What is the problem to which MedTech Bridge is the solution?
For many ambitious European medtech companies, the US represents a significant commercial opportunity, but entering and scaling in the market requires the right expertise, relationships, and local understanding.
At the same time, bringing innovative products to market in Europe has become increasingly challenging under the MDR/IVDR framework. The European Commission itself has acknowledged bottlenecks around notified-body capacity and the complexity of the conformity-assessment system. For smaller companies, the resulting uncertainty and extended timelines can consume significant amounts of capital before commercialisation.
The challenge does not end with regulatory approval. Reimbursement and market access are also fragmented across Europe, with companies having to navigate different national healthcare and reimbursement systems. This can make the commercialisation journey considerably more complex when the company needs to build a market country by country.
The US offers a different model. Regulatory clearance is handled through a centralised federal system via the FDA, with established pathways such as 510(k), De Novo and PMA depending on the device. Once regulatory requirements and the relevant coverage and reimbursement strategy are addressed, companies have access to a single large healthcare market of more than 300 million people, rather than having to build separate market-access strategies for multiple European countries.
For a company with limited capital, time-to-market and access to revenue can therefore be critical. If a company cannot afford to spend several additional years waiting for European commercialisation, the US can become an increasingly attractive route for bringing the product to market and scaling the business.
This is where MedTech Bridge comes in. We help European medtech companies understand the US market, connect with the right experts and stakeholders, and build the relationships needed to move from regulatory clearance to reimbursement, first customers and commercial scale.
Our ambition is not simply to help a company enter the US once. We want to stay with our members over time and give them access to the right expertise at each stage of their journey – from regulatory and reimbursement to go-to-market, manufacturing, distribution, financing and ultimately scaling.
How is your work affected by the geopolitical situation?
The geopolitical environment has made international expansion more complex, but it has also reinforced the importance of trusted relationships and local market knowledge.
For European medtech companies, the US remains an important market, but companies need to approach it with a clear understanding of the local healthcare, regulatory and commercial environment. At the same time, recent geopolitical developments have increased the value of strong trans-Atlantic relationships and collaboration between European and US ecosystems.
For MedTech Bridge, this means putting even greater emphasis on people-to-people connections, trusted networks and practical market access, rather than simply providing market information from a distance.
Why is Medicon Valley the right location for a company such as MedTech Bridge?
Medicon Valley is a natural base for MedTech Bridge because it combines a strong life science ecosystem with an international outlook and close connections between Denmark and Sweden.
The region brings together medtech and biotech companies, universities, hospitals, investors, industry organisations and highly experienced life science professionals. This provides a strong pool of companies that can benefit from access to the US market, as well as the expertise and relationships needed to support that journey.
At the same time, Medicon Valley has a strong tradition of international collaboration, making it an ideal European hub from which to build and strengthen trans-Atlantic connections.
Ultimately, MedTech Bridge connects two ecosystems: the strong medtech and life science capabilities of Europe and the scale and commercial opportunities of the US market.