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.
Applications for assistance and funding are accepted throughout the year. For further information, visit https://simbex.com/treat-recognized-by-resna-with-leadership-award/ or contact the consortium at TREAT@simbex.com.
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™.
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.
Technical and Business Assistance (TABA) Needs Assessment Report—for Phase I applicants
The TABA Needs Assessment Report provides a free, unbiased, third-party progress assessment to SBIR/ STTR Phase I and Phase I Fast-Track awardees who request it. The report focuses on the following 10 technical and business areas:
- Target market attractiveness (need/size)
- Ability to address market need
- Regulatory path
- Business model profitability
- Competition and intellectual property
- Sales and marketing strategy
- Management team
- Strategic partners
- Funding status/financial plan
- Potential exit plan
The report also suggests the highest priority steps awardees can take to improve the commercial potential of their product or service.
Visit the TABA Needs Assessment website for more information and to request a report.