Podcast
Hester Knol - From App to Medical Device: Why Certification Takes Forever
A conversation with Hester Knol about what changes when a health app becomes a medical device, and why evidence, regulation, and clinical planning have to shape the product early.
In this conversation
Hester Knol explains what changes when a health app is no longer just a product but has to become a certified medical device. The conversation focuses on evidence, clinical trials, regulatory planning, and the timelines that digital health teams often underestimate.
The conversation makes clear that certification is not paperwork added at the end. It shapes the intended use, the evidence plan, the clinical work, and the product decisions from the beginning.
Central question
What has to be true before a digital health product can responsibly reach patients?
What we cover
- Why even apparently low-risk digital tools require evidence and planning.
- How clinical research, safety, and efficacy requirements affect product development.
- Why startups run into trouble when regulatory strategy is treated as a late-stage task.
Guest background
Hester Knol works in clinical research and medical device regulation. Her perspective connects digital health ambition with the evidence standards required before a tool can be used in care.
Things to listen for
- The difference between a useful app and a regulated medical device.
- Why study design and documentation influence product timelines from the start.
- How evidence generation can protect patients while still allowing innovation.
Digital health product paths
App logic
Ship, learn quickly, and improve the experience through product iteration.
Medical device logic
Define intended use, manage risk, generate evidence, and document the work so it can be evaluated.