Forget the US… VCs Sending their Medtech Startups to Europe First
VC are looking across the pond (Richard Nass @ MDDI)
I wrote a blog recently for our sister site, EMDT, where I discussed how many OEMs are going to Europe to design, test, and even sell their medical devices because the investment required to do so is far less than what’s required in the U.S.
In a recent conversation with Peter von Dyck, the CEO of eZassi, my beliefs were confirmed. Peter, an accomplished medical device inventor and entrepreneur with numerous patents and multiple inventions, had this to say:
For the first time, U.S. VCs are actually endorsing NOT launching first in the U.S. and actually going outside the US and acquiring initial clinical data and first revenues in the EU instead. Many U.S.-backed innovations spend up to 4 years outside the U.S. prior to gaining access to their own U.S. healthcare market.
Additionally, data shows that EU VC for med-tech is growing significantly and getting comparable to the U.S. This is due to the fact that emerging med-tech companies actually formed in the EU need about 5X to 10x LESS capital to achieve regulatory market approval than U.S.-based firms!
The average cost for U.S. firms to navigate and win a 510(k) clearance is $24 million, and $75 million for a PMA. And in terms of exit ROI, the typical capital needed to fund a U.S. company to exit is now estimated to go from needing $50 million to $75 million or more! The EU-based firms need only on average $20 million to $35 million to get to commercial viability and an 11-month time period from first contact with a notified body until CE mark registration.
Furthermore, the exit amounts of firms who are acquired is aligning, and EU-based firms are now seeing exit denominations in similar U.S. increments, in the neighborhood of $300 million and above.
Note that we recently added a pair of eZassi tools to our Qmed supplier directory. The two tools are a sample calculator, which provides items like the likely regulatory FDA classification and product codes required for your device. The second tool, called InnoVision, provides a much more comprehensive regulatory view to generate a detailed product analysis that includes both US and EU regulatory classifications.