MASSDEVICE ON CALL — FDA medical device review chief Jeffrey Shuren laid out efforts at addressing device makers’ concerns as he toured life sciences hubs in California.
Stops on his tour included a visit to NuVasive (NSDQ:NUVA) in San Diego, whose CEO Alex Lukianov had announced just days prior that FDA delays were costing the company about $70 million each year.
Shuren was also on hand in San Francisco during the week of the J.P. Morgan health care conference, the largest gathering of life science executives and investors, Xconomy reported.
His efforts to connect with the industry and highlight the agency’s work in improving its device pathways may have a hand in softening tensions between the FDA and med-tech makers.
"To his credit, he’s willing to go out and hear the complaints—I’m sure he’s heard the same complaints over and over—and meet with different people," Ross Jaffe of Bay Area VC group Versant Ventures told Xconomy. "I often joke that the changes he’s trying to make are like trying to turn a battleship with a paddle."
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