The e-C3i course is an online component of the C3i Program and is designed to provide medical device innovators with an educational foundation of business frameworks and tools to assess the opportunity to translate an idea from the lab (concept) to the market (clinic). Through this course, the NIH provides entrepreneurial education for investigators who are interested in better understanding the value of their innovation in addressing an unmet market need. The online curriculum and customized mentoring provided by the e-C3i course are intended to guide investigators as they assess the commercial viability and potential business opportunity for their innovation.
The e-C3i course is an online entrepreneurial education platform, covering 10-weeks and providing valuable business approaches to evaluating the commercial potential of promising biomedical technologies. Participants in the e-C3i Program will learn an initial set of core skills that will enable them to:
- characterize the unmet market need
- identify the key product attributes
- conduct customer and stakeholder interviews
- validate the business opportunity
The teams will be guided through a series of self-learning online modules focused on pressure-testing commercial viability of ideas using universal business criteria as well as the unique requirements of medical device commercialization. Participants will also work with seasoned business advisors who provide insight into the learning objectives from their experiences in the medical device industry. Participants will present their learnings and findings at several checkpoints throughout the course and are expected to create a final presentation that assesses the completion of the learning objectives.
The e-C3i course 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. Additionally, project teams that successfully complete the e-C3i course will be eligible to matriculate into the core C3i Program for continued entrepreneurial training.
The following Institutes and Centers will be participating in the 2021 e-C3i course. Prospective applicants are strongly encouraged to contact NIH Scientific/Research staff for more information about this program before submitting an application.
- National Institute on Aging (NIA)
- National Institute of Biomedical Imaging and Bioengineering (NIBIB)
Ilana G. Goldberg
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- National Institute of Mental Health (NIMH)
- National Institute of Neurological Disorders and Stroke (NINDS)
- National Heart, Lung, and Blood Institute (NHLBI)
- National Institute of Nursing Research (NINR)
- Brain Research through Advancing Innovative Neurotechnologies® (BRAIN) Initiative
For investigators with active BRAIN Initiative awards through NIMH, NIA, NIBIB and NINDS please contact the NIH Scientific/Research staff for that Institute (see above).
For all other BRAIN Initiative investigators, please contact:
Ilana G. Goldberg
The e-C3i course 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 learning how to assess if their project represents a compelling commercialization opportunity.
It is recommended that participating Project Teams consist of at least two members: 1) inventor or technical lead, and 2) graduate student or post-doctoral candidate involved in the project. 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 graduate student or post-doctoral candidate should be an individual with a strong interest in investigating the commercial landscape surrounding the innovation and would be likely to pursue an entrepreneurial role if a company were to be formed. Project Team members are not required to be key personnel on the parent award project.
While the e-C3i course is designed for self-learning with 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 course is only recommended for participants who can commit the time and effort to actively and consistently participate in the coursework, webinars, 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 research project (R01, U01, P41) activity codes.
The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) will support active grant awards with the following activity codes: R01, R15, R21, R25, RC2, P01, P20, P50.
The National Institute of Mental Health (NIMH) will support active grant awards from 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 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 research project (P01, P41, U54, R00, R01, R21, R24, R33, R61, U01, U44, UG3/UH3, UH2/UH3) activity codes.
The National Institute of Nursing Research (NINR) will support active grant awards from SBIR/STTR (R41, R42, R43, R44) and research project (R21, R01) activity codes.
The Brain Research through Advancing Innovative Neurotechnologies® (BRAIN) Initiative will support active grant awards from BRAIN-funded research project (F32, F99/K00, K99/R00, R01, R24, R25, R34, R41, R42, R43, R44, RF1, U01, U19, U24, U44, UF1, UG3/UH3, UH2/UH3) activity codes. Prospective BRAIN applicants are strongly encouraged to contact their program officer for more information about this program before submitting an application.
Application Due Date: April 4, 2022
Notice of Participation: May 10, 2022
Program Start Date: June 20, 2022
Program End Date: September 1, 2022
Project Teams kick-off the e-C3i course with introductory presentations to their Business Advisors and Project Managers. The Project Teams will be 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
Project Teams meet frequently with their Business Advisors throughout the course. These 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.
In between each 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 speak 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.).
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.
The final event of the course consists of a group webconference, in which Project Teams reconvene to deliver final pitch presentations focused on the value proposition and the market 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
The e-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 enhance the Team's understanding of the biomedical technology commercialization process and hone the Team's assessment of a viable business opportunity. 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 2021 e-C3i course, you must complete the application form (below) and submit via email to NIBIB-SBIR@mail.nih.gov. Applications are due by April 4, 2022.
Application Elements and Review Criteria
- Problem/Unmet Need
Describe the scope and nature of the problem you are trying to address.
- Proposed Solution
Describe your proposed solution and the innovation.
Define the impact that you hope to accomplish using metrics most appropriate for you- morbidity, mortality, time, efficiency, costs, etc.
Describe known approaches (current, competing, and "work-arounds") to address the problem.
- Status/Intellectual Property (IP)
Describe the status of your work and any disclosures or patent applications protecting your solution.
- Key Challenges
Describe your current commercialization strategy and identify the key challenges that you hope the C3i Program experience can help you address?
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).