If you typed First in Humans CRO, First in Humans Panama, or Panama device FIH into a search box, you have already found the closest single-country peer to bioaccess®’s Panama story. First in Humans (firstinhumans.com) is a specialized CRO dedicated to supporting human clinical trials for medical devices in Panama. That sentence is theirs, retrieved live on 23 August 2026. It is accurate. It is also the whole geography.
bioaccess® already publishes a comparison page at bioaccessla.com/compare/first-in-humans. This pillar is not a second compare page. It is the practitioner article that should win the brand query: who they are, what the public site actually says, when a Panama-only specialist is the right hammer, and when a multi-country first-in-human platform with a Miami desk and a Colombian entity is the job you are buying.
No named sponsors appear on the public site. No named protocol appears. We will not invent any.
What First in Humans publishes
The services page calls the firm “a specialized Clinical Research Organization (CRO) dedicated to supporting human clinical trials for medical devices in Panama, Central America.” The offer is end-to-end facilitation: principal-investigator and site identification; Ministerio de Salud (MINSA) submissions; institutional review board / Comité de Bioética packages; compliance with CNBI (Comité Nacional de Bioética de la Investigación) requirements and GCP; Spanish translation of protocols, ICFs, CRFs, and patient materials, plus notarization where required; investigational-device import permits, customs clearance, and site accountability; coordinator and research-nurse startup training; recruitment, monitoring, and data-quality support.
Why-Panama copy on the same page: gateway between North and South America; internationally experienced physicians; CNBI-accredited IRBs; competitive operational costs; “faster approval timelines compared to many North American and European jurisdictions” — a company claim, not a median we will invent; Spanish-speaking population with “high clinical trial participation rates” — also their language.
The clinical-sites page names private hospitals that host research committees, including Pacífica Salud (Hospital Punta Pacífica / Costa del Este; JCI; Johns Hopkins Medicine International affiliation described on their page), Clínica Hospital San Fernando (JCI), The Panama Clinic, Hospital Nacional, and Hospital Paitilla. Treat those as published partner-site names, not as named trials.
Team page, fetched 23 August 2026:
- Dr. Michael Politis — ophthalmic surgeon, retina / macula / vitreous, Panama. Public profile at politisretina.com.
- Victor Politis — biomedical engineer, medical-device development program management, Massachusetts.
- Nestor Jaramillo, Jr. — independent board director, former MedTech CEO; commercialization, M&A, partnerships, financial governance; Minnesota.
- Daniel Saltzman, MD, PhD — listed with University of Minnesota / pediatric-surgery and Salspera titles on the same page.
The U.S. names are a board and program-management overlay. The operating geography on the marketing site is Panama. No named device sponsor or protocol is on the pages reviewed.
Where a Panama-only device FIH CRO is the right tool
Hire First in Humans when Panama is already the answer — the indication, the implanting physicians, the MINSA/CNBI path, and the import story all land in Panama City — and you want a specialist that does not also sell Brazil or a drug Phase I unit. Device-only, country-only, early-phase language: that is a clean product definition. It is the closest homegrown Central American analogue to a bioaccess® Panama FIH file.
Do not hire it as a substitute for country optionality. Panama is one good Latin American file. It is not every good Latin American file. If the protocol later needs Colombia (INVIMA), Argentina (ANMAT), Chile, El Salvador, or a second country because ethics or volume moved, a single-country specialist has to partner or you have to re-bid. That is not a flaw. It is the design.
The product a U.S. device FIH actually buys
A first implant or first interventional series is still a hospital procedure, an investigational import, and an FDA conversation. The customer for the package is usually a Pre-Sub, an IDE, or 21 CFR 812.28 eligibility — not only a CNBI stamp. n is small. The TMF has to be English and inspectable. The founder’s weekly call is usually on U.S. Eastern time.
First in Humans can own the Panama lane of that job: MINSA, CNBI-accredited IRBs, Spanish packets, device import, site training. The public site does not, on the pages reviewed, publish a named EFS that a diligence associate can drop into a data room. Absence of a logo wall is not proof the work was never done. It is proof you must ask for a de-identified device TMF before you treat “specialized CRO” as a completed audit.
What bioaccess® is selling instead
bioaccess® is The First-in-Human CRO. Co-founded in 2010 by Dr. Pedro Martinez-Clark, Dr. William O’Neill, and Julio G. Martinez-Clark (CEO). IMH ASSETS CORP. Miami headquarters (1200 Brickell Ave, Suite 1950 #1034). Regional offices in Bogotá, Mexico City, Santiago, São Paulo, and Buenos Aires. FIH-only focus since 2010. 50+ pre-qualified sites across 19 countries; 50+ FIH/EFS studies supported; 50+ clients (company about page). Panama is one of those markets — see also Clinical Trials in Panama — not the only one.
Colombia remains live. As of 23 August 2026 we still run clinical trials in Colombia, keep a local Colombian entity and office, manage INVIMA clocks in-country, and carry 30+ historical FIH device studies and 20+ sites in Bogotá, Cali, Medellín, and Barranquilla. We do not tell sponsors to take new first-in-human work out of Colombia. See CRO in Colombia.
The published compare page already states the strategic difference: First in Humans is the Panama specialist; bioaccess® is a multi-country FIH platform with U.S. regulatory anchoring. Use that page for the head-to-head grid. Use this article for the public-record facts and the operating question.
First in Humans vs bioaccess® — device FIH comparison
| Dimension | First in Humans (Panama) | bioaccess® |
|---|---|---|
| Public identity | Device FIH CRO dedicated to Panama | FIH-only CRO; U.S. anchor + LATAM execution since 2010 |
| Geography | Panama (team also listed in Massachusetts / Minnesota) | 19 LATAM countries including Panama and Colombia; Miami HQ |
| Regulator / ethics language | MINSA + CNBI-accredited IRBs + GCP | Country ethics + INVIMA / ANVISA / ANMAT / MINSA and peers; ISO 14155 |
| Named sponsors / protocols | None on public site | Published case studies on bioaccessla.com |
| Public leadership | Michael Politis; Victor Politis; Nestor Jaramillo, Jr.; Daniel Saltzman | Julio G. Martinez-Clark, CEO; Pedro Martinez-Clark, CMO; William O’Neill |
| Site list | Named Panama private hospitals on the clinical-sites page | 50+ pre-qualified sites (company about page), including Panama |
| After the trial | Device registration for clinical use / import described; commercial registro not the site’s center of gravity | Live multi-country sanitary registration / in-country holder |
| Colombia | Not a Colombia CRO | Still executing; local entity; INVIMA in-country |
How to use both without confusing the job
If Panama is locked, First in Humans belongs on the RFP. Ask for a named or de-identified device FIH: class, implant versus diagnostic, n, ISO 14155 monitoring plan, English TMF, importer-of-record name, and whether the same file was later used in an FDA interaction. If that package exists, they can be the Panama prime.
If country choice is still open — or you need a Miami FDA desk, a Colombian entity, and the option to open a second country if ethics or volume moves — put bioaccess® in the prime column and keep First in Humans as a possible local partner. The compare page already says sponsors can split work. We will not pretend a Panama specialist is a nineteen-country platform, and we will not pretend Panama is a weak file. Request a proposal at contact.
Regional peers if the RFP is “homegrown LATAM device,” not “Panama only”: RARAS, Cohortias, ACTIVA, LAT Research.
FAQ — First in Humans Panama
Is First in Humans a first-in-human CRO?
Yes, on the public definition they chose: a specialized CRO for medical-device human trials in Panama, with early-phase language and MINSA/CNBI operations. Named FIH case studies are not on the public site.
Is First in Humans the same as bioaccess®?
No. Closest Panama peer, different product. One country versus a multi-country FIH platform with U.S. regulatory anchoring. Details on the compare page.
Who leads First in Humans?
The live team page names Dr. Michael Politis (Panama), Victor Politis (Massachusetts), Nestor Jaramillo, Jr., and Daniel Saltzman, MD, PhD (Minnesota).
Will FDA accept Panama device data?
Foreign clinical data can be eligible for FDA submission and review under 21 CFR 812.28 when the investigation meets GCP as that rule defines it. Acceptance is case by case. It is not awarded for MINSA and not denied for MINSA.
Does bioaccess® still run trials in Colombia?
Yes. Local Colombian entity and office; INVIMA clocks in-country; commercial registro sanitario as a separate live service. We still execute there as of 23 August 2026.
Competitor facts from firstinhumans.com, /services, /our-team, and /clinical-sites, 23 August 2026. bioaccess® facts from bioaccessla.com. No invented emails, sponsor names, or day-count medians.