Early feasibility study CRO in Latin America: how MedTech startups accelerate FDA pathways

How MedTech startups reach first patient sooner, on a timeline we confirm for each protocol, through Latin American EFS CRO partnerships.

April 3, 2026

13

min read

By

BioAccess Editorial Team

early feasibility study

EFS

CRO

FDA

medical devices

Latin America

MedTech startups

**Key Takeaways**

• • Parallel start-up from MSA signing — contracts, protocol and ethics packages move at the same time instead of one after another
• • Published sample budgets — illustrative, not a quote, on the bioaccess® sample budget page
• • Colombia and Chile are bioaccess®'s top EFS destinations with proven site networks
• • FDA accepts LatAm EFS data — multiple bioaccess® datasets referenced in IDE/De Novo submissions
• • EFS before pivotal is the most capital-efficient strategy for MedTech startups

**Who Is This For?**

This guide is for MedTech startup CEOs, clinical development leads, and investors evaluating early feasibility study strategies — particularly those seeking the fastest, most cost-effective path to initial clinical proof-of-concept data for novel medical devices.

**The short answer**

MedTech startups can often reach first patients sooner by running early feasibility studies with a LatAm CRO, while generating data FDA can review under 21 CFR 812.28 when the study follows GCP/ISO 14155. Budgets are study-specific; see our published sample budgets (illustrative, not a quote). Compare how to evaluate CRO proposals and what trials cost in Latin America before you commit.

What does FDA require for an early feasibility study?

Early feasibility studies (EFS) are the critical first step in clinical development for novel medical devices. Under FDA's EFS guidance, these small-scale studies (typically 5-15 patients) provide initial safety and performance data before committing to larger, more expensive pivotal trials.

For MedTech startups with limited capital, EFS represents the most efficient use of clinical development resources: generate enough clinical data to validate the concept, refine the device, optimize the protocol, and attract pivotal-trial funding — all before spending $2-5M on a US pivotal study.

What does FDA EFS guidance mean for LatAm execution?

FDA's EFS guidance (published 2013, updated 2021) explicitly acknowledges that early feasibility studies may be conducted with:

• Limited preclinical data (including non-GLP animal studies when justified by risk analysis)
• Prototype-stage devices (not requiring full GMP manufacturing for investigational use)
• Small patient cohorts (as few as 5-10 patients for initial performance evaluation)
• Modified stopping rules (allowing earlier study termination based on safety signals)
• Iterative device modifications (design changes between patient cohorts based on clinical findings)

This flexibility maps directly to Latin America's regulatory environment, where several countries accept R&D-grade preclinical data and non-GMP investigational devices — making LatAm the natural execution ground for EFS programs that would face significant regulatory barriers in the US.

How fast can you go from MSA to first patient?

What does the 6-month sprint look like?

The critical difference between bioaccess® and traditional CRO timelines is parallelization. While most CROs execute sequentially (MSA → protocol → ethics → site activation → enrollment), bioaccess® overlaps phases to shorten the overall timeline. How much depends on the protocol, the country and the device; we confirm it at the proposal stage.

Which site networks recruit fastest for EFS?

For a medical device early feasibility study, bioaccess® leads with Panama, El Salvador, Chile, Costa Rica, the Dominican Republic, and Colombia. Colombia is included. bioaccess® runs first-in-human studies in Colombia now, devices included:

• Colombia: bioaccess® runs first-in-human studies in Colombia now, devices included. Drug and biologic trials stay under Resolución 8430 de 1993
• Chile: ISP-registered sites in Santiago with subspecialty surgical capability and established device importation pathways
• Both countries offer GCP-trained investigators with US training backgrounds who understand FDA submission requirements
• bioaccess® pre-qualified sites maintain active IRB/CEI relationships, which helps avoid avoidable ethics-review delays
• Patient recruitment leverages KOL referral networks — not advertising — for faster, higher-quality enrollment

Should you run an EFS or go straight to pivotal?

**Strategic Insight: The EFS-First Approach**

For MedTech startups with $500K-$2M in available clinical budget, the optimal strategy is: EFS in Latin America → Use data for Series A/B fundraising → Pivotal trial with adequate funding. This approach generates clinical proof-of-concept early, while producing FDA-referenced data that strengthens both the regulatory and investor narratives.

What does a LatAm EFS cost?

For budgeting: budget depends on study design; we provide a study-specific quote.

Frequently asked questions

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bioaccess® · A CRO purpose-built exclusively for first-in-human and early feasibility clinical trials across Latin America. 50 companies accelerated since 2010.

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Related resources:

• Early Feasibility Studies — /early-feasibility-studies
• First-in-Human CRO — /first-in-human-cro
• FIH Medical Device Trial Chile — /blog/first-in-human-medical-device-trial-chile
• INVIMA Approval Colombia — /blog/invima-clinical-trial-approval-process-colombia
• Medical Device CRO LatAm — /blog/medical-device-cro-latin-america