Question 1

How much does a medical device clinical trial cost in 2026?

Accepted Answer

A typical first-in-human (FIH) or Early Feasibility Study (EFS) for a medical device runs $250K–$1.2M total in Latin America, or $15K–$35K per patient — roughly 30% lower per-patient than US/EU full-service CROs, which typically bill $40K–$75K per patient. Pivotal device trials scale to $2M–$10M+ depending on cohort size, imaging, and follow-up length.

Question 2

How much does an Early Feasibility Study (EFS) cost?

Accepted Answer

An EFS under FDA 21 CFR 812.28 typically costs $250K–$800K total when run by bioaccess® in Latin America (10–15 patients, 6–12 months). The same EFS in the US typically runs $600K–$1.8M due to higher site fees, insurance, and IRB timelines.

Question 3

How does the cost compare between the US, EU, and Latin America?

Accepted Answer

For the same device FIH protocol: US $40K–$75K per patient, EU $35K–$65K per patient, Latin America (bioaccess®) $15K–$35K per patient. The difference comes from lower site overhead, faster ethics/IRB approval (4–8 weeks vs. 6–12 months), lower insurance/indemnity, and a fixed-fee engagement model instead of pass-through pricing.

Region	Per patient	Ethics/IRB	FIH start
Latin America (bioaccess®)	$15K–$35K	4–8 weeks	6–8 weeks
United States	$40K–$75K	3–9 months	6–12 months
European Union	$35K–$65K	4–10 months	8–14 months

How much does a medical device clinical trial cost in 2026?

2026 per-patient cost benchmarks