The foundation welcomes this challenge. It provides an opportunity to enhance or expand its current biomedical engineering programs or possibly launch new initiatives for the field. To prepare for an increased level of grant expenditures, the foundation invited a group of outside experts to assess the current status and project future directions in the nation's educational, research and biomedical industrial enterprises.

The Strategic Directions in Biomedical Engineering meeting was held October 6-7, 1997, in Washington, D.C. Twenty-six prominent individuals joined the Foundation Governing Committee and staff to discuss issues in science and engineering, health care, the biomedical industry, research universities and support for biomedical engineering. Among the participants were university presidents, Nobel laureates, a medical school dean, the president of a major hospital complex, academic leaders, and representatives from industry, other private foundations, government agencies, and academic leaders from the United States, Europe and the Far East. Following are the major conclusions reached at the meeting.

1. Life sciences and engineering are becoming increasingly complex, requiring integrative and novel approaches to both. One example is neuroscience. Understanding the neuron says nothing about how higher-level neural functions, such as cognition, work. The same is true in genetics. The molecular sequence of a gene does not fully explain gene function or regulation or how the gene product influences the function of a cell, tissue or organ. Major new initiatives are needed for understanding how complex behavior arises. These initiatives must tie together different levels of biological organization, from molecular to cellular to organ to organism. They must also bridge disciplines, such as biology and engineering.

Engineering itself is becoming more complex. Society requires that engineers be trained not just to analyze but to synthesize systems with engineering, societal and humanistic components. Engineering education thus needs to become more integrative and innovative. Engineers need to learn to formulate problems, not just solve them. They need to manage complexity and deal with ambiguity.

2. The health care system is chaotic and unpredictable. Broadly trained individuals and flexible organizations are needed to deal with the ongoing upheavals.

The health care system in the United States is undergoing chaotic changes involving technological, economical and political components. The future is unpredictable. The current system is market-driven, rather than value-driven. Academic medicine is being pressured by these changes into downsizing. The trend is toward increased utilization of outpatient treatment and home health care. New infrastructure and new technologies are needed to support these changes, but they must be flexible.

3. For the U.S. health care industry, this is the "best of times" and the "worst of times." Major, possibly risky, investments are needed to achieve paradigm-shifting advances.

On the one hand, the U.S. health care industry enjoys great opportunities created by advances in technology and the life sciences. On the other hand, it is facing strong challenges by the demand for cost containment. Regulators, competitors and globalization pose additional challenges. Industry must shun "me-too" products. Innovative approaches must be adopted to generate cost-effective products with substantial additional value beyond existing products. There appears to be a trend to move both research and manufacturing "off shore" to avoid perceived over-regulation, reduce costs, and decrease the time required to bring a product to market.

Because these systems are becoming more complex, individuals trained for industrial employment should be broadly trained in both engineering and the life sciences. They must be able to deal with complex issues and to look at the whole problem, rather than a small part of it. Paradigm-shifting advances in a few selected disease-related areas can be achieved by major, long-term investments and by encouraging risk-taking.

4. The traditional model of the research university is being challenged by high costs, changes in clientele, and by for-profit educational ventures. Increasing productivity through the use of technology and emphasizing interdisciplinary activities are some of the approaches for redefining the research university.

Research universities are undergoing profound changes. The average student is no longer a teen-ager fresh out of high school, but an employed 26-year-old. The cost of higher education is rising faster than the cost of health care. Universities are competing with the Internet and the proliferation of teaching materials generated by commercial companies. Undergraduate students learn more from each other than from faculty. It is important to preserve what is valuable, but some redefining is inevitable. Future research universities must encourage the development of infrastructure that transcends traditional departmental boundaries and encourages interdisciplinary approaches. Biomedical engineers, with their interdisciplinary training, will become increasingly important as new permeable structures are developed in research universities. This will require increased funding for biomedical engineering research from federal funding agencies and private foundations.

5. Enhancing biomedical engineering research requires appropriate infrastructure at federal funding agencies, such as the National Institutes of Health (NIH). Private agencies are and should be increasingly involved in the support of interdisciplinary research.

Some major funding mechanisms have not kept up with the increasingly multidisciplinary nature of research and the need to innovate and take risks. The institute-based grant-making at NIH, for example, makes it difficult to support high-risk multidisciplinary projects. Biomedical engineering, in particular, has received little recognition at the NIH, which continues to be the principal source of funds for academic medical research with a 1997 budget of $13 billion and major increases expected in future years. Of this total, about $350 million, or 2.7 percent, goes to biomedical engineering. An identified organizational structure would help foster biomedical engineering research at the NIH, preferably an inter-institute center for biomedical engineering with its own appropriation and platform for growth. As a step in the right direction, the NIH has created an internal organization, BECON, to provide a central focus for bioengineering issues at NIH. BECON is composed of senior level representatives from each of the NIH institutes, centers, and divisions. One aim of BECON is to improve the current mechanisms for reviewing biomedical engineering grant applications. Meanwhile, private support of biomedical research is becoming increasingly important. Research collaborations, partnerships, and personnel exchanges should be encouraged to enhance biomedical engineering and other research disciplines. Interdisciplinary efforts, such as functional genomics, clinical research involving new technologies and the study of the biological basis of behavior are new frontiers.

These findings make it clear that biomedical engineering will become increasingly important in medical research and the delivery of cost-effective health care. In this atmosphere, The Whitaker Foundation must remain flexible and seek opportunities to enhance biomedical engineering in a rapidly changing environment.

Current structures will not disappear overnight, however, and the foundation will continue its current biomedical engineering grant programs. But to continue to be an effective proponent and sponsor of biomedical engineering, the foundation must be prepared to modify these programs or create new ones as opportunities arise.

Fortunately, the unanticipated increase in the investment portfolio will enable the foundation to respond to new opportunities.