What the FDA’s Approval of Apple Watch Means for the Future of Monitoring

Product Creation Studio is pleased to bring you exclusive, on-going content by Heather Thompson, a senior editor for Medical Design & Outsourcing and former editor-in-chief of MD+DI magazine.  With 15 years of experience covering medical technologies and FDA regulations, Heather specializes in delivering the latest trends and news in the medical device industry. 

Smart phones keep getting more and more sensitive. The time to harness that power for medical patient monitoring is now.

Last month, Apple announced that it had gained clearance from FDA for two new features for the Apple Watch Series 4: an electrocardiogram and an irregular heart rhythm notification system. Both features will be available on the device later in 2018.

This is not the first patient monitoring system on the market. There are several examples in the direct-to-consumer monitoring market (think sleep apnea and baby vitals monitoring), but in many ways, it represents a watershed moment. Most importantly, the increased sensitivity of the technology has yielded far greater accuracy, meaning the medtech community developing both hardware and software can rely on commercial products to meet FDA standards. Further, developers are finding innovative ways to use the technology already within smart phones to capture biometrics.

We believe the industry will continue to see more and more monitoring applications that tap into the advances in existing commercial devices and will include both hardware and software to meet medical needs. 

For example (also last month), Philips signed a non-exclusive patent license agreement with the U.S. Air Force Research Laboratory for a mobile software application that provides integrated, real-time patient monitoring. The Batdok (Battlefield Assisted Trauma Distributed Observation Kit) includes software developed by the 711th Human Performance Wing at Wright-Patterson Air Force Base. It features wearable sensors that allow a medic to monitor multiple casualties wirelessly using a smartphone or tablet. Philips believes the application has civilian telemedicine capabilities.  

Tech transfer from universities for patient monitoring technology looks promising as well. In 2017, it was a something of a poorly-kept secret that Google’s home automation business Nest purchased Senosis Health. Senosis, which was started by serial entrepreneur, Shwetak Patel, created apps that use smartphone’s inherent technology to collect various health measures. Senosis has created additional apps that monitor lung health and hemoglobin counts, among other things, using the phone’s accelerometer, microphone, flash, and camera. To measure hemoglobin, for example, the app uses the phone’s flash to illuminate a user’s finger.

More recently, Michigan State University has invented a proof-of-concept blood pressure app that provides accurate readings using an iPhone—with no special equipment. The original technology required optical and force sensors, but with advances in smart phones that include “peek and pop” features, those additional sensors might not be needed. Peek and pop allows users to open functions and apps with a finger push, and uses haptics technology to sense the pressure of that push.

Likewise, technologies such as a phone’s camera flash are being harnessed to check for head injuries. PupilScreen, a technology developed by University of Washington’s Paul G. Allen School of Computer Science & Engineering, uses the phone’s camera flash, camera, and video recording capabilities to measure pupillary reflexes.

As we move into the future, it’s clear that we’re at the dawn of a new era for patient monitoring – and that’s a good thing! The promising technologies that have been emerging over the last decade seem to be finally taking hold in the monitoring space in a meaningful way. As with all consumer-facing technology, one of the most critical factors to success will be designing for usability and human factors. Any app, software, and hardware developed will have to meet usability needs based on the idea that users might not have medical training‑—patients will manage the devices themselves.

Check back for more on Product Creation Studio’s blog as we continue to keep an eye on this market!