Unique Requirements for Bio/Med Tech Ventures
- Regulatory approval is often required for biotechnology products, e.g., Food and Drug Administration. The FDA regulates medical devices, radiological health, over-the-counter and prescription drugs including biological therapeutics, and biological products including certain human cells and tissue products, medical test kits, and drug products.
- You may need to make modifications to the product in response to obtaining regulatory approval.
- Health insurance reimbursement (for biomedical products) – Make sure that health insurance will pay for use of your product or the medical procedure for which it will be used.
(Manbachi et al., 2018)
Resources
U.S. Food and Drug Administration – Official website
FDA Resources – NCI SBIR Development Center
How to Get FDA Approval – Registrar Corp. 2021
FDA Review and Approval – A toolkit provided by NCATS
3 Key Medical Device Reimbursement Challenges Manufacturers Face Globally – Infiniti Research
Breaking the Myths of Medical Device Reimbursement – MediClever Reimbursement Consultants
Health Insurance Coverage and Reimbursement Decisions – Issue Brief. American Academy of Actuaries. 2008
FDA Small Business Assistance – Includes:
- The Center for Biologics Evaluation and Research (CBER)
- The Center for Drug Evaluation and Research (CDER)
- Office of Regulatory Affairs (ORA) District Offices and Small Business Representative
Licenses and Permits
Depending upon the nature of your business and location, you may need various federal and state licenses and permits for your small business. Become aware of the fees and waiting periods involved. Keep track of expiration/renewal dates. Examples:
- Sellers permit – If you sell tangible items to the public, you may need this permit from your state.
- If a federal agency regulates your business activities you need a permit or license. For example, in agriculture, if you import or transport animals, animal products, biologics, biotechnology including genetically engineered organisms, or plants across states lines, check with the U.S. Deparment of Agriculture.
Resource on Starting a Small Business, Licenses and Permits:
Apply for licenses and permits – Small Business Administration resources
The Small Business Administration (SBA) website is a good place to start when founding a business, particularly:
