Bethesda, Maryland 20014 -aT. FO R SUBLIC | JEALTH Public Health Service Publication No. 1658 U.S. DEPARTMENT OF HEALTH, EDUCATION, AND WELFARE Public Health Service TABLE OF CONTENTS Resume of the Proceedings of the Workshop, with Comments — Richard J. Gowen, Ph.D. Chairman of the Workshop Schedule of the Workshop Opening Remarks — Eugene A. Confrey, Ph.D. Director, Division of Research Grants NIH Considerations that Led to the Workshop — Errett C. Albritton, M.D. NIH Project Officer for the Workshop Panel Discussion Questions Panel Members Panel Reports and Discussion Panel I, Victor W. Bolie, Ph.D., Chairman Panel II, Otto Schmitt, Ph.D., Chairman Panel III, Robert G. Allison, Ph.D., Chairman Panel IV, Richard J. Gowen, Ph.D., Chairman Panel V, Arley T. Bever, Ph.D., Chairman Summary and Closing Remarks, Arley T. Bever What next? — Richard J. Gowen List of Participants 11 TAG A / Na L 196 5 PUBLIC HEALTH LIBRARY {1 — po 11 13 15 17 19 31 49 57 71 82 83 85 RESUME OF THE PROCEEDINGS OF THE WORKSHOP, WITH COMMENTS by Richard J. Gowen, Ph.D., Captain, USAF Workshop Chairman Associate Professor of Electrical Engineering USAF Academy, Colorado Introductory: The National Workshop on Bioengineering and Manpower met on November 9, 1965, in Philadelphia, Pennsylvania, at the Sheraton Hotel. Forty-two participants were invited (p. 85 ff), including 31 panelists distributed into 5 panels, and 12 other participants. The workshop, sponsored by the Division of Research Grants, National Institutes of Health (NIH), addressed itself to the task of further sharpening the picture of what has been variously called an "emerging discipline in the biomedical sciences" and an "emerging specialty in the field of engineering." Selection of Participants: Since it was hoped to arrive at estimates meaningful for all bioengineering activities, it was decided to invite, as participants, not only distinguished scientists engaged in bioengineering research, but also representatives of the various professional organizations, of journals publishing bioengineering research and of governmental agencies interested in bioengineering. A list of the participants will be found on page 87 ff. Opening Remarks by Director, DRG, NIH: Dr. Eugene A. Confrey, Director of the Division of Research Grants, NIH, referred to bio- engineering in his opening remarks (p. 9) as "an evolving field of singular importance to biomedical research programs" and made clear his awareness of the ambiguous status of the field -- either to be regarded as a new and emerging engineering specialty, or as essentially a new entity, genetically part biomedical science and part engineering. He foresaw bioengineering as making an important future contribution to the solution of problems in health and med- icine, and already deeply involved in current biomedical research, via instrumentation, design and development of prostheses, the growing use of computers and the more recently recognized power of systems analysis. Dr. Confrey regarded as essential first steps the defining of the field, estimating the manpower and identifying some of the future expectations. Introductory Remarks by NIH's Project Officer for the Workshop: Dr. Albritton, NIH Project Officer for the Workshop, recently had the task of identifying all bioengineering research projects presently supported by the NIH and had found that unless an engineer was on the research team, or unless modeling or simulation happened to be men- tioned in the brief description of each project that was available, deciding whether a research was bioengineering or not was sometimes an impossibility. He emphasized the need for basic definitions or concise descriptions of (a) bioengineering research, (b) the research area in which it operates and (c) the research competence that marks the bioengineer as contrasted with the traditional physiologist or the life scientists in other fields. He anticipated that the research area would be identified as the entire panorama of the medical and re- lated biological sciences and that the peculiar contribution of the bioengineer would be identified as the quantitation or simulation of feedback control mechanisms (a) within an organism or an organism- environment complex, and (b) within mechanisms the bioengineer might design, e.g., to keep the organism operating at an optimal functional level. Panel I: The question assigned the panel was, "What is bio- engineering?" Their first approximation to an answer was: Bio- engineering is an interdisciplinary bridge between the engineering and biological sciences, with emphasis on the use of the technology~ of engineering to solve problems in the biological sciences. The most descriptive characterizations of bioengineering today are (a) the development of new knowledge in the biological sciences through engineering methods; (b) the investigation of biological problems using the techniques of engineering analysis; (c) the design and development of biologically-oriented instrumentation. The following definition encompasses the essential features of these characterizations: "Bioengineering is the application of engineering technology to the solution of problems in biology." The "engineering may be systems engineering, electrical and electronic, hydraulic, mechanical, civil, chemical, optical, radio- logic, nuclear, materials or psychological. The "technology" may be 1/ Both analytical and design. - 3 - the design and development of new or improved *hardware™ -- instruments and prostheses -- or may be the analytical techniques the engineer has command of, including analysis, modeling (e.g. computer simulation) or synthesis. The "problems" are the questions yet to be answered about living systems and the difficulties in de- sign and development yet to be overcome. The living systems range from reacting molecules, to mitochondria, to micro-organisms, up to man himself, and his environment. Panel II: The second panel was asked the question, "What are the types of research now supported in bioengineering? The question was answered with a 3-way classification of papers on the program of the ACEMB=': (a) bioengineering research in the domain of "theory" (modeling, etc.) -- 23%; (b) bioengineering "substantive" research (toward discovery of the "facts of nature") -- 27%, and (c) "applied bioengineering" (the application of engineering tech- nology toward design and development of biomedical instrumentation, etc.) -- 50%. An increase in the percentages of "(a)" and "(b)" may be looked for in the future. In more detail, bioengineering activities include: 1. "Theoretical" research in engineering sciences as useful to biology; biomathematics, mathematical modeling, basic engineering theory, transfer functions, systems analysis, control and communi- cation theory, computer technology; 2. Theoretical and factual research in the biological sciences: research in physiology and other disciplines into which engineering has penetrated substantially, and in disciplines (e.g., biochemistry) that are hardly touched, as yet, by engineering analytical techniques; 3. Design and development of communication and other facilities, based on research and biological systems (“bionics"); 4, Design and development of improved versions of the artificial heart and artificial kidney, artificial arms, and other needed re- placements or supplements of functioning parts of the human organism; 5. Design and development of hospital and other information and con- trol systems and of their component hardware; 6. Design and development of improved forms of certain instrumentation of extreme importance in biomedical research (e.g., more powerful electron microscope) and of instrumentation in general that is made use of in biomedical research and medical practice. 1/ 18th Annual Conference of Engineering in Medicine and Biology, at the same hotel, Nov. 10, 11, 12, 1965, Philadelphia, Pa. - bw 7. Research with new energy modalities that appear to have potential for use in either biomedical research or practice, such as lasers, ultra-sound, fiberoptics. 8. Teaching of bioengineering in both its research and design aspects. Serving as it does as a bridge between biology and engineering, it seems unlikely that bioengineering will emerge as an additional major sub-specialty of engineering. Bioengineers may be drawn from all the present branches of engineering, and will ultimately be active in the solution of problems in all the major biological sciences. It was felt that if bioengineering research is to receive the financial support necessary for its continued growth, there must be present, in the review of research proposals from the area, an aware- ness of what bioengineering is and what it can contribute. Panel III: The third panel was asked the question: "What can be expected from bioengineering?" The panel suggested as timely R & D objectives for the bioengineer, (1) development of ever more sophisticated analytical tools, for continuously deeper penetration and resolution of the almost incredible complexity of biological systems, (2) analysis of the growth and differentiation of the total organism, particularly as relates to biochemical genetics, (3) analysis of in- formation processing in the nervous system, (4) development of computer diagnostic programs, (5) of instrumentation for monitering patients or experimental subjects, so unobtrusive that the subjec! under observation can operate undisturbed in a real life situation, (6) development of life support systems for environmental extremes, and (7) of a "bloodless animal laboratory,™ with a computer as the "animal." A "bloodless man" could be used for human experimentation. Also open to bioengineers, a career in the training of life scientists and clinicians in the use of the analytical tools of the engineer, to enable them to become bio- engineers. The panel members also expressed the need for a better com- municating system for new developments in bioengineering. The day should be hastened when biomedical scientists are aware of the analytical technology that engineering is able to offer, and can themselves put it to use. Panel IV: The fourth panel was asked the question, "Can an estimate of bioengineering manpower be made?" The parel discussed the use of "bioengineering competence” as an identifying mcrk of a bio- engineer, a mark obviously necessary in attempting an estimate of bio- engineering manpower, The level of education attained in engineering or one of its branches, and in one of the biological sciences, might serve as an identifying mark. However, the relative weighting to create a well-trained bioengineer has yet to be determined. Another possible mark could be a professional certification of the individual (as a bioengineer) by a peer group, or peer-group evalu- ation of the individual's training. One such group has met to review the standards for NIH-supported biomedical training. Professional certification of the bioengineering competence of individuals is not foreseen for the near future, however. Whether or not an individual has bioengineering competence could be decided with assurance by consideration of what he has accomplished toward the solution of bioengineering problems. However, this involves a greater "in depth" examination than seems practicable in an attempt at a manpower estimate. The pilot questionnaire, developed by the chairman of the present workshop with the collaboration of the NIH project officer for the workshop -- to be made available to those attending the ACEMBL/ meeting beginning the next day -- should bring much nearer the selection of one or more identifying marks of a bioengineer for use in arriving at an estimate of bioengineering manpower. The dichotomy existing in bioengineering (as in medicine) between research and practice was referred to in this panel as in most of the others. There is an increasing need for both -- the bioengineer who can build things and the bioengineer equipped with broad basic concepts and competent in the area of functional analysis of biological systems. Training must be available for both. Panel V: The question assigned to the fifth panel was, ''Can the problems in future support of bioengineering research be identified?" The thinking on this question was dominated by concern that bioengineering research grant applications to a granting agency be assured informed and sympathetic evaluation. In the first place, bioengineering research proposals should be readily identifiable as such. Then peer judgment should be available for their evaluation. It was estimated that the required research support, per bioengineering project, would reach the level of $50,000 per annum in the near future. The life scientist must become more aware of the quantitative and analytical capabilities offered by engineering, and the engineers must learn more of the rich opportunities for quantitative and analytical exploration offered by the life sciences. This might be accomplished by providing an opportunity for interested engineers to have a period of internship or traineeship in a medical school. 1/ The 18th Annual Conference of Engineering in Medicine and Biology, November 10, 11, 12, 1965, Sheraton Hotel, Philadelphia. The question of financial support (e.g., fellowships) to complete the education of bioenginers who wish to go into instrumentation design and production is a serious one. Recruiting bioengineers to work in the area of design of hardware is difficult at best, inasmuch as most bio- engineers are trained in higher degree programs and thus often become oriented toward analysis rather than design. Accomplishments of the Workshop: The workshop arrived at consensus on Question I, "What is bioengineering?’ and (II) '"What are the types of research now supported in bioengineering?" A definition of bioengineering is, of course, basic before questions can be answered. A broad view of the activities included under the term is perhaps next in importance, and was formulated in answer to the second question. Little more than discussion was accomplished on Question III, "What can be expected from bioengineering?" It seems necessary that formulation be made of the benefits to the biological sciences to be expected from the introduction of engineering analytical techniques into biological research. The utter dependence of biological research on bioengineering design and development of instrumentation is already recognized. On Question IV, "Can an estimate of bioengineering manpower be made?" the workshop recognized that an identifying mark characterizing a bioengineer had to be found, and looked to the pilot questionnaire made available to those attending the ACEMBL/ as a first step in determining what the mark (or marks?) should be. On the last question (V), "Can the problems in future support for bioengineering research be identified?,'" the workshop considered the need of peer judgment in the evaluation of research grant applications as a problem of perhaps greatest importance. Acknowledgments: Grateful acknowledgment is made to the scientists and other representatives of bioengineering interests who gave of their time and thinking to make the workshop possible, and to all others who participated or were involved. 1/ 18th Annual Conference of Engineering in Medicine and Biology, November 10, 11, 12, 1965, Sheraton Hotel, Philadelphia. 10: 10: 10: 11: 11: : 30 1 45 : 00 00 20 50 10 40 : 15 +35 : 05 125 115 335 : 05 : 20 SCHEDULE OF THE WORKSHOP Opening Remarks - Doctor Eugene A. Confrey, Director, Division of Research Grants, NIH What Led Up to This? - Doctor Errett C. Albritton, Chief, Office of Research Accomplishments, NIH Panel Organization Sessions Panel 1 Open Discussion - Panel I Panel II Open Discussion - Panel II Lunch Panel III Open Discussion - Panel III Panel IV Panel 1V Open Discussion Panel V Open Discussion - Panel V Summary and Closing Remarks - Doctor Arley T. Bever, Associate Director for Research Analysis and Evaluation, Division of Research Grants, NIH What Next? - Doctor Richard J. Gowen, USAF Academy; Workshop General Chairman - 9 = OPENING REMARKS by Eugene A. Confrey, Ph.D. Director, Division of Research Grants NIH, PHS, DHEW In view of the limited time available for your deliberation of some complex and difficult issues, I hasten to assure you that I do not intend to burden you with a prolix speech. I should like to say, however, that the Division of Research Grants is indeed pleased to be able to sponsor this workshop on bioengineering, an evolving field of singular importance to biomedical research programs. Certainly Captain Gowen and Drs. Bever and Albritton deserve special commendation for their efforts to organize what promises to be a lively and useful session. I use the term "lively" because I am aware of divergent opinions among you on such matters as this: whether the concept of "bioengineering" should be viewed simply as classical engineering expertise -- e.g., mechanical engineering, electrical engineering -- applied to biological problems, or whether the juxtaposition of the two disciplines -- engineering and the biomedical sciences -- involves certain new characteristics, requiring specialized, restructured training and education. The Public Health Service, especially the National Institutes of Health, is particularly concerned with the development of bio- engineering activities and the utilization of engineering talent toward the solution of some perplexing problems in health and medicine. I am confident that, when I say this, I speak not only for my colleagues from NIH here today, but for the Director of NIH as well. The reasons for our interest should be apparent from even a superficial examination of what is happening in current biomedical research: the prominent role of instrumentation, such as cardiac pacemakers; of engineering techniques, such as computers; of engineering concepts, such as systems analysis. All of you are aware of NIH's involvement with such projects as the development of an artificial heart and an artificial kidney. There are additional reasons for DRG's interest, more provincial, perhaps, but relating to important operational responsibilities. To illustrate: when we expect our data retrieval system to indicate the amount and type of grant support in "bioengineering', a prior exercise - 10 - Opening remarks (cont.) in classification and subclassification is presupposed, When we consider the caliber of our grant review mechanism for determining the technical merit of bioengineering research proposals, the organ- ization and composition of study sections and committees requires scrutiny. This may be the time to propose the establishment of study sections and committees exclusively engaged with bioengineering. But there is work to be done first: defining the field, estimating the manpower, identifying some of the expectations. These problems are part of the charge to which you will address yourselves today. I sincerely thank you for your interest in the workshop and wish you well in your discussion, ww 11 = INTRODUCTION by Errett C. Albritton, M. D. Division of Research Grants NIH, PHS,DHEW Recently I attempted a survey of all bioengineering research projects currently supported by NIH. Such information is easy to obtain about almost any research area one could name, for the Division of Research Grants publishes each year an index of subject areas of NIH-supported research. In the case of bioengineering research, however, the compilers of the Grants Index were able to identify only a compara- tive few research projects as bioengineering. Such research can occur in any one of the medical and related sciences, but, in the absence of some identifying mark pointing to bioengineering, its special nature cannot be recognized. Aside from projects in which an engineer was a member of the research team and projects in which the descriptive abstract of the purposes of the project included mention of simulation or modeling, a large number of research projects that might have been included in the survey figures had to go into a doubtful category, or be left out altogether, The frustration in this attempted survey has been one factor that has led to this workshop. Your chairman today, Captain Gowen, was aware of the difficulty I have mentioned and was in emphatic agreement that the time was ripe for an attempt not only to define what bioengineering research was and the area in which it operated, but also to try to find and agree upon some identifying mark that was always present in the bioengineer doing research in, say, physiology, but missing in the life scientist working beside him. Engineers are in- creasingly being incorporated into life-science research teams and increasingly heading life-science research teams. What is the ''some- thing that has been added" to the previously existing biological research competence? This we want to know. You will recognize that I am talking exclusively about the added competence furnished to life-science research by engineering training, not whatever it may be that the engineer needs, to engage in life-science research. It would seem that what must be added to make an engineer into a life scientist is merely knowledge of the properties of the material he “ 12 = is to work with, and this is no new requirement for an engineer. Living material is a complex of many interrelated feedback systems, one or another of which the engineer must become acquainted with if he is to be doing bioengineering research. The physiologist has dealt with feedback systems since the days of Claude Bernard, the originator of the concept of homeostasis, but he cannot quantitate at this level. I believe it is here that the mark of the engineer will be found; that the ability to quantitate these systems the biologist has been working with so long is the peculiar competence routinely trained into the scientist who achieves an engineering degree. This competence is needed whether the bioengineer is studying systems already devised and active -- those operative in a living organism or in an organism-environment complex -- or is himself devising a system (mechanism) to serve an organism (e.g., man), either directly (artificial kidney) or indirectly (sewage disposal system; hospital telemetering system), and keep the organism functional at an average or optimal level. PANEL TI - PANEL II - PANEL III - PANEL IV - PANEL V - PANEL DISCUSSION QUESTIONS What is "bioengineering?" a. What is the area of interest? b. What are the disciplines which bound the area of "bioengineering?" c. Is a definition or concise description of "bioengineering" possible? If so, what is it? What are the types of research now supported in "bioengineering?" a. In engineering research? b. In life science research? c. In instrumentation development (versus application)? d. Is there any research in progress in "bioengineering" that is not directly related to perhaps more "classical" disciplines? What can be expected from "bioengineering?" a. New or improved life science technology? b. New or improved engineering technology? c. What can be done to improve the interchange of new concepts, techniques and devices? Can an estimate of "bioengineering' manpower be made? a. How do you determine if a person is a "bioengineer?" b. How do you establish competency in "bioengineering?" c. Is a national '"bioengineering' survey necessary? Can the problems in future support for '"bioengineering' research be identified? - 15 = PANEL MEMBERS Panel I - Chairman - Victor W. Bolie James F., Dickson Samuel A. Talbot Francis J. Hassler Homer Warner Saul D. Larks Panel II - Chairman - Otto H. Schmitt Carl Berkley Newman Hall John H., U. Brown Lloyd E. Slater David Fleming Thomas B. Weber Panel III - Chairman - Robert D., Allison Francis M. Long Richard Thackray John H. McLeod Robert E. Robards Panel IV - Chairman - Richard J. Gowen Gilbert B. Devey Robert L. Schoenfield Edward J. McLaughlin Lawrence Stark Lawrence M. Patrick Panel V - Chairman - Arley T. Bever William W. Akers Wayne E. Springer Dean Franklin Jan A. J. Stolwijk John E. Jacobs NOTE: For institutional affiliation and other information see p. 87ff. - 17 = TRANSCRIPTS OF THE PANEL SESSIONS Report of Panel I Chairman, Dre Victor W. Bolie: As Dr. Gowen pointed out, we will attempt to arrive at some delineation of the problem of "What is Bioengineering?'" We have about three minutes apiece for making our comments. Dr. Larks would you like to lead off? Dr. Larks: I wrote to Captain Gowen and presented the following suggested definition for our consideration: '*Bioengineering is the physical mathematical study of living phenomena and systems at organ and higher levels." In regard to its relationship with neighboring disci- plines, biophysics has tended to concentrate on molecular and sub- molecular levels, whereas bioengineering has concerned itself with organs, organisms, and environment. A long time ago, bioengineering could have been described as the '"Mapplications'" of engineering, but bioengineering today 1s able to make real contributions to basic knowledge, not merely "applications.'"™ Another word necessary in an understanding of what bioengineering is today 1s '"solutionji' we seek solutions of problems. Like the mathematician, like the physicist, we would like to arrive at elegant solutions, but we do not shrink from solutions that are slightly less than elegant. We strive for a solution, period. Dr. Warner: We should make our definition of bioengineering broad enough to include all aspects of engineering as applied to the study of living systems. To recognize that bioengineering applies the engineering approach to the study of living systems does not degrade bioengineering. It is true of any scientific discipline that information from many other fields is applied to the study of that particular discipline. By such application new fundamental insight is always gained. This word "applied" should be part of the definition; that is, applying the techniques from engineering to the study of living systems. Also keep the definition as broad as possible in terms of what we mean by engineering techniques. Dr. Dickson: I concur with Dr. Warner's comments, and beyond that would like to yield to Dr. Talbot. ~ ZO = Panel I (cont.) Dr. Talbot: I, too, am in agreement with Dr. Warner -- and with Dr. Larks, before him -- but I would like to fill in a little more detail. As engi- neering schools have gotten in this field in the last four or five years, there has been a tendency for interest in the schools to be centered on time-dependent problems; electrical engineering problems in which dif- ferential equations with respect to time are primarily involved. This indeed is perhaps the richest and most active area of biomedical engineer- ing at the present time. However, I do think there are many other variables in biomedical engineering besides those involving differential equations with respect to time. Chemical engineers seem to have had a hard job getting into the picture, and there is a certain amount of resistance to mechanical engineers. Even systems engineers have had a hard job getting established in engineering schools because they wouldn't tie themselves to the existing engineering disciplines. They tended to get off into such things as economic and sociologic systems, because that is systems engineering, per se. I think systems engineers have much to contribute to biomedical engineering. Living systems seem not to have learned, as yet, to recognize the distinctions between electrical, mechanical, fluid and other kinds of engineering. Living systems involve all of them all at once. Biomedical engineering needs to be defined broadly enough to include all of them -- electrical, mechanical, civil, chemical, optical, and radiologic engineering. Materials engineering should not be over- looked. It is an extremely important field and has little to do with differential equations -- but a tremendous lot to do with non-linear systems. Systems for which, in fact, the mathematics has not yet been developed because they are so extremely complex. Nevertheless, materials engineering can be handled analytically with computers, which do not need explicit mathematics. Nuclear engineering should also be included. The application of its techniques and theory has already given access to a great many of the elementary processes, such as nuclear activation. The engineering aspects of interpersonal relations belongs in the definition. Some of it is to be found in industrial engineering and some in psychological engineering. Interpersonal relations in hospitals is an important example. It will tie in with patient monitoring and with the whole design and organization of the hospitals and hospital fac- ilities. Psychological engineering is important, also,in the engineering w TY Panel I (cont.) of humans under mental stress and physical stress. Our definition should be uninfluenced by any thought of this or that granting agency -- as NIH, NSF, NASA, or the Department of Agricul- ture -- and the engineering techniques they are especially interested in. The whole breadth of engineering science, with very few exceptions, can be applied to the study of biological systems, This is point one. Also biological engineering should not be limited to considerations of only organs and systems, but should include intracellular feedback mechanisms involving mitochondria and even molecules. I think that the future is going to see a quantitative relationship established between thought processes, cognition, psychocentric processes, and neurological processes. I want to get away from definitions a moment to give some advice to the bioengineer. The bioengineer can make applications of systems analysis in other dimensions than time. In the visual system there is a tremendously interesting interchange of temporal and spatial variables (in brain function) that even electrical engineering has little to say about. The bioengineer can even work with data in which the mechanisms are completely unknown -- through multivariate statistical processes. The engineer, with his strong background in multivariate mathematics, can make use of the matrix and vector formulations of statistics and make them a powerful tool in medical research. Particularly if he is willing to study the biological systems so he comes to understand them as deeply as the medical scientist does. Another aspect of engineering which has forced itself upon me recently has been the emphasis that engineering places (as Homer Warner and Victor W. Bolie have both pointed out) on the solution of problems in terms of getting the job done, and done optimally. In other words, the engineer is an expert in brinksmanship. He seeks a solution, however close he may have to come to failure. The best engineering takes account of both costs and optimal performance -- but no better than optimal. That is, optimal with respect to this, optimal with respect to that, optimal with respect to utilization of personnel, optimal with respect to the minimization of communication channels needed, optimal with respect to the orthogonality of the variables -- not using any that overlap one another. This kind of engineering, working on the good side of failure, is top engineering. The medical scientist often has to work on the bad side of failure. He has to be interested in failure mechanisms, and for this reason, the medical aspect of bioengineering is extremely important. Chairman: Thank you, Dr. Talbot. We've run out of time, and we haven't fully agreed on the answer to the question. We do have a definition, which we are not totally agreed on, which is that: bioengineering (or - 22 - Panel 1 (cont.) biomedical engineering) is the application of engineering sciences and practices to the solution of the problems of living systems. This brings us to the question period for this panel. May I ask Dr. Talbot to re- summarize the areas that you feel are within bioengineering that are not included in conventional biophysics. Dr, Talbot: Dr. Bolie has asked me to do this, I am sure, because he knows I started off as a biophysicist., Engineering has created several new physical sciences in the last twenty years, which are not to be found in physics curriculums. One of these is the field of systems per se. A science of systems quite apart from control. A science of interaction, such as the flow diagram; the way that coupled and linked systems are coupled and linked; the exact nature of these couplings and linkages -- quite apart from the whole area of control. The engineer differs from the physicist in that he asks "What is this designed for?" I doubt if the physicist would ask the question, '"What is a particular mechanism for?'"" He asks how it works, but not why it is the way it is. The engineer is very much purpose-oriented in his design and differs basically from the physicist in his understanding of purpose and his ability to be illuminated by purpose as found by evolution. Engineering has made great use of open systems, that is, systems which have considerable flow. And in the flow, the study of energy and entropy has been developed to a much higher extent in engineering than in physics. Elementary open systems and their basic understanding have been developed by physicists. However, I think the major applications of open systems have come through engineer- ing. Chairman: Thank you, Dr. Talbot. So the panel feels that there are definite distinctions between biophysics and bioengineering. May we now have any comments or questions from the audience? Dr. Confrey: I had the opportunity to sit in on the workshop session of this panel group and it was, as predicted, a very lively one, I need not tell you that I am not an engineer by training, but found the session, nonethe- less, both enlightening and stimulating. What the panel was engaged in was an attempt to plot the logical geography of a few terms and concepts. ~ 23 ~- Panel I (cont.) This was not merely an exercise in semantics. It was concerned with something a bit deeper than terminology per se. Actually the definitions proposed were stipulative definitions. That is to say, proposals to use terms in certain ways. I trust that we are not engaged today in a search for any metaphysical '"real' definitions, but are willing to accept de- finitions on the basis of their usefulness. The next question is: Use- ful for what purpose? And as you examine the different proposals, you find linguistic advantages, and disadvantages in each proposal. If one uses a very broad definition of bioengineering one doesn't know what to exclude. It's too liberal. Any work on developing plastics would have to be included because it might have some application to development of an artificial heart, say, and this of course relates it to the field of medicine. On the other hand, if the definition of bioengineer- ing is too narrow -- such as restricting it to biomedicine -- then it may exclude some activities that are germane. The key to all this, in my judgment, is: Definitions for what purpose? One purpose that was identified in the course of the panel deliberations was, '"What is the relationship to support from NIH?" NIH's charge is to support meritorious research that has health-relatedness. As I commented in the course of the panel discussion, happily we have the opportunity to interpret what is "health-related." If you are thinking of NIH, this is one possible purpose, If you are thinking of a broader charge, including what other agencies support, then this is a different purpose. If you are thinking of putting a label on a student in a graduate school, and knowing what a bioengineer is when he comes out after he completes his training, then this is still another purpose. But all of these are stipulative definitions, and one has to identify the purposes for which they are advanced. Chairman: Thank you, Dr. Confrey. Are there any other comments or questions? Br. Weber: I think these terms are relatively meaningless if you don't put them in context. In the discussion so far the terms bioengineer, bio- medical engineer, biophysicist, systems engineer, biomathematician, and physiologist have been used somewhat interchangeably. We try to define what is the difference between a biophysicist and a bioengineer, but I wonder if it is really important. As a biochemist I might think it im- portant to define the difference between the biochemist and the bio- engineer, and the physiologist might think the same about his discipline. But semantics can disrupt our whole creative process here today. - Ol = Panel 1 (cont,) Dr. Fleming: Panel I was asked, I believe, to answer, if it could, what is bioengineering? Can we identify a constellation of attributes that we would consider to be germane to the core of bioengineering? I think there is no disagreement among us that bioengineering spills out into a whole host of fields. It tends to interact with almost the entirety of the physical sciences and also, in its entirety, with the biological sciences. Therefore I ask again, particularly of those of us who have been engaged in the problem of training, can we think of a general con- stellation of attributes which we would consider germane to the core of bioengineering, excluding all the factors found only in its interactions with one or another of these other fields? Chairman: The interaction with other fields -- also referred to by Dr. Talbot =-- is illustrated by the connections our Joint Committee on Engineering in Medicine and Biology has, including the Instrument Society of America, The American Society of Mechanical Engineers, and the American Institute of Electrical and Electronic Engineers. In another year, I hope, our chemical engineering colleagues will be joining with us, They have done some outstanding work as you well know in the field of bioengineering. But I shall ask Dr. Warner to take your question about a constellation of attributes at the core of bioengineering. Dr, Warner: In several medical schools around the country the departments of physiology are labeled departments of biophysics and physiology, or of physiology and biophysics. The motivation seems to be that they want to emphasize that they're doing quantitative physiology. Two years ago we ourselves set up a department in which we wanted to do bioengineering, or quantitative physiology, if you will. We wanted a name for it, and I consulted Otto Schmitt and we finally named it the department of bio- physics and bioengineering. We chose this instead of just bioengineering, because we wanted to emphasize that our Ph.D. graduates were going to be really well trained in the physiological and the biological aspects of bioengineering and would not be primarily engineers and only dabbling in physiology. In defining bioengineering maybe it would be simpler to pick out a crew of people we know are bioengineers and start from there. In the course of time the definition will take care of itself: the people - 25 Panel I (cont.) whom we now label bioengineers will, through their own activity, define what a bioengineer is. Chairman: Dr. Larks, do you have something to say on the question? Dr. Larks: Yes, on the constellation of attributes, what it means to be a bioengineer. Suppose an individual is given the responsibility of considering what health care should be, fifty years from now. This is a good bioengineering task. As an engineer he would begin asking: What are the contemplated services? What are the flow patterns? How much does it cost? What is the economy? But also, he would have to know what the end product is going to be. He has to know both the biology and the engineering -- as well as is humanly possible in the same individual. He would not be thinking in terms of just a modified hospital, larger and larger in one complex. He would have a much larger view of the ways health service can be brought to the people. Perhaps people will not go to hospitals at all except for surgery or specific things like that, but care will be given in the homes, with telemetry back to a central point. This is the kind of bioengineering I would like to see develop. Now, very briefly on another aspect. A very large part of everything we call biology is bioelectricity. Yet the electrical engineer doesn't consider that his world. The electrical engineer of the future should be concerned with all the phenomena of electricity in our world, both living and non-living. They will be at home in the world of electricity as no one else can. Chairman: Dr. Hassler, do you have any comments? - 26 - Panel I (cont.) Dr. Hassler: The engineer faces the challenge "to make things work." It's therefore up to him to use any methodology whatever, even of the greatest sophistication. He should also have the prerogative to ask the questions that other disciplines are better prepared to answer, in the specifics needed in his approach to optimize his designs. The plant pathologists have done this. To accomplish their purpose, to control plant disease, they have had to become geneticists or plant breeders to develop plants with disease resistance, and thus accomplish the solution of their problem. Agricultural engineering is broadening into biological engineering. Its methodology is applicable beyond the limits of agricultural productions. It seems to be a common approach to inte- grate a number of technical specialties with the other sciences, I fore- see that this is the direction that we in engineering are going, as we approach the general area of life science. Dr. Schmitt: May I add systems design to the telltales we have been using to define bioengineers? Shouldn't systems design be included in the tell- tales of a bioengineer? It seems to me that a knowledge of systems is an essential for a bioengineer, just as he needs to know a little about algebra or a little bit about arithmetic. Presumably we are all knowledgable about generating and using theoretical algorithms. Why aren't we devising a few more or less orthogonal components? As an example, devising a three component product and saying this is the degree of bioengineering-ness of this man, or of this project. I haven't heard a single approach to a quantitative specification in our discussion. Why can't we be quantitative -- indeed bioengineering -- about it? Chairman: I think Dr. Talbot, when he spoke, covered a lot of that, Dr. Schmitt. He mentioned systems engineering and chemical engineering, you remember, These and others have a host of attributes that all of us will buy as acceptable material. Now, Dr. Lowenberg, may we hear from you? - 37 = Panel I (cont.) Dr. Lowenberg: We can't do with bioengineering as we would do with regard to arriving at some structure, specifying certain properties -- you either have those properties or you don't. You can't even define engineers. Would you use licensing as a basis? Degree as a basis? The type of work,gs a basis? If it is college degree, who accredited it? Does ECPD~" accredit bioengineering degrees? This problem will be solved only when there are enough bioengineers so that you won't worry about the fringe of people who can't be identified. There are people in engineer- ing whose identification -- whether they belong to the class of engineers or to the class of engineering technicians -- is questionable. The same thing will be true in bioengineering, and this will resolve itself only with time, Chairman: Some years ago, when I was heading the Iowa State program, we formulated and presented before the San Diego Conference on Bioengineering a list of minimum attributes to get through a bioengineering training program. It was published in their Proceedings, in 1961, or about that time. Dr. Frommer, do you have any comments? Dr. Frommer: I regard biomedical engineering as simply the application of engineering technology to problems in biology. To include in the definition the difference between a bioengineer and, say, a biophysicist is a rather impossible undertaking. It is like trying to separate, by definition, a neurophysiologist from a neuroanatomist. The same individual can be both. A particular endeavor encompassed in the field of medicine can be spoken of as bioengineering, or it may be spoken of as physiology, and so on down the line. I think the effort to split it up and categorize it so you punch only one card, one box in an IBM card, is futile, yet that's what we seem to be trying to do here. Chairman: I agree. And you, Dr. Goodman? 1/ Engineering Council for Professional Development. - 28 - Panel I (cont.) Dr. Goodman: Bioengineering can be defined as the application of the methodology and technology of the physical sciences and engineering to problems in the context of the living system. I would like to emphasize the words application and technology in contrast to some of the sympathies, empathies, and expressions of people on the panel and others who are a bit too strongly devoted to trying to define bioengineering in terms of a man's research capabilities. I would like to see more emphasis on hardware. Therefore, I stress application and technology. Chairman: Again, I agree. Now Dr. Akers, your turn. Dr. Akers: I'd like to speak from the basis of a traditional engineer with years of ECPDL/ background. The essence of engineering is design. That's straight out of the ECPD manual. Engineering is the application of science to man's benefit. Engineering is design, it is application, it's not engineering science. The bioengineer therefore might make the application to biological systems or biological sciences, but I'd like to emphasize that the essence of engineering is design. Chairman: Good point from a real pro engineer. Mr. Harte: In a dynamic and rapidly moving field, a definition is likely to change with time. The biochemists have been striving for the past sixty years to get a definition of biochemistry. The most recent definition -- biochemistry is what biochemists do today. I've tried my hand at making a definition of bioengineering: Bioengineering is the application of existing technologies and the development of new technologies, to develop ways for modifying the interaction between biological systems and their environments. 1l/ Engineering Council for Professional Development. - 29 =~ Panel I (cont.) Chairman: Thank you. We have arrived at what is certainly close to a consensus. Our time is now up. I want to thank the members of the panel: Dr. Hassler, Dr. Larks, Dr. Warner, Dr. Dickson, and Dr, Talbot for their contribution and sufferance, and you folks as well. Particularly I want to thank Dr. Gowen and Dr. Albritton for the hard work they have done in organizing this workshop. I personally believe that this sort of thing is needed on a bi-annual or tri-annual basis to reassess where we are going. - 31 = Report of Panel II Chairman, Dr. Otto Schmitt: I should like to begin by making a general statement and then ask the panel members to strengthen this statement or to point out any disparity of opinion, Our charge was to determine what are the types of research now being supported in bioengineering. The answer to this is determined by how you define bioengineering. There seems to be an almost unanimous feeling that one is not a bioengineer unless he is able to devise a quantitative theoretical model upon which to base his work; he must work with empirical fact, and must be able to apply engineering techniques to the solution of life-science problems, Let me propose titles for these three activities. They are (1) theory, (2) substantative knowledge and (3) technology and instrumentation, Any bioengineer knows and uses some theory. He will probably not be a specialist in theory alone, except in certain limited areas, or you would be likely to call him a biophysicist. You'll probably call him a biomathematician if he is capable purely in theory. If he is totally "substantive' -- absorbed in getting facts about nature -- this is the primary interest of a biologist rather than of a bioengineer, although many bioengineers are very closely associated with problems of getting facts about nature, If he is concerned with technology of instrumentation, it is very likely that he may be classified as a bioengineer, I took the troub 9 to separate, as best I could, the papers to be presented at this ACEMB—' Meeting, using the broad titles, and came up with the following count: forty-one of these papers are essentially theory; fifty are essentially substantive, and eighty-three are essentially technology and instrumentation, This distribution is, I believe, represent- ative of bioengineers at large, Dr. Brown of NIH is an expert on what is actually being supported by NIH under the title bioengineering and he points out that NIH is supporting very little research under the name bioengineering. I believe, however, that NIH must be supporting a good deal of bioengineering research and there is a feeling that much more might, and legitimately should, be supported. I should like to compare the mechanism for determining support of bioengineer- ing research -- compare it with a filter that lets the good bioengineering re- search projects pass through as the filtrate. If the filter should happen to be unsuitable, very little filtrate may go through. Let me picture a highly 1/ 18th Annual Conference of Engineers in Medicine and Biology Panel II (cont.) unsuitable filter. It is for, say, a2 biophysicist to examine all bio- engineering projects and pass only those in which the biophysics is good biophysics; then an electrical or some other engineer examines what is left and passes only those in which the engineering, in his judgment, is good engineering and finally for a medical person to examine what is left and pass only those in which the medicine is good medicine. One can build a filter this way that will indeed pass a few projects that are good bio- engineering, but it will hold back the majority of things that are legiti- mately bioengineering. This is one reason bioengineering has to be recogn- ized as an emerging major focus and has to be given a name and a reality with a filter designed for it, rather than one cobbled up out of auxiliary concepts. We have said relatively little about what isn't bioengineering, and you remember that good definitions include not only what is, but may also give a little attention to what isn't. There is, for example, a great deal of physiology research that is not bioengineering, and a good deal of taxonomy, yet there are areas of taxonomy that are very fine fields for bio- engineering research and development. I do not accept the idea that bio- engineering does not include bioengineering science. May I now call on Dr. Brown? Dr, Brown: I think there is no question that NIH supports a good deal of biomedical engineering. I think we support it in a variety of contexts, because, in a sense, this is the way the money comes to us. As a concrete example, it is very easy for the Heart Institute to support a problem on devising an artificial heart. It is very easy for the Neurological Institute to support nerve network studies. It is very easy for the Cancer Institute to study the perfusion of organs, and so on, and so on, and so on. As a result, each of these programs which may legitimately be bio- medical engineering in its own right, is divided up among the various institutes. The programs which cannot be assigned to a specific categor- ical institute, such as biomathematics, mathematical modeling, material sciences, computer technology, engineering, basic engineering theory, the study of transfer functions, the systems, and systems controls, and so on, fall together in a box which is actually labeled biomedical engineering and happens to fall into the National Institute of General Medical Sciences. - 33 - Panel II (cont.) I should add that NIH has been supporting physiological research and research in other disciplines in which engineering analytical tech- niques are made use of, and will undoubtedly support bioengineering re- search in other disciplines (e.g., biochemistry) that have had little or no exposure, as yet, to the analytical techniques of the engineer, The evaluation of bioengineering research proposals is another matter but I think you can see that the support of such research depends on where legitimately the right interest falls -- for example, does the study of artificial hearts fall more logically under the study of cardio- vascular phenomena or under the study of biomedical engineering? I think this is the question that has to be resolved and it is a semantic question that must be solved on both a political and scientific basis. Chairman: We're all familiar with research proposals that turn up for evaluation -- let us say,gt NIH -- that could very rationally be referred to the BBC Study Sectiom' or that could be referred to the Physiology Study Section, or that could be dispatched to the Cardiovasular Study Section, or that could be dispatched to the Computer Study Section. Where it goes makes a great difference in the fate of a grant application. Should it not be possible, for things that are central to bioengineering to be dis- patched to a Bioengineering Study Section? Dr. Brown: It is possible, but it is necessary to make clear the basic aim in the proposed research. If, for example, you are studying cardiovascular physiology, and you are using engineering as a means of getting at the physiology, perhaps this is cardiovascular physiology. But if you are looking for biomedical engineering as such, you should say so. Chairman: And if you are using cardiology as a way of implementing, of demonstrating, or utilizing engineering techniques, is this then bio- engineering? 1/ Biophysical and Biophysical Chemistry Study Section Panel II (cont.) Dr. Brown: Now you are getting into a point that gets into a gray area. Dr, Fleming: In engineering, there are three somewhat interrelated, but perhaps orthogonal problems: first, analysis, succeeded by synthesis, and finally implementation. Whatever the engineering undertaking -- suppose it is a comprehensive NIH program to develop an artificial heart -- the program can- not succeed if the basic scientific information which is necessary to bring about the design or synthesis does not exist. And only when these phases are completed can the program proceed to implementation, the "fruition" of the system in terms of the industrial development, and the medical or bio- logical applications. After the end of World War II, physics was found lacking and engineer- ing was faced with the problem of developing its own science, the beginning of the scientific development of engineering. The mother of engineering was technology. And the technology came out of the industrial applications, or the applications of society. In early medicine, a doctor was first a healer, who finally went to school. When licenses to practice came to be required, going to school got you licensure. The same thing is true in engineering. Getting the degree or getting the title o professional engineer is in a sense an equivalent, and certainly the ECCP= and the Association of Medical Colleges fulfill similar roles, I would like to stress the point that engineering has these three orthogonal aspects: analysis, synthesis and implementation. Chairman: These are not merely orthogonal, but very appropriately, are dif- ferent cuts. Let me now call on Carl Berkley. 1/ Engineering Concepts Curriculum Project - 35 - Panel II (cont.) Mr, Berkley: Doing my homework on the question of what types of research are now supported in engineering, I went to the NIH Research Grants Index, and looked up "biomedical engineering," and found six projects, all dealing with the engineering design of hospitals, wiring, making operating room suites explosion-proof, and that sort of thing, Under biomedical engineer- ing there were also references to a few other categories, like instrumentation. And I looked up instrumentation, and I was very sympathetic with Dr. Albrit- ton's remarks, because I found six pages of stuff which I had hoped to photo- copy for the panel, but this was too much of a job, Practically everything that should have been identified as biomedical engineering was listed under biomedical instrumentation. The result is that there really isn't any good understanding in the whole scientific community of what one is doing when he is doing biomedical engineering, There is some disagreement among the members of the panel as to how far instrumentation development really constitutes biomedical engineering, and this perhaps is worth a session entirely of its own. To give you an example, there is a strong feeling in some parts that instrumentation as such should not be supported by NIH and I think this is a shame. This means that if someone has an idea to do something very sorely needed, such as to double the resolution of the electron microscope and thereby enable us to see molecules if they are frozen in place, he couldn't get an application approved for this unless he joined with, say a dentist as the principal investigator, and entitled the project, "A study of the calcification of tooth enamel." Chairman: We can cite an example on the contrary to that in NIH. Mr. Berkley: Oh, I'm sure you can, but we also have another difficulty, the difficulty that a bioengineering problem may not be related to just one of the disciplines, but may be related to several or all of the other disciplines. For example, an artificial heart project would require a power engineer, interested in fractional horsepower motors and in doing the kind of optimization of the pumping that Dr. Talbot talked about; - 36 = Panel II (cont.) would also call for a materials specialist interested in molecular design; also an immunologist to tackle any problems arising from the immunology of some of the materials that are used; also a physical chemist, interested in surface properties; a hematologist aware of the interactions between the materials used and the clotting properties of blood; also possibly a neurologist who understands what the neurological implications are of tran- secting the aorta with its neural control and the musculature involved. It should probably include a plastics fabrication specialist, and a metal- lurgical engineer, and finally the kind of mechanical engineer who has to put the patient and the thing together, who is nowadays called a surgeon. So more than one discipline can be involved in a bioengineering problem and it may not be possible to assign it to just one, Chairman: Would you care to say a few words, Mr. Slater? Mr. Slater: I'd like to suggest that the NIH might find it advantageous to set up a special extramural program in biomedical engineering, title or definition notwithstanding. As Dr. Brown ,pointed out, the various institutes support mission-oriented engineering,=" =-- the artificial heart an exgmple -- but engineering falling within Dr. Schmitt's first two categories=' also deserves recognition and support, and identifying this field by name should bring it into sharper focus and gain it more acceptance. Dr, Weber: When the engineer says something, he's basically talking about design and application, and really, he thinks of himself as a technologist. The physician, too, thinks of himself as a technologist, even though he won't call himself that. The Ph.D., in physics or a related discipline, considers himself a basic researcher, hopefully, but generally he gets into applied research. There are these very distinct and real differences and we are probably going to have to take these facts of life into account if we are going to get a definition of bioengineering. 1/ Dr. Schmitt's third category (page 31); 2/ Theory and substantive (page 31); also p. 42. - 37 = Panel II (cont.) I'm with an instrumentation company. Engineering research is our function, and management gives us good support in engineering research. Almost all of our technical people: are engineers. Does management give us good support in the life sciences? We are starting to get this support over the last three or four years. Before I joined this group, I was with the School of Aerospace Medicine which had several hundred of our classical M.D.-Ph.D. types, and only a handful of engineers, and the whole picture was reversed there. So, again, what bioengineering is depends on where you find it -- on the type of specialist with whom we deal. Dr. Hall: The most important consideration is the sense of identity of the bioengineer himself. Bioengineering activity exists as an entity when you have a group of individuals who call themselves bioengineers, and who claim that they are carrying out work in bioengineering, and that this is their primary domain of activity and concern. It had to happen in physical chemistry, had to happen in biochemistry, had to happen in chemical engineer- ing, and it happened many years ago in electrical engineering when it split off from mechanical engineering. Until this happens with bioengineering, and it becomes clearly established as an entity, it is going to be extremely difficult to know what we are talking about, or to identify fields of research in bioengineering. At present, as we all know, much of the bioengineering research is done by people who are members of electrical engineering faculties, mechanical engineering faculties, or medical faculties. And these individuals may claim that they are working in bioengineering, but they don't call themselves bio- engineers. A sense of identity is needed, and is very important. Drawing on my experience as Chairman of the rccpt/ National Accredit- ing Committee, which I shepherded through a number of years, I believe no academic institution is going to recognize, offer training in, any domain of engineering, be it bioengineering or any other, unless accreditation is in prospect. And to have accreditation you have to have an established group of individuals who identify themselves as members of this branch of the engineering profession. Until this happens in bioengineering, the field, as an academic field, is in a precarious position, and the task of identifying 1/ Engineering Concepts Curriculum Project Panel II (cont.) research as bioengineering research will be an ambigious task. I think this does tie into accreditation, and I think that if ECPD doesn't ever get around to accrediting bioengineering, then there is something missing. I don't know quite what it is, but it is very substantial. Another point in this regard, is that ECPD is not going to accredit any activities that are not identifiable as engineering. First, do the students who are working in the field believe that they are working in an engineering domain. Second, does the faculty who are resonsible for this field believe that they are training engineers. And third, when they are all through, do the students who complete this program become engineers. This is as important in bioengineering as it is in any other engineering discipline. Chairman: The meeting is now open for general discussion. Dr. Warner: I'd like to ask Dr, Schmitt if he really meant it, that there is a lot of good work going on which wouldn't be considered good medicine by the people in medicine, nor would it be considered good engineering by the engineers, but it is still good work. Chairman: Yes, there is work that clearly is excellent work by virtue of bring- ing out the interrelationships in living systems, making it excellent bio- engineering, but that really would not pass scrutiny from a class of well- established medical clinicians and would not be understood appreciably by, let's say, a run-of-the-mill group of excellent engineers. Dr. Hall: May I add that new areas of engineering arise because the old areas do not accept this new area. Chemical engineering had to come into the picture that way. Panel II (cont.) Dr, Brown: You were not saying a lot of projects are going on that are actually bad medicine and bad engineering but good bioengineering, Otto. You were just saying they are different. Chairman: Yes, they are different, but more than that. I'm saying they are good, but they don't pass the filter that has been patterned to pass good projects in one or another of the established disciplines. Can't you visualize one of the good old line physiology study sections, Homer, not understanding what on earth you were talking about in a computer analysis? Dr. Warner: Not understanding is one thing, but, not being good work, not acceptable to the people who work in this or that area is another. Any new field, be it bioengineering or computers, or whatever, has a tendency to accumulate a certain number of people who really can't make the grade. Can't make it in engineering, or can't in physiology or something else. The criteria of excellence must be applied in the new discipline. Granted, there will be occasions when people who must apply the criteria will fail to appreciate certain things because they are new and different, because maybe they don't understand the new thing. But if they think something doesn't hold water or that the contribution to physiology made by some bioengineer- ing project is completely uninteresting because it's been done so many times in so many other ways, and the project is just a means of doing the same thing again, applying this or that technique, and adds nothing, then to me, that is a legitimate criticism and the work should be subjected to that kind of criticism. - 40 - Panel II (cont.) Chairman: With respect to accreditation, the licensed people in engineering are generally licensed specialists, technologists, aren't they? You don't find many licensed physiologists in medicine. You don't find many licensed health physicists. There are many people in bioengineering and bioengineering science who are not going to become licensed technologists. Dr. Talbot: You have raised a very important issue, As the engineering schools become more sophisticated and put more emphasis on the theoretical aspects, accreditation itself becomes a question of engineering science versus engin- eering practice. This point is already almost splitting the engineering schools. Chairman: You mean, the question whether the accreditation moves to the school, rather than to the product of that school. Dr. Talbot: That's right. I think we should do very well at this early stage in bioengineering to firmly straddle this issue and say that we are in- terested in both engineering science and engineering practice. Mr, Harte: Are we confusing accreditation and licensing? Accreditation is an action of a peer group with established standards within a community. Lic- ensing is a legal device to protect the public. Dr, Hall: Bioengineering activity is undergoing a very substantial and desirable development in the engineering schools. It is going to be carried on by interested engineering researchers in the faculty. But the school's educa- tional programs must be considered for accreditation. I know of only one reputable engineering school in the country at the present time which is not accredited. w 4) Panel II (cont.) Dr, Weber: Don't you think that bioengineering is going to stand on its own merits and on the value that it creates in our scientific community? For example, consider computers. Obviously, that is an integral way of life now, even though it's something that's relatively new, and it's going to be developed on the same line as bioengineering. Dr. Warner: In an editorial -- some of you may remember -- in Science about a year ago, it was suggested that perhaps the way that science should be evaluated in a particular discipline would be by having people in other disciplines look at it and see how general it is. In my opinion this is an excellent suggestion. For if we who are working in this new area of bioengineering are unable to sell our end product to the peoole who are in the subject matter area that it applies to, we should look carefully at ourselves, Chairman: Of course you should look carefully at yourself. You are quite right that into any inter-discipline there roll a lot of incompetent people. However, as soon as a hard core of competence develops in the field, the incompetents are eliminated. In my opinion we are right now accumulating respectable, reputable, sound people in the bioengiueering area. If any scientist in the area proposes work that is not good science it should of course not pass in this area. Dr. Talbot: The issue o1 accreditation points up the question of whether bio- engineering is indeed a sub-specialty of engineering. Nuclear engineering and astronautic engineering are among the more recently accredited sub- specialties, are making new contributions to engineering science not previously uncovered, and are obviously sub-specialties of great strength. However, any type of engineer, if he is sufficiently competent and is interested, can find in the biological sciences applications for his kind of thinking. If you are going to have 18 different kinds of engineers, all doing excellent work in problems directly related to biological science and biological practice, then how are you ever going to get accreditation for bioengineering or biomedical engineering as an engineering sub-specialty? Panel II (cont.) Chairman: Dr. Bolie, Dr. Bolie: Since the panel disagreed with our little definition of bioengineer- ing in that it should include the application of the advancement of engineer- ing principles and techniques towards the solution of biological medical problems, I would like to ask what their definition is. For example, would you specifically include as bioengineers, personnel who, though highly qualified in some other areas such as biochemistry or biophysics, could not demonstrate competence in at least one area of engineering? Chairman: And you will provide the definition of engineering? Dr. Bolie: Yes, I think Dr. Akers’ definitiont’ is acceptable, Dr. Fleming: Well, we all disagree. Dr. eber: Bioengineering activities fall into three distinct categories, and anyone in bioengineering would hopefully have some degree of competency in all of them, but would obviously specialize in one. First is the develop- ment of theory, and here you go back into your models, and your computers. The second is seeking the basic facts of nature, an activity in which many of the physiologists and other life scientists are competent, and here again there must be appropriate machinery and techniques. The third is putting the theories and facts to practical use. 1/ Page 28 - 43 - Panel II (cont.) Dr. Bolie: Would you include among bioengineers, people, who though highly qualified in some particular area of science, could not demonstrate com- petence in a specific area of one of the many engineeyjng fields? By com- petence I mean either a degree from a recognized ECPD=" - or if no engineer- ing degree, then its equivalent. There are physicists, for example, who have become very good engineers, but they don't have a degree from an engineering college, but they are highly competent engineers and everyone recognizes them. Dr. Fleming: We find very successful bioengineers who had their undergraduate, even their masters' degrees in physics, yet at the graduate level, the courses they take are almost exclusively in engineering, and they are equipped to go into the most esoteric work in engineering with very little dislocation. Dr. Hall: I think one of the most important things here is the sense of identity within the domain. It's futile to try to pin down what is an engineer, but an individual will identify himself as an engineer or not -- and will also identify himself with bioengineering, or he will not. Chairman: Dr. Schoenfeld? Dr, Schoenfeld: Enrico Fermi was undoubtedly a great engineer, but he wouldn't have identified himself as an engineer. He would identify himself as a physicist. I think the question of whether or not people in the field, or whether the field itself, is identified as an accredited engineering discipline is not a problem that need concern us. We are concerned with a definition of the discipline. Whether or not this is studied in an engineering school or identified as part of the engineering curriculum is not important. Let the chips fall where they may as far as that is concerned. Let us go on with the scientific discipline and the application that we are concerned with. - lly = Panel II (cont.) Chairman: Dr. Frommer. Dr, Frommer: If one goes back to the definition of bioengineering, that it is "engineering applied to medicine and biology", then one is forced to the conclusion that to have a good bioengineer you have got to have a good engineer. The kind of person that's needed in bioengineering is a good engineer who will then go ahead and learn the other things he needs to know, to apply his techniques -- at the graduate level let me emphasize -- to biological problems. Chairman: Let me raise a question at this point. The question whether we are to look forward to having two species of research workers in the biological- biomedical sciences, one of them the Ph.Ds in this or that discipline, such as in physiology and biochemistry, and the other species the bioengineers, biophysicists, biomathematicians, and the like. Let me call this the two- track plan, and I'll ask my question again: Shall we look forward to having a two-track plan or a one-track plan? It is clear that present medical and biological research makes only peripheral and limited use of the quantitative analytical and other appli- cable techniques of bioengineering, biophysics and biomathematics. Some of us believe that these techniques should be used to a considerable extent. Will this be by upgrading training and research in the biological sciences -- a one track plan? Shall bioengineering, biophysics, biomathematics, con- stitute the new life sciences or shall they be a separate little track? Dr. Brown: They will constitute the life sciences. The life sciences are gen- erally moving in a more quantitative direction. We support most of the basic training programs in the life sciences. Some of you who have been on biophysics, biomedical engineering, and physiology training committees know that we have been emphasizing to these committees that science and scientific training have to move in a more quantitative direction. To be sure, it's a - 45 = Panel II (cont.) little difficult to turn gross anatomy into a more quantitative direction. With biophysics it is very easy. For life sciences in general it's going to take a considerable degree of patience. Remember we have a generation of scientists or two generations -- if you take 25 years of science as one generation -- who are trained in the old tradition. It will take a whole new generation, trained in the new techniques, before there is much noticeable change. We are working in that direction at NIH. It has to start with training. Dr. Fleming: I'd like to explore this point just a little further; one track, or two. By extrapolating your argument, biophysics and bioengineering should do themselves out of existence, at least in the theoretical side, in the next generation or two, if the existing biological sciences take over these analytical tools. Then these two fields (biophysics and bioengineering) would ostensibly disappear because, starting from high school level and, working through the generalized curricula at the under-graduate level atc., the bioscience graduate will be at home with the concepts of the physical sciences as well as the biological. Then, what happens to the bioengineer and the biophysicist? The answer, obviously, has to be one of two: either they disappear like the dinosaur, or else they adapt. By adapting I mean the biophysicist amd the bioengineer must shoulder the responsibility of developing an ever more sophisticated analyti al frame- work in which biological experimentation and modeling can be cast. The most pressing problem facing us today, is biological complexity, for adequate techniques for resolving complexity simply do not exist. We have not been able to crack, as yet, the basic problems in growth and differentiation of the total organism, particularly as relates to biochemical genetics, and in spite of computers we are a long way from relating electrophysiology to in- formation processing in the nervous system. The question of how to deal with biological complexity must be faced forthrightly, for if today's production of data is a flood, tomorrow's will be a deluge. Data processing, alone, will provide us no shelter. 1/ 1It is noteworthy that this is the only mention of the bioengineering research theoretician found in the proceedings. -- Ed. - 46 - Panel II (cont.) The bioengineer faces a challenging role, that of developer of new analytical approaches, and by whatever name he may be called, he will not meet the fate of the dinosaur. But he has to stay ahead. In the sense of the theoretician vs. the practitioner, the engineer-scientist has to stay ahead of his colleague who is in practice, or else he disappears. He's no longer functional. Chairman: You're making this two-track story very clear. It doesn't matter what you call this new successful generation of bioengineers, whether you call them biologists or biophysical scientists or something else, If they do get generated and are more successful, then they will simply take over. Dr. Goodman: The panel has been asked, "What are the types of research now sup- ported in bioengineering?" I would like to raise another: What are the types of design and development now supported in bioengineering? Dr, Brown: I can answer this to a considerable degree. The design and develop- ment we have been supporting has been largely along the line of the develop- ment of new concepts, of new approaches to the measurement of energy, physical systems and so on. We have not been supporting development in the sense of taking an ordinary recognized piece of apparatus and making it a little bit more accurate, a little bit better or a little bit finer, or what have you, The reason for this is very simple and straightforward. That is, with a limited amount of money, we feel that we do better in the long run to try to get a new development started than to try to refine an old development which can be done on a commercial basis if it's of commercial interest to people to do it. And this basically comes down essentially to the financial reasons. We've support such work as, for example, new techniques in lasers, new techniques in ultra sound, some new techniques in electron microscopy, fiberoptics, and a good deal of instrument development, It's been in what you might call the newer elements - the new methods of measuring energy or newer parameters - rather than an exploitation or a development of an old established method, - 47 - Panel II (cont.) Let me add that the NIH is of course supporting and has supported other design and development activities, notably toward improved versions of the artificial heart and artificial kidney, and will undoubtedly be interested in work toward needed supplement or replacement of other vital parts of the human organism, Dr. Warner: Let me add one more comment on this two track versus one track matter. There is some concern whether the bioengineer might disappear. I think there might be some equal concern that the physician might dis- appear in his present form, It is obvious that changes are going to occur and medical education must conform to the new techniques and practices that come along in medicine. A different kind of practitioner will come about, I don't think we should concern ourselves too much with how permanent the field is going to be, but simply what is the need for the field, at the moment. Dr, Hall: There is a parallel in chemical engineering. Chemical engineering, as you know, was an outgrowth from chemistry, Chemical engineering depart- ments were for many years -- and still in many institutions =-- much more closely allied to chemistry than to the rest of the engineering school. Yet there is no question on the part of either the chemists or the engineers that chemical engineering is a discipline that has added a tremendous amount to our well being. I would like to stress that this discipline developed and was established in the context of chemistry much more than it was in the context of engineering, although there is no question about its being an engineer- ing discipline rather than a pure science, It is entirely possible that the real viability of bioengineering may derive from its biological and medical association, and its development from that domain, rather than from engineer- ing. Chairman: I thank the panelists and the others who have participated in the discussion, Maybe we haven't settled anything, but I hope that some of these arguments will go on in your minds, until the next session -- that I hope NIH is planning. - 49 - Report of Panel III Chairman, Dx, Robert G, Allison: We in Panel III have addressed ourselves to the question, "What can be expected from bioengineering?'' Naturally we were interested also in what is bioengineering. If there is any consensus, it is (whatever the term implies and whatever its context entails) ~- is a disciplinary bridge between the life sciences and engineering. Not just a discipline in terms of terminology, but a bridge in terms of conceptual approach to a problem. Furthermore, it needs to be emphasized that just because someone is called a bioengineer or a biophysicist does not guarantee that he is a scientist. With these brief comments, I would like to get away from trying to define bioengineering and just accept its existence as a fact and go on from there. Perhaps we can define a little more thoroughly how an overlap between the life scientist and the engineer will be beneficial in some types of scientific research. Dr. Robards will you give us some of your thoughts on the benefits to life science that a bioengineering approach might afford? Dr. Robards: First, I'd like to comment on what is not bioengineering. Two groups come to mind: a collateral disciplinary group calling themselves human enginers, and another, a new term that is used sporadically, the bio-environmental engineers. Bio-environmental engineering appears to be a new name for industrial hygiene and sanitary engineering. Human engin- eering, on the other hand, is more in the behavorial sciences area. And I just throw that in as a non-sequitur to this discussion. Next, as to what bioengineering can do in the life sciences: Medicine is still called the art of medicine. It is largely empirical, the application of past experience, There is much stored knowledge in medicine, coming from past experience. Bioengineering has to tap that stored knowledge that we attempt to put into the medical student -- hence the medical practioner -- and bring it out and make it available in a logical order, - 50 ~ Panel III (cont.) One of the best areas for future work is that of diagnosis, The bioengineer has a real challenge in the area of medical diagnosis, to tap the knowledge stored there and analyze it and try to unload the mind of the practitioner a little bit. I also think that the bio- engineer must try to standardize some of the subjective information we use, He can help us distill or fractionate all of the living phenomena that we are looking into. The nervous vs. the chemical vs. tne mechanical relationships. It's quite easy intuitively to come up with a mechanical model or a simulator for a living system. The bioengineer can come up with mathematically modeled devices which take into consi- deration both the neural and the humoral control mechanisms, not just the mechanical. He can help us to arrive at a better understanding of the regulating mechanisms for biological functions in general. And in the new life sciences technology we need new devices -- maybe in the computer area -- for logically orienting the practitioner's diagnostic armamentarium, Chairman: Thank you Dr. Robards. Dr. Thackray, you've had experience that is germane to this problem, being oriented in terms of psycho- physiology. This marriage between two very divergent disciplines -- psychology and physiology -- has been very productive. I wonder if you will give us your views on the reason for the marriage and then, perhaps, what you see as the benefits to be expected from the marriage between engineering and the biological and medical sciences. Dr. Thackray: I don't know whether the marriage between psychology and physiology actually came about logically or not. I suspect that it didn't. Psycho- physiology is endeavoring to look at not simply physiology in an isolated sense, or in terms of psychology, or behavorial phenomena as restricted to themselves, but rather is trying to merge the two in the areas of primary interest -- including such areas as emotional response, and psychosomatic stress, Any of you who have ever been instrumented in a psychophysiological laboratory, as it exists today, can appreciate the problem that we have. Because if you try to study stress as an inde- pendent variable and you begin to attach devices, transducers, and so forth, for measuring blood pressure, heart rates, skin resistance, breath- ing, EEG, etc., you begin to create a stress situation itself. We lose many subjects simply because of the trauma of being exposed to such a situation. - 51 - Panel III (cont.) Our bioengineering colleagues are going to have to develop devices for us which will minimally interfere not only with the physiology which we are trying to measure, but with the psychology, so that we can look at these physiological behavioral inter- relationships in their real-life or true state. With telemetry we can get rid of many of the wires and tubes and so forth which conventionally have been used. But we have to go further than this. We have to get transducers and devices which will allow measurements of these functions to such an extent that the individual is able to operate in a real life situation and become almost completely unaware that he is being submitted to study and also that others, as well, are not aware that he is instrumented, This is a long-range goal, a very definite future research need in the area of bioengineering. The techniques and devices presently available are clinically oriented, not designed around research goals. The equipment we have to use sometimes lacks calibration features, or lacks linearity, or has insufficient amplification. There is need for an entity of some sort which we can call a bioengineer, who can understand the problems and can communicate with other scientists and can come up with improved devices that we need in our work and with the new ones we will be needing. Chairman: Thank you, Dr. Thackray. Next, Mr. McLeod, you've been working in simulation problems for a great number of years. Let me ask you what you mean when you define a model in terms of an engineering concept applied to the life sciences? Also what do you see as the probable effect of bioengineering, as representing engineering itself as related to life sciences? Mr. McLeod: In answer to the first question I would point to electronic computer models of dynamic systems -- systems in which the parameters that describe them vary in some relationship to each other which can be stated mathematically. Concerning the second question, what I expect from engineering that will be helpful to the life sciences, I will point to computers as engineering devices that are already proving to be extremely helpful. We have today computers that already have more potential than we are presently able to make us of, and computers -- and computer techniques -- are continually being further improved. - 59 = Panel III (cont.) I would like to introduce the concept of a complete physiological model, no matter how far that may be out of reach today. The concept of a bloodless animal lab, if you will, where you can go and perform ex- periments on a computer that probably can be made to relate as well to the person as some animal experiment. '"Animal'" experimentation on com- puter models would be further along today were it not for the misconcep- tion that for computers to help you, you must be able to describe math- ematically and in numbers what your problem is, I take strong exception to that. I have done experiments without having numbers, I mean enough numbers, and without being able to describe some of the concept math- ematically. And they have produced useful results, Now let us assume that we can bootstrap ourselves up to a useful model of the whole human physiology. And by bootstrap I mean learning something from the laboratory, putting it in the model, having the model suggest other things you need from the laboratory, going back and forth like that, until you get a useful model. Needless to say, a complete model would be much too complete. And here is one of the strong points of simulation: you don't have to look at the whole picture in detail. You can get your simulation up in such a way that you can take a detailed look at the part of the simulation that is of interest at the moment. To be sure the rest of the simulation cannot be ignored, but the rest of the simulation model can be represented by simple transfer functions. That's what they do in the missile's flight. They do no simulate the whole missile in all the details. If they are examining the control system, they simulate the control system in detail and use simple transfer functions to get the effect of the rest of the system. I invite you to consider, then, the development of a useful model of the whole human being. It could be so programmed on the computer that you could look only at some part of interest at the moment, a heart, a lung, a kidney. The relationship to the rest of the body would be car- ried in a gross manner. You could instrument such a model. You could measure any of its variables -- they are readily available -- without disturbing the rest of the system, something you can't do in any living system; for once you try to measure something, you disturb the living system and it doesn't behave the same any longer. You can use the complete physiological model to test any hypothesis. You can make diagnoses that are incorrect, and try them out, and kill your computer "patient'" and there is a little button on the computer called "reset" so that you can bring him back to life again. - 83 - Panel III (cont.) If your complete physiological model happens to be an astronaut, you can communicate with him better than you could with one of our real astronauts -- where your communication channels are very limited. You could telemeter a few key variables in your astronaut model and from the simulation on the ground, could measure what the probable condition of the astronaut in space is. This is some of what bioengineering can do for the life sciences. Chairman: Thank you Mr. McLeod. Next, Dr. Meyers, would you care to comment on the cross disciplines to be expected between electrical engineers at the graduate level and those who are at the graduate level in the biosciences? Dr. Meyers: This morning, at breakfast in the coffee shop, I overheard a conversation between two men I knew, one an engineer and the other a physician. Both were on the IEEEL program to give a paper and the engineer said to the physician, "Do you think the medical profession will ever go for all this mathematical analysis?'" And the physician said, "Never." I think the names would be very familiar to you. Only education can change the picture. In addition to having engineers, we also have many physicians who have some engineering training, but in our educational program, we have yet to have our first M. D. who is actually taking our bioengineering graduate program. A most important element in the graduate training of the biomedical engineer, be he originally a physician or originally an engineer, or originally a physicist or chemist, is that he be well grounded in the fundamentals of mathematics and physics. Plus a very good grounding in the fundamentals of physiology. When this comes to pass the communica- tion problem will be solved, and the physicians will be able to believe the mathematics without having to work through all the mathematics and perhaps the engineers will believe the experiment without wanting to do the experiment. Chairman: Thank you, Dr. Meyers. Dr. Long, you have been directly affiliated with an educational venture in bioengineering for the last several years. Would you give us your views on what can be done to increase knowledge levels in this broad area of bioengineering? 1l/ The 18th Annual Conference of Engineering in Medicine and Biology beginning the next day (Nov. 10). - 54 = Panel III (cont.) Dr. Long: May I run down this set of notes I have taken, even though they're not exactly responsive to your question? Currently, about the only way to get a good interchange of information between biologists and engineers is to publish twice -- once in an engineering journal and once in a medical journal. If one is interested in knowing what's going on in a field or what's been done in a field, one available resource is the Library of Congress system of descriptors and abstracts. It's mostly descriptors and not much abstracts, meaning that to get anything you must select a dozen descriptors and then look for what you want in the literature. It's certainly better than nothing, Another help would be to do again what was done about beginning 1958 I believe -- a publication of titles and authors and the bibliographic references. Another is the publication of grants with titles, as done in the American Journal of Medical Electronics, periodically.=’ Another is national meetings such as the IEEE meeting that will be going on here in the next three days. Workshops like this are another help to informal communication on what is being done currently in bioengineering. I'd like to make two other comments while I have the microphone. Whatever change is made in the training of the biologists and engineers should, I think, come about as a result of what's going on currently in bioengineering. The new biologist, if you want to call him that, will certainly have more quantification in his training, stimulated by bio- engineering, and we'll also see more life-sciences of one type or another appearing in engineering programs. The bioengineer, with his measurement background, should be able, in time, to reevaluate the store of physiolo- gical and other measurements used by the clinician. Research along this line should lead to identification of new key variables in the clinical work being done today. Chairman: Thank you, Dr. Long. Our subject is now open to general discussion. Mr, Springer: First let me say that I wholeheartedly agree with the comments on the need for better communication. We will have to have it if we are to talk to each other, 1/ Also done by the NIH in its yearly Grants Index. - 55 - Panel III (cont.) Then, regarding excluding bioenvironmental engineering, in my opinion environmental engineering is a part of bioengineering. Environ- mental engineering, to me, includes the determination and control of temperature and humidity relationships, of contaminants, or any other parameter that is part of the environment, and determination and control of the effects of changes in each of the many environmental variables on the operation of a biological system. Mr, McLeod: I'm with you all the way on that, Dr. Long: If you'll notice, no one has mentioned botany anywhere in the discussion, yet we're talking about biological engineering or bio- engineering. Are we limiting bioengineering to 'zoo-engineering'? Dr, Franklin: In regard to John McLeod's remarks on modeling: There is another word that's as essential as "model" as an integral part of research, and that word is hypothesis. One observes the natural phenomena, one forms a hypothesis to explain the phenomena, one observes further and may have to modify his hypothesis. The hypothesis is the simplest type of model, one that can be kept in one's mind. But the model as the temm has been used here is the model of a very complex situation, and can't be kept in one's mind, Mr. McLeod: 1 agree with you. A hypothesis is a mental model, but as you say, in this discussion I believe we're considering models that are really too complex for one to be able to comprehend all the interrelationships on a single time basis as they take place. In fact you might say the model is the computer mechanization of the hypothesis. Dr, Franklin: One other comment, if I may. I have a good bit of sympathy with a comment made earlier, that there should be support for more research on the development of instruments, This kind of research is certainly a contribution that bioengineering can make to the life sciences. One of the major impediments to diagnosis is the inability to measure. Further- more, one can't check his model without the ability to measure. - 56 ~ Panel III (cont.) Chairman: Let me comment on that if I may. I don't believe that the bioengineer's problem is just instrumentation-oriented. I think our problem has a very broad orientation indeed -- toward the direction and technique of problem solving. We are able to go beyond the classical physiological approach and to evaluate life sciences in general, includ- ing such areas as life support systems and environmental comfort. Certainly the space venture has emphasized this, I think we have to ask ourselves a question again: Why do we measure many of the things we measure? We seem to be almost, at times, set on certain types of measurements. Heart rate, for example, We measure it routinely and I defy anyone to give a good explanation why. I hope, however, that bioengineering is going to ask many more why's than the medical sciences have asked in the last hundred years. Mr, Slater: I want to add a comment to Dr. Long's statement about communi- cations, I'm in the communications business now. A little organization has been formed called "BIAC™=' which was set up essentially to help answer the problem you mentioned. The biologists were the prime movers in this organization, and the major part of its effort will be to serve as a communications center between the people in the engineering and physical sciences and the biologists. You can contact me about it if you wish, Chairman: Any more comments? If not, I would like to thank the members of the panel for their efforts, 1/ Bioinstrumentation Advisory Council - 57 = Report of Panel IV Chairman, Dr. Richard J. Gowen: The question assigned to our panel is hopefully to make an estimate of bioengineering manpower, or to decide if and how it should be done. Perhaps we might ask first if we should even bother to look at bioengineering manpower. Is there any real need to look at it? Dr. Schoenfeld, would you like to start our discussion? Dr. Schoenfeld: A number of universities offer Ph.D's in bioengineering and a number of engineering schools offer Master's degrees. There are bio- engineering training programs for biologists and medical people and if you want to project the future you need to identify what's being done at the present time as a basis for future predictions. I have been concerned for some time that we may be overemphasizing the more sophisticated and theoretical and significant aspects of the field, at the expense of its more plebeian aspects. It's all very well to emphasize engineering's unique contribution to biology -- its method- ology -- but it has made an older contribution -- the plain ordinary production of good instruments for making well-known biological measure- ments. There are people in the universities doing bioengineering as a division of applied science and they are doing what is essentially re- search. There's a different training that's required for somebody who's going to make a spectrophotometer -- who's going to work in the area of spectrophotometry as an instrument engineer -- and someone who's going to do original creative work in physiology. I think it's very important to find out how many of each category are presently employed and what are the rates of expansion in the two categories. It's an old problem in the IEEE medicine and biology —_— as to how many of the four thousand or so members of this group are actually working in the field and actually have a sentimental interest in the field and I think some of these basic facts ought to be obtained. Chairman: If you decide that you should determine bioengineering manpower, the next question is how do you identify the bioengineer? And then follows the even tougher question: how do you determine the bioengineer's competence? -- because it is a lot easier to put a tag on a person, say he's a bioengineer, than to say how good is he as a bioengineer. 1/ The Institute of Electrical and Electronic Engineers Division of Engineering in Medicine and Biology. - 58 = Panel IV (cont.) Perhaps some of you may wonder, why be at all concerned about this. Part of the why came out in Panel IV's discussion this morning. The possibility was alluded to that perhaps some one of those present might send a research proposal in to a granting agency such as NIH. The evaluation procedures used in any granting agency necessarily in- clude an assessment of the competency of the investigator. The agency must even decide if the proposal is in the area of bioengineering. Both of these are reflected in what research techniques the investigator is actually master of. As a panel we've discussed this. Doctor Patrick, would you give us some ideas on the competency problem? Dr. Patrick: First of all, what is a bioengineer. Unfortunately, our instru- mentation colleagues have not developed any spectograph or other device that we can apply to an engineer or other individual and catagorize him as some particular type. My own experience has been that a bioengineer is an engineer who has some training and competence in biological areas. Regarding competence -- what a bioengineer is able to do -- let me give you a few examples in our own particular university. For one, we have an interest in blood flow. The flow of blood is pulsating and in disten- sible tubes -- certainly the most complex flow problem that one can imagine. Another, we are studying the neurological systems and, indeed, we're study- ing many other biological systems. If one stops to think of the different facets of bioengineering competence required, we can say that in one study we have to have somebody who is tops in engineering mechanics; in another we have somebody who is, say, the best chemical engineer, The living body presents some of the most complex chemical engin- eering problems and functions that are known and if we go down through a list of these, we find that in each case we need the very best in some area of engineering competence. One may well ask -- and I do ask it -- how can we possibly set up a bioengineering curriculum that will provide the student with competence in all of these engineering areas and then throw in all of the biological sciences and expect him to know everything about biological sciences? I don't think that it is feasible. This is a a utopia that we're not going to see realized in the immediate future. - 59 - Panel IV (cont.,) The best that seems to be possible is to produce bioengineers each of whom is competent in at least one phase of engineering and is also conversant with one or more areas of the medical sciences, I think this can be achieved and has been achieved in our current bio- engineers. This means then, that a man will have some of the basic courses in medicine, perhaps anatomy and physiology or biochemistry. He will also have a thorough understanding of some particular area of engineering. Then when he starts to work in the field of bioengineering, he can concentrate on that part of the medical science that he had some training in and apply his engineering to that. He can even switch to some other part of the biological system if he so desires and with some concentration can become conversant with that area. I think, however, that he must work very closely as a team member with people who may be far more competent in the biological areas, as he will be in engineering. So if the team 1s working on, say, blood flow, he will supply engineering competence applicable to blood flow, but he must also work with physicians and other people who are far more competent in the biological aspects of blood flow. Getting back to how to determine if a person is a bioengineer, one way that we use to determine competency is level of education. So far, we dont't have many people who are graduated as bioengineers so most of us in the area have gotten into it from engineering and experience, with a few courses in biological sciences. To summarize, I think we're going to have to look at the individual as primarily an engineer and then find out what he has done in the biolog- ical area to determine whether he is, in truth, a bioengineer. So from this standpoint I think that identifying who is a bioengineer is going to be, immediately, the experience he has had, but ultimately perhaps his education. I don't think we should ever overlook the experience end of the capability. Chairman: Dr, McLaughlin, would you, perhaps, like to add anything to that on determining competency? Dr. McLaughlin: Speaking from the point of view of the Office of Manned Space Flight, not NASA, but just one segment of it, we have a series of questions which we must answer about man in space. All of these questions, as far as we're concerned, are related to instrumentation; instrumentation which fits within the systems engineering concept, within a bio-instrumentation system, within the spacecraft constraints and also fits on the astronaut, so it doesn't inconvenience him too much. - 60 - Panel IV (cont.) I think what Dr. Patrick just said is closest to the kind of situation we've run into. Tom Weber and Otto Schmitt have struggled through some of our problems with us. At the moment we are dependent upon the team concept. We have a problem to solve. We ask somebody how can we solve it, and a group of people get together. There is an expert in physiology, perhaps, and an expert in engineering, and we hope a bioengineer someplace along the line, to tell each one what the other is saying. This is about the level that we are working with and the competence is not an individual competence but a group competence -- the team's ability to get a job done and certainly in an applied sense, Chairman: Dr. Stark, would you like to add some comments? Dr, Stark: First let me say that the team competence may be all we can get, but it must be recognized as a makeshift, a stage in the evolution of bioengineering, until we can get something better, The question, "What is a bioengineer?" is like a Rorschach test. You put it to someone and he immediately exposes all his background and prejudices and ideas or lack of ideas. I'm no better off than anyone else when I try to say what a bioengineer is. I'm just exposing my own prejudices and background. One of the problems I have had in trying to define bioengineering is that engineering is a schizophrenic field. There are engineers who build and then there are engineers who analyze. The engineers who build things maybe never meet the engineers who analyze things (ideas). Around the halls of a big engineering school like MIT, for instance, you never meet any engineers who build things. All the ones you meet are working on new higher order functional analysis of something -- not working on a thing, but on an idea. So that engineering is divided in these two ways, and bioengineering is also divided. But in any case I am going to identify approximately five areas of bioengineering. And of course I'm just exposing my own biases. Area No, 1 is the application of engineering science to biology and this mainly falls into the category of cybernetics, the study of con- trol and communication in animals and machines, as defined by Wiener. - 61 - Panel IV (cont.) This involves the study not only of control systems but of complex systems like the cardiovascular system, and roughly meshes with analy- tical physiology. One reason bioengineering has been so successful is that most physiologists are not educated to the present day and age. They have little or no background in math and physics and none in engineering, so that they really can't approach their present problems in an effective way. My area No. 2 is a promising area but has had only a few shining achievements, the area of bionics or, as Warren McCulloch first called it, bionometics., The best example of this that I can think of is the use by von Neuman of McCulloch's neurons to do the logical design of the Edvac computer. This is the first computer with a stored program and I have some figures showing how von Neuman used McCulloch-Pitts neurons to do the logical design of this computer. And, in general, the names we give to computer parts, like the "memory organ' and the "input-output organ' and the "logical organ," point up biological or specifically brain similarities. So here we can see concepts and ideas obtained from cortico-neurons turned into detailed mathematical concepts (by McCulloch) and see these used (by von Neuman) to design engineering instruments which in some ways are more important than the studies of brain physiology from which they were derived. My No. 3 area is that of instrumentation, and here we're getting to the bioengineer as a builder and there are not only transducers or other instrumentation such as the gentleman from NASA mentioned, but there are also prosthetic devices, not only artificial arms, but artificial hearts and kidneys -- maybe artificial intelligence, since computers as instruments are used more and more in biomedical research. My area No. 4 is the complex area of information systems. I am thinking of such things as hospital information systems and controlling the whole hospital by a computer; Medlars, the NLM's information re- trieval system for medical literature; complex man-machine systems such as space ships, where you have to control a very complex environment subject to rather large fluctuations in, say light, temperature, radiation, and gravitational potential. And now we're coming to think of the earth itself as a space ship -- and not too terribly big when you think how big space is -- and we're worrying about such concepts as the metabolism of cities which certainly falls into the area of bioengineering. My fifth and last area really isn't an independent area. It is the area of teaching -- teaching bioengineering. Teaching can generate need for more teachers. There are a lot of subjects in universities, like Sanskrit, say, where teachers teach pupils some of whom become professors and teach other pupils some of .... You see there is a positive feed-back system. The same for bioengineers. The more we have, the more good jobs there are for them, It's almost a regenerative system. - 62 - Panel IV (cont.) Then there's the problem of the need in medicine, which we can call the applied side of biology. It is related to the building aspect of engineering. It seems as if our society has almost an infinite need for more research in this area. The Congress is surely representing the spirit of the people in directing more and more money into medical research, because there never is enough of it. There aren't enough trained medical people and not enough who get the right training for advanced medical research. Research is not only very necessary; it can be a very good outlet as an end in itself for our society. There are sociological problems and an infinity of problems in the biological and medical sciences and our young men and women have the vision to tackle them. The bioengineering aspects, alone, of all of these problems will use as much manpower as anybody can generate biologically. Chairman: Another question is how do we determine what the facts are on bioengineering manpower. You have been exposed to a small effort towards this end in a survey form included in the packet which was given to you. It represents an initial effort toward arriving at a definitive measure of what a bioengineer is. We have already received many suggestions for improvement of the form and I wholeheartedly invite more. In this connection I should like your view on whether there is need for a large survey and if so, how would we handle it, and perhaps, what is the ultimate outcome or use for such a survey. Mr. Devey, would you like to take that? Mr. Devey: I would like to join the few people who have voiced the opinion that bioengineering activities include more than research. The questionnaire form we have been given, and the discussion today, seem to be largely directed toward the research phase. Further, there is a fairly direct orientation to the problems, aspirations and interests of the National Institutes of Health. These do indeed represent a considerable part of the federal picture, but not all of it or of the national program in this general field. In fact the federal agencies involved are not just a few; there are a multitude of them. So I would recommend that, if a further survey is to be made, it be designed to cover the total picture of the national program, and take into account not only research, but also get over into other areas such as instrumen- tation, and also include a survey of the bioengineering potential and manpower requirements in industry. - 63 = Panel IV (cont.) Chairman: Thank you. At this time let us open the discussion for general comments from the floor. Dr. Fleming: By sheer coincidence, about three weeks ago we assembled and be- gan to circulate a similar questionnaire. It developed as an outgrowth of a suggestion made in the aduinigtrative committee of -- it's now the group on engineering, the "GEMB.'"=' Our questionnaire is directed to a different segment, so redundancy will be limited. We sent the question- naire primarily to the deans of schools of engineering and questions were designed to get the deans to specify what they consider to be bio- engineering, biomedical engineering, medical electronics and a whole range of topics. Through this survey we hope we can determine what the local definitions are as well as the definitions we are trying to impose from above. Next, I am in wholehearted agreement with Larry Stark on the team approach. It is only a necessary interlude until the merger of the biological and the physical sciences -- or the engineering in this case -- into a formal range of disciplines or programs of study which we can call bioengineering. If you look at electrical engineering, you find it covers almost the entire range from physics on up through motors and generators to some of the most exotic questions out toward the limits of theoretical physics. In the same engineering school department there is such diversity that these people in fact cannot talk to each other. The same condition is found in mechanical engineering, where the aerospace people, those who work in digital logic and the entire range in mechanical engineering, cannot talk to each other except in faculty meetings and on general policies. So in bioengineering we're not really facing anything that's unique or different. The problem will finally resolve itself when the different inputs from the biological side -- from anatomy, neuro-anatomy, physiology, certainly from biochemistry, and from other areas of biology -- and the inputs from the various fields in engineering finally shape themselves into a graduate curriculum in bioengineering. Then you will have bioengineering courses that are neither physiology nor engineering. Instead they will have captured the unique essence of bioengineering. We're at the stage now where what we are dealing with is so big you can't put it in one small book, too big to put in a compendium because it hasn't reached the point where the essence can be distilled out of it. This is the practical dilemma we have to live with, until we can distill out that essence, arrive at the kernel of bioengineering. 1/ Group on Engineering in Medicine and Biology Panel IV (cont.) Dr. Stark: Using your examples there, I think that as far as the mechanical problems, the electrical problems and so on go, the living body is so complex that we have to attack these problems with the very best know- ledge we have in each of these engineering areas. I don't see how we're ever going to take any one individual and train him adequately in all these areas -- all the mechanical areas, the chemical areas -- I don't see how one man can assimilate all this and be competent to work on probably the most complex system that we know of, the living body. It seems to me we'll end up with a man who is not competent enough in any of the engineering and the biological areas. In regard to activities other than research, I think that the bioengineers have to be trained, or if you like be educated, so that they can go into areas in which the bioengineering is perhaps only a small part of their total job. Go, for example, into aerospace engineer- ing, or the design of safety controls in the automotive industry. There are many places where the bioengineer can be used, but my own feeling is still that he has to be a top-notch engineer with only basic training in the life-science disciplines. Then he will have to depend on adding to this the more detailed knowledge he needs on the particular problem he works on, by some intensive further study when he encounters the problem. Chairman: Dr. Brown did you wish to say something? Dr, Brown: I don't agree. I think that a bioengineer has to be in a sense as well trained in biology as he is in engineering. I think that to make him a good engineer but to give him only a smattering of life sciences is a waste of time on everybody's part, and we might as well not start the program if this is what we are going to do. Secondly, I think that an engineer working in this discipline -- if bioengineering becomes a disci- pline, as I think most of us hope that it will -- will be just exactly like a scientist in any other discipline, a biochemist or a physiologist or what have you. Any physiologist knows the general field of physiology, but he has to be an expert in some one area. A biochemist has to be an ex- pert in one area of biochemistry and have a general knowledge of the rest of the field. The same for any area you care to name, including Panel IV (cont.) engineering, where a man is an electrical engineer, an auto-mechanical engineer, a chemical engineer, or other specialized engineer. I think that what we need to do is face the problem a little realistically because I think that it can be done if for no other reason than that it is being done right now in several places around the country. Dr. Schoenfield: I would like to agree with Dr. Brown on this, The engineering schools are "infamous" for preserving specialized courses long after the discipline disappears. If bioengineering means a basic program in engineering and a basic knowledge in physiology (and in its root-sciences, the biological and chemical sciences), it obviously means a lot of work for the engineering faculties that are going to have to do the training. It means cutting and paring out a lot of material that might have been useful in the practices of certain areas of engineering, but this is a job that, after all, engineering professors get paid to do and have to do if they're going to have this discipline emerge. Universities turn out bioengineers who are basically trained in both the life sciences and engineering. As a matter of fact, if we go back in our history, the outstanding physicists of the 19th century were both physicists and biologists and this is still possible. Chairman: Interesting and important though this discussion is, may we not, please, get the discussion back on the subject of how to identify bio- engineering competency. Can we arrive at some criterion that can be used to determine a man's competency? Dr. Larks, can you help out? Dr. Larks: Please let me say a few more words about the team approach. We are coming to the end of the notion that bioengineering competence can only be had in a team, not an individual. There still are some areas to be sure, in which there must be teams, but there are a number of areas in which one bioengineer might be better than one large team. I can cite an example in the area of research in obstetrics -- where ten years ago it was thought that in order to begin research we had to bring together one obstetrician and one engineer. In an actual instance it solved no problems; they couldn't talk to each other. They tried to work together, did the best they could, but nothing happened. In those Panel IV (cont.) days it was the only way the problem could be approached, since there was no one man who had strength in both areas. We have got to develop a new generation who can be at home in solving a problem that has both biological and engineering ramifications. All of man's history has shown that one man with one idea is usually the ultimate answer and the major breakthrough has come from one man's brain; they don't come at the same time in the brains of two people, even if they happen to be sitting together. Let me say a word also about our responsibility. When the thalidomide disaster struck in Western Europe, it was an affront to the whole human race and a reproach to us in engineering and bioengineering. When the first damaged infants were born, the information was, to be sure, posted on bulletin boards and chance exhibits in Western Germany, but it took months for the information to reach us here in the United States, and six to eight months more before we really knew much about it. In this world, this generation, with major tragedies of that kind occurring, com- munication is just crawling; in this case an oxcart could have gone faster! It is entirely possible to organize worldwide telemetry, and it is our responsibility, the bioengineers' responsibility. I proposed such a system to the World Health Organization several years ago. In outer space research in which I work, we can have communication and biotelemetry with our astronauts and cosmonauts over distances of hundreds of miles, but we still can't communicate or know something about the human fetus one inch away from our eyes and fingers, in inner space. This is another responsibility. Bioengineering must begin to develop hard information about man's prenatal first year of life about which, incred- ibly, we have acquired essentially zero information up to the present. And in general it is our responsibility to begin to develop measurements which can strengthen man's health. Chairman: Thank you Dr. Larks. It is still our question, perhaps even our responsbility, to come up with some guidelines on recognition of bilo- engineering competency. Dr. Brown, I believe you've been ready to speak up now for several minutes? = 67 = Panel IV (cont.) Dr. Brown: I think that the identification of a biomedical engineer is beginning to emerge. One group of peers in the discipline has already met to review what they consider to be the standards of training for biomedical engineers, and the standards of research in those training areas. Conferences like this will ultimately give us standards on what is a biomedical engineer and what a biomedical engineer will gradually become. Let me clarify, I hope, by emphasizing something that I believe has not been mentioned today. Basic to engineering, be it mechanical or electrical or chemical engineering, is engineering science. Engineering science is the fundamental basis for all engineering, and is basic to biomedical engineering, no matter what the area of research. Dr. Stark: I agree with Dr. Brown's emphasis on engineering as a science. Adopted by the universities, it would leave the bioengineering student plenty of time to take a full biological curriculum as an undergraduate. A bioengineering student majoring in electrical engineering, for example, would get essentially the engineering science aspects of electrical engineering, and could also take all the required premed courses and still graduate as a bioengineer. I think Jack Jacobs has a program like that at Northwestern. There a bioengineering graduate can go to medical school and get his M. D. with a background in electrical engineering. Dr. Flemming: This raises an interesting problem. Those of you who have worked on medical school admissions committees recognize that the premedical requirements -- for admission to medical school -- have been reduced to practically a bare skeleton: two semesters of biology at the university freshman level (this would be physiology and either zoology or biology) plus organic chemistry and physical chemistry. Anyone contemplating a career in medical research must have more than this premedical minimum, and in the case of the Ph.D. can get the additional training and education he needs in these areas in his graduate years. Panel IV (cont.) Dr. Flemming: (cont.) The bioengineering student, to qualify for a research career, must likewise have more work in these subjects than the minimal amount required for admission to medical school. It should be relatively easy to provide it, by injecting a similar life-science background into undergraduate programs in one of the existing engineering fields or in engineering science. But the bioengineer must be thoroughly trained in the use of the analytical tools of engineering science that he needs to go into graduate work, Chairman: Dr. Francis Long. Dr. Long: I have been experimenting for a number of years, out in Wyoming, with a training program for bioengineers., I don't have many students but I have some that have gone through various areas now. My experience has been that it is better to bring the student up in the two areas together -- biology and engineering -- than it is to first train them in one area then train them later in another area -- as was the case for most of us. Regarding the medical school admission requirements, if you know your man is heading for medical school, then you can prepare him along the lines you have suggested, but if he is not heading for medical school, then I suggest that he continue with his biology courses every semester Or however you happen to fit them in your curriculum. Then, when he hits a department, say of physiology, at the graduate level, or the department of biochemistry at the graduate level, he is able to con- pete with the other students who are there at the graduate level. The students must be able to compete with these other students or you've lost what you are really trying to do, that is train a man in some depth in at least two areas. Panel IV (cont.) Chairman: I think, gentlemen, there is much more that could be said about this competency at the undergraduate level but we need your advice on recognizing competency in the bioengineer who has finished his train- ing -- the practicing type of competency. Dr. Weber: I'm with an instrument company and I deal with people who have been out of school of many years. They are still basically engineers, and their biggest problem is learning bioengineering. They put out all these well designed commercial instruments, but they really are putting them out strictly from the standpoint of an engineer and not from the application viewpoint. I have made it a point for the past three years to try to teach them an appreciation of it from the user's viewpoint -- that is the biological aspect. This should be a key requirement in any bioengineering training program. Chairman: Mr. Harte, did you want to say something here? Mr. Harte: Yes, if I may. The question how to determine competency today when the piece of paper comes in to you with a man's name on it may not be very simple as an immediate problem, but if you can get a responsible group of peers in the field to set up what amount to an accrediting organization, in the course of time you will have a peer operation which determines competency. Chairman: Thank you. Yes, Dr. Hall. Panel IV (cont.) Dr, Hall: It may be worthwhile to remind this group of the recent findings of a study by the American Society for Engineering Education on what it takes to prepare a student in the field of engineering. For the student who is going to go into engineering practice, it was recommended that he carry through his studies to the Master's level rather than just to the Bachelor's level and that the Master of Engineering degree be made the prerequisite to the practice of engineering. The same standard has been recognized for at least five, maybe ten years in the field of sanitary engineering. They are required to have the Master's degree before they practice in their field. Chairman: Thank you. Gentlemen, the time for this panel has just about run out. Let me express my appreciation to the panel members and to you for your contributions towards our efforts to achieve -- in some degree at least -- a measure of competency. - 71 - Report of Panel V Chairman, Dr, Arley T. Bever: This is the fifth panel on the agenda. The one question addressed by this panel is, "Can the problems in future support for bioengineering research be identified?®™ This question, obviously of interest to bio- engineers engaged in research, is no less interesting to NIH,whose basic mission is the advancement of biomedical science. The principal distil- lation that came out of our panel discussions was that communication bridges must be built between the engineers and biophysicists and mathematicians on the other hand, and the medical and biological com- munity on the other. The need for more instrumentation was pointed out, however, as another important problem, as well as the need for more trained people -- people with the necessary professional competence. We also discussed NIH's review of applications for grant support in the bioengineering area and the nature of the growth in this field, whether linear or exponential -- a growth that is certainly fulminating in medical technology -- and as you might have predicted, we were unable to come up with any formula. Without more ado, let me call on the panel members: Dr, Akers, will you lead off? Dr, Akers: One. of the primary needs in this area is to establish a dialogue between engineering and medicine. The bioscientist, when he thinks of an engineer as possibly making a contribution to biomedical research, thinks of someone who can design a circuit to do this, or an instrument to do that, or who can recommend or devise a material with certain desired properties where materials presently available have some serious fault for the use needed -- obviously a limited concept. The engineer, on the other hand, fails at first to understand the limitations imposed by the greater complexity of living material as con- trasted with the material he has dealt with in the physical sciences. In the biological field, he is not able to make measurements that are reproducible to the sixth decimal point, or the fifth decimal point, day after day. In bioengineering we are dealing with multi-variable systems, almost all highly non-linear, whereas in engineering, we are normally working with single variables or at the most, two or three. Panel V (cont.) So there is a problem of getting on a common ground of under- standing, where the capabilities of the engineer can be made available in the general field of medicine, A possible solution to this lies in perhaps an engineer intern- ship or traineeship in a medical school. The deficiency is not nec- essarily a formal educational one. There's instead an opportunity for a greater number of engineers, who are quite competently trained in their own specialty, to see what the problems of medicine are on a day - to-day basis and to be in contact with the medical people who are en- gaged in research. This, then, would become a two-way educational program, both for the doctor and for the engineer. I think really this question of the dialogue is one that is most important today. Chairman: Thank you, Dr. Akers. I would now like to ask Dr, Stolwijk if he would give us his ideas on what kind of model would one build for the growth and development of bioengineering? What would a model of this field look like? Dr. Stolwi jk: It's safe to predict that there will be a very substantial increase in the biomedical engineering component in the research of the future. In other words biomedical research will gradually have a greater and greater biomedical engineering or quantitative content. There will be less em- phasis on descriptive research, and more on the analyzing type and constructive type of research which results from the quantitative approach. The number of biomedical engineers now being educated is estimated -- I think Dr. Jacobs estimated -- at abp t 25 per year. This will undoubtedly increase. Research support per manm=' will require on the order of 50,000 dollars per year if they are working effectively. So this gives some rough estimate of what is ahead. 1/ 1i.e., per principal investigator or bioengineering research project. = J3 = Panel V (cont.) Chairman: Thank you, Dr. Stolwijk. Another topic discussed in our panel was how research grant applications are to be evaluated in any given federal granting agency -- the agency being, in our particular case, the NIH -- and whether the Division of Research Grants might consider a bioengineering study section to be needed. Dr. Jacobs, could you distill for us some of the panel discussion on this? Dr. Jacobs: I'm sure everyone in this room has served at sometime as the bioengineering representative on an ad hoc committee to judge the content of a research proposal. We have seen programs which are almost trivial in bioengineering content approved for very considerable amounts of money -- one factor, at any rate apparently, being the magic of the term "bioengineering." I get a feeling that within the NIH each of the Institutes likes to have a finger in bioengineering. The bioengineering training programs are resulting in a growing output of students trained to the Ph.D. level who are and will be entering the basic science faculties in the medical schools. They, in turn, will generate research proposals and programs which are to a large extent based upon the bioengineering training, right or wrong, which they've obtained. It was the consensus that these bioengineering research proposals should find a study group that understands the field as it's evolving, and that within the next year or so the National Institutes of Health should consider the general problem of setting up a study section whose scope would be, essentially, biomedical engineering as ideally defined through this meeting today. Chairman: I must say at this point that I have had to wear two hats at this meeting, one as one of the representatives from NIH and the other as Chair- man for this particular panel. There is correlation between the two hats -- both reflect my taste in hats. But there is no causal connection between them -- I've never enjoyed wearing two hats simultaneously. Down to - 74 - Panel V (cont.) particulars: I have nothing to do, in my job, directly, with the establishment of new study sections in the Division of Research Grants. It is my understanding, however, that new ones are set up when research fields grow and differentiate, and when it is felt that none of the pre- sently active study sections can give the best informed consideration to grant applications from the newly differentiated research areas. But, as I have just said, aside from whatever my contributions may have been to the panel discussion this morning, I am only a friendly and sympathetic observer, impressed with the importance of this emerging field. I might add that each of the newer areas that many of you are bound up with went through the same development so far as evaluation of grant applications was concerned. We now have the Computer Sciences Study Section and the Biophysics Study Section, each of which resulted from some- what the same kind of study of need. Another topic on which our panel had something to say was the nec- essity for medical scientists and other biologists to acquire competence in using the intellectual tools in every day use by their engineering colleagues. Dr, Franklin, can you talk to this point? Dr. Franklin: For there to be a dialogue -- as has been emphasized here -- the physician or the investigator in medicine or biology must as least be aware of the capabilities of engineering in biology and medicine. For this to be possible the medical scientist must have had more physics and math courses. For example, university departments of physics give "pre-medical"™ physics and give other coursework for physics majors. In my opinion a pre- medical student taking physics should be a physics student, not a pre- medical student. I believe that these specially oriented courses are often not just simplified physics but really poorer physics. The physician will not be able to grasp physical concepts fully with poor or inadequate train- ing in physics. Our panel recommendations, then, are that for a dialogue, the biologist and medical scientist must have better training in the sciences basic to engineering, just as it is necessary for the engineer to have some life science training. Panel V (cont.) Chairman: Thank you, Dr. Franklin. Our panel also discussed the problem of professional identification of bioengineers, wherever they find themselves, whether with university responsibilities, or in industry. Mr. Springer? Mr. Springer: Our problem here is that we're trying to induce the younger students to join a program which we are unable to define, and work in an area which we tell them is interesting and worthwhile, but we can give them little assurance that they will have a particular function to perform for a good long period of time. I've been trying to hire a physiologist in a mechanical engineering department for two years but how do you convince a physiologist that he'll have a job in a mechanical engineering department for a good long time? This problem of recruitment into a field where the future may seem insecure goes right along with the communication problem. Not only do we have to worry about being able to talk each other's language but we also have to have some means of communicating, within the scientific bioengineering com- munity, what job openings are available for the various people who identify themselves as bioengineers. Chairman: The time allotted us has ended; however, I shall give up some of my later time here to continue this for just a little bit longer. Dr. James Pratt of NIH sat in with our panel discussion. He is with the Research Grants Review Branch of DRG. I'd like to ask Dr. Pratt if he has any comments to make at this time. Dr. Pratt: Thank you, Doctor. The problem of setting up a study section in- volves a number of different considerations and one of the most important is the recognition of the area's interest. From the discussions I have heard today, I should judge that bioengineering could very well encompass virtually all -- in some ways all -- of the research that's reviewed and supported in NIH. Under these circumstances it's very likely that bio- engineering proposals will continue to be reviewed to the extent that seems reasonable within the framwork of the existing study sections. It might, however, be very useful to identify bioengineering research proposals as such, for as you know, the fundamental philosophy of the review system is evaluation by a peer group. Panel V (cont,) I was impressed with Dr. Schmitt's comments about the highly in- judicious, even lethal, development of what might be called a grant elimination filter by the seemingly judicious referral of bioengineering research proposals first to people competent exclusively in engineering and then to people exclusively competent in the clinical or biological areas, each group applying its own rigorous and possibly even narrow criteria to the evaluation of each proposal and perhaps missing the point of the bwidge which bioengineering effectively represents. Under these circumstances it has been our attempt, at least in the past, to have on the group reviewing a proposal, at least one person and hopefully even more than this, who do reflect precisely this bridge competence. In this connection let me mention a consideration which I haven't heard mentioned as yet, but one that would seem to be of great importance. If all biological investigation is to become more and more quantitative, we shall insure that the existing study sections improve their function to evaluate precisely the proposals with quantitative approach which come before them, Chairman: Thank you, Dr. Pratt. TI believe the thinking you have just expressed is in line with a recommendation from the Wooldridge Report; namely, that physical and mathematical competence be represented on reviewing groups across the board. So, it seems NIH can or has considered, and even considered favorably, two steps -- one or both of them -- namely setting up a separate study section for certain kinds of applications and at the same time strengthening the study sections throughout so that they can evaluate with precision grant applications that are more quantitative in their approach. I will at this point open the panel discussion to the floor. Dr. Goodman: I am from the Division of Research Services, NIH. This Division is engaged -- part of it at any rate -- in the everyday work of engineers working on instrumentation problems. Panel V (cont.) I hope that the survey undergoing a pilot trial on us and on the EMB=' meeting here the next three days, will yield figures on the relative percentages of bioengineers in research and in everyday R and D work, The great majority are, I believe, going to be in the latter group. We have these practicing bioengineers in our Division of Research Services. They are engaged in making devices needed in the clinic, in the laboratory, in the hospital; and in making computers. They publish no research papers, write no textbooks or monographs, do not get up at technical meetings and present papers, but they are face to face with very meaningful and literally critical problems. In our Division we need more of these bioengineers -- B.S. types, M.S. types and Ph.D. types, and we need more engineers, I foresee a growing demand for bioengineers to design and produce the hardware on which depends much of the advance in the care of the sick and in prevention of disease. And from this will come a feedback of demand for more research manpower. I look for a doubling of bioengineering manpower needs every three of four years. Mr. Rosenthal: I'm Joe Rosenthal, from the Office of Program Planning of the Office of the Director, NIH. We are interested in knowing just what industry is doing in bioengineering and have gone so far as to make a pilot test on some fifteen companies, of a survey we have designed. And lo and behold, the people with whom we have talked have had no difficulty in understanding what we mean by bioengineering. One or two of the companies were ready even to pull out their records and tell us in dollars and cents just exactly what they are doing in the support of the things that we have been talking about. We may therefore be able to provide some parameters of where your bioengineering graduates will be going. Chairman: Thank you, Mr. Rosenthal. Are there any other comments? Yes, Dr. Lowenberg. 1/ 18th Annual Conference of Engineers in Medicine and Biology - 78 - Panel V (cont.) Dr. Lowenberg: It is my understanding that NIH makes grants only for research, not for design and development. Yet we hear on every side thac new and improved engineered laboratory and clinical hardware leads the procession, as medical research and clinical medicine make new break-throughs in their advance. Where are these so badly needed people who do design and develop- ment going to get the funding for their thesis research if it is design- and-development oriented? A lot of companies used to hire from the top quarter of engineering graduating classes, but this group now 80 on to graduate schools and by the time they get their Ph.D.'s they are no longer engineers in the design sense. Industrial organizations have expressed concern about this. Should there be design-oriented Ph.D. programs and development-oriented Ph.D. programs? And I wonder if our own group here, too, are facing the clear distinction between design and development vs research? Dr. Brown: The distinction is fairly clear at NIH, for a very simple reason, and that is the law which defines our mission. For the law says very precisely that the money at NIH will be spent for research and research training. Period. We cannot use NIH funds to give a man technical train- ing -- training for design and development -- without a special mandate from Congress. We can support only graduate training for research. When it comes to research itself, what NIH can support must be related to health and in general this does not extend to design for its own sake. Primarily because of the restriction on funds, we have been supporting the basic developments in a medical research field and leaving design to the companies -- things they can put into production and make money out of. Chairman: Thank you, Dr, Brown. Dr. Talbot? Panel V (cont.) Dr, Talbot: I wonder how much of this is not purely administrative decision on the part of a few people around NIH. There is no difficulty whatsoever in broadly interpreting anything that is needed in research as a legitimate research expense, and if an improved design of something is necessary for successful research, it seems to me that design is a legitimate research expense, There are many areas of need for design, areas that are far short in production and design. There are many research items needing improvement in design that are not developed far enough in the research laboratory for any company to venture to take them over and perfect them. It seems to me that a simple re-interpretation would be all that would be required to in- clude this kind of design into research. Chairman: There are complicating factors in the decision making, as we all know, It is not simple. NIH has made some decisions in the past, however, that had in them a certain amount of risk. The decision by categorical disease-oriented institutes to support basic medical research is an instance. However there is another factor bearing on the possible support of instrumentation development, per se: the shortage of funds combined with the system of priority ratings -- the rating given to every grant application. The more important the possible payoff in the advancement of scientific fact or theory, the better (nearer the top) the priority score, other factors of scientific merit- judgments in the proposal being equal. Under this sytem, wdevelopment™ grants per se are not able to compete well. Contracts offer a better chance for them. Dr. Brown, do you want to add to that? Dr. Brown: I want to add just one more point -- just casually -- and say for example that in man-in-space R & D, something like 200 million dollars has been spent on what has been called basic research and a half billion on development, If we spent money in the same proportions at NIH, we would be out of funds in the first week. I mean we just can't do it; there is just no way. “ 80 = Panel V (cont.) Dr, Akers: Where the design of an instrument is an essential part of a parti- cular research project -- in physiology for example -- the design and development will be funded if the research proposal in the application is otherwise meritorious and carefully thought out. However, where the application is to develop an instrument without a goal in mind, I have a great deal of sympathy with the view that it should be turned down. The goal should be in health, physiology, or whatever, and the development of the instrument should really be incidental to the research. Chairman: I think that perhaps one more question and then we must close this area, much as we might like to continue it, Is there any one last-minute question or any last comment? Dr, Schmitt: I would like to compliment Captain Gowen on the excellent job he did in organizing this workshop in the completely inadequate time he had. Chairman: For Captain Gowen, thank you very much. So would I. I would also like to thank the members of Panel V for their participation before going on to the summary I want to make. Yes? Dr, Schoenfeld: NIH is able to support instrumentation as the main objective of a project if the goal is an instrument that will obviously of great use in biological research. As you know, NIH supported the LINC=' computer, a multi-purpose instrument for biological research and it was not linked to any specific research project. 1/ Laboratory INstrumented Computer - 81 - Panel V (cont.) Chairman: True enough. Sometimes this kind of thing can also be supported under contract mechanisms. They may have considerable flexibility, and other agencies have also found them to be satisfactory. NIH is cautiously -- in view of funds available -- beginning to look at this as an inter- esting adjunct to its grants policy. Dr. Schoenfeld: At the present time we bioengineers are conducting a half-hearted program with an inadequate force -- just ourselves -- and have not yet broken through in any major way. But I assume this is going to happen, because it's evident that the biological sciences are going to build toward approximately the same order of magnitude as the physical sciences in their basic and their technological research. Very few of us have considered what we're going to do about it. It would be very interesting to speculate on what we will do when we're faced with the necessity of justifiably spending, let's say the same amount that's going into the space program. After all, biomedical research, including bioengineering, is at least as important a job as space research. We've done very little planning towards such an emergency, which I hope won't occur. Chairman: You raise a very interesting question (laughter). Now I'm faced with the emergency -- it has actually occurred -- of trying to summarize all of today's wordage and thought. I wish that someone who is a bio- engineer would take it off my hands. I don't expect to make a summary that will be very meaningful. I'm a biochemist, and for the last couple of years I have been quite interested in the development of bioengineering and its possibil- ities in a biochemical framework. To me this has been an exceedingly profitable seminar on the points of view, on the problems and on the current status of this particular field as it has developed. The results will, I am sure, be very useful to us at NIH. -« 82 = Panel V (cont.) In Dr. Confrey's absence -- he has had to leave to catch a plane -- it falls upon me to thank you on behalf of the Division of Research Grants and of the NIH for coming here and participating in this workshop. TI hope that the tape recordings have been good and that our secretaries can decode the names and the technical expressions. Dr. Gowen will no doubt have something to say about a transcript of the proceedings. Now to summarize the highlights as they have impressed me: The subject of training kept coming up, but we could not, of course, give it more than cursory attention. It deserves a full session, perhaps many, all by itself. Regarding the definition of bioengineering, the feeling was that we must include both engineering science and applied techniques in any definition of bioengineering. Bioengineering must be firmly rooted in engineering, but the matter of how much training in biology still remains an open question for the growth of the field to decide. Instrumentation is a strong component in bioengineering. I am somewhat embarrassed, may I say, to learn that NIH's Research Grants Index has all the apparent bioengineering research indexed under "instrumentation," but this can be interpreted as a reflection of the ready identifiability of this aspect of the total field. The scientists in peripheral areas recognize, of course, that bioengineering is not just instrumentation alone. Competence in bioengineering got attention, and with it, the ac- creditation of schools of bioengineering training. The need for the build- ing of bridges of communication between the people in this area was emphasized. The problem is, of course, not new. We have had it in my field, biochemistry, as it split off from physiology and more recently in biophysics, as it differentiated from biochemistry. Every field has had a turn at this. TI am particularly intrigued by the enthusiasm with which the engineer is now confronting the complexity of living systems and beginning to wrestle with it. I was struck by one thought that didn't seem to catch too much play, but it appealed to me, that bioengineers are and will be interested in constant retesting and reevaluation of physiological and other life-science concepts and methods. TI should say there is plenty of work ahead for the bioengineers. - 83 - Panel V (cont.) With these thoughts from a person not involved in bioengineering per se, but much interested and concerned with it, I'll leave any further attempt at a summary to the study of the transcripts of the proceedings of this meeting. Again, for DRG and NIH, thank you all very, very much. The closing of this meeting is yours, Dr. Gowen. Dr. Gowen: As you said, the final summarizing will involve taking the transcript of the tapes, and extracting the core of meaning that is obviously there. You have described the area of bioengineering; you have given NIH some guidelines; you have discussed manpower, at least enough to know where we should go. We have a very good start in putting something on record, now at least on record, and we should consider further meetings in a year or two for further clarification of ideas and discussion of problems. I did not expect that as a group of people we could get together and almost say the same thing, as we've demonstrated, on so many of these important questions. I can only say that my heart-most desires have been achieved. Another item which will be of interest to you, I am sure, is the survey form. We hope that it will be distributed at the EMBL meeting at registration time tomorrow. I hope that in six months or so we can come up with a report which will give you an idea of the profile of the research manpower in bioengineering. We shall push the typing of the proceedings of this workshop and get them printed and into your hands as soon as possible. May I now extend my thanks to each of you for cooperating and being here and working so hard to make this come off so successfully. Also, I'd like to thank Dr. Albritton and Dr. Bever for their part in making this conference possible. Their interest in bioengineering as an emerging field is very obvious and genuine. Anyone else care to say anything? Then we are adjourned, and again, thank you very much. 1/ Engineering in Medicine and Biology - 85 = PARTICIPANTS . 37 = NATIONAL WORKSHOP ON BIOENGINEERING RESEARCH AND MANPOWER PANEL MEMBERS William W. Akers, Ph.D. V Department, Chemical Engineering Rice University Houston, Texas 77001 Robert D. Allison, Ph.D. III 5200 Gibson Blvd., S. E. Lovelace Foundation Albuquerque, New Mexico 87108 Carl Berkley, Editor II American Journal of Medical Electronics Great Notch, New Jersey 07424 Arley T. Bever, Ph.D. Iv Associate Chief Division of Research Grants National Institute of General Medical Sciences Bethesda, Md. 20014 Victor W. Bolie, Ph.D. I Chairman Joint Committee on Engineering In Medicine Biology Research and Development Division Autonetics Anaheim, California 92805 John H., W. Brown, Ph.D. 11 Assistant Director for Operations National Institute of General Medical Sciences National Institutes of Health Bethesda, Md. 20014 - 88 ~- Gilbert B. Devey Division of Engineering National Science Foundation Washington, D. C. 21550 James F., Dickson, III, M.D. Head, Medical Sciences Branch National Institute of General Medical Sciences National Institutes of Health Bethesda, Md. 20014 David Fleming, Ph.D. Department of Biomedical Engineering Case Institute of Technology Cleveland, Ohio 44106 Dean Franklin, Ph.D. Chief, Biomedical Engineering Scripps Clinic and Research Foundation LaJolla, California 92037 Richard J. Gowen, Ph.D., Capt., USAF Workshop Chairman Assoclate Professor of Electrical Engineering USAF Academy, Colo. 80840 Newman Hall, Ph.D. Executive Director, Committee on Engineering Education 1501 New Hampshire Avenue, N.W. Washington, D. C. 20036 Francis J. Hassler, Ph.D. Head, Department of Biological and Agricultural Engineering Box 5906 North Carolina State University Raleigh, North Carolina 27007 Iv II Iv II - 89 = John E. Jacobs, Ph.D. Bio-Medical Engineering Technological Institute Northwestern University Evanston, Illinois 60201 Saul D, Larks, Ph.D. Professor of Electrical Engineering Marquette University Milwaukee, Wisconsin 53233 Francis M. Long, Ph.D. Professor of Electrical Engineering University of Wyoming Laramie, Wyoming 82070 John H. McLeod, P.E. Editor, Simulation Councils Incorporated 8484 La Jolla Shores Drive LaJolla, California 92037 Edward M. McLaughlin, Ph.D. Office of Manned Space Flight National Aeronautics & Space Administration Headquarters Building Washington, D. C. 20546 George H. Myers, Ph.D. Department of Electrical Engineering New York University New York, New York 10003 Lawrence M. Patrick Head, Department of Biomechanics Wayne State University Detroit, Michigan 48202 Robert E. Robards, M.C. Col, USAF Biomedical Sciences Program Manager Headquarters USAF DCS/R&D (AFRSTA) Room 1D373 Pentagon, Washington, D. C. 20330 III IIL IV III IV 11} - 90 =- Otto H. Schmitt, Ph.D. Professor of Biophysics University of Minnesota Minneapolis, Minnesota 55455 Robert L., Schoenfield, Ph.D. Rockefeller Institute for Medical Sciences New York, New York 10021 Lloyd ,E. Slater BIAC=" Executive Secretary 3900 Wisconsin Ave., N.W. Washington, D. C. 20016 Wayne E. Springer Department of Mechanical Engineering Kansas State University Manhattan, Kansas 66504 Lawrence Stark, M.D. 1753 West Congress Parkway Chicago, Illinois 60612 Jan A, J. Stolwijk, Ph.D, John B., Pierce Foundation Laboratory 290 Congress Avenue, New Haven, Connecticut 06519 Samuel A. Talbot, ph.p.2/ Associate Professor of Medicine Biomedical Engineering Program Johns Hopkins Medical School Baltimore, Md. 21205 Richard Thackray, M.D. Research Psychophysiological Institute of Pennsylvania Hospital 111 North 49th Street, Philadelphia, Pennsylvania 19107 1l/ Bioinstrumentation Advisory Council 2/ Deceased II IV 11 Iv III - 9] =~ Homer Warner, M.D. I Chief, Department Biophysics and Bioengineering University of Utah Salt Lake City, Utah 84103 Thomas B, Weber, Ph.D, IT Head, Advanced Research APO Beckman Instruments 2500 Harbor Drive Fullerton, California 92631 OTHER PARTICIPANTS Errett C. Albritton, M.D. Scientific Evaluation Section, ORE Division of Research Grauts National Institutes of Health Bethesda, Maryland 20014 Robert L. Bowman, M.D. Chief, Laboratory of Technical Developmant National Heart Institute National Institutes of Health Bethesda, Md. 20014 Eugene A. Confrey, Ph.D. Director, Division of Research Grants National Institutes of Health Bethesda, Maryland 20014 Richard Emberson, Ph.D. Institute of Elctrical and Electronics Engineers 345 East 47th Street, New York, New York 10017 Peter Frommer, M.D. Cardiology Branch National Heart Institute National Institutes ot Health Bethesda, Md. 20014 Lester Goodman, Ph.D. BEIR, Division of Research Grants National Institutes of Health Bethesda, Md. 20014 Mr. Roger B. Grau Surgical Laboratory Colorado State University Fort Collins, Colorado 80521 Edwin Lowenberg, Ph.D. Department of Electrical Engineering University of Nebraska Lincoln, Nebraska 68508 Sidney Margolin, M.D. The Medical Center University of Colorado Denver, Colorado 80220 Martin Peller Resources Analysis Branch Office of the Director National Institutes of Health Bethesda, Md. 20014 Joseph Rosenthal Resources Analysis Branch Office of the Director National Institutes of Health Bethesda, Md. 20014 # U.S. GOVERNMENT PRINTING OFFICE : 1967 0—263-753 4 j | | ~ i ) 1 i : { Public Health Service Publication No. 1658 o ' U.C. BERKELEY WING C029401924