Technology Development Process
The pathway from technical innovation to accepted clinical practice is long, arduous, and costly. Although the activity and investment in research aimed at developing new technologies for early breast cancer detection have increased substantially over the last decade, biomedical research has also become more complex and capital intensive. Moreover, in addition to the developers of new technologies, many groups participate in the process, including FDA, health care insurers and managed care organizations, and other technology assessment institutions.
These public and private organizations and policy makers play a role in evaluating medical technologies at various points along the way, making decisions about FDA approval, insurance coverage, and reimbursement that ultimately determine whether new technologies will be adopted and disseminated. Those who evaluate the potential of new technologies consider many factors, including clinical need, technical performance, clinical performance, economic issues, and patient and societal perspectives.
Government funding of research in the health care sector has traditionally focused primarily on basic scientific discovery, but recently, a new emphasis on the translation of science into practice through the development of technology has received considerable attention, including the creation of joint public- and private-sector initiatives.
The private sector has made considerable investment in this area as well, although private investment in breast imaging technologies appears to be less attractive than investment in other areas of the health care industry. A variety of factors may contribute to this phenomenon, but it is likely due to the perception that there is a high degree of economic risk in this field, including considerations of the time and resources needed to develop technologies, the size of the potential market, and the remuneration possible.
The end results of research are always unpredictable, but for medical devices, the requirements for FDA approval and insurance coverage have been variable and unpredictable, adding additional levels of risk to the development process. Furthermore, because technical innovations are often first introduced into the system in rather crude form, it can be difficult and problematic to judge them solely on the basis of their early versions.
Sharyl J. Nass, I. Craig Henderson, and Joyce C. Lashof
Committee on Technologies for the Early Detection of Breast Cancer
National Cancer Policy Board INSTITUTE OF MEDICINE and Division of Earth and Life Studies
NATIONAL RESEARCH COUNCIL