Practical Moves for Practical People, with Assistance from The Practical Solutions Group.
After performing a standard due diligence (technical, financial, legal,
etc.) on a newly invented medical device, a private investor hired us to
perform a regulatory strategy assessment for the product he was considering
investing $750,000 in. The investor's feeling was that a good regulatory
strategy would minimize the risk of delays and additional costs to remedy
deficiencies, and he wanted us to obtain the information without providing
the inventor with a "roadmap" of what the proper regulatory strategy should
To meet this challenge, we created two questionnaires: one for a US
submission and one for an EU submission. Both questionnaires consisted of
open-ended questions rather than multiple choice or true/false questions.
This approach allowed us to test the inventor's understanding of the
regulatory environment and regulations (it forced the inventor to detail his
strategy in the absence of leading questions), and also to evaluate whether
the timelines that the inventor had outlined in his business plan were
realistic and supported the projected revenue.
It turned out that the proposed regulatory plan was designed for the wrong
type of submission, which made the time to the market look a year shorter
and more profitable than it really was. At the end of the day and after
being $6,000 short (cost of our assistance), the investor decided that the
return on his investment was not acceptable and that he would be better off
investing the money somewhere else. Now, that is practical!