Jeffrey Shuren, director of the FDA's Center for Devices and Radiological Health, traveled to Minnesota this week to hear what medical device industry leaders have to say about the FDA's device regulation efforts. Minnesota is home to about 50,000 medical device employees, and about 550 people showed up to air their grievances with the agency.
One of the primary complaints is the FDA review process, which investors and physicians claim is hampering innovation in the industry. John Sherman, a spine surgeon and former CMO of a medical device start-up, lamented his company's demise, saying venture capitalists were unwilling to invest in technology that faced significant regulatory hurdles. Added VC Peter McNerney, "[T]he regulatory process has become long and uncertain, and in many instances unnecessarily burdensome. As a result, we have lost our ability to evaluate regulatory risk." He added that nationwide, device VC has dropped more than one-third in two years due to uncertainties about regulatory barriers.
Shuren assured attendees that the agency is trying to strike a balance between fostering innovation and protecting the public from unsafe devices. The FDA has faced a number of high-profile recalls and safety issues in recent years, leading to questions about how effective the current review process is. "At certain times in the past, the pendulum has swing far to one side or the other," Shuren told the audience. "To fulfill our mandate we must embrace both parts of our mission--that is what it means to truly take a balanced public health approach."
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