1. Research Funding
  2. Concept to Clinic: Commercializing Innovation (C3i) Program
  3. C3i Validation/Execution

C3i Validation/Execution

A lit up lightbulb in front of a chalkboard with gears drawn on it.

Purpose

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.

 

Background

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 400 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, 82 projects have raised more than $2.2 billion in venture capital, 47 projects have been licensed to industry partners, and dozens more have received SBIR support. Most importantly, these efforts have given risen to more than 35 products, with 22 more advancing through Phase II or III clinical trials. 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.

 

Program description

The C3i Program is a 24-week entrepreneurial training course, divided into two 12-week phases, and consists of one in-person event, weekly teleconferences, lectures, and coursework.  Participants in the C3i Program will develop a comprehensive set of core skills that will enable them to:

  1. evaluate whether a compelling unmet market need exists for their proposed solution
  2. assess whether there is a viable business opportunity that can be built to meet this need
  3. build a compelling pitch presentation to secure support from potential investors and other business partners.

The teams will be guided through a series of lectures and interactive exercises, pressure-testing commercial viability of ideas using universal business criteria as well as the unique requirements of medical device commercialization. Participants also work with experienced business advisors and subject matter experts who provide insights into the market sector, intellectual property, regulatory, and reimbursement requirements specific for their projects.

The first 12 weeks, Phase I of the course, will focus on characterizing the unmet market need, identifying the customer and stakeholder segments, conducting customer and stakeholder interviews, and validating the business opportunity. The second 12 weeks, Phase II of the course, will provide commercialization planning support, covering intellectual property strategy, regulatory and reimbursement requirements, risk assessment, milestone creation and valuation, and preparations for pitching to investors and/or strategic partners.

The C3i Program is being offered to investigators with active NIH-funded research grants from participating Institutes and Centers. All costs associated with participation in the program are covered with the exception of travel to and from the in-person events. 

 

Participating Institutes/Centers

The following Institutes and Centers will be participating in the 2021 C3i course. Prospective applicants are strongly encouraged to contact NIH Scientific/Research staff for more information about this program before submitting an application.

 

Eligibility

The C3i Program is being offered to investigators with active NIH-funded research projects from participating Institutes and Centers. It is designed for medical device innovators who are interested in understanding whether they have a compelling commercialization opportunity and how they can package this opportunity to interest investors and/or business partners. Much of the course is dedicated to validating the basis for further investment of time, energy, and money by the Project Team and future business partners. Project Teams are pushed to question and challenge the fundamental assumptions and basis for the 'business hypothesis' they are trying to validate during the Program.

It is strongly recommended that Project Teams consist of at least two members: 1) Inventor or Technical Lead, and 2) Business Lead. The Inventor or Technical Lead has primary responsibility for achieving the technical success of the project. The Technical Lead should be the PD/PI for the parent award project, or a co-investigator, with in-depth knowledge of the technology or innovation. The Business Lead has primary responsibility for guiding the overall business development and commercialization strategy for the project. For existing companies, the Business Lead should be the Chief Executive Office (CEO) or other C-level officer (e.g. Chief Technology Officer or Chief Operating Officer). For academic teams, the Business Lead should be an individual with a deep commitment to investigate the commercial landscape surrounding the innovation and would be most likely to take on the role of CEO if a company were to be formed. In the scenario in which the Technical Lead (PD/PI) might also serve as the Business Lead (CEO) for the project, applicants are encouraged to consider identifying an additional Project Team member with considerable commitment to the project. Project Team members are not required to be key personnel on the parent award project.

While the C3i Program is designed for interactive learning and one-on-one coaching elements, there is a structure and cadence to the course such that consistent participation is required across the exercises and sessions, which build upon each other. Thus, the Program is only recommended for Participants who can commit the time and effort to actively and consistently participate in the Boot Camps and one-on-one coaching sessions (estimated 10-15 hours per week).

Eligible grant award mechanisms are listed below for each participating Institute and Center:

The National Institute of Aging (NIA) will support active grant awards from SBIR/STTR (R41, R42, R43, R44) activity codes.

The National Institute of Biomedical Imaging and Bioengineering (NIBIB) will support active grant awards from SBIR/STTR (R41, R42, R43, R44) and research project (R01, U01, P41) activity codes.

The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) will support active Phase I SBIR/STTR grant awards (including Phase I of a Fast-Track award) with the following activity codes R41, R42, R43, R44.

The National Institute of Mental Health (NIMH) will support active grant awards from SBIR/STTR (R41, R42, R43, R44) and research grants including R01 and U01 activity codes. Specifically, grantees developing devices focused on the Central Nervous System, Psychiatry or Autism, including those utilized as interventions, biomarkers, assessments/diagnostics and digital health technologies, would be considered eligible. Please contact NIMH program staff prior to submitting to ensure your award is eligible.

The National Institute of Neurological Disorders and Stroke (NINDS) will support active grant awards from SBIR/STTR (R41, R42, R43, R44, U44) and research project (R01, R24, U01, U24, UG3/UH3, UH2/UH3) activity codes.

The National Heart, Lung, and Blood Institute (NHLBI) will support active grant awards from SBIR/STTR (R41, R42, R43, R44) and research project (P01, P41, U54, R00, R01, R21, R24, R33, R61, U01, U44, UG3/UH3, UH2/UH3) activity codes.

National Institute of Nursing Research (NINR) will support active grant awards from SBIR/STTR (R41, R42, R43, R44) and research project (R01, R21) activity codes.   

Timeline

Application Due Date: August 5, 2022

Notice of Participation: September 8, 2022

Program Dates: Introductory Boot Camp (virtual) October 25 – 27, 2022

                            Mid-Course Boot Camp (in-person) February 7-9, 2023, Dallas, TX

                            Final Presentations (virtual) April 2023

 

Course Details

Boot Camp 1

Project Teams kick-off their C3i Program experience with an intensive, 2-day virtual workshop. Through a series of lectures and interactive exercises, Project Teams are introduced to key concepts and tools they can use to validate the unmet need and the business opportunity. During the exercises, Project Teams receive mentoring from Business Advisors, as well as feedback from other participating Project Teams.

Weekly One-on-Ones/Stakeholder Interviews

Following the completion of Boot Camp 1, Project Teams meet weekly with their Business Advisors throughout the course. These weekly one-on-one meetings are held via web or teleconference. During this time, Project Teams delve into validating both the unmet need and business opportunity of their technology, identifying and learning from the key stakeholder groups and organizations that will influence the commercialization success of their product. Due to the complexity of the health care system, the analysis of key stakeholders and how they stand to benefit or lose from the adoption of new technology is critical to understanding the potential business opportunity and to informing the go-to-market strategy, if there is one.

In between each weekly session, Project Teams conduct interviews with key stakeholders and report back how the findings have helped inform or refine the commercialization landscape for their envisioned product.  It is recommended that a Project Team speaks with at least 30 stakeholders to gather sufficient breadth of perspective. It is equally important that these interviews are held with various stakeholder groups, as applicable for the envisioned product (e.g. health care provider, referring providers, patients, health care payor, purchasing agent or other entities with direct buying authority, potential strategic partner, potential investor, etc.).

Group Teleconferences

Following several weeks of stakeholder interviews, groups of Project Teams meet via web conference to present what they have learned from their stakeholder interviews. The goal of these group meetings is to share progress, receive feedback and coaching, and learn from the entire Business Advisor group. Several group teleconferences are held throughout the course on topics relevant to the business model and final pitch preparation.

Lectures

There are a number of lectures given throughout the course, addressing specific topics related to medical device commercialization. These lectures average 30 minutes in length with additional time for questions and discussion directly following the lecture. Subject matter experts are recruited to deliver these lectures. Some of these lectures are given during the Boot Camps and some are given via web conference.

Boot Camp 2

Between Phase 1 and Phase 2 of the program, an in-person workshop will be held to further engage with Business Advisors and Project Managers and to network with other participating teams.  Lectures and interactive activities will be focused on topics being covered in Phase 2 around commercialization planning support.

Final Presentations

The final event of the Program consists of a 1.5-day virtual workshop in which teams reconvene to deliver final pitch presentations focused on the value proposition and the investment opportunity. As they have throughout the Program, Business Advisors will be on hand to provide real-time feedback and guidance.

Business Advisors and Project Managers

C3i Business Advisors and Project Managers serve as a critical and knowledgeable resource with direct and extensive experience in biomedical technology commercialization, particularly working with early-stage innovators and small companies. The role of the Business Advisor and Project Manager is to: 1) enhance the Team's understanding of the biomedical technology commercialization process, 2) hone the Team's business case and investor pitch, and 3) increase the Team's chance of securing follow-on funding, through SBIR, VC, strategic partners, and other capital sources. Each Project Team is assigned 1 Business Advisor and 1 Project Manager with the assignments largely based on the closest match between the business experience of the Business Advisor and the product the Project Teams are seeking to commercialize (e.g. devices, diagnostics, imaging).

 

How to Apply

To be considered for participation in the 2022 C3i course, you must complete the application form (below) and submit via email to NIBIB-SBIR@mail.nih.gov. Applications are due by August 5, 2022.

C3i Application Form

Application Elements and Review Criteria

  1. Problem/Unmet Need
    Describe the scope and nature of the problem you are trying to address.
  2. Proposed Solution
    Describe your proposed solution and the innovation.
  3. Impact/Significance
    Define the impact that you hope to accomplish using metrics most appropriate for you- morbidity, mortality, time, efficiency, costs, etc.
  4. Competition
    Describe known approaches (current, competing, and "work-arounds") to address the problem.
  5. Status/Intellectual Property (IP)
    Describe the status of your work and any disclosures or patent applications protecting your solution.
  6. Key Challenges
    Describe your current commercialization strategy and identify the key challenges that you hope the C3i Program experience can help you address?
  7. Team
    Briefly describe the team members who will be participating in the C3i program, identifying their roles and experience as it relates to the commercialization effort. Provide clear statements to indicate that all team members are able to meet the time-intensive requirements of the training program (expected to be 10-15 hours per week per team member).