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SBIR/STTR Consulting

RegSolutions

While most founders envision using the typical startup pathway (Seed-> Angel -> Series A,B,C, etc. -> Exit) to fund their product's development, this is not a practical option for many emerging medical technology companies. Research has shown that only 4.5% of biomedical startups receiving angel investment go on to receive venture capital investment.* It is important for founders to consider grants as a way to fund continued research and development, especially if early investors are not able to provide additional infusions in the absence of venture investment. The NIH's Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs over a source of non-dilutive investment that can be renewed through the demonstration of continued scientific progress. 

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Complete a Funding/Product Fit assessment to determine if your research program is a strong candidate for SBIR/STTR grants. Determine which Institutes, ICs and SRGs will be the best targets for your application. 

Document how your company will spend the requested funds. Identify your team of researchers, employees, consultants and subcontractors and highlight support from key disease state opinion leaders and potential customers.  

Argue for the significance of your research program and illustrate how your product is an innovation that advances medicine. Identify the current unmet treatment needs your product will provide a solution for. 

Successfully demonstrate the technical feasibility and commercial potential of your product during Phase I. Determine if your company should expand its R&D program (Phase II) or move to commercialization (Phase III).

While the traditional SBIR/STTR program is structured around three phases, the NIH also maintains a network of Research Evaluation and Commercialization Hubs (REACH). There are currently 8 proof-of-concept hubs that are partnered with 51 universities and technical colleges across 12 states. REACH hubs focus on implementing the NIH's Phase 0 Proof of Concept Partnership pilot program which provides entrepreneurial training for innovators on topics such as: 

  • Strategies for bringing new medical technologies to market

  • How to solicit and incorporate feedback from federal and industry experts

  • How to fund early-stage product definition studies

  • How to create business infrastructure to support your research and development activities

TDA maintains active relationships with the  NIH's Centers for Accelerated Innovations (NCAI) and the Research and Evaluation Hubs. Our advisors can help you determine the right academic center to partner with on your technology development using TDA's proprietary Research University IP matching database.

*Financing Biomedical Ventures - Myths and Realities, Dr. Jeff Scott Behrens, presented at the Swiss Federal Institute of Technology Lausanne, 5/28/2020

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