Blog Article
We run MedTech searches regularly, and a few patterns come up often enough that I've started paying closer attention to them. All three are about the same question: how founders and CEOs build a leadership team that fits where the company actually is.
1. The leadership conversation is starting earlier
This year I've spoken with more seed-stage founders who want to talk about commercial and regulatory leadership than I did two years ago. Back then, that conversation usually started after a Series A. Now it often comes up at seed, at least with the founders I work with.
I'm seeing this most with European companies that pursue FDA first. They know they need FDA regulatory experience and commercialization expertise for a market they don't yet understand. Last year I spoke with about 100 European MedTech companies that don't have MDR in their priority plans.
I'm not claiming this reflects the whole market. It's what I'm seeing in my own conversations. And an early conversation doesn't mean an early offer letter. The founders who handle this well keep two decisions separate: when to start planning a role, and when to fill it.
Good planning covers which leaders the path to market will need, roughly when each has to start, and what the budget and next raise must cover to make those hires possible. With the timing set before the pressure arrives, each hire happens on schedule rather than in a panic. It also avoids the opposite mistake: waiting for a funding event to justify a hire that should already have been made. And sometimes the right first step isn't a hire at all: some founders add that experience to their Board initially rather than hiring full time.
Plan early, hire on time. The next two patterns are about what "on time" actually means.
2. Commercial and market access are moving ahead of clearance
Many founders still wait for clearance before hiring commercial leadership, on the reasoning that there's nothing to sell yet. In practice, that delays revenue by months and puts fundraising at risk as well.
A commercial leader needs lead time. They have to build the strategy first, including whether to sell direct or through distributors, then build relationships with key opinion leaders, test pricing, shape the launch plan, hire the first people on the ground, and have a pipeline ready for the day the product can legally be sold. Starting on the day of clearance means first revenue is still months away, and the company pays for that gap out of its runway.
Market access is even more time-sensitive. Coding, coverage decisions, and health technology assessments take a long time. The evidence payers want often has to be designed into the clinical studies from the start and can't easily be added later. A company that only plans for reimbursement after clearance may find its trial data doesn't answer the questions payers are asking.
Companies without reimbursement clarity are finding it much harder to raise funds.
Most companies build their leadership team the way a large corporation would, because that's the model the person in charge expects will work best. A MedTech startup's needs follow its clinical and regulatory path instead. Every company is different, but the sequence tends to look like this:
- Seed and pre-clinical: build the leadership roadmap. Regulatory and clinical strategy matter now, even if the expertise comes from an advisor or a fractional leader.
- Entering clinical studies: a clinical leader and an RA/QA leader with hands-on submission experience (FDA, CE marking, or other pathways) in seat.
- Around 12 to 18 months before the regulatory decision: the first commercial leader and a reimbursement and market access leader.
- Clearance and launch: the sales team and country managers, built out under a commercial leader who is already in place.
- Scaling into new markets: leaders with direct, on-the-ground experience in each specific market.
3. Stage fit matters more than the brand on the CV
Once the timing is right, the next question is who. Here the instinct is often to reach for a familiar big-brand name, and the results are mixed.
I've seen corporate hires go very well, bringing exactly the process discipline a young team was missing. I've also seen them struggle without the budget, ready-made team, and existing relationships that made them successful before. The CV looks the same in both cases.
The difference is whether the person has built something from the stage this company is at, or has only managed something that already existed. A VP who scaled an established product line and a VP who took a device from first sale to first 100 accounts can have similar titles. For an early-stage company, only one of those is the relevant experience.
The founders who get this right
They ask what their stage requires, and in what order, before they ask who the best available candidate is. They start the conversation early enough to plan the answer, then make each hire when the path to market calls for it. That question is uncomfortable, because it means being honest about where the company really is. It's usually where we add the most value, more than in the sourcing itself.
If you're mapping your leadership team against your regulatory timeline, we're happy to talk it through.
