What Jon Rourke Looks for in Latin American Early Feasibility Sites

Jonathan Rourke, who was co-founder and CEO of MitraSpan when this episode was recorded, does something useful in this episode: he narrows the Latin America conversation. He is not presenting the region as a generic shortcut. He is describing where it fits, based on his own cardiovascular device experience in Argentina, Chile, and Colombia.

In conversation with Julio Martinez-Clark, Rourke explains why South America can be especially attractive for early feasibility work when a study depends on operator skill, practical site support, and rapid iteration.

The best fit is not every study

One of Rourke’s clearest points is that Latin America is not automatically the right setting for every device trial. He repeatedly limits his comments to the kinds of programs he has actually run: cardiovascular devices, early feasibility work, and studies where operative excellence is central.

Rourke’s answer is more disciplined. The real question is whether the study needs world-class procedural execution, a committed investigator, and a center that can work with a sponsor’s team in a flexible way.

He describes South America as especially strong in that narrow zone. In his view, the region is less about high-volume enrollment for simple studies and more about situations where the operator and the clinical environment make or break the result. That is why he keeps returning to alignment: the right study, the right investigator, and the right support around the site.

For startup leaders, that is a useful filter. Before comparing countries, fees, or timelines, define what kind of trial you are actually trying to run.

Reputation beats publication counts

Rourke is direct about principal investigator selection. He starts with word of mouth, personal recommendations, and the judgment of people who have real experience with a specific center and clinician. Publications matter less to him than many sponsors might expect.

He gives a simple test: "if my mother needed the procedure, are we going to this guy?" That line captures his whole standard. He is looking for clinicians who can deliver technically demanding cases safely, not just investigators with visible academic output.

His reasoning is tied to the clinical reality he has seen in South America. He argues that some highly capable physicians there carry a heavier patient burden than peers at major U.S. research hospitals. In that setting, a thinner publication record does not necessarily mean a thinner skill set. For early feasibility work, he cares more about whether the operator is respected in practice and whether the team can execute.

Rourke’s advice is to talk with people who have been in the country, in the hospital, and in the cath lab or operating room with the clinicians under consideration. In his telling, that firsthand reputation check is far more predictive than a literature search.

Local execution is not a detail

If there is one operational lesson founders should take from the episode, it is that local knowledge is not optional. Rourke says that in every country he has worked in, strong local guidance changes the outcome.

His example is device and equipment importation. He makes the point plainly: "it is really not mundane to get the armamentarium required onto the site." A study case does not happen because most of the needed material arrived. It happens because everything is there, on time, in the correct regulatory category, with the right plan for both scheduled and short-notice shipments.

In his experience, sponsors need local CRO support that understands the regulatory path, logistics, and site workflow well enough to prevent avoidable delays.

Rourke says the same principle applies after approval. Data quality, in his view, is not the core concern if the study has the right site coordinator and a capable CRO working together. The harder part is the unglamorous coordination: confirming follow-up visits, making sure imaging and tests happen on time, and handling the practical details that keep a small early study from drifting.

Why Colombia can feel different on site

Rourke’s most interesting comments about Colombia are not about price. They are about how work gets organized inside and around the hospital.

He describes a model in which major clinicians have significant freedom inside the clinic, while companies bring outside support for everything beyond that boundary. It can allow a sponsor to assemble a mixed team of local physicians, U.S. clinicians, engineers, and study support without the heavier institutional friction he associates with other settings.

That is why he calls this arrangement "it's the nearly ideal way to work." In the example he discusses, team building happened step by step: initial physician relationships, shared animal work, observing cases at the center, and then constructing the broader support structure needed for the study.

He also says Colombia’s regulatory path was reasonable from his perspective, even if it included some quirks and required strong local guidance. Importantly, he does not present regulation there as the main decision driver. For him, the more important question is whether the study design and device type can take advantage of the local clinical model.

Speed, not just cost, is the strategic variable

When Rourke compares South America with the United States and Europe, timing becomes the bigger issue. He says the U.S. environment for early feasibility became more constructive after the early 2010s, but he still sees meaningful hurdles to starting there first.

His summary is practical: "if you can start six or 12 months sooner in South America … I think it's something to contemplate." That is not an argument to leave the United States behind. It is an argument to think carefully about sequence.

He also notes that Europe had become more challenging and expensive, which he saw as an opening for South American centers. Put together, his view is that Latin America can offer a strategic first step for certain device programs, especially those involving complex structural or hybrid procedures where hands-on team assembly matters.

Listen to the full episode

The value of this episode is that Rourke does not talk in slogans. He gives founders a tighter decision framework: match the region to the study, choose investigators by trusted reputation, and invest heavily in local execution. If you are weighing first-in-human options for a cardiovascular device, the full conversation is worth your time. You can listen here: Jonathan Rourke, Co-Founder & CEO, MitraSpan.

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.