Concept to Clinic: Commercializing Innovation (C3i) Program

Overview: The eC3i course is an online entrepreneurial education platform aimed at teaching academic innovators methods to assess the commercial value of their biomedical technologies.

Eligibility: Investigators from a small business or research institution with active NIH-funded research projects

Application Due Date: April 12, 2024

Notice of Participation: April 29, 2024

Program Start Date: June 3, 2024

Program End Date: August 22, 2024

Overview: The C3i Program is an in-depth, entrepreneurial training experience designed to help biomedical innovators validate a market need and viable business opportunity, as well as develop a compelling pitch for prospective investors and partners.

Eligibility: Investigators from a research institution or small business with active NIH-funded research projects

Application Due Date: August 2, 2024

Notice of Participation: August 23, 2024

Program Start Date: October 1, 2024

Overview: The C3i Accell program provides product development and business support to assist academic innovators in accelerating the translation of their biomedical technologies.

Eligibility: Investigators from a research institution with active NIH-funded research projects who have completed the C3i Program

Application Due Date: April 2024

Notice of Participation: May 2024

Program Start Date: June 2024

Program Length: 12 months

The C3i Program is designed to provide medical device innovators with the specialized business frameworks and essential tools for successful translation of biomedical technologies from the lab (concept) to the market (clinic). Through this program, the NIH fosters the development and commercialization of early-stage biomedical technologies by engaging investigators who are interested in better understanding the value of their innovation in addressing an unmet market need. The curriculum and customized mentoring provided by the C3i Program are intended to guide investigators as they assess the commercial viability and potential business opportunity for their innovation.

The C3i Program is based on the Coulter Commercialization Process, an approach to biomedical research translation developed and continuously refined by the Wallace H. Coulter Foundation in collaboration with its academic partners across the country. Since 2001, the Foundation has supported more than 700 interdisciplinary teams of scientists and engineers, to bring the latest biomedical innovations to market for the benefit of human health and society at-large. To date 186 projects have raised more than $5.3 billion in venture capital and more than 500 Thousand in SBIR funding, 61 projects has been licensed to industry partners, and dozens more have received SBIR support. Most importantly, these efforts have given risen to more than 52 products with more than 50 advancing through the various FDA pathways. The key features and elements which define the Coulter Commercialization Process have been captured and condensed into an intensive, fast-paced training course, the C3i Program.

In 2014, the NIBIB and the Coulter Foundation established a public-private partnership to offer the C3i curriculum to NIH-supported investigators. Over the past five years, five courses have been offered, providing mentored business training to 70 participating teams. Cumulatively, these teams have received over $24M in NIH SBIR/STTR grant funding and have raised over $94M in private capital financing, and two products have been cleared for marketing by the FDA.