Waltham, MA--CDRH director Jeffrey Shuren was forthright in talking about some of the performance issues for which his center has been criticized. "I have issues with the number of the times we're asking you for things we shouldn't," he said. "It's 8%. That's a problem you have when you don't have enough managers."
In a Q&A session at the MassDevice New England Regional Roundtable Monday night in Waltham, MA, Shuren spoke to some 250 medical device executives about his center's performance and challenges.
He acknowledged the staffing difficulty he faces in an echo of speeches he's made at other events. "We have high staffing manager turnover, about an 8.6% rate." Furthermore, "we have inexperienced reviewers, most with four years of experience or less; our managers, three years or less." He added he's starting a mentoring program and sending people out for training.
Semprus Biosciences CEO David Lucchino expressed enthusiasm for the idea. He also emphasized that CEOs should be part of that training. "Let the FDA reviewers and managers sit with CEOs. We want them to understand our needs."
The safety and efficacy aspects of product development are a given. Reviewers might benefit by better understanding the businesses they regulate.
Lucchino said also that he was "pleased with Shuren's transparency" about the challenges facing CDRH.
When FMD pointed out that everything sounded great for Semprus and its relationship with the FDA, Lucchino chuckled and explained that it all depends on who you work with from the agency. He followed that up by saying he became acquainted with a retired FDA reviewer who had helped him by telling him "not just what questions the reviewers were going to ask, but why." And that background helped in his relationship with the actual reviewer.
While attendees were polite and attentive, Shuren has faced a tough crowd at past meetings. Last year, for example, Shuren traveled to Minnesota to hear what medical device industry leaders had to say about the FDA's device regulation efforts. And several aired their grievances to the CDRH head. Minnesota is home to about 50,000 medical device employees, and about 550 people showed up to air their grievances with the agency.