Catalyze Product Definition Medical Device prototype design/testing and disease target identification and assay development (R61/R33 - Clinical Trial Not Allowed)

US National Institutes of Health (NIH) — National Heart, Lung, and Blood Institute (NHLBI) grant open #RFA-HL-26-019

Response due Dec 23, 2027 · 00:00 UTC

Summary

This NIH National Heart, Lung, and Blood Institute (NHLBI) funding opportunity (RFA-HL-26-019) solicits R61/R33 phased innovation award applications focused on two tracks: (1) medical device prototype design and testing, and (2) disease target identification and assay development. The opportunity is part of the Catalyze Product Definition program, which is designed to advance early-stage biomedical research toward defined, testable product concepts. Clinical trials are explicitly not allowed under this announcement. The opportunity opened in November 2024 and remains open through December 2027.

What they want

Applicants must conduct phased R61/R33 research projects under one of two tracks: (1) Medical device prototype design and testing — activities that move a device concept toward a defined prototype, including iterative design cycles and bench/pre-clinical testing; or (2) Disease target identification and assay development — research to identify and validate disease targets and develop corresponding assays. Clinical trials are not permitted. The R61 phase is a milestone-driven feasibility/planning phase; progression to the R33 phase is contingent on meeting predefined milestones. No direct patient interventions (clinical trials) are allowed.

Technical requirements

Two-track structure: (1) medical device prototype design/testing or (2) disease target identification and assay development
R61/R33 phased award mechanism with milestone-driven progression
Clinical trials not allowed
R61 phase must include predefined milestones for advancement to R33 phase

How they evaluate

Scientific and technical merit
Milestone feasibility and rigor
Relevance to NHLBI mission and Catalyze Product Definition program goals

Submission: Grants.gov federal grants portal electronic submission

Risks & flags

Extremely long open window (3+ years) may indicate rolling review cycles — applicants should verify specific submission due dates in the full FOA
Funding ceiling and award size not disclosed in the synopsis — full FOA review required before budgeting
Track-specific eligibility rules may effectively limit competition to institutions with existing device or assay pipelines

Market context

inferred from NAICS

Professional, Scientific & Technical Services

NAICS 541714

US market size: $2.0T
Typical award: $25K – $50M

Typical buyers

All federal civilianDoDStates

Commonly required

8(a)WOSBSDVOSBPE/PMP

Sector-level estimate — full code lookup not yet in catalog.

Catalyze Product Definition Medical Device…

Due Dec 23

Onboard ↗