Miiskin on its initial regulatory assessment
Back in 2019, our member company Miiskin took advantage of MedTech Bridge's initial regulatory assessment service, the first step in the process of receiving the right FDA classification. We talked to Jon Friis, founder & CEO, about his experience with the regulatory process and to share important learnings.
Miiskin is a digital health and imaging platform for the purpose of assisting patients and dermatologists in monitoring changes in skin and skin lesions.
In 2019, Miiskin received an initial regulatory assessment from the MedTech Bridge to identify Miiskin's position in a regulatory context and increase its knowledge of 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 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".
He has one clear piece of advice to other MTB members:
"Prepare yourself! A detailed 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 are ready for its next step: B2B market entry in the US. Read the full interview with Jon Friis, below.
Interview with Jon Friis
Why did you initially decide to join the MedTech Bridge?
For us, it was the focus on life science and medical technologies which made it obvious. Also MedTech Bridge’s focus on creating business value in the US which is our primary market, currently.
Other considerations include the way The MedTech Bridge adds value to members through US market entry and by removing barriers such as getting the right clearance, being introduced to the right US people and access to the US ecosystem.
What was your expected outcome of the initial regulatory service?
It is extremely important when you market a product to know where you are at in a regulatory context. We had the opportunity to upgrade our product from being mainly focused on the consumer to a device that allows for integration between the doctors and the patients.
With the initial assessment, we got the fundamental learnings about FDA that we wanted to - as we wanted to be classified as a mobile app. Then, through the MedTech Bridge’s network, we found a service provider that had the right expertise to do the regulatory strategy in the US. But it was thanks to our initial assessment that we were able to enter the discussion with the regulatory experts. You could say that the overall outcome was that it initiated the dialogue with the regulatory experts by preparing us as we identified our target and aim in a regulatory context.
How did you experience the process with our service provider?
It was a good learning process for us. With the initial preparation, we were able to meet the service provider at a high level and have the right kind of discussion. As FDA classification is an area with a lot of uncertainty, it was great to be well-enough prepared to be able to challenge the experts and discuss it forward and back, which ultimately led us to have the classification that we wanted to.
What are your key takeaways?
Prepare yourself! It is an area with a lot of complexity and different guidelines so it requires an in-depth understanding.
Another one of my key learnings was about the breakdown itself and assessment of yourself as "digital health" - and how the FDA regulates it. The FDA guidelines and regulatory classifications for digital health companies seem more mature and operational than the European counterpart, especially for digital health apps whose primary task is to collect and transport health-related information.
Further, the selection process and introduction to the right people were extremely helpful. MedTech Bridge did an excellent job in getting us all the way in the front door to the right people for a reasonable price.
What is your next step?
Business to business market entry. We already have over half a million users in the US. We are using this traction to boost and initiate our B2B.
FDA is really important for both sales and marketing as it moves some of the market barriers. As we approach the B2B market, we know that hospitals and decisions makers ask "are you compliant - what are your FDA classifications?", so we have learned the hard way that we needed to remove this barrier if we wanted to sell our product to clinics and hospitals in the US.
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.