Wearable Devices: When Purpose is More Than Just Fashion, Quality and Compliance are Not Optional

When we think of wearable devices we usually think of watches, or goggles. Well, these smart watches do more than just tell time or weather or incoming caller ID, and the goggles do more than project some image in our field of view. The upcoming iWatch from Apple is poised to deliver more than just a slaved device function, whence it is merely a remote display with events pushed from the smart phone. The devices like FitBit or Nike+ or most of the Android Gear are merely lifestyle devices. iWatch on the other hand is intended as a health device which gathers vital signs, stores and even notifies your health care professional when certain thresholds are breached, through the HealthBook and HealthKit applications. Then, guess what? Now this smart watch has become a medical device!

Apple is rumored to be talking to the FDA to obtain clearance for the iWatch as a medical device. Why? It conceivably can triage and make medical decisions by logging vitals and notifying your doctor. The iWatch is designed to sense and track blood glucose levels through skin induction, and through BLE. Together with an insulin pump it could deliver doses of insulin based on set thresholds Now it is a medical device, and as such it should be regulated and certified by FDA. Thus, Apple’s foresight and drive to gain a broader application not just today, but tomorrow through app and hardware extensions could make this a true medical device, even a class II device. With such proclamation brings challenges to OEMs like Apple – there is 21 CFR Part 11 for complaints, post-market surveillance, eMDR/eMDV, CAPA, audit trails and FDA scrutiny to name a few.

Now let’s look at goggles, or smart glasses. The most ubiquitous one is Google Glass, and the Oculus Rift also comes to mind. These are not intended for anything other than recreational use or a mere extension of displays placed in front of your eyes. These devices, like the smart watches, have extended purposes through apps or integration with other devices through WiFi, BLE or NFC. Think about all of its useful purposes in other areas: an aircraft engine mechanic could call up diagrams and test instructions literally in front of his face while having both hands free to handle the work in front; a surgeon requesting a chart or a zoomed view from a camera while performing surgery, freeing up his/her hands; or a recreational/private pilot using this device as a HUD (Heads Up Display) which greatly enhances flight safety in inclement weather; or how about an oil rig worker with heavy gloves and tools needing to refer to technical drawings while at a hazardous work site. All of these examples are not simply recreational use, but each as some type of critical safety component. Therefore, they should be certified under strict industry regulations, and have proper post-market surveillance.

To be successful in the short and long terms, these manufacturers should carefully weave quality and safety processes as part of the product life cycle, and extend it out to their entire supply chain. When government regulatory bodies get involved in the manufacturing process it is critical to establish the following:

1. Put an integrated, enterprise quality system in place to build global quality processes throughout the organization and supply chain

2.  Hire and train dedicated personnel on these systems and the quality processes

3. Build and maintain proper records for product quality, reliability, safety and consumer satisfaction.

For more information, download "A Fresh Look at Quality in High Tech Manufacturing"

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