Biotech/Biomed Industry Unique Requirements
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Learn the Requirements of Your Industry Sector
Industries have their own requirements you must follow in addition to the basic requirements for any business. For example, in the biomedical industry, many products must gain FDA approval.
US Food and Drug Administration (FDA) Regulation
- The FDA regulates. . .
- Medical devices
- Radiological health
- Over-the-counter and prescription drugs
- Biological therapeutics and products, including some human cell and tissue products, medical test kits, and drugs
- Products with color additives and new food additives
- Start learning about FDA approval early in your business planning. The FDA sponsors workshops, conferences, and trainings. Some NIH institutes, such as the NCI, offer support for communications between small businesses and the FDA.
- New drugs go through three phases of clinical trials. If the data shows the therapy is effective and safe, you submit a new drug application to the FDA.
(Registrar Corp, 2023)
Health Insurance Reimbursement
- If your product is a biomedical treatment or device, make sure health insurance companies will provide reimbursement for its use.
- If a medical procedure is involved, you may need to secure a new procedural code to permit billing for it.
(ULP, 2022)
References
Registrar Corp. How to Get FDA Approval. Registrar. 2023.
University Lab Partners. Reimbursement for MedTech and Biotech Startups. October 17, 2022.
Planning Your Research Environment
Location for Life Science Research and Biotech/Biomedical Businesses
Consider locating your business near a center for life science research and biotechnology—such as Boston, San Francisco, San Diego, or the Research Triangle in North Carolina—because it will facilitate hiring, networking, and collaborations. A lab location that all key personnel can access facilitates communication and productivity (Chitale et al., 2022).
Planning Your Lab
The following cost- and time-saving options can help expedite getting your research started (Chitale et al., 2022; Manbachi, 2018):
- Renting bench space in an established lab during their off hours.
- Renting lab space in an incubator, an organization that supports the growth and success of startups by providing physical workspace, shared facilities, guidance, and some funding.
- Engaging a lab or a contract research organization to conduct all or part of the research for you.
- University employees or students may be allowed to conduct sponsored research in their university lab (at some negotiated cost and with conflict of interest details worked out), which saves the cost and effort of setting up a separate lab.
References
Chitale S, Lawler C, Klausner A. So you want to start a biotech company. Nat Biotechnol. March 2022;40(3):296–300. doi:10.1038/s41587-022-01239-9.
Manbachi A, Kreamer-Tonin K, Walch P, et al. Starting a Medical Technology Venture as a Young Academic Innovator or Student Entrepreneur. Ann Biomed Eng. January 1, 2018;46(1):1–13. doi:10.1007/s10439-017-1938-x.
Tips
- If your product needs FDA approval, seek help from attorneys and other expert consultants familiar with the process.
- Show that you understand the regulatory pathway in your grant proposals.
- Be sure to collect all the data you will need for FDA approval or to support insurance reimbursement when you have the chance to collect it.
- Determine whether medical products fit within existing clinic protocols or whether a change would be needed for your product to be adopted.
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Planning Your Research Environment
Industry-Specific Requirements, Licenses, and Permits
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