Annals of Biomedical Engineering, Vol. 19, pp. 547-650, 1991 0090-6964/91 $3.00 + .00 Printed in the USA. All rights reserved. Copyright �9 1991 Pergamon Press plc

I. BME EDUCATION A N D TECHNOLOGY

I. 1. B M E Education f o r the 21st Century

Organizer: David B. Reynolds, Wright State University

91-1. The Commonality among Bio/Biomedica! Engineering Curricula Blair A. Rowley, Wright State University

At the Workshop on the Undergraduate Curricula in Bioengineering held 7 through 10 March 1991 the participants from all nineteen ABET accredited undergraduate programs and representatives from industry, the VA, NSF, IEEE & ABET, and Clinical Engineering inves- tigated the commonality among curricula. This paper presents information about courses, lab- oratories, design, textbooks, and how curricula can prepare the students for the 21st century. Common goals and related factors have already led us to a high degree of commonality. Some of the recommendations for improvements involve seeking alternatives to animal based under- graduate teaching laboratories, reviewing and incorporate course/s on biotechnology, and en- couraging faculty to produce textbooks designed to meet teaching rather than reference needs. (The workshop was supported by a grant from the NSF, Office of Undergraduate Science, En- gineering, and Mathematics Education.)

91-2. Undergraduate Bioengineering/Biomedical Engineering Curricula: Current Status and Issues for the 21st Century Eric J. Guilbeau, Bioengineering Program, Department of Chemical, Bio and Materials Engineering, Arizona State University

This paper presents a number of issues related to undergraduate Bioengineering Curricula that were discussed at the National Science Foundation's Workshop on Undergraduate Cur- ricula in Bioengineering. The results of a survey of the 19 ABET accredited undergraduate cur- ricula will be presented. Although each of the accredited undergraduate curricula evolved independently, commonalities exist among the group. There is also a desirable diversity and flexibility among the curricula. The relative flexibility of ABET accredited Bioengineering cur- ricula in comparison to curricula in other disciplines is viewed as a strength. This flexibility will help Bioengineering educators prepare students for the "explosive" increases in technology projected for the 21st century. For example, the life science and biology content of existing bi- oengineering curricula provides some of the basic fundamental skills needed by students seeking training in the engineering application of modern biotechnology and genetic engineering. These skills and others in the life sciences are important in evolving areas such as cellular and molecu- lar engineering and tissue engineering. This paper outlines Arizona State University's plans to add an area of emphasis in Molecular and Cellular Engineering that builds on the basic biol- ogy content of the current Bioengineering curriculum.

91-3. Graduate Education in Rehabilitation Engineering Dr. Paul N. Hale, Jr., Biomedical Engineering Department, Louisiana Teeh University

The passage of federal rehabilitation legislation has increased opportunities for Biomedi- cal Engineering graduates. These opportunities are in both the private and public sectors and emphasize product design, development and the application of rehabilitation engineering/tech- nology. This presentation will discuss graduate-level rehabilitation engineering education and the opportunities that exist for graduates.

91-4. Incorporating "Hot" Topics (Biomedical Imaging and Biosensors) into Undergraduate BME Curriculum G.M. Saidel, Department of Biomedical Engineering, Case Western Reserve University

New and sophisticated research areas in biomedical engineering present potential employ- ment opportunities for undergraduates. To incorporate these areas into the undergraduate cur-

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riculum, however, requires a re-evaluation of course content and specialty sequences. These issues are currently being addressed in the BME program at CWRU with respect to biomedi- cal imaging and biosensors, in which we have very active research programs. In biomedical im- aging, we are emphasizing image processing, which requires background in digital signal processing. In biosensors, we emphasize micro-electrochemical and electromechanical sensors. A challenge for us is to give juniors enough background so that they can begin projects in these areas by the senior year. Even though our students choose specialty sequences, an appropri- ate balance between depth and breadth is difficult to achieve.

1.2. B M E Industry and Academic Programs

Organizer: Michael J. Kallok, Medtronic. Inc.

91-5. Industrial Collaboration at the Duke-North Carolina National Science Foundation/Engineering Research Center for Emerging Cardiovascular Technologies T.C. Pilkington, NSF/ERC for Emerging Cardiovascular Technologies, Duke University

A major purpose of the Duke-North Carolina National Science Foundation/Engineering Research Center (NSF/ERC) is to facilitate transfer of knowledge and technology between in- dustry, education, and research. This ERC is designed on the premise that students are the heart of the work force, and we believe that personal contact between industrial researchers, students, and university researchers is an effective way to achieve knowledge/technology transfer. We have developed the Educational Partners Program as a strategy to enhance the engineering edu- cation of NSF/ERC Fellows while developing meaningful industrial collaborations and knowl- edge/technology transfer. This program sponsors industrial internships for undergraduate and graduate Fellows and provides industrial advisors for predoctoral Fellows. In return for their financial support and contributions to the Fellow's education, industries joining the Partners program have access to research through preprints of all ERC publications and a newsletter published three times each year; workshops designed in response to industry's needs; and an- nual ERC industry meetings.

91-6. Co-Sponsorship of Research by Industry and the University WA. Tacker, Jr., William A. Hillenbrand Biomedical Engineering Center, Purdue University

Cosponsorship of scientific research by industry and university has increased in scope dra- matically during the recent past, and has proven beneficial to both institutions in many cases. However, not all collaborations are successful, and all too often, they do not meet the expec- tations of the parties involved. Based on two decades of participation in, and observation of such collaborations I have observed several factors which are associated with success. I also have observed some factors which do not seem to be very important. Those associated with suc- cess include: (1) clear definition, and agreement by all parties, of the objectives of the co-spon- sorship, and of the priorities of the project components; (2) a true team attitude and approach to the achievement of objectives. On balance there is greater commitment to the task at hand than to personal career development of the participants; (3) complementary and/or supplemen- tary expertise and resources of the institutions; (4) clear, frequent, honest communication be- tween all members of the team; (5) commitment by all parties of adequate resources to complete the project; (6) a relatively short project duration; (7) resolution of commonly encountered problems (i.e., patent issues or policy concerning publications) as early as possible; and (8) ab- sence of personality conflicts. It should be emphasized that these factors apply just as much within one of the institutions as they apply inter-institutionally. Of course, all of the above eight items will not stay on ideal course throughout the collaboration, and effort is required to make in-flight corrections to get back on course. Of lesser, and sometimes virtually no importance are size of the organizations, magnitude of the scope of work, proximity of the organizations, and personal friendships of individuals in the two institutions.

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91-7. A Model for Academic and Industrial Cooperation Kevin J. O'Toole, Massachusetts Institute of Technology

For the past 75 years, students in the Department of Electrical Engineering and Computer Science have had an unusual opportunity to combine industrial experience with their academic work. The Department considers practical experience to be a valuable component of an engi- neering education. Although the Program is designed for Electrical Engineers, the policies, prin- ciples, and procedures can be adapted to other disciplines. This paper will review the salient features of the Program and present it as a model for other applications.

91-8. The "Academic-Industrial" Complex, An Industry Perspective Edward R. Duffle, Jr., Becton Dickinson & Co.

The potential association between the academic community and industrial device and drug companies is an obvious and natural one for both communities. A unique opportunity exists to forge a new and stronger alliance that depends on the understanding that the two groups have far more common interests than conflicting ones. Some potential problems do exist, how- ever. There must be clear and agreed upon definitions of "ethical" behavior. The underlying missions of the two groups are different as well as their styles and reward systems. In addition, there is an incomplete understanding of each other's cultures, policies, programs and proce- dures. Identifying the issues and solving the problems will lead to closer ties that will benefit both communities as well as the health care industry at large.

91-9. Optimizing Academic-Industrial Research Collaborations Michael J. Kallok, Physiological Research Laboratories', Minneapolis

Of all the possible types of research interactions between Universities and industry, the most satisfying and perhaps most productive is the true collaborative arrangement. The medical de- vice and pharmaceutical industries conduct a wide range of research, from basic biochemis- try and physiology studies to applied, product-specific work that is directed and goal-oriented. Many research efforts are broad-based and require a wide range of disciplines. Often indus- try lacks the breadth of expertise required to conduct all elements of the research project. The role that Universities can assume is one of providing members to serve on the multidisciplin- ary team. Funding is provided by industry and protocol design is a joint effort by the academic and industrial scientists. Work is carried out in both the industrial and university laboratories, often with scientists working in both settings. Issues that need resolution before these collabora- tive arrangements can be effective include patent rights, confidentiality of proprietary infor- mation, timing and authorship of publications. Despite these obstacles, effective collaborative arrangements have occurred to the mutual benefit of universities and industry. Although in- dustry cannot and should not assume the funding role that the federal government has histor- ically held in biomedical research, academic-industrial collaborations do provide a source of funding for academic research that is generally viewed by industry as a sound investment.

1.3. Successful Strategies f o r Transferring Biomedical Technology to Industry

Organizer: Dan Winfield, Research Triangle Institute

91-10. Technology Transfer to the Medical Device Industry--An Industry Perspective Robert J. Morff, Medical Devices and Diagnostics Division, Eli Lilly and Company

The medical device industry has a long history of adopting and rapidly developing innovative new technology. Many examples of successful transfer of new technology from the university or private laboratory setting can be recalled, and many opportunities exist today. For exam- ple, at Eli Lilly and Company we review three- to four-hundred new technology transfer op-

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portunities each year. One challenge is clearly to select from these many opportunities the few that are most promising, and then to actually implement the transfer. Broadly speaking, tech- nology transfer opportunities are assessed based upon their strengths/weaknesses in three cat- egories: clinical, business/legal and technical. Specific assessment criteria within each of these categories will be presented and discussed, along with some case examples to illustrate the as- sessment process. Some common pitfalls and roadblocks to successful technology transfer will also be presented.

91-11. Why Technology Transfer? Daniel L. Winfield, Research Triangle Institute

To open this session on biomedical technology transfer, this paper sets the stage for the fol- lowing speakers to discuss their respective views on how to facilitate technology transfer. Here we focus on why we should be concerned about technology transfer. If we define technology transfer as "the transfer of technical knowledge from one individual or organization to another for the purpose of developing new or improving existing products or processes," then it is ap- parent that it takes place routinely in the business day. Yet, in recent years the U.S. has trailed Japan and other countries in the actual implementation of new technology into products; in part due to closer ties between industry, government and universities in Japan. For the U.S. to regain preeminence as developer of products, not just a developer of technology, the objec- tive of technology transfer then is to expedite the transition of research results into products. Despite this universal objective, implementation of technology transfer, particularly across or- ganizations (government to industry or university to industry) is by no means straightforward. Understanding the differing, sometimes conflicting, motivations of the parties involved is cru- cial to building the kind of win-win situations that are essential. Recent legal and cultural changes to support technology transfer are reviewed. Finally, we present a model for technol- ogy transfer as a problem-solving process; requiring a clear, up-front understanding of the prob- lem to be solved, the tasks to be performed, and the roles of the collaborators.

91-13. NASA's Technology Applications Engineering Program F.H. Farmer, Technology Utilization and Applications Office, NASA~Langley Research Center

The Technology Applications Engineering Program is one of several programs that is used by NASA to transfer applicable aerospace technologies to other Government agencies and/or American manufacturers. By working very closely with the technology users and the clinical evaluators, NASA uses this program to "spoon-feed" specific technologies to carefully selected medical instrumentation manufacturers and other users. Several technology transfer case studies will be discussed, including the application of NASA/LaRC-developed, high frequency ultra- sonics technology to the measurement of skin burn depth and to the measurement of in- tracranial pressure. Factors which affect successful technology transfer include company size, R&D capabilities, and current share of market in the technology area. NASA/LaRC's current procedures for selection of commercial partners will also be discussed.

1.4. Bioengineering and the Costs o f Health Care

Organizer: Joseph D. Andrade, University o f Utah

91-15. "What, Me Worry?" Bioengineering and the Costs of Health Care J.D. Andrade, University of Utah

The rapidly increasing cost of health care in the United States is now a subject of consid- erable interest and concern for all segments of society. Historically, the academic bioengineering community has not been particularly concerned with the cost implications of the technologies

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and instruments which it develops. The medical community, which applies the results of bioen- gineering research and development, has also been generally unaware and unconcerned with cost considerations until relatively recently. The situation of course has changed dramatically in recent years. It is now imperative that at least a portion of academic bioengineering educa- tion, research, and development be directed to the health care cost issue.

The graduates of academic bioengineering programs nationally go on to work in the health care products industry, in government regulatory bodies, and in academia. Students in bioen- gineering programs should be induced to consider the cost-benefit implications of their graduate research work and should have some general familiarity with the concepts and techniques of technology assessment and cost benefit analysis.

Academic bioengineering should take a global look at primary medical care activities and should create new and novel approaches which could have a significant impact on decreasing health care costs. It is not someone else's p rob lem- it is also our problem.

91-16. The Changing Environment for Bioengineering Robert P. Huefner and Joseph Andrade, University of Utah

Our health care delivery and financing systems are going through revolutionary change. The biggest changes are likely to come from some form of national health insurance, probably within the next two decades.

"Access, access" was the call behind most health care reform after World War II, but in 1965 we bit off more than we realized. Within half a decade the twin reforms of Medicare and Med- icaid greatly increased the utilization of health care services, and with that brought crisis to state and federal budgets during the Seventies and through the Eighties. The explosion in costs was not limited to government. Utilization and costs of health care also burgeoned for the privately insured and the uninsured. Governments and employers raised a new cry: "cost containment!" They drowned the calls for access-but only temporarily. Cost management and a structurally flawed insurance market today create desperate access problems, especially for small businesses and for individuals with prior medical problems. In the Nineties the health care delivery sys- tem fails our expectations on both counts of access and costs, and we wonder if attempts to address these two concerns soon will threaten quality as well.

For the next few years there will be desperate, confused, and sometimes innovative actions at both the state and federal levels. These deserve careful watching and guidance, in part be- cause they will determine the health care system which will form the environment for the fu- ture of bioengineering.

The future certainly means the introduction of new levels of cost consciousness in bioen- gineering. Experimentation with unproven technologies, especially expensive technologies, will be discouraged, as much as they were encouraged in the past. Whether funding for new tech- nologies will be easier or tighter is less certain. What seems reasonably predictable is that the funding sources, whether public or private, will shift their interests to cost-saving technologies. Opportunities here are largely untapped, and appear to be enormous.

91-17. Medical Technology and National Health Care Proposals William W. Cimino, Department of Bioengineering, University of Utah

The use of "high technology" in the practice of medicine is frequently cited as one reason for the rapidly escalating cost of health care in the United States. At the same time, advance- ments in medical technology have increased both the quality and capability of available med- ical care. Thus, technology is directly involved with both the cost and quality issues of medical care, and it seems appropriate that the role of technology would be a central issue in any na- tional health care proposal.

This paper examines the relationship between the use, availability, and development of med- ical technology and five proposed national health care plans: (1) the Basic Health Benefits for All Americans Act (BHBAAA, the Kennedy-Waxman Bill); (2) the Physicians for a National Health Program proposal (PNHP); (3) the Consumer-Choice Health Plan for the 1990's (CCHP) by Enthoven and Kronick; (4) the National Health System for America (NHSA) pro- posal from the Heritage Foundation; and (5) the Health Access America (HAA) proposal from

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the AMA. Each of these plans address health care coverage, plan financing, and cost contain- ment strategies to varying degrees, yet none of the plans specifically address the role of tech- nology, other than to suggest that technology assessment would be required for success of the plan (PNHP and CCHP). However, implementation of any of the plans would have direct and/or indirect effects on the availability, use, and development of medical technology, and hence, the quality and cost of health care under the plan.

91-18. The Oregon Priorities: A Bioengineering Resource .I.D. A ndracle and R. ttuefner, Departments of Bioengineering and Political Science, The University of Utah

The State of Oregon is leading the nation with an ambitious and important effort to address the health care cost problem (J. Kitzhaber, "A Healthier Approach to Health Care," Issues in Science & Technology, Winter 1990-91, pp. 59-65). l After a 2-year effort, involving all seg- ments of the Oregon population, Oregonians have categorized and prioritized health care into 17 generic categories and nearly 800 specific procedures. At the top of their priority list are " . . . life-threatening conditions for which treatment will return a person to health; maternity services; preventive care for children such as screening and diagnosis; and preventive care for adults." At the bottom are " . . . treatments which will marginally improve a person's quality of life although they may not prolong it." (Oregon Basic Health Services Program Report, April, 1991, Dept. of Human Resources, Office of Medical Assistance Programs, State of Or- egon, Salem, Oregon). 2 The data they have collected and the assessments and prioritization they have developed can serve as a resource for bioengineering researchers and developers in their choice of cost-effective projects and studies. We review the Oregon categories and sug- gest areas where academic bioengineering activities could have an important influence on de- creasing the costs of health care.

II. C A R D I O P U L M O N A R Y E N G I N E E R I N G

II. 1. Fluid Shifts in Humans Exposed to Microgravity

Organizer." Alan R. Hargens, N A S A A m e s Research Center

91-19. Fluid Shifts in Humans with Actual and Simulated Microgravity-An Overview Alan R. Hargens, Life Science Division (239-11), NASA-Ames Research Center

On Earth, gravity normally imposes blood pressure gradients on the cardiovascular system. These gradients increase blood pressure, blood flow and fluid accumulation in dependent tis- sues of the body. On the other hand, actual or simulated microgravity causes blood and tis- sue fluid to shift from the lower to upper body. Studies of humans in space have documented increased heart rate, narrowed pulse pressure, reduced plasma volume, decreased heart size, headache and facial edema. Return of astronauts to Earth is accompanied by orthostatic hy- potension and decreased exercise capacity. These factors reduce performance during descent from orbit and increase risk during emergency egress from the space craft. Models of simu- lated microgravity that are relevant to the cardiovascular system include head-down tilt, wa- ter immersion, and prolonged horizontal bedrest. Further verification of ground-based models with flight experience is needed along with development of noninvasive technology in order to understand underlying mechanisms of adaptation. Possible countermeasures to speed readap- tation of crew members to gravity after prolonged space flight include exercise, lower body neg- ative pressure, and artificial gravity. (This research was supported by NASA.)

91-20. Cardiovascular Studies on SLS-I: The First Dedicated Life Science Spacelab Mission

Jay C. Buckey, University of Texas Southwestern Medical Center

Experiment 294 on SLS-1 (one of three cardiovascular experiments, P.I.: C. Gunnar Blomq- vist) was designed to measure the human cardiovascular adaptation to zero-gravity and the