Although many big medical device companies are content with higher FDA standards, Medtronic and its CEO William Hawkins have taken an opposing stand at a Q&A at a J.P. Morgan investment conference. As FDA expectations have risen over the years, Medtronic found itself receiving warning letters and delayed approvals for multiple cardiac, neural and diabetes devices.
As EE Times notes, Hawkins heads a working group within AdvaMed that has lobbied the FDA on its proposed 510(K) changes. "I am reassured there's a good dialog, and hopefully we will not see dramatic changes," he said.
"There's an ecosystem in our industry that requires different levels of players, and in our whole country overall less barriers [to innovation are] needed," Hawkins said, according to EE Times. "I'd rather have [regulatory] barriers lower and have more innovation occurring that could help [smaller] companies we could integrate." Hawkins' tenure as Medtronic's CEO comes to a close at the end of this fiscal year.
As Hawkins put it, 2010 was a perfect storm, both for the industry and Medtronic specifically. Healthcare reform and economic struggles led many hospitals and potential patients to postpone surgeries and other procedures that would require medical devices. And without Joshua Sharfstein at the FDA, there's a possibility that the standards will become more relaxed.
- read the EE Times article