It can be a stressful and difficult journey to be a founder in the MedTech space. So my teaching methodology is to have a goal in mind and always work our way backwards towards the goal. Use regulatory end-point to guide clinical trial strategy.

During the presentation, we delved into the importance of understanding the regulatory pathway for clinical strategy, including finding the right product code and deciding on the concept of predicate. We also discussed the de novo submission process, its pros and cons, and how it can be a high-risk, high-reward path.

We explored the concept of ‘indication for use’ and how it can inform your clinical trial strategy. We also touched on the importance of having a ‘home run indication’ and a ‘must have indication’ to guide your market entry strategy.

Lastly, we looked at some useful resources for software as a medical device, clinical trial strategy, and FDA submissions.