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

US National Institutes of Health (NIH) – National Heart, Lung, and Blood Institute (NHLBI) grant open #RFA-HL-26-020
Response due Dec 23, 2027 · 00:00 UTC

Summary

This NIH funding opportunity (RFA-HL-26-020) under the Catalyze program supports medical device prototype optimization in the product definition phase. The R33 mechanism funds late-stage research and development activities focused on refining and optimizing medical device prototypes, explicitly excluding clinical trials. Issued by the National Heart, Lung, and Blood Institute (NHLBI) within NIH/HHS, this opportunity is open from November 2024 through December 2027.

What they want

Applicants are expected to conduct product definition and prototype optimization activities for medical devices under the NIH R33 research grant mechanism. Clinical trials are explicitly not allowed under this funding opportunity. The work falls within the Catalyze program, which supports the translation of biomedical innovations toward commercial viability. Specific technical scope details beyond prototype optimization are not provided in the available text.
Technical requirements
  • No clinical trials permitted
  • Must align with R33 research grant mechanism
  • Scope limited to product definition and prototype optimization phases
  • Must be for a medical device application

How they evaluate

Submission: Grants.gov federal grants portal submission

Risks & flags

  • Extremely long open/close window (over 3 years) may indicate rolling admissions with selective award timing
  • Highly specific program mechanism (R33) and phase (product definition) may favor teams already embedded in the NIH Catalyze pipeline
  • No dollar value or award ceiling disclosed, limiting competitive assessment

Market context

inferred from NAICS
Professional, Scientific & Technical Services
NAICS 541714
US market size
$2.0T
Typical award
$25K – $50M
Typical buyers
All federal civilianDoDStates
Commonly required
8(a)WOSBSDVOSBPE/PMP

Sector-level estimate — full code lookup not yet in catalog.

Catalyze: Product Definition Medical Devi…
Due Dec 23
Onboard ↗