You’ve built something real. Your device works. You have clinical evidence, a growing team, and investors who believe in the vision. Now comes the next chapter: the United States.
It’s the largest medical device market in the world. It’s also one of the hardest to crack, not because of the science, but because of the people you need to hire to get there.
European MedTech founders consistently underestimate this. The US market isn’t just bigger. It operates differently, thinks differently, and rewards a very specific kind of expertise. Getting your hiring right from the start can be the difference between a successful expansion and an expensive detour.
Here’s where the real challenges tend to show up.
Finding FDA Regulatory Talent Is Harder Than You Think
Your CE mark got you this far. But the FDA is a different animal entirely and the talent that understands it deeply is in short supply.
Experienced regulatory affairs professionals with genuine FDA submission experience are scarce, expensive, and in high demand. The ones who know their way around a 510(k) or PMA process are often already embedded in established companies, well-compensated, and not actively looking.
What makes this harder for European companies is credibility. US regulatory talent wants to know that leadership understands the process, that the budget is real, and that the company is serious about the market. If any of those signals are unclear, the best candidates will choose a safer option.
The lesson: start your regulatory hiring conversation early — often before you think you need to. And be prepared to pay US market rates, which will likely surprise you.
US Commercial Leadership Is a Different Profile
Hiring a VP of Sales or Chief Commercial Officer who has thrived in Europe will not automatically translate. The US healthcare sales environment has its own rhythms, relationships, and expectations.
The best US commercial leaders for MedTech typically bring a mix of things that are hard to find together: deep relationships with hospital systems or IDNs (Integrated Delivery Networks), an understanding of how purchasing decisions actually get made, and the ability to build a team from scratch in an ambiguous, fast-moving environment.
Founders often make one of two mistakes here. The first is hiring someone too junior to open the right doors. The second is hiring a big-name executive from a large MedTech corporation who has never operated without significant infrastructure and support.
What you actually need is someone who has scaled something before — ideally in a company at a similar stage to yours, in a comparable clinical space. Those people exist, but finding them requires knowing where to look.
Clinical Adoption Requires People Who Speak the Language
In the US, getting a device into a hospital is one thing. Getting clinicians to actually use it, consistently, at volume is another challenge entirely.
Clinical adoption roles, whether that’s clinical specialists, clinical educators, or medical science liaisons, require people who can sit comfortably in a cath lab, an OR, or a cardiology department and be taken seriously. They need to understand the clinical workflow, the physician mindset, and the practical realities of how new technology gets integrated into daily practice.
This is not a role you can fill with enthusiasm alone. The candidates who perform best here typically have hands-on clinical backgrounds combined with a genuine commercial sensibility. They’re relatively rare, and they’re often hired away quickly.
Reimbursement Knowledge Is Non-Negotiable
If there’s one area where European founders consistently have a blind spot, it’s US reimbursement.
The US system — Medicare, Medicaid, commercial payers, coding, coverage, and payment is genuinely complex. Without someone on your team who understands it, you risk building a commercial strategy on a foundation that doesn’t hold up.
Reimbursement expertise isn’t just a regulatory or finance function. It shapes how you price, how you position, and how you sell. Physicians and hospital administrators will ask about it directly. If your team can’t answer confidently, it creates doubt.
Hiring for this early — even if it’s a fractional or advisory role to begin with — sends the right signal and protects you from costly assumptions.
What This Means in Practice
Expanding to the US is one of the most exciting and demanding things a MedTech founder can do. The hiring challenges are real, but they’re not insurmountable.
The companies that get it right tend to do a few things consistently: they start conversations earlier than feels necessary, they’re honest about what they don’t know, and they invest in finding people who have done this before — not just people who look good on paper.
The US market rewards preparation. And preparation, in this context, starts with the right team.