Checking your phone to see when you took your last medication? Your watch vibrating and telling you to lay down because you will have a seizure soon, while at the same time notifying your emergency contact with your exact location? This may seem a little futuristic, but it is actually more realistic than you would expect. Both your phone and watch are so-called “wearables”; things that can be worn, that contain computer technology being able to measure vital body functions, in other words: that are “smart”.
The use of these wearables in the diagnosis and prevention of diseases becomes more realistic every day. There are already numerous wearables on the market which are classified as medical devices since they have a function in preventing or diagnosing of diseases. It is not necessarily the wearable device itself that is classified as a medical device, but it could also be the software used with the device which is considered a medical device, so called stand-alone software. The last is the case when the software can be used independently of the device it is installed on. Software, which drives a device or influences the use of a device, falls within the same medical device class as the device.
The combination of data from medical health records, wearables and biosensors could definitely facilitate the focus to preventive healthcare instead of reactive healthcare.
Great example is Apple’s ResearchKit, a software framework enabling medical researchers to develop apps that use the iPhone or Apple Watch to diagnose, prevent, monitor and better understand diseases. Already developed apps with this framework are able to screen children for an early diagnosis of autism disorders, can help predict seizures by tracking the onset, duration and severity of the seizures and an app that tracks changes of moles to diagnose melanomas and create an algorithm that can screen for melanomas in an early stage.
Besides smartphones and smartwatches used as wearable medical technologies, other innovative devices are emerging as well. The smart pill is one of these technologies. This device is often composed of a regular capsule containing a sensor, camera or tracker that sends data to a receiver outside of the body which can further transmit the sensor’s data to a mobile application. The sensor can measure various parameters like pH, pressure and temperature to diagnose gastrointestinal problems. The camera can replace the traditional invasive endoscope techniques. A smart pill containing a tracking sensor is already approved by the FDA to monitor the drug intake compliance of patients. In this case the tracking sensor is combined with the drug in a tablet formulation. Each time the tablet is ingested it sends a signal to the receiver creating an objective and precise drug intake profile. The smart pill technology offers a wide range of opportunities for the future and is expected to help reducing the health care costs.
Another growing technology are the non-invasive glucose sensing patches that allow continuous monitoring of glucose levels in the sweat or interstitial fluid on the skin of diabetic patients. Although these devices still require further development, evaluation and extensive validation, they offer a considerable benefit for patients suffering from diabetes  .
However, these technologies will have to face the same regulatory challenges that all other medical devices face. Additionally, the legal, ethical and privacy aspects of these medical technologies have to be considered. But most important, it are the patients that must always benefit from the devices.
Are you having any questions concerning the classification, regulatory aspects, validation,… of your medical device? We have the expertise in-house to consult you on every aspect within the lifecycle of your medical device.
 Kim, J., Campbell, A. S., & Wang, J. (2018). Wearable non-invasive epidermal glucose sensors: A review. Talanta, 177, 163–170.