What Early-Stage MedTech Teams Can Learn From Laura Minarsch

If you work on early-stage medical devices, geography is never just geography. It is a decision about evidence, timing, operator access, cost, and what regulators will accept next. In this episode, Laura Minarsch brings that tradeoff into focus from the perspective of a clinical affairs strategist who spends much of her time on First-in-Human work.

In her conversation with Julio Martinez-Clark, Minarsch does not offer a grand theory of global expansion. She offers something more useful: a practical view of how small MedTech companies sequence studies, why Europe still matters under the EU MDR, and why parts of Latin America can be valuable before commercialization. The result is a useful framework for founders and clinical leaders who need to decide where an early study belongs.

Europe is still relevant, but not as a default first move

One of the clearest takeaways from the episode is that the EU MDR did not push U.S. device companies to abandon Europe. Minarsch’s answer is direct: Europe is still on the table. What changed is the path companies take to get there.

As she puts it, "Some companies are approaching a parallel path..." In her description, a company may complete an early First-in-Human effort outside the U.S., often in a non-tier-one country, and then move into parallel planning that can include both an FDA early feasibility route and a European plan.

That is an important distinction. The old shorthand of Europe first and U.S. later does not capture the operating reality Minarsch describes. For many small companies, the question is no longer which region comes first in a simple sequence. The question is how to use an early clinical experience to support two regulatory tracks without wasting time.

She also notes that, before the new regulations took effect in June 2020, some companies were trying to get applications in front of notified bodies earlier. That detail shows how regulatory transitions affect behavior long before a deadline arrives. Startups do not just react to rules; they reposition development plans around expected bottlenecks.

The MDR affects more than approval strategy

Minarsch makes another useful point that is easy to miss in high-level MDR discussions: the burden is not limited to getting a CE mark. For the portion of her clients that already have CE mark activity, registries, or clinical protocols meant to support CE mark submissions, the MDR changes operational work after market entry as well.

Her examples are concrete. She mentions post-market clinical follow-up, vigilance, and coordination with European authorized representatives. The cost shift she describes is especially telling: "So a couple of thousand dollars a month. It's a whole new business."

That is more than a pricing anecdote. It signals a broader planning issue for small companies. If responsibilities for reporting increase, then external partners become more central to execution, and partner costs move from a minor administrative line item to something that can affect budget timing. In other words, regulatory rigor does not stop at the submission. It changes the operating model around the product.

For clinical and regulatory leaders, that means Europe should be evaluated not only as a place to generate data, but as a system that now asks more from the sponsor and from its service partners.

Latin America is an early-clinical option, not a revenue substitute

When Minarsch turns to Latin America, she draws a sharp line between clinical use and commercial use. She says she does not see the early-stage MedTech companies she works with treating Latin America as an alternative to Europe for revenue generation. Instead, she sees the region as a place for pre-commercialization work.

That distinction matters. Too many discussions about global trials collapse market access and evidence generation into one decision. Minarsch separates them. In her experience, Latin America is useful because it can support early experience, not because it replaces Europe as a first commercial market.

She is particularly positive about Brazil and Colombia, and she gives Brazil a strong endorsement: "I think data collected in Brazil is a very high quality..." She also mentions work in Paraguay, the Dominican Republic, Panama, and Chile.

What founders should learn from that is simple. A country does not need to be your first revenue market to be strategically important. It may be the right place to answer a technical or procedural question early, build operator confidence, or prepare for more formal studies elsewhere.

Paraguay’s appeal is operational control

The most distinctive part of the conversation is Minarsch’s explanation of why Paraguay has been useful in her work. She describes it as a private hospital setting where companies can gain very early experience before moving on to Europe. But the real advantage, as she tells it, is control.

In her words, "Companies love it because they can make his facility their own, they can bring their own operators." That is a major operational benefit for early-stage device programs, especially when a U.S. physician has already been deeply involved in preclinical work and the sponsor wants continuity into first clinical cases.

Minarsch contrasts that with settings where it is harder for a company’s preferred physician to scrub in and participate. She says that challenge can arise in Brazil and in European countries such as the Czech Republic or Poland. Her point is not that one geography is better in every way. It is that the practical rules around who can operate, participate, and shape the procedure can materially affect the usefulness of an early study site.

She also explains why the work there has been primarily cardiology. That is tied to the expertise and setup of the lab she uses, not to an inherent limit of the country itself. In her telling, other kinds of work can be done if the right equipment and specialist support are brought in.

Listen to the full episode

This episode is worth hearing in full because Minarsch connects regulatory strategy to the realities of running early device studies. If your team is thinking about First-in-Human sequencing, EU MDR pressure, or whether Latin America fits your evidence plan, start with the complete conversation here: Laura Minarsch, President at MMC Medical International Services.

About Global Trial Accelerators™

Global Trial Accelerators™ is the podcast for MedTech, Biopharma and Radiopharma founders navigating first-in-human clinical trials. It is hosted by Jesús E. Moreno and produced by bioaccess®, a CRO purpose-built for first-in-human trials across the Americas.