Catalyze: Product Definition Medical Device Prototype Optimization (R33 - Clinical Trial Not Allowed)

The National Heart, Lung, and Blood Institute (NHLBI) invites applications for the Catalyze: Product Definition – Medical Device Prototype Optimization (R33) funding opportunity. This initiative supports the development and optimization of medical devices, diagnostics, and research tools targeting heart, lung, blood, and sleep (HLBS) diseases. The R33 mechanism focuses on refining prototype designs, enhancing usability, and preparing for preclinical product optimization. This funding aims to transition innovative discoveries to advanced stages where they can secure further support from NHLBI’s preclinical programs or other development resources. Eligible projects include advanced prototype testing for medical devices, diagnostic assay development, and research tools such as algorithms or high-throughput drug screening systems. Successful applicants must demonstrate prior progress, including initial prototype development, in vitro and limited in vivo testing, or preclinical testing of diagnostics. Proposed projects must align with NHLBI’s mission and address significant clinical gaps or unmet needs. Non-responsive applications include those focused on early-stage development, therapeutic agents, or clinical trials. Applications must include a detailed research plan, milestones, timelines, and descriptions of project management strategies. Accelerator Partners are required to provide commercialization guidance and mentoring, enhancing the transition to further development or commercialization. Applicants must also submit preliminary intellectual property (IP) and regulatory strategies. Cost matching is expected, with a recommended non-Federal match of 0.25:1 for Federal direct costs. Non-compliance with these requirements will render applications incomplete and ineligible for review. Award budgets are capped at $300,000 in direct costs per year, with a maximum project period of two years. NHLBI anticipates funding up to eight new awards annually from 2026 to 2028, contingent upon appropriations and the quality of applications received. Applicants should budget for attendance at an NHLBI innovation meeting annually in the Washington, D.C., area. Eligibility extends to U.S. higher education institutions, nonprofits, for-profits, and government entities. Foreign entities are not eligible, though non-U.S. components of U.S. organizations are permitted. Applications are due annually, starting February 11, 2025, with additional deadlines in June, October, and subsequent years. Applicants are encouraged to contact NHLBI program staff to discuss their proposals and ensure alignment with program objectives. This funding opportunity represents NHLBI's commitment to advancing translational research and accelerating the development of innovative HLBS technologies. Successful projects will enhance the pipeline for addressing critical health challenges, improving outcomes, and reducing the societal burden of HLBS diseases.