KEY IDEA: A panel of leading cardiologists weighed in in the Apple Watch and it wasn’t pretty. While they like the idea that it can alert patients to a potential problem they will never accept the apps, or any apps, a diagnostic tool.
I had the opportunity to watch cardiologists in a focus groups talk about their practice and in particular the trend in apps and the Apple Watch. Not one person said they would ever use an app on ANY device as a diagnostic tool although they said “if it alerts patients to a potential problem it could be good”. They want to see more clinical evidence that mobile apps or devices can help them help patients.
Two weeks ago I received a free Apple Watch, series 5. As a techy I was excited to play with this game changing device but it has serious drawbacks. First, it has to charged every 24 hours which, in my opinion, is a huge disadvantage. Second, even for someone who loves new gadgets I found the watch to be less than user friendly. Finally, the idea that older demographic might use the watch are seriously in doubt given its complexity.
What’s good about the watch? Well I canst activity goals and it updates me on those goals throughout the day and it has some decent apps to help me relax. I wouldn’t, however, pay $400 for the product.
Now back to the cardiologists. The focus groups took place in Sacramento and went on late into the night. The Food and Drug Administration is in a tough spot when it comes to health-tracking wearables. As the U.S. government agency in charge of regulating medical devices, it can’t promote health-oriented technology that doesn’t do what it claims, but it also doesn’t want to stifle innovation at a time when Silicon Valley is finally turning its attention to the field. “We are taking a very light touch, an almost hands-off approach,” Bakul Patel, the FDA’s associate director for digital health, says. “If you have technology that’s going to motivate a person to stay healthy, that’s not something we want to be engaged in.”
“If the watch can inform patients to a potential problem then that’s an advantage,” said the groups but, “we need to know how many people will actually act on the data?” A thought leader for a leading pharma company said it best “I want to see clinical evidence that it helps patients and can be a benefit to them but how many of them are going to be diligent in wearing the watch, setting it up and charging it every day?”
The FDA did not ‘approve’ the Apple Watch EKG writes one medical device attorney. “That would involve a lot of testing that Apple did not do. Don’t be misled if you read news reporting about FDA ‘approval’ or ‘approved.’” He describes a failure to make this distinction on the part of reporters as, “Sloppy and wrong for this product.”
Apple is selling a lot of watches but there are other wearables that do a lot better job and are more user friendly. For now the Apple Watch is a nitch product.