Empowering NIH Small Business Innovators and Entrepreneurs

Strengthening market commercialization strategies for early-stage biomedical small businesses

The challenges of bringing healthcare technology innovations to market

Innovators face many uncertainties when bringing an idea—such as a new treatment for a disease or a novel technology—to the marketplace. After conceptualizing, testing, and developing a new product or service, innovators must uniquely position their idea within a highly complex market, develop a sustainable business model, and secure sufficient funding. Otherwise, promising ideas can fail in a competitive market.

Innovators in the healthcare and medical technology industries face added challenges. To launch a new medical device, therapeutic, or software application, the regulatory implications require innovators to understand how to navigate and obtain the necessary safety and efficacy data. Compared to less-regulated industries, this creates longer development timelines and requires increased capital investment to reach milestones. Additional support, both financial and strategic, is often needed to help biomedical innovators advance their technologies and understand their competitive and partnering position. If successful, launching these technologies has the potential to prevent or treat diseases, streamline healthcare workflow, and improve patient outcomes.

The NIH enables the acceleration of emerging medical technologies through entrepreneur and small business support

Recognizing the need to help biomedical innovators overcome early development challenges, the National Institutes of Health (NIH) developed several programs to support small businesses. Many of these programs are housed under the Small business Education & Entrepreneurial Development (SEED) office. Of these, the Technical Assistance and Business Analysis (TABA) program seeks to cultivate and support scientists and entrepreneurs in the life science and biomedical fields by connecting them with resources to accelerate and convert scientific discoveries into healthcare solutions. The NIH remains the largest source of early-stage capital for the life sciences industry in the United States, helping bring new ideas to the marketplace that could otherwise be limited to research labs or the concept phase.

RTI provides third-party assessment for the NIH Needs Assessment Program

RTI Innovation Advisors works with the NIH to perform a third-party needs assessment for eligible Phase I Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) awardees. The SBIR program awards $1.1 billion annually to small businesses  engaged in federal research and development, which can lead to product commercialization. The STTR program uses a $150 million budget to facilitate research and development between U.S. research institutes and small businesses, also with the potential for commercialization.

As a third-party commercialization advisor, RTI provides an unbiased needs assessment and gap analysis tailored to the needs of each participating SBIR and STTR awardee.  This support guides the companies’ short-term and long-term business strategy and commercialization plans.

Broadly, these suggestions include understanding the needs of their potential customers, end users, potential partners, key opinion leaders, and other stakeholders; as well as guidance on how to approach regulatory, intellectual property, and other business considerations. We provide expertise and counsel to help program participants reach their commercialization goals within four key commercialization areas:

1. Marketing needs and competitive advantages
2. Intellectual property and barriers to entry
3. Business model profitability
4. Manufacturing, regulatory, and clinical planning

Our subject matter experts provide thoughtful and customized insights into each of the four commercialization areas. For example, within the marketing needs and competitive advantage section, we provide advice on how to engage key stakeholders to test and gather feedback on an innovations’ perceived value by the end user. This helps small businesses better position their products to address their customer’s unmet needs as they advance their technology and company, enabling them to secure future funding and new commercialization opportunities.

Driving Impact for Small Businesses via the SEED TABA Needs Assessment Program

RTI Innovation Advisors has worked with over 200 individual small businesses to conduct these needs assessment gap analyses across a wide range of biomedical disciplines, and our support to the entrepreneurial community continues. Company participants in the RTI-executed program have embraced the impact of the resulting needs assessments and have incorporated the RTI recommendations into their company strategies.

According to the small businesses that RTI has supported, the needs assessments have: 

• Supported companies to shape their business strategy by identifying gaps in their approach in the four focus areas.
• Provided new approaches and identified ways to foster future partnership and customer relationships.
• Informed business decisions to construct stronger commercialization plans, including strategies on how to improve intellectual property protection. 
• Provided strategies to strengthen how the small businesses communicate their milestones for future funding requests, including non-dilutive and private funding sources.

Strengthening biomedical and life sciences innovation, supporting innovators, and improving patient outcomes

RTI Innovation Advisors have been supporting innovators and technology programs for over 55 years by providing data-driven recommendations for our clients. Through our role supporting the NIH SEED TABA Needs Assessment Program, we help NIH-funded SBIR/STTR companies improve their business and commercialization strategies, enabling scientists and entrepreneurs to strengthen their positioning in helping advance and improve patient health outcomes.

Learn More about RTI Innovation Advisors and Transformative Health Research.