Whether you have yet to launch your small business, or are working on your Phase II or IIB application, there are many resources to assist you during both technical and business development endeavors. These resources can include educational opportunities, additional or matching funds, mentorship or training, technical assistance, networking opportunities, and other events and workshops. Many of these are useful across disciplines.
Below, find resources in the following categories:
- Commercialization, Business Development, and Operation
- Regulatory, Reimbursement, and Intellectual Property
- Research & Development
- Regional, State, and Local
You may find that your local incubator, accelerator, university, or other local networks are the best sources for comprehensive references for commercialization, business development, and operation resources. Beyond these networks, a number of government and non-government groups have prepared resources for all types of small businesses:
National Institutes of Health (NIH)
The NIH offers entrepreneurs and innovators programs and resources to support development of their products. Current offerings can be found on the Support for Awardees page. These include Technical and Business Assistance (TABA), as well as Education programs. The NIDDK is participating in the I-Corps and Concept to Clinic: Commercializing Innovation (C3i) programs.
U.S. Small Business Administration (SBA)
The SBA hosts an extensive library of articles, tools, and other resources for small businesses at any stage of development:
- SBIR.gov - A portal for all things SBIR/STTR
- SBA’s suite of tools
- SBA Learning Center - Online training, videos, and chat sessions
- SBIR.gov - The SBA administers the SBIR & STTR programs and hosts additional resources specific to applicants and awardees at www.sbir.gov; you may find a useful local event or webinar on their Events page
The NIDDK and other Institutes and Centers of the NIH are working with industry and trade groups (e.g., AdvaMed and BIO) to provide opportunities to grantees. Eligible grantees will receive emails regarding these opportunities when they become available. In the meantime, find resources from these groups below:
- MedTech Innovator Webinars YouTube Channel
National Science Foundation (NSF)
NSF I-Corps is a program designed to foster entrepreneurship that will lead to the commercialization of technology that has been supported previously by NSF-funded research
Beyond SBA, resources from across the U.S. Federal Government have been centralized at the Business.USA.gov portal. It may be worth checking to see if any additional resources specific to your needs can be found there.
SCORE, a nonprofit association dedicated to helping small businesses has vast array of resources, including local networks of mentors, business tools and document templates, business counseling, and local and online educational workshops. If you haven’t started a company before, raised money for your company, or taken a life science or medical product to market, having a devoted mentor can be critical. Tap your local network or search through SBA or SCORE to find help.
Do you have banking, accounting, payroll, human resources, or legal needs? Again, tap your local network for advice, and don’t be afraid to ask a candidate service provider for references and their experience working with startups. A number of websites and online services, not affiliated with or endorsed by the federal government, are tailored to startups and small businesses.
Many of the technologies developed with the support of NIDDK SBIR & STTR awards will require FDA approval to be used in a clinical study and ultimately to be marketed and sold in the United States. If FDA approval is required for your technology it would behoove you to include some detail of your regulatory strategy in your Commercialization Plan (component of Phase II and IIB applications) and in your progress reports to the NIH. In this section we provide starting points for your consideration of this process as well as some resources pertaining to regulations abroad.
The SF424 (R&R) SBIR/STTR Application Guide offers a list of several resources and references (Section 1.6.1 Other Resources) which may be useful for you in formulating a regulatory strategy. We outline several additional resources below.
U.S. Food and Drug Administration
Keep tabs on regulatory perspective on topics from oversight of next-generation sequencing to new medical devices for treating obesity at the FDA’s official blog, FDA Voice. The FDA assumes a proactive role in the development of a number of technologies relevant to the NIDDK (e.g., the artificial pancreas). Lend your expertise to the conversation. Search for guidance documents and public workshops pertaining to your area of innovation. Several programs offer opportunities for accelerated review, and eligibility or acceptance into these programs may be attractive to investors or partners.
Drugs and Biologics
Information about regulation of drugs and biologics is available from the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER):
- CDER Small Business and Industry Assistance (SBIA) - Information source for regulated domestic and international small pharmaceutical business and industry
- Small Business and Industry Education Series - Web-based tutorials on topics relating to drug regulation and review
- Priority Review, Breakthrough Therapy, Accelerated Approval, and Fast Track - FDA's approaches for accelerating the development and review of drugs that treat serious conditions or fill unmet needs
- Rare Pediatric Disease Priority Review Voucher Program - Priority review vouchers, which may redeemed to receive a priority review of a subsequent application – a valuable asset
Devices and Diagnostics
Information about regulation of devices and diagnostics is available from the FDA's Center for Devices and Radiological Health (CDRH):
- Device Advice: Comprehensive Regulatory Assistance
- Overview of Device Regulation
- Investigational Device Exemption (IDE) - Allows the investigational device to be used in a clinical study
- In Vitro Diagnostics
- Companion Diagnostics
- Expedited Access Pathway (EAP) program - A voluntary program for certain medical devices that demonstrate the potential to address unmet medical needs for life threatening or irreversibly debilitating diseases or conditions; the FDA works with device sponsors to try to reduce the time and cost from development to marketing decision
- Obesity Treatment Devices
- Blood Glucose Monitoring Devices
- ClinicalTrials.gov - A registry and results database of publically and privately supported clinical studies; use it to learn about ongoing clinical trials in your area of research and gain insight into study design (e.g., endpoints)
- EU Clinical Trials Register - Contains information on interventional clinical trials on medicines conducted in the EU or the EEA
- National Institute of Allergy and Infectious Diseases (NIAID) ClinRegs (BETA) aggregates clinical research regulations from around the globe
A strong intellectual property strategy can be critical to gaining access to markets and the success of your small business. One of the benefits of the federal grants is that intellectual property developed with the funds is retained by the company. To help the NIH understand and improve our programs, please comply with requirements to report inventions through iEdison. Educational information regarding intellectual property in the U.S. and globally can be found below.
U.S. Patent and Trademark Office (USPTO)
The USPTO has a broad range of resources which can assist your efforts to develop a strong intellectual property portfolio:
Patent Cooperation Treaty (PCT)
PCT is the International Patent System and also offers several resources:
- e-Tutorial on Using and Exploiting Patent Information
- Patentscope - Search International and National Patent Collections
A number of programs at the NIH support translation of therapeutics and other biomedical technologies:
- Bridging Interventional Development Gaps (BrIDGs) - A program operated by the National Center for Advancing Translational Sciences (NCATS) assists researchers in advancing promising therapeutic agents through late-stage pre-clinical development toward an Investigational New Drug (IND) application; assistance may include scale-up, IND-directed toxicology, and formulation
- Therapeutics for Rare and Neglected Diseases (TRND) - A program operated by NCATS to speed the development of new drugs for rare and neglected diseases
NIH Portals and Data and Sample Repositories
Many of the NIH’s resources for investigators are also available to for-profit institutions. Confirm data sharing and intellectual property stipulations of each resource align with your commercialization strategy. The following resources could help you continue work in, or direct a platform technology at, a mission area of the NIDDK:
- The NIDDK Information Network (dkNET) - Access to large pools of data relevant to the mission of the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- NIDDK Central Repository - Data and samples from NIDDK-supported studies
- NIDDK Central Repository links to other relevant repositories
- NIDDK Research Centers - NIDDK Research Centers support research in areas of interest to the NIDDK; center-to-center activities vary, but you may find pilot and feasibility opportunities, support facilities, and collaboration opportunities that can help advance your research
- NIDDK Health Topics - Information about the plethora of health and disease topics falling under the purview of the NIDDK
- Translational Research for Therapeutic Discovery and Development - NIDDK Funding Opportunities and related resources mapped by NIDDK Program Directors to critical stages along the therapeutic discovery and development pipeline
Our curated list of state and local resources is currently under development. Contact Daniel Gossett (email) if you need help identifying resources available in your area.
- The NIH Research Evaluation and Commercialization Hub (REACH) program – Proof-of-concept centers (Hubs) that facilitate and accelerate the translation of biomedical innovations into commercial products; current REACH Hubs are The Long Island Bioscience Hub, The University of Louisville ExCITE Hub, and the University of Minnesota MN-REACH
- NIH Centers for Accelerated Innovations (NCAI) - At the link above you will also find information about NHLBI-funded NCAI Centers
- Clinical and Translational Science Award (CTSA) - Institutions funded by these awards have established programs supporting clinical and translational research (collaboration, training, pilot program funding); find a local funded institution
Resources mapped by other sites:
- Business USA
- U.S. Small Business Administration
- SCORE Association Chapters