Small Business Innovation Research (SBIR) Program - Biomedical Product Development

Small Business Innovation Research (SBIR) Program - Biomedical Product Development is sponsored by National Heart, Lung, and Blood Institute (NHLBI/NIH). Supports small businesses developing innovative biomedical technologies, including implantable drug delivery devices for cardiovascular, pulmonary, and related applications. Phase I funds proof-of-concept; Phase II scales development. This program should be reviewed carefully against your organization's mission, staffing capacity, timeline, and compliance readiness before you commit resources to a full application. Strong submissions usually translate sponsor priorities into concrete objectives, clear implementation milestones, and measurable public benefit.

For planning purposes, treat rolling deadlines or periodic funding windows as your working submission target unless the sponsor publishes an updated notice. A competitive project plan should include a documented need statement, implementation approach, evaluation framework, risk controls, and a realistic budget narrative. Even when a grant allows broad program design, reviewers still expect credible evidence that the proposed work can be executed within the grant period and with appropriate accountability.

Current published award information indicates $50,000 - $1,800,000 Organizations should verify the final funding range, matching requirements, and allowability rules directly in the official opportunity materials before preparing a budget. Finance and program teams should align early so direct costs, indirect costs, staffing assumptions, procurement timelines, and reporting obligations all remain consistent throughout drafting and post-award administration.

Eligibility guidance for this opportunity is: U.S. small businesses (fewer than 500 employees) If your organization has partnerships, subrecipients, or collaborators, define responsibilities and compliance ownership before submission. Reviewers often look for implementation credibility, so letters of commitment, prior performance evidence, and a clear governance model can materially strengthen the application narrative and reduce concerns about delivery risk.

A practical approach is to begin with a focused readiness review, then build a workback schedule from the sponsor deadline. Confirm required attachments, registration dependencies, and internal approval checkpoints early. This reduces last-minute issues and improves submission quality. For the most accurate requirements, always rely on the official notice and primary source links associated with Small Business Innovation Research (SBIR) Program - Biomedical Product Development.

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Below is a list of funding opportunity announcements that offer small business entrepreneurs a chance to obtain funding without requirements to give up equity or ownership for early-stage research and development. Get answers to frequently asked questions about the NHLBI Small Business Program .

Learn more about the Innovation and Commercialization Office (I&C) , which coordinates the institute’s Small Business Program, offers services to SBIR/STTR applicants and awardees, provides digital education and online resources, and supports other SBIR/STTR awardee opportunities. Small Business Program Coordinator Julia Berzhanskaya, Ph. D.

NHLBI SBIR Phase IIB Small Market Awards to Accelerate the Commercialization of Technologies for Heart, Lung, Blood, and Sleep Disorders and Diseases (R44 Clinical Trial Optional) NHLBI SBIR Phase IIB Bridge Awards to Accelerate the Commercialization of Technologies for Heart, Lung, Blood, and Sleep Disorders and Diseases (R44 Clinical Trial Optional) Innovations for Healthy Living - Improving Minority Health and Eliminating Health Disparities (R43/R44 - Clinical Trial Optional) PHS 2024-2 Omnibus Solicitation of the NIH, CDC and FDA for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical Trial Not Allowed) PHS 2024-2 Omnibus Solicitation of the NIH and CDC for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical Trial Required) PHS 2024-2 Omnibus Solicitation of the NIH for Small Business Technology Transfer Grant Applications (Parent STTR [R41/R42] Clinical Trial Not Allowed) PHS 2024-2 Omnibus Solicitation of the NIH for Small Business Technology Transfer Grant Applications (Parent STTR [R41/R42] Clinical Trial Required) SBIR/STTR Commercialization Readiness Pilot (CRP) Program Technical Assistance and Late Stage Development (SB1, Clinical Trial Not Allowed) SBIR/STTR Commercialization Readiness Pilot (CRP) Program Technical Assistance and Late Stage Development (SB1 Clinical Trial Required) Notice of Special Interest (NOSI): Small Business Initiatives for Innovative tools and Technologies for Improving Outcomes for Maternal Health Small Business Transition Grant for New Entrepreneurs (R43/R44 Clinical Trial Not Allowed) Small Business Transition Grant for New Entrepreneurs (R43/R44 Clinical Trial Required) Small Business Transition Grant for New Entrepreneurs (R41/R42 Clinical Trial Not Allowed) Small Business Transition Grant for New Entrepreneurs (R41/R42 Clinical Trial Required) Notice of NHLBI Participation in NOT-AI-24-007 "Notice of Special Interest (NOSI): RNA Delivery Technologies to Allow Specific Tissue Target Homing (RNA-DASH)" Notice of Special Interest (NOSI): Translating Biomaterials-Based Technologies to Commercially Viable Products Notice of Special Interest (NOSI): Validation of Digital Health and Artificial Intelligence/Machine Learning Tools for Improved Assessment in Biomedical and Behavioral Research Notice of Special Interest (NOSI): Improving Adherence to Treatment and Prevention Regimens and Maintenance of Health Behaviors to Promote Health Notice of Special Interest: Womens Health Research Notice of Special Interest (NOSI): Development of Functional Assay Sites to Evaluate Candidate -Omics Variants Associated with Heart, Lung, Blood, or Sleep Disease (R01, R41, R42, R43, R44) View all active NHLBI funding opportunities Innovation and Commercialization Office NHLBI&#039;s Small Business Program Frequently Asked Questions Small Business and Academic Innovation Success Stories NIH&#039;s Small Business Education and Entrepreneurial Development (SEED) website Innovation and Commercialization Office Inquiry Form Freedom of Information Act (FOIA) HHS Vulnerability Disclosure Related Government Websites Health and Human Services National Institutes of Health Office of the Inspector General Live Chat with us, Monday through Friday, 8:30 a.

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