The aim? To make the best watch in the world. That was what Tim Cook, Apple’s CEO, revealed to the world back in 2014 upon the watch’s release. A watch that had a new user interface, was a touch screen and contained designs to motivate people to be active. “…a revolutionary product that can enrich people’s lives. It’s the most personal product we’ve ever made,” announced Tim Cook. And it truly proved to be personalised. With the Apple Watch, one could receive a detailed summary of one’s daily activity, encompassing data such as the amount of calories burnt, a single-lead ECG reading, and other tracking tools designed for optimal well-being.

This leads to the question – can the Apple Watch be considered a medical device? While it doesn’t aim to treat a specific disease or condition, and hence should not be considered a replacement for medical care, the watch still does assist with general wellness, helping the user manage their weight, fitness, and sleep. Although the Apple Watch has limited medical capabilities, such as being just a low to mid-range electrocardiogram reader, the FDA has cleared the Apple Watch as a Class II medical device. Coupled with talk of the use of Apple Watch in clinical trials, due to its enhanced sensors and data collection abilities that allow in-depth insight into one’s health, it is clear that the use of wearable technology in healthcare is important enough to be further researched, developed and regulated for the future.

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Innovation S-curve for IoT in the medical devices industry (Source: GlobalData Patent Analytics)

Although digital technology, aptly represented by devices like the Apple Watch, has reshaped the healthcare system for years by providing “passive monitoring” of a patient’s physical health, it has only just begun “actively” providing treatment and actually changing healthcare itself – under the name of digital therapeutics (DTX).

An example of an electronic medical monitoring device is the continuous glucose monitor (CGM), which is used for diabetes. It automatically estimates blood glucose levels at 5-minute intervals using a subdermal probe. Such integration of small wearables into patient lives has proven tolerable worldwide. They have even been shown to be empowering – through feedback from diabetics – because they can follow their blood sugar data throughout the day, especially preprandial and postprandial. The use of consumer wearable wristbands alongside CGMs only enhances this further; in a 2021 study conducted to see if such usage would increase the classification accuracy of eating and non-eating activities, the results showed that the addition could reduce false positive rates.

Besides CGMs, many other digital therapeutic devices have been developed – and some may even have the potential to deliver insulin automatically, which would ease diabetic management. There are many other examples of DTX systems, most of them incorporating sensors that measure a variety of parameters, and it is clear that DTX is a growing market that should increase the efficiency and delivery of care without requiring continuous monitoring by patients, and should improve their overall health.