Catalyze: Product Definition Medical Device Prototype Optimization (R33 - Clinical Trial Not Allowed) | RFA HL 26 020

Opportunity Information: Apply for RFA HL 26 020

Catalyze: Product Definition - Medical Device Prototype Optimization (R33 - Clinical Trial Not Allowed) is a National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI) funding opportunity designed to help early-stage translational projects move from promising scientific concepts into more defined, testable, and commercially realistic medical device and diagnostic product candidates. The broader NHLBI Catalyze Program is built to close the gap between basic research and real-world health technologies by pairing funding with a structured product-development mindset. A central theme is helping investigators become more fluent in the practical steps of product development and entrepreneurship, so that projects do not stall after initial proof-of-concept results.

This particular Product Definition initiative focuses on hands-on, early translational work that strengthens and refines prototypes before any human testing is considered. The supported activities emphasize prototype testing and design modification (iterating the device based on performance findings), assay development tied to diagnostic disease targets, and creation or refinement of research tools intended to support the treatment of heart, lung, blood, and sleep (HLBS) diseases and disorders. In practical terms, the program is meant to de-risk a concept by improving functionality, usability, reproducibility, manufacturability, and overall readiness for the next development stage.

A key boundary of the opportunity is embedded in the mechanism description: "Clinical Trial Not Allowed." That means applicants should not propose clinical trials or human subject efficacy/safety studies under this award. Instead, the intent is to generate the design, engineering, and performance package that positions a project to advance into later-stage in vivo testing and preclinical optimization work with additional support. NHLBI explicitly frames the expected outcome as projects becoming poised to move forward into in vivo testing for optimization, safety, and efficacy, potentially through NIH or other federal and private funding pathways.

This opportunity is also described as part of a larger ecosystem of NHLBI innovation funding that helps projects progress toward meeting entry criteria for the NHLBI Catalyze Preclinical Program. There is a companion initiative for therapeutics and combination products, while this one is geared toward medical devices and related prototype optimization efforts. The overall structure signals an intentional pipeline: refine and define the product early, then transition to more advanced testing and development programs once the prototype and supporting data are mature enough.

On eligibility, the program is open to a wide range of U.S.-based organization types across government, academia, nonprofit, and industry. Eligible applicants include state, county, and local governments; special district governments; independent school districts; public housing authorities/Indian housing authorities; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized Native American tribal governments and other Native American tribal organizations; nonprofits with or without 501(c)(3) status (other than institutions of higher education); for-profit organizations (other than small businesses); and small businesses. The notice also highlights additional eligible applicant categories such as Historically Black Colleges and Universities (HBCUs), Hispanic-serving institutions, Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, and Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), as well as faith-based/community-based organizations, regional organizations, U.S. territories or possessions, and eligible federal agencies.

Foreign eligibility is restricted in a way that is common for NIH opportunities: non-domestic (non-U.S.) entities are not eligible to apply as applicant organizations. However, non-domestic components of U.S. organizations may apply, and foreign components (as defined in the NIH Grants Policy Statement) are allowed, meaning certain work elements may be performed internationally if they meet NIH policy requirements and are justified within the project structure.

Administratively, this is a discretionary grant opportunity under NIH, with Funding Opportunity Number RFA-HL-26-020 and associated CFDA numbers 93.233, 93.837, 93.838, and 93.839, reflecting NHLBI-related funding streams. The original closing date is listed as December 23, 2027, indicating a multi-year window in which applications may be accepted according to the opportunitys schedule and NIH submission cycles. The listing does not provide an award ceiling or expected number of awards in the supplied data, so applicants typically need to consult the full announcement for budget limits, project period, review criteria, required milestones, and any program-specific deliverables.

Taken together, the opportunity is best understood as an NHLBI-backed push to turn an early medical device or diagnostic concept into a well-defined, iteratively improved prototype with a clearer product profile, stronger technical evidence, and a credible path to the next stage of preclinical and in vivo evaluation, without crossing into clinical trial activity during the award period.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Catalyze: Product Definition Medical Device Prototype Optimization (R33 - Clinical Trial Not Allowed)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.233, 93.837, 93.838, 93.839.
• This funding opportunity was created on 2024-11-22.
• Applicants must submit their applications by 2027-12-23.
• Eligible applicants include: State governments, County governments, City or township governments, Special district governments, Independent school districts, Public and State controlled institutions of higher education, Native American tribal governments (Federally recognized), Public housing authorities/Indian housing authorities, Native American tribal organizations (other than Federally recognized tribal governments), Nonprofits having a 501 (c) (3) status with the IRS, other than institutions of higher education, Nonprofits that do not have a 501 (c) (3) status with the IRS, other than institutions of higher education, Private institutions of higher education, For-profit organizations other than small businesses, Small businesses, Others.

Apply for RFA HL 26 020

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