Medical Device Link.

To address this problem, in 2006 the Institute for Health Technology Studies (InHealth), a nonprofit organization based in Washington, DC, awarded a grant to a research team at Stanford University to examine how medical technologies are developed, approved, brought to market, and subsequently improved, or how they evolve. The research team is led by John H. Linehan, PhD, consulting professor of bioengineering in the university’s Biodesign program and in the department of bioengineering, and Jan B. Pietzsch, PhD, consulting assistant professor in the department of management science and engineering.

The results of this study should be available in the fall of 2007. The Stanford researchers are documenting how medical devices are approved and enhanced, both before and after they receive regulatory market clearance or approval (see sidebar). The researchers are reviewing the critical role played by FDA, and clarifying the different development paths followed by medical technologies, pharmaceuticals, and biotech products (see sidebar). The results will show that medical devices require a broader range of development cycles than drugs to achieve full commercialization, and that this requirement has a significant impact on the timely availability of safe and effective technologies.

A key objective of the research team is to build a medtech-specific model of the product development process that will be of value to current and future government initiatives aimed at enhancing the efficiency and efficacy of the regulatory process.

Policy Applications

There are a number of initiatives currently under way that are expected to benefit from the Stanford University study. They include FDA’s critical path initiative, the medical device innovation initiative at FDA’s Center for Devices and Radiological Health (CDRH), efforts to develop collaboration between FDA and the Centers for Medicare and Medicaid Services (CMS; Baltimore), and proposals to optimize the use of postmarket information.

The objective of the critical path initiative is to understand why the pipeline for innovative medical therapies continues to be backed up, and why the pace of approvals appears to be slowing down. FDA has linked this slowdown to the fact that “the current medical product development path is becoming increasingly challenging, inefficient, and costly,” and has urged the development of “a new toolkit . . . to improve predictability and efficiency along the critical path from laboratory concept to commercial product.” By clarifying and adding insight about the current development processes for different types of medical devices, the Stanford research funded by InHealth is expected to help manufacturers and regulatory agencies identify possible scientific shortcomings that could be corrected, thereby accelerating the delivery of new health innovations to the public.

In the description of its medical device innovation initiative, CDRH states that it “will need to develop better ways to predict earlier in the process which new products are likely to be safe and effective in patients and how to best deploy new technologies to maximize benefits and minimize harm.”² The center further states the need “to ensure that clinical trials, product reviews and approvals, and manufacturing processes are conducted in the most efficient and effective ways.” By illuminating different development pathways, the InHealth- Stanford study can contribute substantially to FDA’s continued strategy- setting efforts. A relevant example is the process of targeted development or overhaul of guidance documents.

The Stanford researchers also see the potential impact of their study on FDA’s Bayesian statistics initiative. Announced in May 2006, this initiative aims to employ a Bayesian analytical framework to speed up the overall approval process by using previously available information about safety and effectiveness to design more-efficient clinical trials. The successful application of Bayesian methods requires an understanding of the different types of data available at various stages of device development and trial planning. The Stanford researchers believe that this study will help to identify device clusters that can be expected to benefit most from the use of Bayesian methods.

The study results may also be useful in aiding collaboration between FDA and CMS. The product development model developed through the Stanford research may provide useful information for determining appropriate collaboration strategies that optimally support the commercialization of safe and effective new technologies. Such information could be helpful to manufacturers, regulators, and healthcare practitioners in bringing a disciplined and consistent approach to the evaluation of the safety and effectiveness of medical technologies over the long term.

The final report of the InHealth-Stanford study results is expected to include the following elements.

• A literature review of existing device and drug development models and a review of the current medical device regulatory process.
• The construction of a systematic classification of devices.
• An analysis of the development of medical devices supported by case studies and in-depth interviews.
• An analysis and development of a core model of the medical device development process, including variations that explain the differences among different types of devices and innovations.

Conclusion

The world of healthcare is on the cusp of major advances in medical technologies that promise to change the way health problems are identified, prevented, and treated, and to reduce the treatment costs to society. By providing a better understanding of the processes involved in the development of novel technologies, the InHealth-funded research at Stanford University should help to improve the regulatory environment by removing barriers for scientists, engineers, physicians, and entrepreneurs dedicated to the advance of healthcare through medical innovation.