Practical Moves for Practical People, with Assistance from The Practical Solutions Group, LLC
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 be.
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!