Do you have a Fitbit, Apple Watch, or other general wellness device to track your activity, monitor your heart rate, lose weight, or count calories? Are these smart technologies considered medical devices, general wellness devices, or both?
In this episode, Jon Speer invites guest Mike Drues of Vascular Sciences to join the show as the two discuss the pros and cons, go-to-market pathways, and other considerations for general wellness products.
“A wellness medical device is not a regulated medical device. It does not diagnose, treat, prevent a disease, injury, or condition.” Mike Drues
“When FDA originally released the guidance for the wellness exemption...either purposefully or inadvertently, you’ve opened up a Pandora’s Box.” Mike Drues
“A lot of people are looking at this as a loophole that they can avoid the compliance and the regulation side of things as a fast path to get something on the market.” Jon Speer
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The Global Medical Device Podcast powered byGreenlight Guruis where today's brightest minds in the medical device industry go to get their most useful and actionable insider knowledge, direct from some of the world's leading medical device experts and companies.
Nick Tippmann is the Chief Marketing Officer for Greenlight Guru, a MedTech Lifecycle Excellence Platform (MLE) that provides an industry-specific solution to help medical technology innovators around the world use quality as an accelerator to move beyond baseline compliance and achieve True Quality. Tippmann is...