Blueprint MedTech Translator (UG3/UH3 - Clinical Trial Optional)
NIH funds milestone-driven translational development and optional first-in-human clinical feasibility studies for therapeutic or diagnostic devices for nervous or neuromuscular disorders, including prototype development, nonclinical testing, and regulatory preparation.
⚑ Cooperative agreement with NIH staff involvement in final project plan and progress monitoring. · Milestone-driven; funding depends on negotiated milestones. · Clinical trial optional, but FOA explicitly supports IDE/IRB preparation and clinical feasibility studies. · Applicants may use NIH-funded consultants and NIH contract research organizations for specialty activities.
Unit fits — one characterization, each unit's own rules
| Physical Sciences & Engineering (demo) | 80 strong | technical depth: central; funds applied research |
| IPPRA | 45 partial | peripheral portfolio topic: public_health; social/behavioral work is none; funds applied research; biomedical core — IPPRA health lane is communication/crisis/policy (capped); clinical-trial/biomedical core — IPPRA angle is policy/community (capped); capped at 45 (limited social-science role) |
| Tom Love Innovation Hub | 45 partial | funds applied research; prototyping/demonstration stage; deep-tech content |
Description
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.
Eligibility
Other Eligible Applicants include the following: Alaska Native and Native Hawaiian Serving Institutions; Asian American Native American Pacific Islander Serving Institutions (AANAPISISs); Eligible Agencies of the Federal Government; Faith-based or Community-based Organizations; Hispanic-serving Institutions; Historically Black Colleges and Universities (HBCUs); Indian/Native American Tribal Governments (Other than Federally Recognized); Non-domestic (non-U.S.) Entities (Foreign Organizations); Regional Organizations; Tribally Controlled Colleges and Universities (TCCUs) ; U.S. Territory or Possession.
Apply
View on Grants.gov → CONTACT: National Institutes of Health <grantsinfo@nih.gov>
Proposal brief SEE AN EXAMPLE →
A one-page internal memo: fit assessment, submission requirements, document scaffold, and next steps dated back from the deadline — tailored to your project idea if you add one.
Proposal shell · National Institutes of Health conventions SEE AN NIH EXAMPLE →
Funder-faithful document skeletons — National Institutes of Health's document set with section headings, page limits, reviewer guidance, and writing prompts; add a project idea to get [DRAFT] starter bullets. Download as .md for Word or Overleaf.