Understanding FDA classification and pre-market process.
Seeing the best path forward.
Writing a better business plan.
Strategizing to fund productions while maintaining as much ownership of my company as possible.
Actions I’ve taken so far
Wrote a business plan, learned it needed to be narrowed to one focus, decided which branch of the plan to pursue. Successfully filed a provisional utility and design patent, done a fair amount of research on the FDA pre-market process and hit some walls there. I would like to write another business plan, this time with a mentor so I do a better job than last time.
My future goals
Clarify the FDA process and take the right path. File for the full patent.
Identify the best steps to fund, manufacture, and launch this product on the market. I see several possible paths and I need someone with experience to help me make decisions.
My motivations to work with a mentor
I have spent countless hours and dollars already, and so far, mostly failed at my mission to help end unplanned pregnancies and end the suffering women go through with modern birth control. After doing things the hard way and learning from my failures, I have learned that the experience of others is very useful, and I should look to those who can guide me.
This startup does not yet have a website.
About my venture
I have filed a provisional patent on a new birth control device that centers a harm-free, enjoyable contraception experience for the woman. No hormones, no implants, no hassle.
I am needing help with FDA classification and pre-market notification.
I also need help with rewritng my business plan, and coming up with a strategy to fund manufactoring and get this product on the market.