Catalyze Product Definition Medical Device prototype design/testing and disease target identification and assay development (R61/R33 - Clinical Trial Not Allowed)
About
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 initi.
The NHLBI Catalyze Product Definition grant supports early-stage translational researchers and entrepreneurs developing medical devices, diagnostic tools, and research solutions for heart, lung, blood, and sleep (HLBS) diseases. This phased initiative (R61/R33) funds prototype design and testing, disease target identification, and assay development—critical steps before human clinical trials. The program is designed for researchers transitioning basic science discoveries into viable diagnostic and therapeutic candidates ready for in vivo testing. If you're an academic institution, research organization, federal agency, or community-based organization working on innovative medical device solutions or diagnostic assays for HLBS conditions, this grant provides comprehensive support and services to accelerate your product development timeline. The R61 phase supports initial prototype testing and disease target identification, while the R33 phase funds continued development, design refinement, diagnostic product generation, and large-scale trial testing. Successful completion positions your product for advanced NIH funding or private sector investment. This is an excellent opportunity for translational researchers seeking to bridge the gap between laboratory discovery and clinical application without the immediate burden of human trial requirements.
Funding Facts
● Applications openDeadline
December 23, 2027
Who can apply
Last verified July 5, 2026 · Source: Grants.gov
Grant Details
Funding Range
Varies by phase and project scope
Deadline
2027-12-23
Grant Type
federal
Application Cycle
Cycle-based (consult NHLBI website for current deadlines)
Best For
Early-stage translational researchers, academic institutions, minority-serving institutions, federal agencies, and community organizations developing medical devices and diagnostic assays for heart, lung, blood, and sleep diseases
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 Govern
Frequently Asked Questions
Who is eligible for Catalyze Product Definition Medical Device prototype design/testing and disease target identification and assay development (R61/R33)?
Eligible applicants include HBCUs (Historically Black Colleges and Universities), Hispanic-serving Institutions, Alaska Native and Native Hawaiian Serving Institutions, AANAPISIs (Asian American Native American Pacific Islander Serving Institutions), Indian/Native American Tribal Governments, eligible federal agencies, faith-based organizations, and community-based organizations. For a complete and current list of eligible entity types, visit the official NIH/NHLBI Catalyze Program website.
How much funding does Catalyze Product Definition provide?
Specific funding amounts are not currently available in the summary information. Award amounts typically vary by phase and project scope. Visit the official NIH grant announcement for detailed budget information and funding ranges for R61 and R33 phases.
How do I apply for Catalyze Product Definition?
Applications are submitted through the NIH ASSIST system (grants.nih.gov). You will need a DUNS number, SAM.gov registration, and an eRA Commons account. Prepare your research proposal, budget, and supporting documentation addressing prototype development, disease target identification, or assay development. Consult the official NIH/NHLBI Catalyze Program funding opportunity announcement for specific requirements, review criteria, and submission instructions.
What can Catalyze Product Definition funding be used for?
Funding supports: (R61 Phase) initial prototype design and testing, disease target identification and experimental design, identification and piloting of research tools for HLBS diseases; (R33 Phase) continued prototype development and testing, design modifications based on user feedback, diagnostic product generation, assay component exploration, research tool improvement, and large-scale trial testing. Clinical trials in humans are not permitted under this initiative.
Last updated: July 5, 2026