The Northwestern findings—based on survey responses from more than 350 medtech product designers and developers, entrepreneurs, academic physician inventors, and regulatory affairs professionals—are expected to help identify key opportunities for improving FDA's product review process.
The survey 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.
Who: Survey findings will be presented by investigators John H. Linehan, PhD, professor of biomedical engineering at Northwestern University, and Jan B. Pietzsch, PhD, president and CEO of Wing Tech Inc., a technology consultancy, and a consulting associate professor in Stanford University's Department of Management Science and Engineering, and the Biodesign Program.
Robert J. Rubin, MD, clinical professor of medicine at Georgetown University and chair of InHealth's Research Council, will moderate a respondents' panel comprising Susan Alpert, MD, PhD, recently retired senior vice president and chief regulatory officer at Medtronic; Peter Barton Hutt, senior counsel at Covington & Burling LLP, author of the Medical Device Amendments of 1976; and Philip J. Phillips, president of Phillips Consulting Group LLC and former deputy director for science and regulatory policy in the Office of Device Evaluation at FDA's Center for Devices and Radiological Health. Senior leadership from FDA has been invited to participate.
Where: Zenger Room, The National Press Club, 529 14th Street NW, Washington, DC
The news conference will be broadcast live via the web.
When: Tuesday, May 24, 8:30 a.m. to 10:30 a.m.