Question 1

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

Accepted Answer

Budget depends on study design; we provide a study-specific quote. 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, a timeline that varies by study (we confirm it per protocol)). 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

Budget depends on study design; we provide a study-specific quote. Cost drivers include lower site overhead, faster ethics/IRB approval (varies by study; we confirm per protocol vs. a timeline that varies by study (we confirm it per protocol)), lower insurance/indemnity, and the engagement model.

Region	Per patient	Ethics/IRB	FIH start
Latin America (bioaccess®)	See sample budget	4–8 weeks	Varies by study; we confirm per protocol
United States	—	3–9 months	6–12 months
European Union	—	4–10 months	8–14 months

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

2026 per-patient cost benchmarks