Medtech Insight: Hello and welcome to Medtech Monthly, brought to you by the staff of Medtech Insight. I'm managing editor Elizabeth Orr and I'm here today with attorney and data science expert Bradley Merrill Thompson.
Brad's been a regulatory attorney for more than 30 years. Some of you might recognize his name from his work with the Combination Products Coalition and other industry initiatives. In addition to his day job at Epstein Becker Green, he's recently turned his hand to data analysis, earning a master of applied data science from the University of Michigan's School of Information in February 2022.
And he's on the show today to talk about some research he did into the US Food and Drug Administration's Breakthrough Devices Program. The Breakthrough Devices Program is, of course, an FDA effort to get innovative devices to patients more quickly. The program was first launched as a pilot under a different name in 2011, and the final guidance came out in December 2018. The FDA’s website touts 693 devices that have received the designation, of which 54 are authorized for market.
Brad used his own Python program to analyze publicly available data from Open FDA. The analysis was published under the title "Unpacking Averages: Assessing Whether FPS Breakthrough Device Designation Is Helpful" on legal website JD Supra on August 3. And today, he's here with us to talk through what he found and what significance might be.
Brad, I'm happy to have you here with us.
Bradley Thompson: Thank you very much. I'm glad to be here.
Medtech Insight: Going back in time when the breakthrough device/extended access program was first announced, what was your opinion? Did you have any concerns about it?
Thompson: Well I have to be honest with you, it'll probably sound like I was biased during the analysis that I did. But my initial reaction to the program was it was a negative one. It was it was negative for a couple of reasons.
First, as I read through the materials that describe the program, there was really no commitment by FDA as to what they would do in exchange for a company applying for and being admitted to the program. They didn't commit to how much faster the review process would be, they didn't commit to making sure that the company would only be expected to meet the least burdensome evidentiary obligations. There just really wasn't much substance there in the way of FDA committing to do something for the company.
But the other thing that bothered me, quite honestly, is that the program sort of positioned FDA as this almost consultant who would come in and work sort of side by side with the company in order to move the development process forward. And that just runs counter to all of my experience with FDA. And I'm not being at all, I hope, I mean, in saying that, we all play the role we're responsible for playing, and FDA plays a very important role, their role is protecting the American citizens. They are the government; they are there to make sure that unsafe or ineffective products don't reach the market. And that's a very different role than sitting on the other side of the table where your job is to try to figure out how to get the best possible safe and effective devices to market in the quickest amount of time. And so while those two missions overlap, they're not identical.
And FDA can be structurally far more conservative in its decision making than someone else would be so. So to have the FDA sort of hyper-involved in the development process with that sort of acknowledged mindset that was concerning to me.
So I'll be honest with you, I had a lot of clients who came in my door and said, you know, we want to be part of this breakthrough program. And I talked him out of it. I suggested to them that, that the benefits were dubious. But all that said, I hope I kept an open mind when I did the data analysis. And I tried to do it in a transparent way so that if I have a bias, the reader can can figure out maybe where I went wrong. So I tried to show my math, as it were, to explain how I did it.
Medtech Insight: One thing you talked about in your analysis is that the program assumes that more contact with the FDA is better, whereas you usually tell your clients to go the other way. Can you unpack that a little?
Thompson: Sure. So I'm used to sitting across the table with FDA, where we're talking about, for example, the evidence that will be required for a submission, whether it's a 510(k) or de novo, or whatever it might be, and we might come in there with a proposal as to the kind of evidence that we want and FDA inevitably takes the view that that they want more than that they want.
It's natural, as I said, it's part of their job. But they'll say, you know, we think the clinical trial is, is really underpowered, we'd like to see a lot more subjects in it. We'd like to see a more complex design where we've got additional controls that provide us even greater assurance of safety and effectiveness. They'll just sort of pile on or add on to the evidence that will be ultimately required in order to get through the agency.
So I've made it a habit, honestly have tried to not involve FDA unless it's absolutely necessary, because I know that I'll get that conservative advice. And I think if you talk to consultants across the industry, and I've talked to several, they will say, if you make a good-faith determination of what the clinical trial ought to look like, and it's scientifically justified, and you do all your homework and you go into present it, inevitably, you can get something through the agency review process with less data than if you went in right from the get-go and just said to FDA, “Well, what do you want? What do you want us to do?”
It's cheap and easy for them really specify a very burdensome set of evidentiary requirements. There's an art to getting something through the agency, and the agency isn't there to help you identify that quickest pathway?