The Food and Drug Administration (FDA) has appointed Ross Segan as the new director of the Office of Product Evaluation and Quality (OPEQ) within the Center for Devices and Radiological Health (CDRH). This decision follows a nationwide search for a suitable candidate, as disclosed by an FDA spokesperson. OPEQ is responsible for the premarket review process of medical devices, in addition to overseeing recalls, conducting inspections, and monitoring postmarket safety.
Ross Segan, a distinguished former U.S. Army surgeon, brings a wealth of experience to his new role, having held senior positions in several prominent medical device companies. Prior to this position, Segan served as a consultant for device companies and also sat as an observer on the board of directors for Delphi Diagnostics. His professional history includes roles such as the chief medical officer at Olympus Corp., and executive positions at Johnson & Johnson and Covidien. According to his LinkedIn profile, Segan left Olympus in March 2023 following issues the company faced, which were highlighted in FDA warning letters concerning the safety of its endoscopes earlier that year.
Most recently, Ross Segan founded Medical Scientific Advisors, where he was managing director until his appointment at the FDA. Expressing his dedication, Segan stated that he is committed to servant leadership and is passionate about ensuring patients have access to innovative, clinically relevant, effective, and safe medical technology.
Segan is succeeding William Maisel who retired in spring after serving five years as the director of OPEQ and 14 years with the CDRH. Post-retirement, Maisel took up the role of senior medical officer at Intuitive Surgical, a company known for its robotic surgical systems. Following Maisel’s departure, the position of director was temporarily held by Owen Faris, the principal deputy director of OPEQ.
The appointment of Segan comes at a transitional period for the CDRH. Jeff Shuren, who had led the center for 15 years, stepped down as the director this summer. Michelle Tarver, the center’s deputy director for transformation, is currently acting as the CDRH director while the search for a permanent director is underway. This leadership change occurred shortly after ethical concerns were raised when The New York Times reported that Shuren’s wife, Allison Shuren, represented medical device companies as a part of the law firm Arnold & Porter. The FDA defended Shuren’s record following the publication of the story.
In response to concerns over the effectiveness of the FDA’s device safety oversight, lawmakers and patient advocates have been vocal in their calls for strengthening the product safety system. Specifically, the handling of a significant recall by Philips, which involved over 15 million sleep apnea machines and ventilators, has come under scrutiny. Senators Dick Durbin (D-Ill.) and Richard Blumenthal (D-Conn.) spurred a review by the U.S. Government Accountability Office last December, addressing these issues. Additionally, in August, a report was published by the government watchdog highlighting the challenges faced by the FDA in its efforts to enhance device safety oversight.
Through all these leadership and oversight transitions, the focus remains on ensuring the efficacy, safety, and reliability of medical devices, which play a crucial role in the healthcare industry, directly impacting patient care. Ross Segan’s leadership will be pivotal in steering the OPEQ through these challenging times, ensuring compliance with regulatory standards and fostering innovation in medical device development.
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