When taking your innovation to market, I recommend using MIT's advisors for regulatory affairs (SME). The subject matter experts (SME) will guide you with both regulatory requirements and a regulatory pathway for your innovation, and guide you on whether you should use the FDA or EU for commercialization or market access.
The SME will help you at the beginning and identify if your idea favors the EU market route or FDA route. Depending on the technology of your ideation many times, it helps to go the EU route for market access. A typical example of the approval rate through the FDA is 10-years; however, the EU approval rate may only take 1-year. This strategy helps your startup make profits sooner and opens your innovations to a diverse population of 27 plus countries. Waiting for FDA approval could bury your idea before it's even born. Starting with the EU approval funds FDA approval and provides you with relevant data for your FDA submission. Now, this strategy helps you build a brand and gain a global customer base.
It's always best to include an advisor, regulatory strategy in your think tank and let them help you get market approval in a timely and cost-effective manner.
Your advisor, regulatory strategies is your mini-CFO.
Trilo Das, Regulatory affairs, pharma and medical devices expert
Professional Advisor at the Martin Trust Center for MIT Entrepreneurship
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