The September 11, 2018 online edition of MD+DI features No, a Wellness Device Can’t Save Your Life (not Directly, Anyway), by StarFish Medical mechanical engineer, Nigel Syrotuck. Subtitled “Be sure to understand the distinction between medical devices and wellness devices”, the article examines differences between medical devices and wellness devices along the regulatory, risk, and patient safety implications.
Nigel explains: “The responsibility and choice to claim a device as either wellness or medical lies completely with the manufacturer. It is extremely important that manufacturers understand the rules. Mistakenly seeking FDA approval for a wellness device might be costly, but not seeking FDA approval for a medical device could be a deadly.”
The article includes a case study of the iBeat, which launched this summer. Nigel concludes that Patient Safety Is Number One and offers this closing advice: “Always carefully consider your claims and the type of information your device is collecting before deciding that it’s a wellness device—the stakes are too high, both for companies and for patient-consumers who may mistakenly rely on wellness devices.”
Nigel Syrotuck is a StarFish Medical Mechanical Engineer and frequent contributor to the StarFish blog and guest blogger for medical device media including MD+DI, Medical Product Outsourcing, and Medtech Intelligence. He injects humour and imagination into projects big and small and blogs on everything in-between.