Medtronic CEO Bill Hawkins calls 510(k) reforms a "positive sign"

January 19, 2011 by MassDevice staff

Medtronic Inc. CEO William Hawkins tells MassDevice that he's encouraged by changes to the 510(k) program detailed today by the Food & Drug Administration, but adds that there's more work to be done to eliminate "uncertainty."

MDT, Bill Hawkins

Medtronic Inc. (NYSE:MDT) CEO William "Bill" Hawkins reacted positively to changes the Food & Drug Administration announced today for its 510(k) program, calling them a "positive sign" that regulators are open to working more collaboratively with industry but denying that the medical device industry won a round in the fight against stricter regulation.

"I wouldn't say we've won. I wouldn't say that," Hawkins told MassDevice. "I would say that we're working towards a more collaborative and constructive working relationship with the FDA, recognizing that we both have the same common goals to advance innovation that is safe and effective. I think this, in my judgement, is a good sign coming out to the FDA."

Hawkins told us he's encouraged by the approach the agency took in deciding the 25 changes it plans to make to the system by which a majority of medical devices are cleared for market. The news might help eliminate some of the uncertainty among medical device investors and stakeholders about changes to the regulatory system, because it shows that the FDA won't make wholesale changes without hearing from the industry first.

But Hawkins said there is still more work to do in making the medical device review process predictable and consistent.

"That's still an area where we want to work with the FDA," he said.

Below is a transcript of our talk with Hawkins and Medtronic's chief regulatory officer Susan Alpert.

MassDevice: What's your general reaction to the FDA's report? Is this a good sign or a bad one for industry?

William Hawkins: I think the best way to summarize is that we're encouraged by what we heard. It's very balanced, because it certainly retains the authority of the FDA to ask for more information on more product-specific cases, versus perhaps putting forth changes that would affect a broad general class of products, which is where we were concerned. I think the FDA did a lot of work, which we applaud them for. They were engaged, they listened, they were constructive. It's a positive sign.

MassDevice: Susan, can you give us an idea of what impact the new de novo regulations for devices with no predicates might have on Medtronic?