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Federal Grant · National Institutes of Health

Blueprint MedTech Translator (UG3/UH3 - Clinical Trial Optional)

Last verified by NonDilute: 2026-04-29. Official notice and agency instructions control.

Healthcare TechBiotech small-businessstartupuniversity-researcher
The pitch

If you've built a neurological or neuromuscular device prototype and need a pathway to first-in-human testing with expert regulatory and commercialization support, this is designed for you.

Award range
Unspecified
Closes
Jan 28, 2028 · 639d left
Open date
Jun 17, 2025
Difficulty
High
Source
Grants.gov
Agency
National Institutes of Health
Last verified
2026-04-29
Fit language
Possible fit only
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What this is

Blueprint MedTech is a milestone-driven cooperative agreement program supporting translational work on medical devices targeting neurological and neuromuscular conditions. Eligible activities span non-clinical testing, design verification/validation, IDE or IRB approval, and clinical feasibility studies. The program pairs applicants with NIH consultants in regulatory affairs, reimbursement, IP, and commercialization, plus access to contract research services for large animal testing, manufacturing, and biocompatibility work. Award amounts not specified in source; funding period extends through January 2028.

Who can apply

Extremely broad: for-profit and non-profit entities, small businesses, higher education institutions, state/local governments, Native American tribal organizations, and independent researchers all eligible. No explicit geographic restriction mentioned; NIH typically requires U.S. organization or U.S.-based activity.

Eligible applicant types

Full description — from the agency

The purpose of this announcement is to encourage investigators to pursue translational activities and clinical feasibility studies to advance the development of therapeutic, and diagnostic devices for disorders that affect the nervous or neuromuscular systems. Activities supported in this program include implementation of clinical prototype devices, non-clinical safety and efficacy testing, design verification and validation activities, obtaining an Investigational Device Exemption (IDE) for a Significant Risk (SR) study or Institutional Review Board (IRB) approval for a Non-Significant Risk (NSR) study, as well as a subsequent clinical feasibility study. The clinical study is expected to provide information about the device function or final design that cannot be practically obtained through additional non-clinical assessments (e.g., bench top or animal studies) due to the novelty of the device or its intended use. This FOA is a milestone-driven cooperative agreement program and will involve participation of NIH program staff in negotiating the final project plan before award and monitoring of research progress. Participants in Blueprint MedTech receive funding for all activities to be conducted in their own laboratories. In addition, applicants will collaborate with NIH-funded consultants to receive assistance with specialty areas including regulatory, reimbursement, intellectual property, commercialization, and strategic partnerships. Participants can also augment their project with NIH contract research organizations that specialize in large animal testing, sterilization testing, biocompatibility assessment, manufacturing, and medical monitoring. Individuals, institutions, or businesses developing their own devices or that already have established collaborations with device manufacturers are welcome to apply directly to this NOFO or any of the companion opportunities. For more information see BP MedTech website.

Topics: medical device · neurology · clinical trial · FDA approval · translational research · device development · neuromuscular · therapeutic device

Public-source funding discovery only. This summary is generated from public agency data and may be incomplete or stale. NonDilute is not affiliated with, endorsed by, or acting on behalf of any government agency. Official notices and agency instructions control. NonDilute does not determine eligibility, provide grant-writing advice, or guarantee funding.