Why U.S. MedTech Startups Must Think Beyond Borders
This was exactly the challenge discussed during the Innovation Industry Talk “Beyond Borders: Scaling US Medtech Startups”, held on October 29 in San Francisco and organized by Mind the Bridge and Theras.
The problem Alberto Onetti addresses, " The gap emerges between research and company creation: tech transfer effectiveness, incentives for faculty entrepreneurship, access to early-stage capital, and the ability to scale spinouts beyond the lab. The result is a paradox: strong science, weak industrialization of research. "
Unfortunately, this problem is relevant to universities in many countries. This is evident from the map: a number of countries are not even present.
There are already proven tools for solving this. In my opinion, the problem lies with the leadership of a number of countries, which are not ready for change, but simply maintain the status quo that has existed for decades.
Although the event focused on MedTech, its conclusions resonate across nearly every innovation-driven sector.
“American startups should definitely be expanding to Europe,”
said Alex Gonzalez, Director of International Business Development and Distributor Partnerships at Levita Magnetics.
“There’s a misconception that you must be fully commercialized and FDA-approved before entering Europe. In reality, these processes can — and should — happen in parallel.”
Yet most U.S. startups still follow one deeply rooted rule.
“The U.S. startup playbook says: U.S. first,”
noted Saumitra Thakur, Managing Partner at MedMountain Ventures.
Why?
“For many Americans, the U.S. is the center of the entire universe,”
Gonzalez added.
Why search for other galaxies when you can scale — and exit — right at home?
This mindset is reinforced by fear, complexity, and lack of understanding, often resulting in what founders know all too well: analysis paralysis.
Europe Is Not a Risk — It’s a Strategic Advantage
Ironically, Europe offers some of the most attractive conditions for early-stage MedTech:
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More open academic institutions
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Lower clinical trial costs
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High scientific and regulatory standards
As Dorian Averbuch, four-time entrepreneur with two nine-figure exits (MediGuide and superDimension), pointed out, Europe combines rigor with accessibility — a rare combination.
There is also a powerful financial incentive.
In MedTech, valuations are often driven by revenue multiples and strategic market positioning. Expanding into Europe creates new revenue streams, which can dramatically increase a company’s valuation and acquisition attractiveness.
So What’s Stopping Them?
Despite being a large market, Europe is structurally complex.
It is not one market — it is 27 different healthcare systems, regulatory regimes, reimbursement models, and cultural approaches to medicine and business.
Today, CE marking and MDR/IVDR certification can be more complex than FDA approval.
And European clinicians are often less commercially oriented, making adoption slower without the right ecosystem.
This makes Europe harder to enter — but also harder for competitors to displace.
The Real Challenge: Translation
International expansion is rarely about technology.
It is about translation.
“This is especially true in MedTech,”
said Massimo Balestri, General Manager of Theras.
“Business models, reimbursement pathways, and go-to-market strategies must be adapted to each national healthcare system. Success in Europe depends on finding the right local partner — one with clinical credibility, distribution reach, and deep institutional knowledge.”
In fragmented markets, startups need catalysts — organizations that can convert innovation into real-world impact.
That is what Theras Group represents: a bridge between global technology and local healthcare ecosystems.
We call this the Partner Advantage — the ability to transform breakthrough innovation into scalable patient access through strategic local alliances.
The Bottom Line
U.S. MedTech startups that think globally — early — build:
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Higher valuations
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Stronger strategic positioning
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More resilient revenue models
Those that don’t risk remaining provincial in a global market.
For deeper insights into the evolving MedTech landscape, explore the report:
“The Future of Medtech – European and Global Trends in Chronic Diseases.”
The future of healthcare is global — and the smartest founders are already building it that way.
Alberto Onetti, Chairman at Mind the Bridge.