The Story Behind Health Tech Pathways: A note from the CEO
I'm often asked why we built Health Tech Pathways. So here it is.
Watch the 2-minute story, or read on below.
It started on a dockside
In 2018, I gathered the first seven health tech start-ups on a dockside in Copenhagen. That was the beginning of Health Tech Hub Copenhagen. Since then, we have supported more than 120 start-ups and scale-ups, reaching more than 5 million people with innovative solutions.
Along the way, one pattern kept repeating. Every start-up faces the same three barriers:
- Funding
- Market access — (i.e. finding paying customers)
- Regulatory approval
For eight years, we worked on the first two: matching start-ups with investors, educating those investors, and opening doors to buyers in Denmark and internationally. Read more about what HTHC offers start-ups here.
Two years ago, we decided it was time to take on the third barrier.
Europe has a regulatory problem
We had discussed all three barriers with the Novo Nordisk Foundation for years. Then one day, they called us back. They had analyzed the market and reached the same conclusion we had: Europe has a serious problem with long timelines and high costs for regulatory approval of digital health and medtech solutions.
The numbers are stark. An analysis by MedTech Europe shows that getting a solution approved is on average twice as fast in the US under the FDA as it is in Europe under MDR (source: MedTech Europe).
The consequences are predictable and painful:
- European companies increasingly launch in the US first
- Some never launch in Europe at all
- Others relocate to the US entirely
Every one of these outcomes means the same two things: European patients wait longer for innovative solutions, and European companies lose competitiveness.
That's the gap Health Tech Pathways exists to close.
What Health Tech Pathways does
Health Tech Pathways is built by regulatory experts for people who aren't. It's for every company that needs MDR approval or wants to find out if they can avoid it. The platform combines expert knowledge, trained AI, and a clear step-by-step structure that guides you through the work.
Our goal is simple: reduce time to market in Europe to be on par with the US.
Want to know more?
Start your free trial at www.healthtechpathways.org
Jesper Grønbæk Founder & CEO, Health Tech Hub Copenhagen