Catalyze: Product Definition Medical Device Prototype Optimization (R33 – Clinical Trial Not Allowed)
🏛 National Institutes of Health (HHS-NIH11)
✓ Free, no account · Source: Grants.gov · Last verified Jul 16, 2026
Can you apply?
This grant is for organizations and individuals seeking to advance early-stage medical device research through prototype optimization and product definition. Eligible applicants typically include nonprofit organizations, educational institutions, small businesses, and researchers at accredited institutions. The program supports non-clinical development activities, including design refinement, feasibility testing, bench testing, and proof-of-concept work—but explicitly excludes clinical trials. Activities must focus on moving a medical device concept closer to commercialization or clinical readiness by addressing technical and design challenges. The R33 grant mechanism is particularly suited for researchers who have completed preliminary development and are ready to optimize their prototype for the market.
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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 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.
Who can apply
Eligible applicants
How to apply
Application links
Required documents
- SF-424 (R&R) form and associated NIH forms (Face Page, Project/Performance Site Location(s) Form, etc.)
- Project narrative (typically 15 pages maximum)
- Detailed budget and budget justification for the full project period
- Biographical sketches of key personnel (typically 2 pages maximum per person)
- Letters of support from institutional affiliations, advisors, and/or industry partners
- Preliminary data and prototype documentation (images, technical drawings, test results)
- Institutional certification of compliance and assurance (F&A rate agreement, etc.)
- Regulatory strategy and commercialization plan documentation
- Equipment justification and quotes (if requesting major equipment)
Program contact
- 👤 National Institutes of Health
- 📧 grantsinfo@nih.gov
- 📞 301-402-2541
Funding track record
Recent awards under CFDA 93.839 from the last 3 years — real organizations that won funding through this same program.
Top 10 Largest Recent Awards
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$70,347,724
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$28,221,244
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$26,367,044
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$26,196,066
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$24,828,830
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$22,197,349
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$20,132,449
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$18,556,003
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$17,136,580
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$16,771,574
Top States by Funding
- MA 15 awards $153.6M
- WI 6 awards $113.6M
- PA 13 awards $111.9M
- CA 9 awards $110.4M
- NY 8 awards $77.5M
Source: USAspending.gov — federal spending transparency. Data covers last 3 years.
Funding history
Annual funding for this program — Federal obligations (CFDA 93.839). How funding has trended year over year.
| 2024 | $431,558,338 | |
| 2025 | $425,332,322 |
FAQ
Who is eligible to apply for this R33 medical device grant?
Eligible applicants include nonprofit organizations, educational institutions, small businesses (including woman-owned and minority-owned firms), and researchers at accredited academic and research institutions. Federal employees may have restrictions; consult NIH guidelines for your specific situation.
What activities are NOT supported by this grant?
Clinical trials are explicitly prohibited. The grant supports pre-clinical development activities only, such as prototype refinement, bench testing, design optimization, and feasibility studies to prepare a device for eventual clinical evaluation.
What is the typical funding range for an R33 award?
R33 grants typically provide $150,000 to $500,000 per year over a 2-3 year project period, though amounts vary based on scientific need and institutional review. Budget justification and detailed cost documentation are essential.
What documents will I need to submit?
Standard NIH application materials include the SF-424 form, project narrative (typically 15 pages), detailed budget with justification, biographical sketches of key personnel, letters of support, and documentation of institutional capacity. Device-specific documentation such as CAD designs, preliminary test data, and regulatory roadmaps are often expected.
How competitive is this program?
R33 awards are moderately to highly competitive. Success typically requires a clear development plan, demonstrated preliminary work, realistic timelines, and a credible path toward commercialization or clinical readiness. Strong letters of support from industry partners or mentors enhance competitiveness.
💡 Tips for applicants
- Clearly distinguish between pre-clinical optimization work and clinical activities. Reviewers will screen out applications that propose clinical testing. Focus on the non-clinical validation steps needed before clinical evaluation.
- Include detailed preliminary data and prototypes. Show evidence that your concept is scientifically sound and that you've already addressed fundamental design challenges. This strengthens reviewer confidence in feasibility.
- Develop a credible regulatory and commercialization pathway. Explain how the optimized device will transition to the market or clinical use, including FDA strategy, intellectual property plans, and potential commercial partners or licensees.
- Assemble a multi-disciplinary team with relevant expertise in device design, engineering, materials science, and regulatory/commercialization strategy. Include letters of support from advisors, industry partners, or potential end-users.
- Budget realistically for prototype development, testing, validation, and materials. NIH reviewers scrutinize device-related costs carefully; provide detailed justification for equipment, contract services, and personnel allocations.
⚠️ Common mistakes
Applications often blur the line between pre-clinical and clinical work, proposing activities that resemble early clinical trials rather than product optimization. Reviewers also frequently encounter applications with weak preliminary data or unclear regulatory pathways—studies that lack credible proof-of-concept or fail to demonstrate how the optimized device will reach the market struggle to compete. Finally, many proposals underestimate the complexity of device development or present unrealistic timelines, undermining reviewer confidence in the feasibility of the project plan.
Similar grants
- OPEN Catalyze Product Definition Medical Device prototype design/testing and disease target identification and assay development (R61/R33 – Clinical Trial Not Allowed) — National Institutes of Health
- OPEN Catalyze: Product Definition for Small Molecules, Biologics, and Combination Products – Preliminary Product/Lead Series Identification and Combination Product Prototype (R33 – Clinical Trial Not Allow — National Institutes of Health
- OPEN Catalyze: Product Definition for Small Molecules, Biologics and Combination Products – Target Identification and Validation, and Preliminary Product/Lead Series Identification (R61/R33 Clinical Trial — National Institutes of Health
- OPEN Catalyze: Enabling Technologies and Transformative Platforms for HLBS Research (R33 – Clinical Trials Not Allowed) — National Institutes of Health
- OPEN Blueprint MedTech Translator (UG3/UH3 – Clinical Trial Optional) — National Institutes of Health