A difficult landscape

Health Tech Pathways addresses significant challenges in the health tech sector, where regulatory requirements often create obstacles for startups with limited resources. HTP is set to expedite and simplify regulatory approval for Danish and Nordic health tech startups, reducing the process in Europe from an average of 18 months to under 10 months. This platform’s development will give startups a vital tool for making informed decisions at every stage of the regulatory journey, with an anticipated impact that reaches far beyond Denmark to the broader Nordic region.

  “The regulatory landscape can be extremely difficult to navigate for health tech startups, often delaying the time it takes to reach patients with their innovative health technologies,” says Mikkel Skovborg, Senior Vice President, Innovation at the Novo Nordisk Foundation. “By supporting health tech startups on their regulatory journey, this initiative aims to provide a clear and faster regulatory pathway, ultimately benefiting people and society.” 

Solving pressing needs

Set to launch in 2025, Health Tech Pathways will address the specific needs of health tech companies facing regulatory hurdles. With functionalities developed for and tailored to digital health solution providers, the interactive platform will serve as an all-round resource for startups.

For startups like UVISA Health, which is developing a first-of-its-kind phototherapy device for treating vaginal infections, the platform is expected to be a transformative resource. “When I look ahead at the regulatory pathway that we will face, I have to expect a lot of work ahead of us. There's no predicate device ahead of us that's been approved for this use before, which means that we are building an entire weight of evidence from the ground up, and we are hoping that we can do that and get our CE mark within two years. But that's a very optimistic outlook. ” says UVISA Health CEO Ella Harris.  

The challenges startups like Uvisa Health are about to face are recognised by Betina Langemark, CEO of  WARD 24/7, a startup that has recently obtained a CE mark. “It took us four years to obtain a CE marking. The ultimate challenge in regulatory approval is finding the knowledge and actually knowing what to do, and getting to understand all the different regulations, and then the money. It is so incredibly expensive.”  

Building a community

Jesper Grønbæk, CEO of Health Tech Hub Copenhagen, emphasizes the importance of community in addressing the regulatory challenges startups face: “Based on our experience with building a community at Health Tech Copenhagen, we can see the power of communities. Now we need to build a community around regulatory affairs. There's so many talents out there, but they're not speaking to each other, and they are not learning from each other, so we need to bring them into a platform where people can share knowledge and share experiences and best practices. We are excited to receive this funding from the Novo Nordisk Foundation, enabling us to create this platform and community for supporting startups in their regulatory approval journeys. ”  

Creating global impact

HTHC anticipates that Health Tech Pathways will empower health tech startups to scale more sustainably and reach markets faster, all while ensuring regulatory compliance across diverse regions. By bridging the knowledge gap in regulatory approval, Health Tech Hub Copenhagen is taking a vital step forward in the pursuit of digital health innovation - bringing transformative health tech solutions within reach of healthcare professionals and patients across Europe and beyond. 

For more information, contact:

Martin Broch Pedersen

Business Development Director, HTHC
martinp@healthtechhub.org