Who Qualifies for SBIR Funding?

Is Your Early-Stage Medical Device Company a Good Candidate?

The Small Business Innovation Research (SBIR) program is a unique opportunity for early-stage medical device companies seeking non-dilutive funding to advance innovative healthcare solutions. If your company is developing breakthrough medical technologies and needs support to validate, test, or commercialize your ideas, SBIR funding could be the catalyst you need.

Ideal Candidates: Early-Stage Medical Device Innovators

SBIR funding is designed for:

• Startups Spun Out from University Research:
  If your team is commercializing technology developed in an academic lab—such as a novel diagnostic device, monitoring system, or therapeutic platform—SBIR is tailored to help you bridge the gap between research and real-world application.

• Young Companies with a Prototype or Proof-of-Concept:
  Early-stage companies that have developed a working prototype or generated promising preliminary data are strong candidates. SBIR Phase I funding can support feasibility studies, bench testing, and the collection of critical data needed for further development.

• Entrepreneurs Seeking Validation and Early Testing:
  If you have a core technology competency and are looking for resources to conduct preclinical studies, verify device safety, or prepare for regulatory submissions, SBIR grants provide the support to move your innovation forward.

Eligibility Requirements for SBIR Applicants

To qualify for SBIR funding, your company must:

• Be a for-profit, U.S.-based small business with fewer than 500 employees

• Be independently owned and operated

• Have the principal investigator (PI) primarily employed by the business at the time of the award

• Demonstrate the potential for technological innovation and commercial impact

University spinouts and companies with strong academic collaborations are encouraged to apply, as SBIR allows for significant subcontracting to research institutions.

What Makes a Strong SBIR Candidate?

The most competitive SBIR applicants typically:

• Have a clearly defined, innovative medical device concept addressing an unmet clinical need

• Possess preliminary data, a prototype, or proof-of-concept results

• Show a well-articulated plan for technical development, validation, and future commercialization

• Are led by a team with scientific, technical, and business expertise—or have access to advisory support

• Demonstrate a commitment to advancing their technology toward regulatory approval and market entry

Why Early-Stage Medical Device Companies Choose SBIR

• Non-Dilutive Capital: Retain full ownership and control while accessing crucial funding for R&D.

• Validation: Federal review and support can boost credibility with investors, partners, and regulatory agencies.

• Growth Pathway: SBIR funding supports the journey from prototype to product, helping you generate data for FDA submissions and attract follow-on investment.

Are You Ready to Take the Next Step?

If you’re an early-stage medical device company—whether spinning out from a university or building on a promising prototype—SBIR funding can help turn your innovation into a life-changing healthcare solution. Our team specializes in guiding startups through the SBIR process, from eligibility assessment to proposal development.