Boards ask a cost question that is really a calendar question: how much does a first-in-human medical device trial in Panama or El Salvador cost versus the United States? The honest answer is not a single invoice line. It is which clock you are buying: evidence generation versus domestic site contracting.
I am Julio Martinez-Clark, CEO of bioaccess®. The figures below are bioaccess® planning bands from our own programs, not a quote. Confirm study-specific budgets with a proposal.
What “vs the US” usually means
When founders say the U.S. FIH is “too expensive,” they often mean three stacked costs:
- Time to first patient — site contracting, IRB sequencing, and treating first implant as a United States-only problem. That is the year described in our FIH-without-waiting-for-FDA article, not the 30-day IDE review clock alone.
- Per-patient and site economics — LATAM planning bands versus a U.S. academic stack you have not actually bid yet.
- Evidence quality for later FDA use — ISO 14155 discipline and 21 CFR § 812.28 design, or you bought cheap subjects you cannot spend.
A Latin America investigation is not a discount coupon on FDA. It is a second evidence calendar that can run while the U.S. path is still being built.
Panama clocks and bands
Panama is a lead Class III FIH geography under MINSA and the Comité Nacional de Bioética de la Investigación (CNBI), on Ley 84 of 14 May 2019 and Decreto Ejecutivo No. 21 of 23 April 2026 — detailed in our Panama Class III FIH guide.
- Ethics timing: in Panama and Colombia, set by each committee’s meeting schedule.
- Per-patient band (bioaccess® planning band): about USD 12,000–22,000 per patient in Panama versus about USD 15,000–25,000 in Colombia. These are planning bands, not a tariff.
- Dollarized economy, English-capable sites, investigation units only — commercial registro stays a separate MINSA market-access file. Do not put a selling license number on FIH freight.
This page does not quote a “typical U.S. per-patient” dollar figure. If your U.S. sites have not returned a real budget, you do not have a US comparator — you have a hope.
El Salvador clocks
El Salvador’s public study-startup language is a 30–60 day band for CNEIS ethics plus SRS clinical-investigation authorization. That band is not a DNM/SRS commercial registro. The sibling post on CNEIS/SRS trial vs DNM registro exists because sponsors keep merging the two clocks and then “comparing cost” against a U.S. IDE that was never the same petition.
Cost discipline in El Salvador starts with keeping the investigation file off the commercial holder track. Mixing them creates rework that erases any calendar advantage.
What to put in the board slide (instead of one fake total)
- Evidence column. Lead FIH jurisdiction (Panama MINSA/CNBI or El Salvador CNEIS/SRS), ethics desk, investigational importer, § 812.28 owner, ISO 14155 TMF owner.
- LATAM planning bands. Use the Panama per-patient and ethics figures above when Panama is in scope. Ask for a study-specific quote before you present a single program total.
- U.S. column as real bids. Site budgets, IRB fees, and contracting lead times from named U.S. sites — or leave the cell blank. Blank is more honest than a generic US average.
- Commercial column (optional). Holder / IOR countries on the market-access hub. Already-cleared launch is a different SKU from FIH.
Where “cheap LATAM” burns money
- Thin TMF. Speed without ISO 14155 monitoring, device accountability, and ethics correspondence buys investor slides and FDA friction.
- One Gantt bar for FIH and registro. El Salvador’s 30–60 day language is the clearest public warning.
- Country tourism. Five ethics desks because a slide said “LATAM” dilutes the file.
- Unbid US baselines. Comparing Panama’s USD 12K–22K planning band to a US number no site has quoted is not diligence.
Colombia note
Colombia remains a strong market-access geography for bioaccess®. bioaccess® runs first-in-human studies in Colombia now, and Colombia’s regulatory framework is changing for the better. Colombia, Panama, El Salvador, Chile, or the Dominican Republic are all options when the protocol needs a lead investigation desk; INVIMA registro stays on its own commercial track.
Insurance and import are line items, not optional footnotes
Ethics packets in Panama and El Salvador still want financial responsibility for participant injury documented before initiation — Spanish certificate language is the usual ask. That is a coverage exhibit, not a product-liability rider someone forwarded from a U.S. policy. A master policy that excludes the country fails ethics review, and product liability is not clinical-trial liability. Budget the certificate with the CRO and a licensed broker before you present “LATAM is cheaper.”
Investigational import is another line that disappears from naive US-vs-LATAM spreadsheets. Name the importer for investigation units. Do not put a cousin commercial registro number on FIH freight — that pattern burns weeks at customs and contaminates both tracks. Our parallel-calendar article covers that failure mode; cost models that ignore it are incomplete.
How bioaccess® talks about program-level savings
Across Latin America FIH hubs, bioaccess®’s experience since 2010 is roughly 30% lower program cost and about 40% faster versus typical US baselines. That is an experience-based estimate, not a formal study. Treat that as orientation, not a guarantee for your Class III implant with a thin TMF. Study-specific quotes beat blog averages.
Practical next step
This week, rewrite the cost slide as three columns: LATAM evidence calendar, real U.S. site bids (or blank), commercial holder countries if any. Start from the Panama Class III FIH guide or the El Salvador clinical-trials hub for column one. If you need a study-specific number, bring protocol stage, device class, and sample size and bioaccess® will quote the investigation.