Editor’s note: The following is the second part of a two-part series on current research trends affecting medical technology innovation.

Evidence-based policy is at the center of the new healthcare landscape, placing even more importance on measuring the effects of medical technology. This holds true no less in the regulatory arena. Continued study by researchers is essential for generating evidence about the effects of regulation on medical device and diagnostic innovation— especially if future regulatory policies are to promote the saving, improvement, and extension of lives.

Few would argue that medical device development has become increasingly complex. The advent of new technology concepts, stricter regulatory requirements, and the ever-increasing role of reimbursement for successful device commercialization require careful planning and strategy-setting, coordinated decisions, and consistent, rigorous processes. Indeed, the design and implementation of such processes have become keys to successful device commercialization.

FDA and IOM activities

In recent years, media attention and public concern for the safety of legally marketed medical products has resulted in legislative scrutiny over the processes used for premarket review of medical devices. In the United States, FDA’s premarket notification (510(k)) process has attracted particular attention.

The 510(k) process enables companies to make new products commercially available when they are confirmed to be ‘substantially equivalent’ to a predicate device already on the market. The process governs Class II products, which make up the vast majority of medical devices cleared for market entry each year.

But several activities now under way have the stated intent of revamping the 510(k) process, and have resulted in heightened debate over the potential benefits and harms of proposed changes.

At FDA’s request, the Institute of Medicine has undertaken an effort to review the 510(k) process through a group called the Committee on the Public Health Effectiveness of the FDA 510(k) Clearance Process. The committee has already convened several hearings at which interested parties have presented anecdotal observations. The committee’s report and recommendations are expected in the middle of 2011.

Meanwhile, Jeffrey Shuren, director of FDA’s Center for Devices and Radiological Health (CDRH), announced earlier this year that the center would undertake its own review. In August, after hearing industry comments at several town hall meetings, the center released an extensive list of proposed revisions and is now seeking public comment.

At a June town hall meeting in Woburn, MA, Shuren and other CDRH representatives were encouraged not to use the input they were receiving as the sole basis for their planning. In testimony and written comments, Pamela J. Weagraff, principal consultant with Quintiles Consulting and regulatory affairs advisor to the Massachusetts Medical Device Industry Council (MassMedic), noted that the IOM project has no formal industry participation, and requested that company representatives and stakeholder organizations be given an opportunity to review and comment on the study’s findings before changes to the program are acted upon. “MassMedic is concerned,” she said, “that CDRH will be pressured to rush implementation of IOM recommendations without adequate consideration of potential implications for the medtech industry.”

Instead, Weagraff recommended that CDRH take regulatory science up a notch to ensure that proposed changes are justified. Commenting on proposed changes to the 510(k) program, Weagraff requested that “any change made to this program be truly warranted as supported by scientific evidence, and not made in response to incomplete or inaccurate media reports or isolated, inappropriate company interactions with FDA.”

In short, healthcare reform has brought the 510(k) process under increased scrutiny, transforming a decades-old process into a hot-button issue. Critics of the 510(k) process are concerned about patient safety, while supporters of the 510(k) process worry that overhaul will deny patients new opportunities for use of advanced technologies that may hold less pain and fewer or shorter hospital stays among their benefits.

But so far, none of the efforts to revamp the 510(k) process has as its focus the systematic collection of evidence about that process. Absent such data, future reforms will have to rely on anecdotes and opinions about the effectiveness of the process itself.

Measuring effectiveness of 510(k) process

To meet the widely recognized need for rigorous evidence to guide assessments of the 510(k) process, the Institute for Health Technology Studies (In- Health) has awarded a $240,000 grant to Northwestern University for a new study, “A Comprehensive Analysis of the FDA 510(k) Process: Industry Practice and the Implications for Reform.”

The Northwestern investigators will undertake a systematic collection of information, data, and input from those who are actively involved in the 510(k) process and know it best––those closest to the design and development of regulated medical products, including entrepreneurs, academic physicianinventors, manufacturers, and federal regulators.

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