Michael Barbe on Building a Latin America Market Entry Plan

Latin America is often discussed as one big expansion play, but Michael Barbe makes a more useful point in his conversation with Julio Martinez-Clark: the region rewards companies that plan for execution, not just ambition. In this episode, Barbe, then a principal at Medaron Consulting, explains why market entry lives or dies on a few unglamorous choices—who controls the registration, how products get reimbursed, how money gets collected, and how much focus a company keeps.

That practical framing is what makes the discussion worth revisiting. Barbe is not arguing that every medtech company should rush into the region. He is saying that once a company decides to go, "You absolutely have to understand what you're getting into with any foreign market."

Treat Latin America as a portfolio, not a single launch

Barbe's own focus has stayed on the larger opportunities: Brazil, Mexico, Colombia, and Argentina. His reasoning is straightforward. Latin America matters because it is large enough to matter globally, but it still has to be judged against a company's real constraints. The United States remains a much bigger revenue engine for most device companies, so a Latin America strategy has to be selective.

That is why one of his strongest lessons is about avoiding sprawl. Smaller markets can look attractive when a physician or distributor shows interest, but every extra country consumes regulatory time, management attention, and working capital. His rule of thumb is memorable: "If you can grow sales in Brazil 5%, it's usually equal to opening a new market." In other words, expansion is not only about adding flags on a map. Sometimes the better move is deeper execution in the markets you already chose.

Regulatory control can matter as much as speed

Barbe describes regulation as a strategic question, not just a filing exercise. Brazil is the hardest case in the discussion. He notes that ANVISA has historically required both the usual regulatory submission and a good manufacturing practices audit at the manufacturing site, with the audit step often becoming the real bottleneck. He also says the process has improved, including provisional registration in some cases while the audit is still pending.

At the other end of the spectrum, as he puts it, "The easiest is Colombia. Colombia is the only country that allows a foreign company to be the owner of the registration." That single policy changes the commercial equation. If the foreign manufacturer owns the registration, it can change distributors without having to rebuild the entire market authorization structure.

That theme runs through his comparison of Brazil, Mexico, Argentina, and Colombia. Speed matters, but control matters too. A distributor that pays for the registration may reduce upfront cost, yet it can also limit the manufacturer later if performance is weak or geographic coverage is uneven. Barbe points to proxy or hosting structures in Brazil as a way to preserve control while still using a local entity where required. For early-stage companies, that is a useful reminder: regulatory design affects channel flexibility long after approval.

Market access is really a reimbursement and cash question

Once the product is registered, the next problem is not abstract market size. It is who pays, at what price, and how reliably. Barbe breaks the region into the public and private markets. Public systems often buy through long, bureaucratic tenders. Private providers may buy fewer units, but they usually pay more and pay faster.

That distinction shapes distributor strategy. In his view, a local partner is valuable not only because of physician relationships, but because collecting payment remotely from the United States is so difficult. The channel has to be able to navigate the hospital system, the payer environment, and the cash cycle.

He also offers a useful correction on pricing. Latin America can be price sensitive, but the deeper mistake is treating U.S. pricing as the universal benchmark. He argues that the United States is the outlier because of how much it spends per capita on healthcare. That means companies entering Latin America have to build a price architecture around local reimbursement logic, not around what the product gets in the U.S. For innovative products, that can still work well; Barbe notes that truly new technology can set a benchmark more effectively than a product that looks like a substitute.

Don't outsource the market to your distributor

Barbe clearly values strong distributors, but he does not support a hands-off model. His preferred setup is a capable local distributor plus company-employed clinical support that visits customers, trains users, and builds direct relationships with key surgeons. He says that approach helps the manufacturer keep the market knowledge that would otherwise stay trapped inside the distributor's network.

That view extends to distributor search and due diligence. For surgical products, he says surgeons and key opinion leaders are often the best source of referrals because they know who actually performs in the local market. But he also warns that referrals can be biased, which is why interviews, networking, and deeper vetting still matter.

The same section of the conversation leads naturally into compliance. Barbe describes ethics as a constant management issue in large device companies, especially in markets where corrupt practices can surface. But he does not frame compliance as only defensive. "Selling through ethics compliance as a competitive advantage is something that actually works." For founders and commercial leaders, that is an important point: governance is part of market access, not separate from it.

Listen to the full episode

The episode also touches on Latin America as a clinical development destination, with Barbe arguing that countries such as Colombia may become more important for initial safety studies as Europe becomes more difficult for foreign companies. If you are weighing commercial expansion, distributor design, or clinical strategy in the region, the full conversation is worth your time. You can listen here: Michael Barbe, Principal, Medaron Consulting.

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.