6
Summary and Conclusions
Kshitij Mohan, Ph.D.
Workshop Chair
Science and technology developments are no longer sequential events. A myriad of changes are occurring in the device development and approval process, including the use of computers, e-mail, teleconferencing and the internet; high- throughput screening, rational drug design, bioengineering and miniaturization; more concern about special populations, including children, the elderly, and women; and greater access to products at their investigational stage. The medical device life cycle is not a simple, linear progression from basic to applied research, to development, to marketing. Rather, it is a complex stream of five parallel tracks involving regulation, research and development, marketing, manufacturing, and legal issues.
There are new challenges in the processes of technology integration and transfer, notably long lead times and the need for many iterations. This tests the adaptability of academia and industry to come up with new models of parallel discovery, development, and economics. FDA has responded by speeding up its regulatory approvals but there will always be new tests of the science behind the regulation. Researchers can no longer adhere to the dogma that there is only one way to test new clinical devices. There is room for continual improvement in the science and in the guidance given to those trying to get new devices through the regulatory process to market. In such guidance, researchers need to determine the appropriate level of transparency and clarity necessary to permit wide application across many types of devices.
Public and private financial resources are available in the field of devices, but such sources are limited and often unpredictable. The Small Business Innovation and Research Program created in the early 1980s is an underused federal
source of funds for device company startups. Underuse of this opportunity is especially unfortunate at a time when 52% of the teaching hospitals in this country are running at a loss. These medical centers are often the source of innovation in the medical device arena. Industry funds much of the innovative work going on in academe. This is a positive influence, and journals and academicians should be forthcoming about the role of private funds in the research and development process.
Researchers also need better mechanisms for quickly establishing reimbursement policies for investigative devices. The basic issue here is: what is the methodology for evaluating the costs, benefits, and values of new devices? This should not be a difficult task given the relatively small contribution of devices to the overall health services environment. The Health Care Financing Administration (HCFA),1 the Veterans Administration, and FDA should get together and address these issues.
Public forums in which FDA, HCFA, the National Institutes of Health (NIH), and companies sit at the same table would be one way of improving the reimbursement dilemma. Such a forum would allow agencies such as HCFA to have a greater sense of the value added by a technology. Approval by FDA of a device’s safety and efficacy is only one step toward the marketplace. HCFA’s responsibility is to represent the beneficiaries, including their economic interests, as well as the economic interest of the American public and the taxpayers. The device industry must be more proactive in approaching HCFA early on in the process.
There are a number of ways in which the regulatory process for devices is improving, including the use of advisory groups, either in public forums or in private sessions; streamlining the process, particularly with respect to second-and third-generation devices; expedited reviews for breakthrough, highly beneficial innovations; early interactions and consultations on new, high-impact products; reducing burdens on companies with an excellent track record; increased access, particularly for smaller companies; facilitating access to and coordination with NIH and HCFA; and better coordination within FDA with respect to combination products.
