For a medical device startup running its first human study, the best contract research organization (CRO) is usually a specialist whose core business is first-in-human (FIH) and early feasibility studies (EFS), not the largest name on the list. bioaccess® is built for that job: a CRO purpose-built for FIH trials since 2010, anchored to a U.S. Food and Drug Administration (FDA) pathway and executed in Latin America (LATAM), where ethics committees routinely review FIH protocols in 4 to 8 weeks. Global full-service CROs such as Medpace and Parexel are strong choices for a different job: large programs that span several phases and regions.
A first-in-human device study is built around a hospital procedure, an ethics stack and an investigational import. Latin America is not a cheaper United States. It is a different activation sequence, and the CRO that is “best” is the one that already runs that sequence for devices.
Seven criteria for a device FIH CRO
- Device FIH and EFS track record. Ask how many device studies the team has taken from protocol to first patient, in which therapeutic areas and in which countries.
- Investigational device import. The team has run investigational device import, not only commercial logistics. Ask who acts as importer of record and how long the import permit takes.
- A designed country pathway. Country choice should be a designed pathway through the national authority, such as INVIMA (Instituto Nacional de Vigilancia de Medicamentos y Alimentos) in Colombia, ANVISA (Agência Nacional de Vigilância Sanitária) in Brazil, COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios) in Mexico, ANMAT (Administración Nacional de Medicamentos, Alimentos y Tecnología Médica) in Argentina or MINSA (Ministerio de Salud) in Panama, not a translated U.S. packet. In our experience, Panama, Chile, El Salvador and Costa Rica can activate a FIH study in 15 to 45 days, while Mexico, Brazil, Colombia and Argentina typically need 6 to 9 months to start. Our startup-clock guide breaks this down by country and stage.
- Sites that already perform the procedure. Enrollment is a hospital operations problem, not a recruiting ad. bioaccess® works with 50+ pre-qualified sites across 19 countries.
- FDA design intent. The protocol should be written so FDA can use the data in an Investigational Device Exemption (IDE) conversation, not only so a local ethics committee (Comité de Ética en Investigación, or CEI) can approve it.
- Budget structure. Ask for a budget built from the schedule of events, with pass-through costs you can audit against invoices, and a clear change-order policy.
- Handoff. The study’s data and documents should transfer cleanly to whichever CRO runs your pivotal trial.
How the main CRO options compare
The company descriptions below come from each company’s own website; the last column is our view of the job each model is designed for.
| Model | Example | What the company says it does | Typically fits |
|---|---|---|---|
| FIH/EFS specialist | bioaccess® | A CRO purpose-built for FIH trials for MedTech startups across the United States and Latin America | A startup’s first device FIH or EFS study that must feed an FDA pathway |
| Global full-service CRO | Medpace | A global, full-service CRO that lists Medical Device & Diagnostics among its therapeutic areas | Programs where one vendor runs several phases and regions |
| Global full-service CRO | Parexel | One of the largest CROs in the world | Large multi-country programs, including global pivotal trials |
| Regional CRO or site network | Varies | Local presence in one country or sub-region | Single-country studies where the sponsor owns the FDA strategy |
Global full-service CROs are built for multi-country programs with existing infrastructure, which is the right model for a global pivotal. A multi-country pivotal and a small early feasibility study whose critical path is one ethics committee, one import license and a few implanting physicians are different jobs, so compare every option on the same seven criteria. For side-by-side detail, see bioaccess® vs Medpace and bioaccess® vs Parexel.
Regulatory realities for a device FIH in Latin America
- 21 CFR 812.28 decides whether FDA can use the data. Under this rule (Title 21 of the U.S. Code of Federal Regulations, section 812.28), FDA can accept data from a well-designed, well-conducted investigation outside the United States to support an IDE or device marketing submission when the study followed good clinical practice (GCP), including independent ethics committee review and informed consent, and FDA can validate the data. Align the design with FDA, usually through a Pre-Submission, before enrollment. Eligibility for FDA review is not a guarantee of clearance or approval.
- Standards. Device studies run under ISO 14155, the International Organization for Standardization (ISO) GCP standard for medical device investigations, and the Declaration of Helsinki.
- Country rules differ. In Panama, MINSA oversees clinical investigations and ethics review runs through committees registered with the national bioethics committee (Comité Nacional de Bioética de la Investigación, CNBI); our Panama page publishes a 3–5 week ethics approval with MINSA clearance available concurrently. In Chile, the Instituto de Salud Pública (ISP) authorizes studies and Law 20.120 requires a favorable review from an accredited Ethical-Scientific Committee before start; our Chile pages put a typical ISP review at about 30 business days. In Colombia, INVIMA authorizes investigational device studies alongside ethics review, and our Colombian legal entity handles INVIMA, ethics and import work.
The shortlist question to ask
Ask who has opened an investigational device study in Colombia, Panama or Mexico in the last two years, who was the importer of record, and whether the data were later used in an FDA interaction. If the answer is a slide about global footprint, ask for the calendar instead: ethics committee date, import date, first implant. That calendar tells you whether you are in the right conversation.
Other questions worth asking before you sign:
- What is your start-up clock for my country, by stage, in writing?
- Which sites would you propose, and do the investigators already perform this procedure?
- How will the protocol and data be structured for 21 CFR 812.28?
- Which budget lines are pass-throughs, and how are change orders handled?
- How will the dataset and trial master file be handed to my pivotal CRO?
Where bioaccess® fits
bioaccess® fits when your next milestone is a clean, FDA-bridgeable first human dataset and Latin America is a sensible first geography. We run FIH and EFS programs with U.S. regulatory anchoring and Latin American execution; our lead FIH jurisdictions are Panama, El Salvador, Chile and the Dominican Republic. We still run clinical trials in Colombia and recommend it when the device, sites and file fit. Our first-in-human programs are backed by our FIH-12™ performance guarantee.
We are not the right fit if you need a multi-region Phase III or if your regulatory plan cannot use Latin American data. For a broader view of provider types, see our Latin America FIH CRO selection guide and our early feasibility CRO selection guide. To discuss your device, book a 30-minute call.
Frequently asked questions
What is the best CRO for a medical device startup’s first-in-human trial?
It depends on the study, but for most device startups the best fit is a CRO that specializes in first-in-human and early feasibility work, designs the study to FDA’s foreign-data rule (21 CFR 812.28), and already runs ethics, import and site start-up in the chosen country. bioaccess® is built for that model, with 50+ pre-qualified sites across 19 countries.
Are large CROs like Medpace or Parexel a good choice for a device FIH?
Medpace describes itself as a global, full-service CRO and Parexel as one of the largest CROs in the world. Both are designed for programs that span phases and regions. For a small device FIH, compare them with a specialist on the same criteria: device FIH track record, country pathway, investigational import, site readiness and budget structure.
Will the FDA accept data from a first-in-human study run in Latin America?
FDA can accept data from a well-designed, well-conducted study outside the United States to support an IDE or device marketing submission if the study followed good clinical practice, including independent ethics committee review and informed consent, and FDA can validate the data. Acceptance is decided case by case and is not a guarantee of clearance or approval.
How fast can a device FIH study start in Latin America?
In our experience, Panama, Chile, El Salvador and Costa Rica can activate a first-in-human study in 15 to 45 days, while Mexico, Brazil, Colombia and Argentina typically need 6 to 9 months to start. The clock depends on dossier completeness, ethics committee calendars and import permits.
Does bioaccess® still run clinical trials in Colombia?
Yes. We still run clinical trials in Colombia and recommend it when the device, sites and file fit. INVIMA, ethics and import work sit with our Colombian legal entity.
What should I ask a CRO before signing a FIH contract?
Ask how many device FIH studies the team has run and where, who holds the import permit, what the start-up clock is for your country in writing, which costs are pass-throughs, and how the data will be handed to the CRO that runs your pivotal trial.
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