WHOOP CEO Says Its Blood Pressure Tool ‘Follows the Law'
What's your view that the FDA does not have authority in this moment, your wellness, not medical device? Well, thanks for having me on. You know, you've spent the last three years developing a very innovative feature called Blood Pressure Insights, and this takes our wrist worn wearable alongside a calibration with a cuff and is allowed to provide you with a daily estimate of your blood pressure. And in turn, it also then gives you insights how your blood pressure may be affecting other things in your wellness. This could be sleep, stress, nutrition, a variety of different wellness factors. And the FDA is coming forward saying that they believe that this should be regulated. Now, the 21st Century Cures Act makes it very clear that wellness intended features are not supposed to be regulated by the FDA, and the FDA is intended to actually just regulate medical devices that are diagnosing something. So there's this key question of intended use. And you can see this with other physiological metrics like heart rate monitoring, for example, where Hari monitoring has wellness applications and medical applications. The wellness applications might be things like exercise or stress monitoring or sleep monitoring. And we do all that right. And alternatively, there could be, you know, a diagnosis for AFib, and that would be an example where the say, well, well, that's what the FDA misinterpreted of. Right. But you're a smart guy and you employ lots of smart people. Why not just go through the FDA process in the first place kind of foreseeing that this might come up? Well, you have to understand, there's different use cases, right? One use case for blood pressure is around wellness. And there's other use cases that might be a medical diagnosis. And we're certainly looking at, you know, cleared products as well and a longer term horizon. But we're providing a lot of value today and we're following the law again. The 21st Century Cures Act makes it very clear if a product is intended for a wellness use case, it's not supposed to be regulated by the FDA. So then the fundamental question becomes, does blood pressure have wellness intended use cases? We believe it does, right? There's an avalanche of peer reviewed research that shows that blood pressure, not surprisingly, is influenced and influences other aspects of your well, well, why call it medical grade? Why market it that way? Well, we recently came out with the WOOP five data and the BMJ and a key distinguishing factor between the five data and the M.G. is that the M.G. has a medically cleared feature on it. Now, both of those products have a number of wellness features associated with it. The WU PMG happens to have an EKG monitor as part of that that can detect A-fib. And by the way, we spent two and a half years working with the FDA to have that be a cleared feature. So that is the distinguishing factor between those two hardware's. And I want to be very clear in the app, there's an enormous number of medical disclaimers explaining what is for wellness and what is for medical capabilities. Well, you've said this is a misunderstanding. What happens next? Will you continue to fight the FDA on or in the background? Are you trying to reach some solution? We have a lot of respect for the team and we've engaged with them on a number of different features over the years. We think in this specific case they have it wrong and so we're going to continue engaging with them on it. We've responded to their warning letter outlining how we feel about this and why we think we're following the law and we look forward to continuing to engage with them on it. Well, that must take up head space and ultimately your time. How does that impact your future product roadmap? How does more broadly, the FDA acting this way affect innovation more broadly, do you think? Ultimately, I think that, you know, innovation needs to be able to thrive in the United States. WOOP is one of the first wearables in the world that can measure blood pressure accurately from the wrist. That's a really big deal. And it's also being accepted in 50 other markets around the world. So, you know, we want to make sure that there's policies that are consistent here in the U.S. that really allow companies to innovate and to operate. It's also worth noting, you know, we have a lot of people using this every single day. And overwhelmingly, if you look at the feedback from our members, they absolutely love this feature and they talk about how accurate is and how it's helping them understand their wellness. So we feel like we're on the right side of history and we're going to continue educating the FDA on what we're doing. Well well, I'm very quickly I'm not a we use it, but I'm very conscious that in the Premier League and other international football players, it's it's very in the public conscience. I just wonder like is this a good PR moment for you to fight America's regulator? I think in the long run will be on the right side of history and that maybe in a very short period of time, too. I think that fighting for innovation, fighting for Americans access to health data is the right thing to do. And, you know, I've spent 13 years building this company. When I first started, the idea that you could measure sleep or heart rate accurately from the wrist seemed impossible. And now we're able to do blood pressure accurately from the wrist. That's a really big deal. And I think it should be celebrated as long as there's the right guidelines in place and the right education in place for members to understand how to use. And that's what we've done with this feature, and that's why we're proud of it.
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