“I predict the next generation of wearables will significantly blur the lines between tech accessory and medical device. These “devices” will include capabilities such as measuring blood pressure, blood sugar, body temperature and more. The FDA is working closely with industry partners to identify common roadblocks to innovation. The De Novo Program, the classification Apple pursued for the Apple Watch, is the category for medical devices that don’t fall within an existing classification. As we blend medical technology with consumer technology, I foresee the De Novo program being utilized by companies such as Fitbit and Garmin. As a consumer, I’m very excited for the potential and advancements.” –  Jon Speer, Founder and VP of QA/RA, Greenlight Guru

“In 2019, medical devices, and software as a medical device, will come even closer to offering a human diagnosis than ever before. To date, most consumer-facing medical devices, like the Apple Watch, only provide general wellness advice and therefore are not regulated by the FDA or the EMA. With advancements in AI and machine learning, it’s easy to imagine the medical device of the future offering a human-like diagnosis, which of course means that software developers must increase their understanding of the complex regulations set forth by the FDA. While I never expect that medical devices will be able to replace doctors or nurses, they will have the capability to augment the work of both in 2019.” – Stephane Donze, CEO, AODocs

“There are three leading trends I see happening in 2019 for medical devices.

More remote monitoring: As hospitals try to reduce readmissions, more ways to monitor a patient in their home will be needed. Devices that provide that kind of remote monitoring capability will go mainstream in 2019.

In-home diagnostic kits: This started a few years back, but we see 2019 as a year where this will really take off. The ability for patients to do simple diagnostics tests like blood work, urine analysis, etc. will be widely available by 2019.

Clinical Decision Support Systems: Again, not a new concept, but we see more of these happening in 2019 that use artificial intelligence/machine learning to assist clinicians in making better decisions regarding the patients’ health and course of treatment.” – Abbas Dhilawala, CTO, Galen Data