1. Research Funding
  2. Concept to Clinic: Commercializing Innovation (C3i) Program
  3. eC3i Program - Education

eC3i Program - Education

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Purpose 

The eC3i 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 eC3i course are intended to guide investigators as they assess the commercial viability and potential business opportunity for their innovation.

 

Program Description

The eC3i 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 eC3i Program will learn an initial set of core skills that will enable them to:

  1. characterize the unmet market need
  2. identify the key product attributes
  3. conduct customer and stakeholder interviews
  4. 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 eC3i 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.

 

Participating Institutes/Centers

The following Institutes and Centers will be participating in the 2023 e-C3i course. Prospective applicants are strongly encouraged to contact NIH Scientific/Research staff for more information about this program before submitting an application.

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
    Toyin Ajisafe, Ph.D.
    Telephone: 301-827-9242
    Email: toyin.ajisafe@nih.gov
  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
    Daniel Gossett
    Telephone: 301-569-0395
    Email: daniel.gossett@nih.gov
  • 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:

Jaclyn Durkin
Email: jaclyn.durkin@nih.gov

Paige Anderson
Telephone: 301-827-6550
Email: paige.anderson@nih.gov

 

Eligibility

The eC3i 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 eC3i 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:

  • National Institute of Aging (NIA): active grant awards with the following activity codes: K99/R00, R01, R24, R25, R34, RF1, U01, U19, U24, U44, UF1, UG3/UH3, UH2/UH3.

  • National Institute of Biomedical Imaging and Bioengineering (NIBIB): active grant awards with the following activity codes: K99/R00, R01, U01, P41.
  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): active grant awards from SBIR/STTR (R41, R42, R43, R44) and research project activity codes including K99/R00, R01, R61/R33, R15, R21, R25, U01, and P50. Applicants are encouraged to contact NICHD prior to submitting to ascertain eligibility and program alignment.
  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): active grant awards with the following activity codes: R01, R15, R21, R25, RC2, P01, P20, P50.
  • National Institute of General Medical Sciences (NIGMS): active grant awards from the Technology Development R01 Program.
  • National Institute of Mental Health (NIMH): active research grant awards, career development awards, and training awards focused on developing a novel technology. 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. NIMH SBIR and STTR grand awardees are not eligible and should apply to the C3i Program. Please contact Paige Anderson prior to submitting to ensure your award is eligible.
  • National Institute of Neurological Disorders and Stroke (NINDS): active grant awards from research project (R01, R24, U01, U24, UG3/UH3, UH2/UH3) activity codes.
  • National Heart, Lung, and Blood Institute (NHLBI): active grant awards from 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): active grant awards from SBIR/STTR (R41, R42, R43, R44) and research project (T32, K99/R00, K23, R21, and R01) activity codes.
  • Brain Research through Advancing Innovative Neurotechnologies® (BRAIN) Initiative: 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.

 

Course Details

  • Introductory Webconference: Project Teams kick-off the eC3i 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.).
  • 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.
  • Final Presentations: 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 eC3i 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 one Business Advisor and one 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).

 

Timeline

  • Application Due Date: April 21, 2023
  • Notice of Participation: May 12, 2023
  • Program Start Date:  June 14, 2023
  • Program End Date:   August 31, 2023

 

How to Apply

To be considered for participation in the 2023 eC3i course, you must complete the application form below and submit via email to NIBIB-SBIR@mail.nih.gov. Applications have been extended to April 21, 2023.

Application Form

Application Elements and Review Criteria

  1. Problem/Unmet Need
  2. Proposed Solution/Innovation
  3. Impact/Significance
  4. Competition
  5. Status/Intellectual Property (IP)
  6. Key Commercialization Challenges
  7. Team