Best countries for a structural heart early feasibility study: a practical shortlist

Sponsors searching for the best countries for a structural heart early feasibility study usually want a ranked list of flags. The useful answer is a short list of decision filters, then a country shortlist that survives those filters. A structural heart early feasibility study (EFS) is a small, early human investigation of a novel cardiac device before a powered pivotal trial. Getting the geography wrong costs a protocol amendment and a missed financing window.

I am Julio Martinez-Clark, CEO of bioaccess®. This brief is for U.S. and European MedTech teams scoping structural heart EFS outside the United States. It complements the Early Feasibility Studies pillar, the EFS vs pivotal sequencing note, and the LATAM FIH startup clock. Public case patterns on bioaccessla.com (for example Axoft’s Panama first-in-human corridor for a novel implant class, and ReGelTec’s OUS path into later U.S. pivotal work) show the geography pattern — they are not structural-heart claims unless the live case study says so.

What “best country” actually means for structural heart EFS

Best is not cheapest. For structural heart, best usually means:

• Ethics and investigation authorization that can start a small cohort on a founder’s runway
• Hospitals with real cardiac imaging, cath-lab or hybrid-OR capacity, and a principal investigator who already implants in the same anatomic neighborhood
• Import rules that let an investigational device clear customs without a commercial registro sanitario
• A data posture that can support a later U.S. Investigational Device Exemption (IDE) or marketing file under 21 CFR 812.28 when the study is run under ISO 14155

Filter 1 — Regulator and ethics desks

Separate the ethics committee from the national investigation desk. Mixing them is how first patient slips a cycle. In Latin America the planning bands bioaccess® publishes for device FIH / EFS work are roughly 4–8 weeks for ethics in several corridors, with national investigation authorization commonly in a 1–3 month band after a complete dossier. Confirm every form on the agency’s current page before you file.

Country examples sponsors keep shortlisting for early device work (not a ranking, a working set): Colombia (INVIMA investigation path plus Comité de Ética en Investigación), Panama (MINSA / CNBI corridor used for several public FIH stories), El Salvador (fast startup band on the published El Salvador FIH cost and timeline page), Chile (ISP investigation authorization is not the same as Exempt Decree No. 25 commercial registro — see the Chile ISP clinical trial path), Mexico (COFEPRIS), Brazil (ANVISA), and Argentina (ANMAT). Pick from that set with the filters below, not from a tourism map.

Filter 2 — Procedure infrastructure

Structural heart EFS fails quietly when the site cannot support the implant or repair workflow. Before you fall in love with a regulator timeline, confirm:

• Echo, CT, and fluoro capacity on the study schedule
• Hybrid OR or cath-lab time that matches your enrollment plan
• Cardiac anesthesia and ICU backup for the risk class
• A principal investigator with recent volume in the adjacent commercial procedure (TAVR adjacency is not automatic qualification for a novel mitral or tricuspid device)

Filter 3 — Import and holder rules

Investigational import is not market clearance. Keep the trial file on the investigation track. If you also need commercial registration later, that is a separate Market Access / Importer of Record conversation — start at LATAM market access and Importer of record across Latin America.

Filter 4 — FDA evidence role

Write one sentence into the protocol: what this EFS must prove for the next U.S. milestone. Foreign clinical data can be considered under 21 CFR 812.28 when the study is inspectable and documented under good clinical practice. Acceptance remains FDA’s decision. Design the evidence drawer at study start: protocol, consent, monitoring, source traceability, and a clinical study report structure.

Practical shortlist pattern

For a first structural heart EFS with a small cohort and a U.S.-anchored later file, sponsors often land on one primary Latin American country plus one backup site in the same or a second country. Panama and Colombia appear repeatedly in public FIH narratives for novel implants because ethics and site activation can move inside a founder’s year. El Salvador shows up when startup calendar pressure is the binding constraint. Chile is a rigor option when the team wants ISP investigation discipline and already understands Decree 25 is a commercial track, not the trial track. Australia remains a peer comparator for some teams (rebate math, English, timezone); the honest ops comparison lives on Latin America vs Australia for FIH — use it, do not invent a rebate for Latin America that does not exist.

Operator checklist before you lock geography

1. Confirm EFS-first is the right sequencing call (see the EFS vs pivotal brief).
2. Name the procedure infrastructure the site must already have.
3. Name primary and backup countries with separate ethics and investigation owners.
4. Write the 21 CFR 812.28 evidence-role sentence into the protocol.
5. Keep commercial registro and Importer of Record work off the investigational clock unless the study truly needs a registered comparator device.

bioaccess® runs structural heart and other early device EFS work as a First-in-Human CRO with U.S. regulatory anchoring and Latin American execution. Bring the device class, the implant workflow, and the financing date — we will return a country shortlist that survives the four filters.