You need to fully understand marketing to hospitals, the FDA, and how clinical trial management works. I would highly recommend finding a local friend/advisor/investor/etc. who is a doctor involved in clinical trials or better yet a clinical trial manager. There are a lot of hoops to get a clinical trial underway and you want to make this as easy as possible and put on paper and give to prospects up front how you have already cleared all the paths and made this a low risk trial.

Of particular concern will be your strategies around HIPAA compliance and how your store patient identified and de-identified data. How does what you are doing compare to software systems that are already FDA approved? Do you interface with all the main electronic heard record and other systems?

I have some friends in the clinical informatics space. These are the types of people you need on your advisory board.

Feel free to call or contact me.