What Is the SBIR Program?

Accelerating Medical Device and Drug Development for Small Businesses

The Small Business Innovation Research (SBIR) program is a competitive, federally funded initiative that empowers U.S. small businesses—especially those in the medical device and pharmaceutical sectors—to turn groundbreaking research into commercial healthcare solutions. Designed to stimulate technological innovation and meet federal research and development needs, the SBIR program is a vital resource for startups and established companies seeking to develop new medical devices, diagnostics, therapeutics, and drugs.

SBIR for Medical Device and Drug Innovators

The SBIR program is a cornerstone of early-stage, non-dilutive funding for companies developing:

• Novel medical device platforms and technologies

• Diagnostic tools and digital health solutions

• Innovative pharmaceuticals and therapeutics

• FDA-regulated medical products and drug delivery systems

Federal agencies like the National Institutes of Health (NIH), National Science Foundation (NSF), and Food and Drug Administration (FDA) dedicate significant SBIR funding to support high-impact research in these fields. The NIH alone is the largest source of early-stage capital for life sciences, helping companies bridge the gap between laboratory research and clinical or commercial application.

How Does the SBIR Program Work?

The SBIR program operates in three phases:

• Phase I: Establishes the scientific and technical merit of your innovation, focusing on feasibility and proof of concept. Medical device and drug development projects use this stage to validate their ideas in the lab and generate preliminary data.

• Phase II: Expands research and development efforts, supporting further prototyping, preclinical studies, and regulatory preparation. This phase is critical for advancing medical technologies toward FDA submission or clinical readiness.

• Phase III: Focuses on commercialization, helping businesses bring their medical products or drugs to market. While SBIR funds are not provided in this phase, successful completion of earlier phases positions companies for private investment, partnerships, and government contracts.

Benefits for Medical Device and Drug Developers

• Non-dilutive Funding: SBIR grants provide essential capital without requiring equity or incurring debt, allowing innovators to retain full ownership of their intellectual property.

• Validation and Visibility: Winning SBIR support signals that your medical or pharmaceutical innovation has been rigorously evaluated and endorsed by federal experts, increasing credibility with investors and partners.

• Access to Expertise: Awardees benefit from technical assistance, regulatory guidance, and networking opportunities—crucial for navigating the complex path to FDA approval and market entry.

• Commercialization Support: The SBIR program is designed to help small businesses move from concept to market, accelerating the development of life-saving medical devices and breakthrough drugs.

Who Is Eligible?

To apply for SBIR funding, your business must:

• Be a for-profit U.S. entity with fewer than 500 employees

• Be independently owned and operated

• Employ the principal investigator within the company

• Focus on innovative R&D with strong commercial potential

Medical Device and Drug Development Focus Areas

SBIR agencies support a wide range of projects, including:

• Diagnostic imaging and monitoring devices

• Implantable and wearable technologies

• Drug discovery and development for conditions such as cancer, infectious diseases, and substance use disorders

• Digital health platforms and telemedicine solutions

• Women’s health and rehabilitation devices

Ready to Accelerate Your Healthcare Innovation?

The SBIR program is a powerful launchpad for small businesses developing next-generation medical devices and pharmaceuticals. If you’re ready to transform your research into real-world healthcare solutions, explore SBIR funding opportunities or contact us to learn how we can help you succeed.