Given the high market potential, many players both from the consumer electronics market and from the classical medical device market are looking to enter the market of medical IoT devices and wearables. But while the time is right, it is not without challenges to enter the space of wearable medical-grade devices.
On the one hand, these devices must be extremely reliable and precise to fulfill the compliance regulations and certifications for medical devices. On the other hand, they need to be unobtrusive and easy to use for the patients or end-users, similarly to what they are used to with consumer devices and wearables.
To go from the consumer to the medical-grade segment, developers and wearable device manufacturers will need to significantly increase their expertise in overall development process execution starting from early product requirements and product concept design into final product solution verifications and documentation. It is also of utmost importance to take the requirements for security and privacy protection into account.
Traditional medical device manufacturers entering the world of wearables, on the other hand, generally have proven processes to secure material requirements, quality, integrity, and privacy, but are faced with a number of new challenges from radios and antennas, security, and battery-powered devices to ease-of-use.