Want to Make Wearable Devices More Appealing? Register with FDA
[Posted on: Thursday, August 4, 2016]

This week Philips Healthcare announced release of a smart watch very similar in functionality and appearance to Fitbit, Apple’s iWatch or Samsung Gear watch. However, the Philips watch has one difference from its competition; it is registered with the FDA as a medical device. Smart watches are not considered medical devices by FDA and do not require registration or approval from FDA. This FDA practice is similar to that for most mobile apps that help educate, monitor or track common bodily functions such as heart rate, blood pressure, weight, diet, etc. So, why did Philips register its smart watch and how did it get FDA to accept registration for a device that FDA has repeatedly announced to be not eligible for registration as medical devices? In a very competitive market of wearable devices, one needs to find creative ways to stand out. In the last 3 years numerous kinds of smart watches have been launched by practically all phone and wearable device makers but most of these gadgets have failed to meet market expectations. There are several reasons for this. It is well known that about 50% of the users stop using wearable devices in about 6 months. Most consumers also do not use the information generated by wearable devices adequately limiting their utility and benefit. Most smart watches try to do too many things such as controlling the phone, playing media, camera functions, and games, highly diluting the healthcare related functionalities. Most wearable devices do not carry any special recommendations from doctors or FDA, and all wearable devices are not allowed to make specific disease prevention, diagnostic or any other medically relevant claims. Most smart watches and other wearable devices are designed with younger, tech-savvy users in mind. Philips used a very creative strategy to address all these limitations. The Philips smart watch is designed to only track healthcare functions. It is connected by Bluetooth to smart phones but uses that capability to only communicate with the Philips HealthSuite App to provide a comprehensive dashboard of vital sign info, but it does not do any other non-health related tasks such as controlling the phone, playing media, etc that are common with other smart watches. By de-cluttering its capabilities and information, the Philips smart watch is expected to be more appealing to less tech savvy consumers who want to use the wearable device for healthcare functions only. The smart watch is not marketed as a fitness device but as a health monitoring device. Philips claims that the accuracy of measurements and algorithms were validated clinically by clinical scientists and behavior change psychologists. By claiming it to be a clinical monitoring device, Philips classified its smart watch as a Class I medical device. Designation as a device makes it possible for doctors to comment on it, and possibly recommend it to patients; and insurance to cover the cost. Philips just showed to the developers of wearable devices how to introduce new healthcare devices and apps in a crowded market. It is too early to say if the strategy will succeed in getting a reasonable market share but Philips did get everyone talking about its products. The strategic approach highlights key areas of improvement for all wearable technologies. Getting an FDA stamp should help any device aiming to make a place in the healthcare environment. The success of Philips smart watch will likely change the paradigm of wearable device market. We hope so.