Northwestern Investigators to Launch 510(k) Survey

approvalRecent controversy surrounding FDA’s processes for premarket review of medical devices has ignited a discussion among researchers in hope of getting to the crux of the issue. A team of investigators from Northwestern and Stanford universities is conducting a comprehensive study to get input about problems facing both FDA and the medical device industry. This week, they will conduct a webcast briefing in order to launch an industrywide survey about industry and agency practices in FDA’s premarket notification (510(k)) regulatory pathway.

In recent years, the 510(k) process has come under fire from many directions. Advocates of a more rigorous premarket review process say that current processes may permit unsafe devices to make their way onto the market. Meanwhile, the device industry complains that current processes are both unpredictable and slow, preventing patients from having timely access to innovative and effective products. FDA acknowledges that problems with the current 510(k) process are complicated, but the agency’s efforts to reform the process are straining the relationships between innovators and regulators.

So far, most of the complaints registered against the 510(k) process have tended to be merely anecdotal, lacking research evidence to back them up. But the Institute for Health Technology Studies (InHealth) is seeking to change that by funding the research of the Northwestern and Stanford investigators. InHealth is a 501(c)(3) nonprofit foundation that supports research and analysis on the role of medical technology in advancing healthcare and patient quality of life.

The Northwestern study, “A Comprehensive Analysis of the FDA 510(k) Process: Industry Practice and the Implications for Reform,” will undertake a systematic collection of information, data, and constructive input from those who participate in the 510(k) process and know it best—those involved in the design and development of regulated medical products, including entrepreneurs, academic physician-inventors, and federal regulators. Results of the study will provide a foundation for assessing opportunities and proposals for improving FDA’s 510(k) product review process.

The Northwestern study team is led by principal investigator John H. Linehan, PhD, professor of biomedical engineering at Northwestern University. Collaborating on the study will be Jan B. Pietzsch, PhD, consulting associate professor of management science and engineering and an advisory faculty member of the Biodesign program at Stanford University, and president and CEO of Wing Tech Inc., a technology consultancy.

The roughly 90-question electronic survey is geared toward individuals and companies that have previously been involved in developing a 510(k) product. Results of the survey will give industry and FDA statistically valid information to inform the discussion moving forward, helping to provide a realistic basis for new policies and proposals.

In a webcast on Wednesday, 22 December 2010, the investigators will provide details about their study, including how industry and agency employees can participate in the electronic survey. Other webcast participants will include Larry G. Kessler, ScD, professor and chair of health services at the University of Washington (formerly director of FDA’s Office of Surveillance and Biometrics), and Paul LaViolette, MBA, venture partner with SV Life Sciences (formerly chief operating officer at Boston Scientific).

“Uncertainty is the thing investors hate most,” says Steve Halasey, vice president for programs at InHealth, “and right now there is a lot of nervousness in the investment sector.

“When investors believe that FDA lacks an efficient review process, or that the agency frequently changes requirements in the middle of a product review, at a certain point they may conclude there is too much risk and simply stop investing,” he adds. “If that were to happen, the U.S. pipeline for innovative products might dry up, and the United States might well lose its historical leadership in the medtech field.”

On 11 January 2011, InHealth will sponsor a workshop at featuring investigators who have recently conducted studies of FDA’s 510(k) process.

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