Resources for Small Business Awardees

Commercialization Resources

• NIH’s Commercializing Innovation (C3i) Program provides medical device innovators with the specialized business frameworks and essential tools for successful translation of biomedical technologies from the lab to the market. The program’s curriculum and customized mentoring are intended to guide investigators as they assess the commercial viability and potential business opportunity for their innovation.
• NIH’s Entrepreneurial Finance Course for Biomedical Innovators comprises five video modules that present a detailed framework for building a step-wise, validated financial plan.
• Phase I Awardees Only: The Innovation Corps (I-Corps™) at NIH Program offers 8-week, hands-on entrepreneurship training specifically designed for companies that received Small Business Innovation Research or Small Business Technology Transfer funding from NIH or the Centers for Disease Control and Prevention (CDC). Graduates are prepared to focus their business plans, reach their potential customers, and effectively demonstrate the value of their innovation.
• SEED’s Entrepreneur-in-Residence Consults offer targeted conversations with subject matter experts in topics including sales, marketing, commercial strategy, corporate development, fundraising, valuation, product positioning, and value proposition.
• Phase I Awardees Only: NIH’s Technical and Business Assistance (TABA) Needs Assessment Report provides a third-party, unbiased assessment of a Phase I project’s progress in technical and business areas that are critical to success in the competitive healthcare marketplace.

General Innovator Resources

• The Food and Drug Administration (FDA) provides the following education materials and other information for small businesses and members of industry:
  • CDERLearn offers training and continuing education courses from the Center for Drug Evaluation and Research (CDER).
  • CDRH Learn is a multimedia educational resource from the Center for Devices and Radiological Health (CDRH), featuring learning modules that address medical device and radiation emitting product laws, regulations, guidances, and policies, across the entire product life cycle.
  • CDRH Management Directory by Organization
  • Device Advice: Comprehensive Regulatory Assistance explains medical device laws, regulations, guidances, and policies, across the entire product lifecycle.
  • Division of Industry and Consumer Education Contact Information
  • FDA and Industry Procedures for Section 513(g) Requests for Information under the Federal Food, Drug, and Cosmetic Act (PDF 358 KB)
  • OTP Learn is the Center for Biologics, Evaluation and Research's web page for industry education, offering numerous online courses.
  • Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program (PDF 262 KB)
• The Pediatric Device Consortia, funded by FDA, provide regulatory, business planning, and device development services to foster advancement of medical devices for pediatric patients. In addition to key advising services, the consortia also provide critical funding to innovators to directly advance these projects.
• The U.S. Patent and Trademark Office (USPTO) offers the following resources:
  • Global Intellectual Property Academy
  • Intellectual Property Assessment Tool
  • Inventors Assistance Center
  • USPTO Bulk Data Products