How MedTech startups achieve first patient on a study-specific timeline (we confirm it per protocol) and lower costs through Latin American EFS CRO partnerships.
April 3, 2026
13
min read
By
BioAccess Editorial Team
**Key Takeaways**
- • First patient on a timeline that varies by study (we confirm it per protocol) from MSA signing — vs a timeline that varies by study (we confirm it per protocol) in the US
- • 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 reach first patients on a timeline that varies by study (we confirm it per protocol) by running early feasibility studies with a LatAm CRO — at roughly 50% of US costs — while generating FDA-submissible data under GCP/ISO 14155. 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?
| 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%.
Which site networks recruit fastest for EFS?
For a medical device early feasibility study, bioaccess® leads with Panama, El Salvador, Chile, Costa Rica, and the Dominican Republic. Colombia is where bioaccess® places drug, biologic, and vaccine trials:
- Colombia: drug, biologic, and vaccine trials under Resolución 8430 de 1993. A device early feasibility study is led from the five countries above
- 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 a timeline that varies by study (we confirm it per protocol)
- Patient recruitment leverages KOL referral networks — not advertising — for faster, higher-quality enrollment
Should you run an EFS or go straight to pivotal?
| 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 |
| 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 → 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. Chile charges no regulator fee; Costa Rica adds a 3% CONIS levy, the only such levy in Latin America.
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.
Ready to start your early feasibility study in Latin America?
bioaccess®'s EFS-specialized CRO model achieves first patient enrollment on a timeline that varies by study (we confirm it per protocol) at 50% of US costs — with FDA-accepted clinical data that supports your next regulatory submission and fundraising milestone.
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