President's Column

A Leap Forward for Biomedical Engineering

During the last days of the year 2000, the United States Congress passed legislation to create a new Institute for Biomedical Imaging and Bioengineering at the National Institutes of Health (NIH). NIH is the major federal government agency that funds biomedical research in the United States. President Clinton signed this legislation into law on December 29, thus directing NIH to establish the new institute with its own director, administrative structure, budget and grant-making authority.

This legislation is likely to have profound implications for the future of biomedical engineering in the United States. I am very pleased and thrilled by the passage of this legislation, having actively participated in a major effort over many years to convince Congress and the NIH of its importance. This legislation also has potential impact on our profession world-wide. As President of IFMBE I believe that the international biomedical engineering community outside the United States can achieve similar support in their own regions and countries and I urge all of us to learn from the US experience.

The new Institute was created with the recognition that engineering, and physical and computational sciences have become essential to progress in biomedical research. It was brought about with the realisation that biomedical engineering approaches and techniques and interdisciplinary efforts are needed for future research advances and for healthcare delivery in the 21st century. The new institute will facilitate basic bioengineering research, assist in establishing strong collaborations between engineers, biologists and medical researchers and accelerate the application of engineering techniques to health research, healthcare and to quality of life.

The new institute was not created overnight. It took many years of hard work and an ongoing dialogue with the NIH and with Congress. This took many forms: from individual discussions with senators and members of the House of Representatives and funding agencies to group efforts by professional societies, working with the medical industry.

In 1994, as a result of pressure by the biomedical engineering community, Congress asked the NIH to conduct a study on the status of funding for research in biomedical engineering and to submit the result of the study to Congress. The NIH convened a group of consultants from the biomedical engineering community to perform the study.

The report contained the following five major recommendations:

  • NIH should establish a central focus for basic bioengineering research. This central focus should be at the highest level and should include resources for the collaborative support of extramural research.
  • The NIH should significantly expand representation of the medical and biological engineering community on advisory groups and in the peer review process.
  • NIH should establish an intramural bioengineering research program. This program would focus on cutting-edge research of national significance that complements ongoing intramural and extramural programs.
  • Communication and co-operation should be enhanced among governmental agencies with significant research activities in health-related bioengineering.
  • The public sector should increase efforts to foster greater private sector participation in determining basic research needs and in facilitating technology transfer.

A year later, the NIH submitted its report to Congress. The NIH report incorporated some but not all of the recommendations of the external consultants. The most important part of the report included the following statement: that the "NIH should establish an Interagency Bioengineering Coordinating Committee." Clearly, the agency was not in agreement with the recommendations of the external consultants report, insisting that biomedical engineering research is embedded in many of the projects that are already funded by the agency and that the profession is already receiving its fair share of funding. Most importantly, however, it was evident that, at that time, biomedical engineering was unlikely to achieve representation at the "highest level" of the agency.

Nevertheless, as a result of mounting pressure from Congress, the NIH Director established in 1997 an internal consortium - the Bioengineering Consortium (BECON) - to improve co-operation among the various NIH institutes and find ways to increase funding for biomedical engineering research. BECON was composed of one representative from each NIH institute. Its function was to make recommendations for a number of trans-NIH symposia and funding initiatives, and assist in establishing collaborations between the various NIH institutes and with other federal agencies in the area of biomedical engineering. BECON had, however, no budget or funding authority by itself.

The biomedical engineering community increased its lobbying efforts. At various times in the ensuing years, Congress attempted to pass different legislations to improve the standing of the field at the NIH. Those legislative attempts included a Center for Bioengineeing at the National Heart, Lung and Blood Institute; an Office of Bioengineeing and Bioimaging; and an Institute for Bioimaging. These initial attempts at legislative actions did not receive sufficient support in Congress.

Pressure intensified when the biomedical engineering community, represented by the American Institute for Medical and Biological Engineering, joined forces with the Academy of Radiology Research, and in 2000, both the Senate and the House of Representatives passed a bill to establish within NIH the Institute for Biomedical Imaging and Bioengineering. The reasons that Congress listed for establishing the new institute were based on eight major findings:

  • Basic research in imaging, bioengineering, computer science, informatics, and related fields is critical to improving healthcare but is fundamentally different from the research in molecular biology on which the current national research institutes at the National Institutes of Health (NIH) are based. To ensure the development of new techniques and technologies for the 21st century, these disciplines therefore require an identity and research home at the NIH that is independent of the existing institute structure.
  • Advances based on medical research promise new, more effective treatments for a wide variety of diseases, but the development of new, noninvasive imaging techniques for earlier detection and diagnosis of disease is essential to take full advantage of such new treatments and to promote the general improvement of healthcare.
  • The development of advanced genetic and molecular imaging techniques is necessary to continue the current rapid pace of discovery in molecular biology.
  • Advances in telemedicine, and teleradiology in particular, are increasingly important in the delivery of high quality, reliable medical care to rural citizens and other underserved populations. To fulfill the promise of telemedicine and related technologies fully, a structure is needed at the NIH to support basic research focused on the acquisition, transmission, processing, and optimal display of images.
  • A number of federal departments and agencies support imaging and engineering research with potential medical applications, but a central co-ordinating body, preferably housed at the NIH, is needed to co-ordinate these disparate efforts and facilitate the transfer of technologies with medical applications.
  • Several breakthrough imaging technologies, including magnetic resonance imaging and computed tomography, have been developed primarily abroad, in large part because of the absence of a home at the NIH for basic research in imaging and related fields. The establishment of a central focus for imaging and bioengineering research at the NIH would promote both scientific advance and US economic development.
  • At a time when a consensus exists to add significant resources to the NIH in coming years, it is appropriate to modernise the structure of the NIH to ensure that research dollars are expended more effectively and efficiently and that the fields of medical science that have contributed the most to the detection, diagnosis, and treatment of disease in recent years receive appropriate emphasis.
  • The establishment of a National Institute of Biomedical Imaging and Bioengineering at the NIH would accelerate the development of new technologies with clinical and research applications, improve co-ordination and efficiency at the NIH and throughout the federal government, reduce duplication and waste, lay the foundation for a new medical information age, promote economic development, and provide a structure to train the young researchers who will make the path-breaking discoveries of the next century.

The legislation spells out the purpose of the new institute.
"The general purpose is the conduct and support of research, training, the dissemination of health information, and other programs with respect to biomedical imaging, biomedical engineering, and associated technologies and modalities with biomedical applications."

The activities of the new institute are to include:

  • research into the development of new techniques and devices;
  • related research in physics, engineering, mathematics, computer science, and other disciplines;
  • technology assessments and outcomes studies to evaluate the effectiveness of biologics, materials, processes, devices, procedures, and informatics;
  • research in screening for diseases and disorders;
  • the advancement of existing imaging and engineering modalities, including imaging, biomaterials, and informatics;
  • the development of target-specific agents to enhance images and to identify and delineate disease;
  • the development of advanced engineering and imaging technologies and techniques for research from the molecular and genetic to the whole organ and body levels;
  • the development of new techniques and devices for more effective interventional procedures (such as image-guided interventions).

To establish the new institute, Congress authorised NIH an amount equal to (plus inflation) the amount currently spent by NIH institutes for imaging and engineering programs. The NIH Director was authorised to transfer personnel, use appropriate facilities to house the new institute, and obtain administrative support from other agencies of NIH.

The biomedical engineering community is now looking forward to the implementation of this legislation. We hope and expect that it would improve collaboration and integration between engineers and biomedical scientists, increase funding for basic biomedical engineering research, open up new areas of cutting edge biomedical research, enhance existing areas, and accelerate the transfer of research results into the clinical setting. We also hope that it can be used as a model by other countries to work toward establishing mechanisms for enhanced visibility of the profession and for a greater role in biomedical research and healthcare.

Dov Jaron Dov Jaron
IFMBE President
Email: Dov.Jaron@drexel.edu