By now, we’ve all heard the latest digital health news: Apple secured FDA clearance for its EKG app on the newest Apple Watch. The tech giants are coming! The end is near!
Since the initial headlines, we’ve learned more facts beyond the attention-grabbing statements. We’ve learned that the FDA clearance is for the app, not the entire system, and is very conditional. We’ve learned that it is only class II, not class III. We’ve learned that Apple barely garnered the clearance in time for the big unveiling. The FDA has even faced scrutiny for what looks suspiciously like an inappropriate accelerated clearance.
In hindsight, it is easy to see how the FDA earned good press in its approach to supporting innovation, especially of the digital variety. We all want to see this, so I certainly can’t begrudge how the FDA approached things, especially with the clear caveats that the regulatory body attached to the clearance letter.
Clearly, Apple wanted something to talk about to its investors. I’m not a follower of Apple nor an early adopter of tech, so I don’t watch the company’s announcements. But I do see the business press and the stock price after they talk and, to be frank, it sounds like the EKG app was one of Apple’s biggest announcements, so it certainly needed this FDA blessing.
It would be easy to dismiss the Apple announcement as investor relations—a move to push a soaring stock valuation instead of a consequential development. In fact, I joined a chorus of experts downplaying the significance, or at least emphasizing all of the remaining barriers. Others jumped up to point out the weakness in the current data, the lack of a mandate to act, the potential nuisance to doctors—yes, all of these are true.
And yet, the Apple Watch EKG app should be a warning shot across the bow for the medtech industry. We’ve felt smug and protected in our walled world of regulations, reimbursement and clinical practice, impervious to the onslaught of Silicon Valley. It’s true that Apple may or may not actually be serious. The tech giant’s specificity may not be so strong. Its detection rates may be lacking. Doctors may not know what to do with the results, or may not be so keen to spend valuable clinic time trying to diagnose and manage their patients who bought a gadget telling them that they are sick. Insurance companies may not know what to do with the insights provided by the watch, preferring tried-and-true methods.
All of that said, the announcement is a very valuable reminder of the imminent threat of disruption lurking in the periphery, as billions pour into health tech. It also reminds us of some of the weaknesses that we have as an industry.
Apple reminds us that medtech companies need to be vigilant, and that:
- The FDA has important and well-established ways of working, but that doesn’t mean that everything will follow the same path. We need to anticipate and demand flexibility in the digital world.
- The winning business model may not be the product-forward models that we know. Stay flexible, and constantly consider how to work differently.
- There’s value in the data. The likes of Google and Facebook know this, too, but why don’t we? We need to address privacy, stewardship, transfer and all of the other issues surrounding data ownership.
- Medtech leaders need to be careful about being dismissive of early generations of devices. Don’t underestimate what a motivated provider, backed by AI, can achieve.
All in all, it’s been an exciting week. The Apple Watch EKG app burst onto the scene and the flurry of attention that it generated already seems to be fading, but we need to be ready for the next tech disruption.
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