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National Institutes of Health – Opportunities For Funding And Collaboration

Impact

The National Institutes of Health (NIH) is the largest biomedical research agency in the world, investing more than $30 billion annually in medical research to improve public health and patient outcomes, spur economic growth, and advance scientific and clinical discovery. The NIH awards more than 80% of its funding through competitive grants and contracts to universities, medical schools, research institutions, and for-profit entities.

The NIH funds small business and academic research in medical devices, diagnostics and digital health technologies, which has a tremendous impact on the discovery and development of novel, life-changing medical technology products across a wide range of therapeutic areas. This non-dilutive funding is a critical source of financing for early-stage medtech companies to advance and de-risk innovative technologies. NIH awards also provide scientific and technical validation, which can help attract equity investors and assist in preparations for regulatory submissions and reimbursement strategies.

In an AdvaMed Member survey, nearly 70% of Members in the AdvaMed Accel division (for small companies) surveyed have applied for Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs, and 90% of these applicants have received funding, primarily in the form of SBIR awards. Companies receiving awards indicated NIH funding had a significant impact on accelerating technology development and attracting investor interest for follow-on funding.

Opportunities

The NIH provides non-dilutive funding for technology development and commercialization through the SBIR and STTR programs. The NIH also offers opportunities for collaborative R&D and licensing of NIH technologies through the Office of Technology Transfer.

Key institutes and centers (ICs) that extensively fund and collaborate with medtech companies include:

Non-Dilutive Funding: Grants and Contracts

Also known as “America’s Seed Fund”, the SBIR and STTR programs are congressionally-mandated set-aside programs for U.S. small businesses, providing early-stage capital for the development of innovative technologies with high commercial potential. 

  • In Fiscal Year 2018, NIH’s SBIR and STTR programs invested over $1 billion in life science companies ($941M for SBIR and $132M for STTR), and approximately 30% of this funding ($300M) was awarded to medical technology companies.
  • The SBIR/STTR programs offer several different types of applications to accommodate the varying R&D needs of small companies, including Phase I (Feasibility and Proof of Concept), Phase II (Development & Commercialization), Phase IIB (Commercialization and Clinical Data), Direct-to-Phase II (Development and Commercialization) and the Commercialization Readiness Program.
  • Applications for standard Phase I and Phase II are accepted three times during the fiscal year (January 5, April 5, and September 5) with estimated award dates 6 months from date of application. Individual Institutes and Centers also issue targeted SBIR/STTR Funding Announcements with variable application dates.
  • The NIH provides several technical assistance programs for companies with SBIR/STTR awards that provide valuable support and guidance on commercialization and market readiness.

The NIH SBIR/STTR programs have been reauthorized and extended through FY2022, including four pilot programs designed to increase technical and business asssitance and to provide further support for product development and commercialization. The pilot programs include the SBIR Direct to Phase II, the Commercialization Readiness Program, the 3% set aside of SBIR Administrative Funds and the Phase 0 Proof of Concept Program.  

AdvaMed advocated for the reauthorization of these four pilot programs, and in a significant win for small medtech companies, the FY2019 National Defense Authorization Act included amendments extending the pilot programs from 2017 through 2022.

Technology Licensing and Collaborative R&D

The NIH Office of Technology Transfer provides opportunities for industry to license or conduct collaborative R&D on innovative healthcare technologies, thereby strengthening development pipelines for medtech companies and supporting further NIH-funded research. The National Cancer Institute (NCI) Technology Transfer Center has a focus on device and diagnostic technologies and facilitates partnerships between industry and the research laboratories of the NCI and nine other NIH institutes and centers.