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 versus domestic site contracting — and which numbers are already published on bioaccess® country hubs versus numbers nobody should invent on a blog.
I am Julio Martinez-Clark, CEO of bioaccess®. This page uses only figures and clocks already live on bioaccessla.com. It is 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 the FIH-without-waiting-for-FDA article already names — not the 30-day IDE review clock alone.
- Per-patient and site economics — published LATAM 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.
Published Panama clocks and bands
Panama is a published 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 — already detailed on the Panama Class III FIH guide.
- Ethics band already published on country comparisons: Panama ethics about 3–5 weeks versus Colombia about 4–6 weeks (live comparison cited on Dominican Republic and Colombia holder pages that point at clinical-trials-panama).
- Per-patient band already published: about USD 12,000–22,000 per patient in Panama versus about USD 15,000–25,000 in Colombia on that same published comparison. Those are hub figures, not a new tariff invented here.
- 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.
I will not invent a “typical U.S. per-patient” dollar figure on this page. If your U.S. sites have not returned a real budget, you do not have a US comparator — you have a hope.
Published 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.
- Published LATAM bands only. 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 blogger’s invented 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.
- Invented US baselines. Comparing Panama’s published USD 12K–22K band to a made-up “US is $80K” number is not diligence.
Colombia note (do not flip the public line)
Colombia remains a strong market-access geography and a historical FIH geography for bioaccess®. The public line still stands: INVIMA clinical-trial approval timelines have become unpredictable, so bioaccess® does not currently recommend Colombia for new first-in-human execution. Use Panama, El Salvador, Chile, or the Dominican Republic when the protocol needs a lead investigation desk — and keep INVIMA registro on the 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. The live insurance intercepts already warn that a master excluding the country fails ethics, and that 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. The parallel-calendar article already lists that failure mode; cost models that ignore it are fiction.
How bioaccess® talks about program-level savings
Across Latin America FIH hubs, bioaccess® has long published experience-based language of roughly 30% lower program cost and about 40% faster versus typical US/EU baselines since 2010 — as experience, not a formal study (already on Dominican Republic and LATAM FIH benchmark language). 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: published 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 — bioaccess® will quote the investigation without inventing a U.S. average to win the comparison.