The Center for Translation of Rehabilitation Engineering Advances and Technology (TREAT)
TREAT is a multidisciplinary, multi-institutional, collaborative consortium that provides infrastructure support and expert consultation to innovators interested in translation and commercialization of rehabilitation and assistive technologies. TREAT is part of the NIH R24 network of rehabilitation resource centers and offers a variety of education and training opportunities to clients.
Concept to Clinic: Commercializing Innovation (C3i) Program
The C3i Program provides medical device innovators with the specialized business frameworks and essential tools to successfully translate biomedical technologies from the lab (concept) to the market (clinic). Through this program, NIH fosters the development and commercialization of early-stage biomedical technologies and engages investigators interested in better understanding the value of their innovation for addressing an unmet market need. The curriculum and customized mentoring provided by the C3i Program help guide investigators as they asses the commercial viability and business opportunity of their innovation. Tenets of the C3i Program are 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 partners across the country.
Entrepreneurial Finance Course for Biomedical Innovators
Learn how rigorous financial planning can help you navigate and mitigate risks for your small businesses and enhance your chances of success along the pathway to commercialization.
The purpose of this course is to present biomedical entrepreneurs with a detailed framework for building a step-wise, validated financial plan. Moving beyond the short-term perspective of immediate financing needs to a comprehensive, long-term financial plan will increase the probability of success for your venture. The primary learning objectives for this course are as follows:
- Understand the importance of financial planning for your small business
- Gain perspective on Small Business Innovation Research/Small Business Technology Transfer (SBIR/STTR) funding within the broader context of your financial plan
- Learn practical approaches to developing a long-term financial plan
- Evaluate the various sources of funding
- Examine the use of comparables in validating your financial plan
For more information and to access the online video modules, visit https://www.nibib.nih.gov/entrepreneurial-finance-course.
Food and Drug Administration (FDA) Resources
The FDA provides the following education materials for small businesses and members of industry:
- Vaccines, Blood, and Biologics: Office of Tissues and Advanced Therapies (OTAT) Learn (webpage for industry education)
- Training and Continuing Education: Center for Devices and Radiological Health (CDRH) Learn (webpage for multimedia industry education)
- CDRH Management Directory by Organization
- Training and Continuing Education: Center for Drug Evaluation and Research (CDER) Learn Training and Education (webpage for educational tutorials)
- Device Advice: Comprehensive Regulatory Assistance
- Division of Industry and Consumer Education (DICE) Contact Information
- Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program (PDF 262 KB)
- FDA and Industry Procedures for Section 513(g) Requests for Information under the Federal Food, Drug, and Cosmetic Act (PDF 358 KB)
Innovation Corps (I-Corps™) at NIH Program—for Phase I applicants
The goal of I-Corps™ is to accelerate the translation of biomedical research to the marketplace by training SBIR and STTR grantees in the areas of innovation and entrepreneurship. Under this program, NIH and the Centers for Disease Control and Prevention (CDC) foster the development of early-stage biomedical technologies by teaching researchers how to understand the value of their inventions in the marketplace, which ultimately helps advance these technologies from the research lab into the commercial world. This program is designed to complement activities within the scope of the parent SBIR Phase I (R43) or STTR Phase I (R41) grant or the Phase I portion of an SBIR/STTR Fast-Track grant (R43/R41, respectively) to help accelerate the commercialization of new products and services derived from NIH- and CDC-funded technical feasibility studies. Learn more about I-Corps™.
NIH Commercialization Assistance Program (CAP)—for Phase II applicants
NIH CAP is a free specialized technical assistance program for SBIR Phase II awardees. CAP is designed to help promising, small, life science companies develop their commercial businesses and transition their SBIR-developed technologies into the marketplace. CAP applications are accepted once per year, usually in the fall. Learn more about CAP.
NIH Niche Assessment Program (NAP)—for Phase I applicants
The NIH NAP is a free nationwide program funded by NIH to help jump-start an SBIR/STTR Phase I awardee's commercialization efforts. Services are provided by Foresight Science & Technology of Providence, Rhode Island.
Foresight provides Technology Niche Analyses™ for 200 HHS SBIR/STTR Phase I awardees. These analyses assess potential applications for a technology and then for one viable application, they provide an assessment of the:
- Needs and concerns of end-users
- Competing technologies and competing products
- Competitive advantage of the SBIR-developed technology
- Market size and potential market share (may include national and/or global markets)
- Barriers to market entry (may include but are not limited to pricing, competition, government regulations, manufacturing challenges, capital requirements, etc.)
- Market drivers
- Status of market and industry trends
- Potential customers, licensees, investors, or other commercialization partners
- Price customers are likely to pay
Pediatric Device Consortia (PDC)
This grant program, from the FDA, supports the development of nonprofit consortia to stimulate projects promoting pediatric device development. The funded PDC help accelerate commercialization of safe and effective technologies for pediatric clinical care by connecting innovators with an extensive network of clinicians, researchers, technologists, and business development specialists located at institutions in their region.
Currently, FDA funds eight PDC across the country. Visit the PDC website for more information.