MedTech Bridge member Miiskin recently received a FDA classification. Miiskin is a digital health and imaging platform for the purpose of assisting patients and dermatologists in monitoring changes in skin and skin lesions.
Last year, Miiskin received an initial regulatory assessment from the MedTech Bridge to identify Miiskin's position in a regulatory context and increase its knowledge on the FDA. Hereafter, Miiskin was matched up with a service provider to get expert advice on its regulatory strategy. For Jon Friis, the initial regulatory assessment ensured that he felt confident to enter discussions with US experts:
"The preparation that we did with The MedTech Bridge was crucial as it allowed us to meet the service provider on a high level ... it was great to be well enough prepared to be able to challenge the experts, ultimately leading us to have the classification that we aimed for."
Miiskin is an app and digital health platform that deploys sophisticated AI technologies in order to assist people with identifying changes in their skin and moles by using images taken by the user at home. Miiskin has more than 500,000 downloads and is recommended by more than 160 hospitals and clinics in the world.
MedTech Bridge reached out to Jon Friis to talk about his experience with the whole process and to share important learnings. He has one clear advice to other MTB members:
"Prepare yourself! A detailed, high-level discussion with your service provider requires an in-depth understanding."
Now, with an FDA classification in hand - and more than half a million users already - Jon Friis and Miiskin is ready for its next step: B2B market entry in the USA:
"FDA is really important for both sales and marketing as it moves some of the market barriers."
Jon Friis, Founder and CEO, Miiskin
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