Apple faces teething troubles in pursuit of creating health tracking watch

Apple’s widening effort to turn its nine-year-old watch from a luxury timepiece into the ultimate all-in-one medical device is taking it into territory that is legally treacherous as well as potentially profitable.

This month’s suspension of Apple Watch sales was the starkest sign yet that the world’s most valuable tech company is treading new ground as it adds health features to the device. While Apple on Wednesday won a temporary reprieve to resume sales, specialists in medical devices say the technical and legal challenges are likely to continue.

For years, Apple has enhanced the gadget with potentially lifesaving monitors for atrial fibrillation, falls and blood-oxygen issues—raising its appeal for an aging population.

Many medical professionals envision a day when devices like the Apple Watch could also allow users to track blood pressure without the need for a bulky cuff, or blood sugar without the pain of skin punctures.

But for that, customers might have to wait. Just as Apple has been a pioneer in personal electronics, companies large and small that have been working in the healthcare tech space for years have their own intellectual property—and lawyers.

“Apple is entering into a new space where their own innovation engine isn’t as up to speed,” said Andrei Iancu, a former director of the U.S. Patent and Trademark Office who stepped down in 2021. “As a result, they might have the need for using other people’s technology.”

Potential buyers had supplies cut off in recent days, as sales of the latest Apple Watch models were temporarily paused during a patent dispute over blood-oxygen sensing. Medical- technology company Masimo alleged in a 2021 complaint that Apple violated its patents. In October, the U.S. International Trade Commission banned the import of the tech giant’s watches. Apple appealed, and a court on Wednesday allowed it to resume sales while the court weighs its request to pause the ban.

Engineering hurdles
The Wall Street Journal has reported that Apple is planning to enhance its watches with health features in the coming years, including working on ways of measuring blood pressure, glucose levels, body temperature and other health metrics. Its cautious approach means it sometimes rolls out features slower than competitors.

The wrist is ideal for gathering health data because it is easy to reach, has a network of blood vessels close to the skin’s surface, and experiences less vigorous movement compared with other body parts, health experts say.

“The skin is very thin at the wrist where we are already wearing watches,” said Irl Hirsch, a professor at the University of Washington School of Medicine. “That’s the sweet spot.”
Yet using the wrist to measure blood pressure and blood-sugar levels, two big areas of expansion, poses significant engineering challenges. It involves advancing sensor technology and refining data analysis.

Samsung already offers blood-pressure monitoring in its Galaxy Watches in some markets outside the U.S. Google’s Fitbit is also experimenting with it. Such wrist-based blood- pressure monitors use algorithms to get an estimated reading. They typically aren’t as reliable as traditional cuff-based measurements, which temporarily halt blood flow in an artery to gauge pressure, say medical professionals.

“The studies that we’ve seen are not yet reassuring that they’re ready for prime time or for clinical use,” said Jordana Cohen, associate professor of medicine and epidemiology at the University of Pennsylvania.

To secure Food and Drug Administration clearance for selling a blood-pressure monitor, companies must demonstrate through the FDA’s 510(k) process that their device’s accuracy is comparable to an existing, already cleared device, she added.

Similarly, tracking glucose through noninvasive skin sensors is generally less precise than direct blood analysis, with factors such as skin tone and temperature affecting accuracy.
Apple might tackle this using light sensors that identify substances in the blood, such as glucose, and account for incorrect readings, according to a 2017 patent filing.

Other companies—including the startups Know Labs in Seattle and Hagar in Tel Aviv—are also working on methods for tracking blood sugar without puncturing the skin. In 2014, Google launched a project to track glucose with an electronic contact lens, but abandoned it four years later because of challenges in achieving reliable readings.

Legal hurdles
As Apple has added more health-sensing capabilities into its smartwatch, the company has found itself increasingly accused of taking technology from smaller players in the market and violating their patents, the Journal reported in April. Apple at the time denied the accusations and said some patents were overly broad.

Legal battles such as Apple’s current fight with Masimo highlight the nature of a highly regulated market where many players have been building one particular type of product for decades, said Ben Bajarin, principal analyst at consumer-technology research firm Creative Strategies. These established companies often have a strong portfolio of patents they can use to defend their markets.

AliveCor, a company that previously sold Apple accessories that performed electrocardiograms, alleged a similar case as Masimo, saying Apple violated several of its patents in a 2018 Apple Watch release. AliveCor also complained to the trade commission and won, but Apple was able to invalidate AliveCor’s patents through an appeal system at the patent office, avoiding an import ban. AliveCor is appealing the patent office’s decision to revoke its patents.

Apple has been, at times, resistant to licensing smaller companies’ technology, the Journal previously reported. At the time, Apple said it pays licensing fees to many companies, including licenses for 25,000 patents over the prior three years.

Each health sensor added to the Apple Watch will come with its own set of new hurdles. “As Apple gets further into the water,” said Bajarin, “there will be more of these companies it will have to navigate around.” The Wall Street Journal