Early Feasibility Study CRO in Latin America: How MedTech Startups Accelerate FDA Pathways
How MedTech startups achieve first patient enrollment in 6 months and 50% cost savings 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**
- • First patient in 6 months from MSA signing — vs 12-18 months in the US
- • 50% cost savings vs US-based EFS programs across all cost categories
- • 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.
EFS Basics: FDA Requirements and Latin America Fit
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.
FDA EFS Guidance: What It Means 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.
Real Timeline: From MSA to First Patient (6 Months)
The 6-Month Sprint
| Phase | Weeks | Key Activities | bioaccess® Role |
|---|---|---|---|
| MSA & Work Order | 1-4 | Contract negotiation, budget finalization, team assignment | Lead negotiation, cost modeling |
| Protocol Optimization | 3-6 | Protocol adaptation for LatAm sites, endpoint refinement | Regulatory strategy, site matching |
| Ethics Submission | 5-8 | CEI/CEC package preparation, informed consent translation | Submission management, EC liaison |
| Ethics Approval | 8-14 | Committee review, query responses, final approval | Response coordination, timeline tracking |
| Site Activation | 12-18 | Investigator training, EDC setup, device importation | Full site activation management |
| First Patient | 18-24 | Patient screening, enrollment, first procedure | Monitoring, safety oversight |
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 compress the overall timeline by 40-50%.
Site Networks: Colombia and Chile for Fast EFS Recruitment
bioaccess® maintains active site relationships in Colombia and Chile specifically optimized for EFS execution:
- Colombia: INVIMA-certified sites in Bogotá, Medellín, and Cali with experience in cardiovascular, orthopedic, neurological, and general surgical device studies
- Chile: ISP-registered sites in Santiago with subspecialty surgical capability and established device importation pathways
- Both countries offer GCP-trained investigators with US/EU training backgrounds who understand FDA submission requirements
- bioaccess® pre-qualified sites maintain active IRB/CEI relationships, reducing ethics approval timelines by 2-4 weeks
- Patient recruitment leverages KOL referral networks — not advertising — for faster, higher-quality enrollment
EFS vs Pivotal: Strategic Decision Framework
| Parameter | Early Feasibility Study | Pivotal Trial |
|---|---|---|
| Purpose | Proof of concept, design iteration | Regulatory approval evidence |
| Patient count | 5-15 patients | 50-300+ patients |
| Duration | 6-12 months | 18-36 months |
| Cost (LatAm) | $200K-$500K | $1M-$5M+ |
| Cost (US) | $500K-$1.2M | $3M-$15M+ |
| Device maturity | Prototype/R&D-grade acceptable | Final commercial-grade required |
| Preclinical data | Limited/non-GLP acceptable | Full GLP required |
| FDA submission | Supports IDE application | Supports 510(k)/PMA/De Novo |
| Best for startups? | Yes — capital-efficient proof | After EFS validates concept |
**Strategic Insight: The EFS-First Approach**
For MedTech startups with $500K-$2M in available clinical budget, the optimal strategy is: EFS in Latin America ($200K-$500K) → Use data for Series A/B fundraising → Pivotal trial with adequate funding. This approach generates clinical proof-of-concept at 50% of the cost of a US EFS, while producing FDA-referenced data that strengthens both the regulatory and investor narratives.
Cost Breakdown: Why LatAm EFS CROs Win (50% US Savings)
| Cost Category | LatAm (bioaccess®) | United States | Savings |
|---|---|---|---|
| CRO project management | $40K-$80K | $80K-$180K | 50-55% |
| Ethics/regulatory | $10K-$25K | $30K-$100K | 60-75% |
| Per-patient clinical | $10K-$20K/pt | $25K-$50K/pt | 50-60% |
| Site management | $30K-$60K | $80K-$200K | 55-70% |
| Monitoring (6 visits) | $12K-$20K | $25K-$50K | 50-60% |
| Data management/stats | $20K-$40K | $40K-$100K | 50-60% |
| Total (10 patients) | $200K-$400K | $500K-$1.2M | 50-65% |
Frequently Asked Questions
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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