Catalyze: Product Definition Medical Device Prototype Optimization (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 prototype testing/design modification, assay development for diagnostic disease targets, and development of research tools for use in the treatment of HLBS diseases and disorders. 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.
The Catalyze: Product Definition Medical Device Prototype Optimization (R33) grant is designed for early-stage translational researchers and innovators developing medical devices and diagnostic tools for heart, lung, blood, and sleep (HLBS) diseases and disorders. This NHLBI-funded initiative supports researchers who have made basic science discoveries and are ready to transition them into viable diagnostic and therapeutic candidates suitable for human testing. The program provides comprehensive support for prototype testing, design modification, assay development for diagnostic targets, and development of research tools—without requiring clinical trials at this stage. Eligible applicants include HBCUs, Hispanic-serving institutions, Alaska Native and Native Hawaiian serving institutions, AANAPISISs, faith-based and community-based organizations, and eligible federal agencies. If your organization has promising early-stage medical device or diagnostic technology for HLBS conditions and needs support moving from concept to prototype optimization, this grant can position your innovation for future in vivo testing and advancement through additional NIH or federal funding. The program specifically excludes clinical trial support, making it ideal for researchers focused on preclinical development and product refinement.
Funding Facts
● Applications openDeadline
December 23, 2027
Who can apply
Last verified July 5, 2026 · Source: Grants.gov
Grant Details
Funding Range
Varies by cycle—consult NHLBI for current amounts
Deadline
2027-12-23
Grant Type
federal
Application Cycle
Annual (Deadline: December 23, 2027)
Best For
Early-stage translational researchers with medical device or diagnostic prototypes for heart, lung, blood, and sleep diseases; minority-serving institutions and community-based organizations
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 Optimization (R33 - Clinical Trial Not Allowed)?
Eligible applicants include historically Black colleges and universities (HBCUs), Hispanic-serving institutions, Alaska Native and Native Hawaiian serving institutions, Asian American Native American Pacific Islander serving institutions (AANAPISISs), faith-based or community-based organizations, eligible federal government agencies, and other qualified research institutions. For complete and current eligibility criteria, consult the official NIH/NHLBI program announcement on grants.nih.gov.
How much funding does Catalyze: Product Definition Medical Device Prototype Optimization (R33 - Clinical Trial Not Allowed) provide?
Specific funding amounts vary by grant cycle and project scope. For current funding ranges and maximum award amounts, visit the official NHLBI Catalyze program page at nhlbi.nih.gov or the NIH grants portal at grants.nih.gov.
How do I apply for Catalyze: Product Definition Medical Device Prototype Optimization (R33 - Clinical Trial Not Allowed)?
Applications are typically submitted through Grants.gov or the NIH eRA Commons system. You will need to prepare a detailed research proposal, biosketches, budget, and institutional support documentation. The deadline for this funding opportunity is December 23, 2027. For step-by-step application instructions and required forms, visit the official NIH/NHLBI program announcement and contact your institution's grants office.
What can Catalyze: Product Definition Medical Device Prototype Optimization (R33 - Clinical Trial Not Allowed) funding be used for?
Funding supports early-stage translational activities including prototype testing and design modification, assay development for diagnostic disease targets, and development of research tools for HLBS disease treatment and diagnosis. The program explicitly does not support clinical trials. Successful projects are expected to advance to in vivo testing (optimization, safety, efficacy) through the NHLBI Catalyze Preclinical Program or other NIH/federal funding.
Last updated: July 5, 2026