Catalyze Product Definition Medical Device prototype design/testing and disease target identification and assay development (R61/R33 – Clinical Trial Not Allowed)
Can you apply?
This grant is for researchers and institutions developing medical device prototypes, diagnostic assays, and research tools for heart, lung, blood, and sleep (HLBS) diseases. Academic institutions (including HBCUs, tribal colleges, Hispanic-serving institutions), federal agencies, faith-based and community organizations, and Indian tribes may apply. U.S.-based organizations with foreign components are eligible; foreign organizations cannot lead applications. Projects must focus on early-stage translational work moving from basic science to human testing-ready candidates.
Support covers two phases: R61 for prototype design, disease target identification, and tool development; R33 for advanced prototype testing, diagnostic product generation, and assay refinement. Clinical trials are not permitted under this initiative.
This grant is for researchers and institutions developing medical device prototypes, diagnostic assays, and research tools for heart, lung, blood, and sleep (HLBS) diseases. Academic institutions (including HBCUs, tribal colleges, Hispanic-serving institutions), federal agencies, faith-based and community organizations, and Indian tribes may apply. U.S.-based organizations with foreign components are eligible; foreign organizations cannot lead applications. Projects must focus on early-stage translational work moving from basic science to human testing-ready candidates.
Support covers two phases: R61 for prototype design, disease target identification, and tool development; R33 for advanced prototype testing, diagnostic product generation, and assay refinement. Clinical trials are not permitted under this initiative.
Program description
The goal of the NHLBI Catalyze Program is to provide a comprehensive suite of support and services to facilitate the transition of basic science discoveries into viable diagnostic and therapeutic candidates that have been cleared for human testing, and to develop translational researchers fluent in product development and entrepreneurship. This specific Catalyze Product Definition initiative will provide the early stage translational support needed for the activities required to develop and test device prototypes, identify diagnostic disease targets and develop associated assays, and develop research tools to treat HLBS diseases and disorders. This is a phased initiative for early stage projects. The R61 phase provides support to identify and test initial prototype designs, to identify a disease target and generate experimental design, and to identify, test and pilot research tools. The R33 phase provides support for continued prototype development and testing, in addition to modifying design features and user feedback, diagnostic product generation, exploration of assay components, and characterization of a load design, and research tool
improvement, large trial testing and data integration. Following successful completion of the program, it is expected that the potential products will be poised to move forward for in vivo testing (optimization, safety, efficacy) with additional support from NIH and/or other federal and private programs. This initiative has a companion initiative that supports development of therapeutics and combination products and is also part of a suite of innovation grants to advance projects to the point where they can meet the entry criteria for the NHLBI Catalyze Preclinical Program.
Who can apply
Eligible applicants
- 501(c)(3) Public Charity
- City / Municipal Government
- County Government
- HBCU
- Nonprofits
- Private University
- Public Authority
- Public K-12 School
- Public University
- Small Business (SBA-defined)
- Special District
- State Government
- Tribal Nation
- Tribal Organization
Details
This grant is for researchers and institutions developing medical device prototypes, diagnostic assays, and research tools for heart, lung, blood, and sleep (HLBS) diseases. Academic institutions (including HBCUs, tribal colleges, Hispanic-serving institutions), federal agencies, faith-based and community organizations, and Indian tribes may apply. U.S.-based organizations with foreign components are eligible; foreign organizations cannot lead applications. Projects must focus on early-stage translational work moving from basic science to human testing-ready candidates.
Support covers two phases: R61 for prototype design, disease target identification, and tool development; R33 for advanced prototype testing, diagnostic product generation, and assay refinement. Clinical trials are not permitted under this initiative.
How to apply
Application links
Required documents
- SF-424 (R&R)
- Project Narrative (Research Strategy)
- Budget and Budget Justification
- Biosketches (all key personnel)
- Letters of Support/Collaboration
- DUNS Number
- Institutional Certifications
Program contact
- 👤 National Institutes of Health
- 📧 grantsinfo@nih.gov
- 📞 301-402-2541
Funding track record
Recent awards under CFDA 93.837 from the last 3 years — real organizations that won funding through this same program.
Top 10 Largest Recent Awards
-
$238,898,122
-
$137,304,316
-
$117,298,604
-
$100,148,361
-
$90,428,339
-
$88,304,328
-
$83,989,552
-
$83,865,426
-
$70,347,724
-
$64,483,725
Top States by Funding
- MD 6 awards $470.1M
- NY 9 awards $439.8M
- MA 5 awards $325.8M
- CA 7 awards $228.1M
- WI 4 awards $217.4M
Source: USAspending.gov — federal spending transparency. Data covers last 3 years.
Funding history
Annual funding for this program — Federal obligations (CFDA 93.837). How funding has trended year over year.
| 2024 | $1,654,455,334 | |
| 2025 | $1,690,039,433 |
FAQ
Who can apply for this grant?
Academic institutions, colleges, universities, federal agencies, faith-based organizations, tribal governments, and community organizations are eligible. Foreign organizations cannot lead applications, but U.S. organizations with foreign components may apply.
What research activities are supported?
Medical device prototype design and testing, disease target identification, assay development, and research tool development. Clinical trials are not allowed.
What is the R61/R33 structure?
R61 is the initial phase for prototype testing and disease target work. R33 is the continuation phase for advanced development and assay refinement.
When is the deadline?
The deadline is December 23, 2027. This is a fixed deadline, not rolling.
What are my chances of funding?
This is a competitive grant from NIH. Strong applications demonstrate clear translational pathways, feasible prototypes, and experienced teams in product development.
💡 Tips for applicants
- Focus on the translational pathway from basic science to human testing readiness. Show clear steps from current work to product viability.
- Address both R61 and R33 phases in your proposal. Clearly define milestones and decision points between phases.
- Emphasize disease impact for HLBS conditions. Show why your target disease and solution matter clinically.
- Include team members with product development and commercialization experience, not just academic researchers.
- Build realistic timelines with clear go/no-go decision points. NIH expects phased risk reduction.
⚠️ Common mistakes
Proposals lack clear product development milestones and viable commercialization pathway. Applications focus on basic science rather than translational engineering and prototype testing. Teams miss the entrepreneurship and product development expertise requirement. Lack of realistic risk assessment and decision-making criteria between R61 and R33 phases. Proposals for clinical trials submitted despite explicit exclusion.
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