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Learn the Requirements of Your Industry Sector
Different 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.
U.S. Food and Drug Administration (FDA) Regulation
- The FDA regulates:
- Medical devices
- Radiological health
- Over-the-counter and prescription drugs
- Biological therapeutics and biological products, including some human cell and tissue products, medical test kits, and drug products.
- Products with color additives and new food additives.
- Start learning about FDA approval early in your business planning. The FDA sponsors workshops, conferences, and training, and some NIH institutes, such as NCI, offer support for communications between small businesses and the FDA.
- New drugs go through 3 phases of clinical trials. If the data shows the therapy is effective and safe, you submit a New Drug Application to the FDA.
Health Insurance Reimbursement
- If your product is a biomedical treatment or device, make sure the health insurance companies will provide reimbursement for use of your product.
- If a medical procedure is involved, you may need to secure a new procedural code so that healthcare providers can bill for it.
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 businesses, such as Boston, San Francisco, San Diego, or Research Triangle in NC, 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:
- 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 research organization to conduct all or part of the research for you.
- For university employees or students: Universities may allow you to conduct sponsored research in your university lab (at some negotiated cost and with conflict of interest details worked out), which saves cost and effort.
- 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 of the data you will need for FDA approval or to support insurance reimbursement when you have the chance to collect it.
- For medical devices or treatments, determine whether your product fits within existing clinic protocols or whether a clinical protocol change would be needed for your product to be adopted.