What does it really take to transform a health app into a certified medical device?
In this episode, I sit down with Hester Knol, a clinical research expert with extensive experience in medical device regulation. Together, we delve into the complex journey of getting a digital health app through clinical trials, the hidden challenges faced by startups, and the rigorous planning and evidence required, even for low-risk tools, to ensure safety and efficacy before reaching patients.
Key highlights include:
- An in-depth look at the process of developing a medical device, from initial idea to regulatory approval, focusing on digital health applications.
- The necessity of systematic literature reviews and the importance of generating evidence through clinical trials to demonstrate safety and performance.
- The role of clinicians and healthcare professionals in shaping and legitimizing digital health solutions, including how their acceptance can significantly impact the success of new products.
- The regulatory landscape, including the distinctions between different classes of medical devices and the implications of strict compliance requirements.
- Insights into navigating the commercial landscape, how to engage with healthcare insurers and understand market dynamics to ensure viability and demand for new health tech products.
If you’re interested in the intersection of technology, healthcare, and regulatory challenges, this conversation is a must-listen!