The WHOOP saga
WHOOP ’s current FDA row is properly binge-worthy. Material for the next Lincoln Lawyer season on Netflix?
But until then, some personal reflections on why it matters for digital health and wearables.
This season’s hottest episodes:
🎞️ Ep. 1 : WHOOP launches Blood Pressure Insights (BPI) as a Wellness feature but claiming medical grade insights.
🎞️ Ep. 2 : FDA’s surveillance picks it up and issues a Warning Letter (made public with exceptional urgency) arguing against the medical disclaimers given the “inherent association” of BP with the diagnosis of hypo/hypertension,
🎞️ Ep. 3 : WHOOP refuses to pull the feature and takes it public/political, meeting with RFK Jr and attacking FDA’s integrity on social media.
I get it, it’s tough to live on the line. Enjoying the aura of “medical-grade” without the burden is the dream of many, but it's getting harder. I’ve been there with multiple startups, and deeply empathise with some of the operational and financial challenges they faced in getting that balance right - often in absence of clear guidelines.
But now: guidance is there, WHOOP already has an FDA-cleared ECG feature (i.e. a QMS) and likely the budget... then why not route the BPI feature under their existing regulated org? Whether from the start or in response to the warning. How is taking up this massive fight a better strategy?
In smaller cases, it would ring a quality culture and integration issue. But in this one, it’s seems a fight on principle - while enjoying the extra PR of being the torch bearer for the freedom of wearables worldwide.
Meanwhile, Hilo by Aktiia quietly secures BP clearance with medical indication for its bracelet without the fuss. 👀
If you’re in the borderline medical space, this is a defining moment.
➡️ Disclaimers may be shorter-lived than ever, careful if you’re relying on those.
➡️ Not all companies are the WHOOP or SPACEX of the ton. Don’t assume this aggressive strategy would work for you, play smart yes, but sustainable. PR and legal repercussions can be devastating for fundability.
➡️ Hire QARA professionals who know how to navigate the redlines vs the negotiables of borderline products.
As Blythe Karow put it in her BEAUTIFUL long read on this story:
“The art lies in reading between the lines and addressing the specific compliance issues rather than fighting fundamental regulatory doctrine.”
Meanwhile, in real life: A friend told me "my sleep/stress score from my watch is looking weird... am I sick??". Familiar? Apparently, WHOOP had an internal policy in place during COVID that employees should stay home if their score was lower than a certain threshold - they either had the virus or could easily get it. If this is how we use these tools, what's so bad in providing assurance of quality and accuracy in the first place?
Only time will tell.. For now, pass the popcorn 🍿
