FDA CDRH chief Dr. Jeffrey Shuren addresses the
audience in a live Q&A
Hundreds of representatives from New England’s medical device industry gathered last night at the MassDevice Big 100 Regional Roundtable at the Westin Hotel in Waltham, Mass., to share their experiences and ideas for the industry’s future.
The event took off with a live Q&A with Dr. Jeffrey Shuren, director of the FDA’s Center for Devices & Radiological Health. In a lengthy Q&A session with the more than 250 attendees, Shuren answered questions and detailed the obstacles his agency faces in workforce turnover and employee inexperience.
He also explained an FDA pilot program with the Centers for Medicare and Medicaid Services aimed at facilitating “parallel review” of devices by the federal watchdog and reimbursement agencies.
"It’s not changing FDA standards," Shuren explained. The purpose of the parallel review is to "shave some time of" of the time it takes to get a device reviewed by the CDRH and to win reimbursement from CMS.
Shuren also tackled the problem of unpredictability in pre-market reviews, saying that FDA has evaluated the 510(k) process and how the industry uses science to identify speedier ways to review devices. Last summer the agency outlined 25 actions necessary for improvement of the PMA process.
Shuren insisted that innovation is a high priority at the CDRH and that the agency will be more responsive to industry concerns. Regarding clinical evidence requirements for 510(k) applications, Shuren said that only about 10 percent of 510(k) submissions need clinical data.
"All we are seeking to do is to provide better clarity on the circumstances of when we would ask for clinical data," he said. Asked about the agency’s accomplishments and what it still has on its plate, Shuren said there have been some signal accomplishments but that, "We have a ways to go."
"Our top achievement is the fact that we have put innovation high on our list of priorities," Shuren said, noting reforms including reducing time of development — which in turn reduces costs — and better tools, including computer models that can potentially reduce the need for animal testing or early human studies.
After Shuren left to catch a flight back to Washington, the evening’s keynote event began. Joe Almeida, the newly minted president & CEO of Covidien plc (NYSE:COV), in a candid, one-on-one interview with MassDevice publisher Brian Johnson, said that successful businesses are, by definition, ethical businesses.
"Big egos don’t have a place in business," noted Almeida, who said he never imagined he’d be at the helm of a billion-dollar organization. His aspirations, he said, once only reached as high as VP of operations.
Almeida also spoke of the pressure to balance shareholder value and innovation.
"What we represent for our customer has evolved," he said, emphasizing the importance of compassion and clinical value in maintaining Covidien’s brand. "Customers need to be happy for the shareholder to be happy."
The evening ended with a roundtable discussion among four life science industry CEOs, moderated by MassDevice executive editor Brad Perriello, on the challenges and opportunities facing their various industries.
Richard Packer, CEO of ZOLL Medical Corp. (NSDQ:ZOLL); Don Hardison, CEO of Good Start Genetics; Scott Rader, CEO of IlluminOss Medical Inc.; and David Lucchino, CEO of Semprus Biosciences discussed the challenges of winning reimbursement for preventive care, the value of physician collaboration in designing products and maintaining an ethical standard for marketing, even in a slow economy.
"Prove the benefit of the product, then take it to the market," said Rader, urging the crowd of medical device executives to make sure their marketing practices are cleaner, better and faster. "Doing it right is the challenge of the entrepreneur."