via @azeem from @exponentialview  Steve Blank The Apple Watch – Tipping Point Time for Healthcare #worthreading

Smartwatches are the apex of the most sophisticated electronics on the planet. And the Apple Watch is the most complex of them all. Packed inside a 40mm wide, 10 mm deep package is a 64-bit computer, 16gbytes of memory, Wi-Fi, NFC, cellular, Bluetooth, GPS, accelerometer, altimeter, gyroscope, heart rate sensor, and an ECG sensor – displaying it all on a 448 by 368 OLED display.

When I was a kid, this was science fiction.  Heck, up until its first shipment in 2015, it was science fiction.

But as impressive as its technology is, the Apple’s smartwatch has been a product looking for a solution. At first, positioned as a fashion statement, it seemed like the watch was actually an excuse to sell expensive wristbands. Subsequent versions focused on fitness and sports – the watch was like a Fitbit– plus the ability to be annoyed by interruptions from your work. But now the fourth version of the Watch might have just found the beginnings of “gotta have it” killer applications – healthcare – specifically medical diagnostics and screening.

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The question is are they are going to create millions of unnecessary doctors’ visits from unnecessarily concerned users or are they going to save thousands of lives?  My bet is both – until traditional healthcare catches up with the fact that in the next decade screening devices will be in everyone’s hands (or wrists.)

 

Medical «wearables», FDA & healthcare «systems»

The FDA has to adjudicate between a whole host of conflicting constituents and priorities. Its purpose is to make sure that drugs, devices, diagnostics, and software products don’t harm thousands or even millions of people so the FDA wants a process to make sure they get it right. This is a continual trade-off between patient safety, good enough data and decision making, and complete clinical proof.

…This rapid clearance process as the standard – rather than the exception – is a sea-change for the FDA. It’s close to de-facto adopting a Lean decision-making process and rapid clearances for things that minimally affect health. It’s how China approaches approvals and will allow U.S. companies to remain competitive in an area (medical devices) where China has declared the intent to dominate.

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Given Apple sells ~15 million Apple Watches a year, the company is about to embark on a public trial at massive scale of these features – with its initial patient population at the least risk for these conditions. It will be interesting to see what happens. Will overly concerned 20- and 30-year-olds flood doctors with false positives? Or will we be reading about lives saved?

The Watch announcement telegraphed something interesting about Apple – they’re one of the few consumer products company to crack the FDA clearance process (Philips being the other). And going forward, unless these new apps are a disaster, it opens the door for them to add additional FDA-cleared screening and diagnostic tools to the watch (and by extension a host of AI-driven imaging diagnostics (melanoma detection, etc.) to the iPhone.) This by itself is a key differentiator for the Watch as a healthcare device.

The other interesting observation: Unlike other medical device companies, Apple’s current Watch business model is not dependent on getting insurers to pay for the watch. Today consumers pay directly for the Watch. However, if the Apple Watch becomes a device eligible for reimbursement, there’s a huge revenue upside for Apple. When and if that happens, your insurance would pay for all or part of an Apple Watch as a diagnostic tool.

 

watch-afib.png

 

And the (potential) future

So what else can/will Apple offer on the next versions of the Watch? After looking through Apple’s patents, here’s my take on the list of medical diagnostics and screening apps Apple may add.

  • Sleep Tracking and Sleep Apnea Detection
  • Pulse oximetry
  • Respiration rate
  • Blood Pressure
  • Sunburn/UV Detector
  • Parkinson’s Disease Diagnosis and Monitoring
  • Glucose Monitoring
  • Sensor and Data Challenges

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Although the current demographics of the Apple Watch skews young, the populations of the U.S., China, Europe and Japan continue to age, which in turn threatens to overwhelm healthcare systems. Having an always on, real-time streaming of medical data to clinicians, will change the current “diagnosis on a single data point and by appointment” paradigm. Wearable healthcare diagnostics and screening apps open an entirely new segment for Apple and will change the shape of healthcare forever.

Imagine a future when you get an Apple Watch (or equivalent) through your insurer to monitor your health for early warning signs of heart attack, stroke, Parkinson’s disease and to help you monitor and manage diabetes, as well as reminding you about medications and tracking your exercise. And when combined with an advanced iPhone with additional FDA cleared screening apps for early detection of skin cancer, glaucoma, cataracts, and other diseases, the future of your health will truly be in your own hands.