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?
Susan Alpert: Until the guidance is out, that’s going to be hard to answer. But they’re going to do some guidance work on de novo and make it available for comment, which will provide a clearer view on what they plan to do and how they plan to move products into and through that process. Until we see that, it’s very difficult to predict.
But what they’ve done in their work so far is demonstrate that they’re going to carefully consider the changes they’re going to make to the product and the way in which we use predicates. Those are very important issues that will impact de novo. We do recognize it will be more than what goes through today.
MassDevice: Do you think this does anything to subdue the lingering uncertainty about the industry that so many in the investment community have complained about?
BH: I do. I’m encouraged. There’s still a lot of uncertainty that affects investors and companies in the industry, but this is a positive indication of where the FDA is moving. And some of the comments coming from Dr. Shuren about what was behind this — that this was to find improvements that would address our competitiveness, that would keep jobs at home, is encouraging.
The other thing that has been a concern for industry is the predictability and the consistency. That’s still an area we want to work with the FDA on.
SA: I think it’s very encouraging that one of the things they’re going to do is the training, very early on, of their staff in providing better guidance and training. That will help industry a lot.
MassDevice: Some of the proposals seemed to come straight off of the industry’s wish list. Do you feel like the med-tech sector won a round?
BH: I don’t think that’s the right word. I wouldn’t say that we’ve won. 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 of the FDA.
SA: This is very balanced. If you look at some of the earlier proposals, they cast a very broad net, where the concern was that many additional products were being pulled in. What they put out today shows much more balance in the application of what they want to do. They’re focusing on the higher-risk products, getting what they need for those products but not pulling everything along, and I think that’s very important.