We Lost Three Years in Australia: Why Sponsors Move First-in-Human Trials to Latin America

An anonymized account of a US device sponsor that spent roughly three years pursuing first-in-human in Australia without activating a site — then moved the program to Panama and El Salvador.

September 6, 2026

7

min read

By

Julio G. Martinez-Clark, CEO, bioaccess®

Australia

Latin America

First-in-Human

Panama

El Salvador

Medical Devices

A note on anonymity. This account is deliberately anonymized. The sponsor is described only as a US device sponsor. No company, device, city, investigator, or other identifying detail appears here, and no figures beyond those stated are claimed.

Why was Australia a reasonable first choice?

Start with the concession, because this is not a hit piece. Australia was a reasonable first choice, and any competent advisor would have put it on the shortlist. The country offers a real R&D tax incentive, a genuinely fast TGA notification pathway, and high data quality from experienced investigators and professional ethics committees. Nothing about Australian institutions failed in this story.

That matters, because the honest version of this argument is the persuasive one. If Australia were simply bad, the decision would be trivial. Australia is good at several of the things sponsors screen for — which is exactly why the mismatch is easy to miss until three years have gone by.

What actually happened over those three years?

Here is the whole of the case, and nothing beyond it. A US medical device sponsor spent roughly three years pursuing a first-in-human program in Australia and never completed site activation. The program then moved to Panama and El Salvador with bioaccess®.

Read that again, because the striking part is not a dramatic failure. There was no rejection, no regulatory setback, no scandal. The program simply never crossed the line from planned to running. Three years of a device company's life passed with the study on paper and no participant treated.

For an early-stage device company, that is the most expensive kind of loss: it consumes runway, delays the next financing on the strength of clinical evidence that does not yet exist, and pushes every downstream milestone — regulatory submission, reimbursement work, commercial planning — back by the same interval.

Where do first-in-human programs actually stall?

Almost never at the regulator. First-patient-in is the sum of three separate stages, and sponsors habitually optimize the first one while the other two decide the calendar:

• Regulatory clearance. Fast in Australia. This is the stage sponsors benchmark, and it is rarely the constraint.
• Site activation. Ethics coordination, contracting, import permits, investigator and staff training, monitoring setup. Sequential, multi-party, and easy to lose quarters inside.
• Patient enrollment. Screening throughput against real inclusion criteria in a real catchment, competing with every other protocol drawing on the same pool.

We work this decomposition through in TGA CTN versus Latin America on first-patient-in timelines, and the enrollment half of it in the Australian catchment math. The short version: a fast notification shortens one of three terms, and not the two that stall programs.

There is also a structural point about ownership. When regulatory work, contracting, import logistics, training, and monitoring each sit with a different party and the sponsor coordinates them remotely across a 14-16 hour time offset, every handoff adds latency. Nobody is accountable for the activation date as a single deliverable — so nobody defends it.

Why did moving to Panama and El Salvador work?

Two reasons, and both are structural rather than heroic. First, activation intervals. Across our Latin American programs, the numbers we plan against are these:

Those intervals describe submission to a site ready to treat, not a regulator's reply in isolation, because one in-country team runs the submission, the contracting, the import permits, the training, and the monitoring setup in parallel. That is the difference between coordinating a launch and owning one. See how the model works in our Panama program.

Second, catchment. Dense Latin American metros put far more eligible candidates inside a workable travel radius of the clinic, which tightens the screening funnel and shortens the interval from activation to enrolled cohort. A multi-country design across Panama and El Salvador compounds that by opening more than one recruiting front under one protocol.

The pattern: the move is about activation and enrollment throughput. It is not a claim that data from anywhere else is better or worse.

How does the data come back to the US?

This is the step that makes the whole strategy rational, and it is the one sponsors most often assume is a problem. Under 21 CFR 812.28, the FDA accepts data from clinical investigations conducted outside the United States when they are run under good clinical practice with adequate documentation, monitoring, and ethics oversight. Offshore first-in-human data supporting a US submission is a designed-for pathway, not a workaround.

So the repatriation pattern is straightforward and repeatable: sponsors that stall abroad move the first-in-human stage to Latin America to reach first-patient-in, generate a clean regulator-ready dataset under GCP, and return to the US with evidence that supports an IDE or a Breakthrough Device submission. The offshore stage buys time and evidence; the US stage remains the destination.

How do you avoid losing three years?

Change what you benchmark. Before selecting a country, ask each candidate for two numbers and make them defend both:

• A projected first-patient-in date, with the activation and enrollment stages broken out separately.
• A projected cost per enrolled participant, not a cost per approval.
• The eligible population inside a realistic drive-time radius of each proposed site, and how many competing protocols are recruiting from it.
• One named party accountable for the activation date end to end — regulatory, contracting, import, training, and monitoring included.

Set a stop-loss too. Decide in advance the date at which an unactivated program gets relocated, and hold to it. The sponsors who lose years rarely make one bad decision; they make a reasonable decision and then decline to revisit it.

For the full head-to-head across cost, catchment, diversity, travel, and entity requirements, start with the pillar: Australia vs. Latin America for first-in-human medical device trials. For the wider option set, see alternatives to Australia for first-in-human trials in 2026.

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