Entrepreneurs, academic physician-inventors, product developers, and regulatory affairs experts that have been involved in developing a 510(k) product in the past three years are being sought to participate in an industrywide survey at www.510k.net. If you fit within that group, Medical Design encourages you set aside 45 to 60 minutes and complete the roughly 90-question anonymous electronic online survey on or before Jan 31, 2011.

A team of investigators from Northwestern and Stanford universities is collecting survey input intended to produce a statistically valid foundation for improving the product review process and to guide the development of new policies that will benefit medtech investors, companies, and patients alike. It is part of “A Comprehensive Analysis of the FDA 510(k) Process: Industry Practice and the Implications for Reform,” a study funded by the Institute for Health Technology Studies (InHealth), a nonprofit foundation that supports research and analysis into the role of medical technology in advancing healthcare and patient quality of life.

For more on the study, see Perspectives.