When are Wearables and Apps Medical Devices?
Before the pandemic, the global wearable medical device market was already projected to grow at a compound annual growth rate of 18.3%, according to the Wearable Medical Devices Market Research Report1. Market drivers ranged from responding to the needs of an aging population and the rising prevalence of chronic diseases to an increased desire to improve fitness. Innovation in this space has accelerated, in part, thanks to the ubiquity of smartphones and their always-on connectivity, and there are now many providers of wearable diagnostic and therapeutic equipment.
The health monitoring capabilities of the Apple Watch are a prime example, having saved lives in several medical emergencies. One incident involved a man in Cincinnati, USA, whose watch automatically called emergency services after a fall2. Blood pressure and heart rate data saved in his smartphone app helped physicians determine the cause of his loss of consciousness – a blood clot that was swiftly treated. Another person in the UK was made aware of his irregular heartbeat by his watch3 that he otherwise would have overseen.
But, as most engineers will be aware, medical electronics is highly regulated, with clear standards covering everything from software testing to product safety. Should an embedded system developed to monitor heart rate and transfer it to a smartphone fitness app be treated like any other medical device? How are daily app and cloud software updates handled in an industry that needs years to certify some medical products? And what responsibilities lie with developers handling patients’ often highly sensitive data?
1 https://www.psmarketresearch.com/market-analysis/wearable-medical-devices-market
2 https://www.wcpo.com/news/health/cincinnati-man-says-apple-watch-saved-his-life-after-he-collapsed-during-walk
3 https://www.indiatoday.in/technology/news/story/apple-watch-saves-life-of-a-36-year-old-user-suffering-from-heart-condition-2345300-2023-03-11