Structural heart early feasibility is not a country-agnostic first-in-human. You need implanting volume, echo and CT that can be read the same way twice, and a site that already treats the disease you are studying. The wrong shortlist is “any fast LATAM ethics committee.” The right shortlist is a handful of hospitals that already do TAVR, TEER, or tricuspid work at a pace your sample size can survive.
What has to be true in the country you pick
- Operators who already perform the index procedure, not a general cath lab learning it on your device.
- Imaging that can feed a core lab or at least a locked acquisition protocol. EFS failures in this category are often echo quality, not device quality.
- An ethics and regulator path that can iterate. Early feasibility is supposed to change. A country that treats every protocol tweak as a new filing will erase the point of EFS.
- Investigational import that can handle a device family, not a single serial, because you will iterate hardware.
How I rank the usual options
United States is still the gold standard when you already have an IDE conversation and the right sites. It is also the slowest and most expensive way to learn whether the device should even go there yet.
Australia works when the protocol is English-native and the implanting volume exists. It is a poor default if your constraint is mitral or tricuspid enrollment speed.
Colombia is often the first LATAM conversation for US sponsors: INVIMA plus CEI, strong cardiovascular hospitals, and a cost base that survives a 15-to-30-patient series. The calendar is the CEI and the import, not the science.
Brazil has depth. ANVISA plus CONEP is a longer stack. Use it when you need volume and a later commercial story, not when you need the first ten patients this quarter.
Panama and selected private systems in Mexico can be the right tactic when import and ethics are designed up front and the operator already has the volume. They are the wrong tactic when someone picked them from a map.
The decision that actually matters
Write the EFS protocol for the question FDA will ask next — design, procedure, or safety signal — then pick the two sites that can generate that imaging and those implants. Country is how you get those sites open. It is not the strategy.
If a slide says “LATAM is faster” without naming the implanting physician, the imaging protocol, and the importer of record, it is not a country recommendation. It is a brochure.
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