This week was a busy week, everybody was writing midterms and therefore there are little updates in terms of technical content. However, we did meet with our assigned mentors from OneStart and have acquired some very helpful information as far as working with the FDA, and IP.
One of our mentors who has experience working as an investor in bioelectronics, encouraged us to start preparing our business plan by conducting market research. He instructed us to look into more primary sources aside from stroke patients such as caregivers and rehab therapists. Then we can look into secondary sources and research the current market for devices similar to ours.
Our second mentor instructed us on the specific content important for preparing a business plan. Firsty, a timeline must be established, it must contain specific milestones such as meeting regulatory requirements, beginning manufacturing, and selling. One of the most important facets in achieving these goals is seeking and acquiring FDA approval.
To our knowledge, there are two paths to earning FDA approval, via PMA or 510(k). At this time we feel as though the 510(k) route will be best. It reduces cost and mitigates process complexity.