Seminars, practical tips, and thought leadership for medical device founders. Explore the ideas behind the decisions that matter.
What MedTech Founders Should Know Before Spending More on Testing
A practical educational session for medical device founders, with time for live Q&A.
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10 resources
A candid conversation with Bruce Prothro about when to approach FDA, how to prepare, and what to do with the feedback.
A free virtual session for founders and early-stage teams, with a practical presentation and live Q&A.
October 8, 2026 · 12:00–12:45 PM Pacific
The question is not simply “Are you FDA accredited?” It is “Are you FDA accredited for my product code?”
A traffic-light approach to Pre-Sub preparation: where FDA is aligned, where clarification is needed, and what may change the strategy.
Why intended users, critical tasks, and use-related risks belong in the conversation during product design.
A closer look at predicates, technological differences, and the questions behind a defensible regulatory strategy.
A founder resource for building a more targeted investor list and finding a clearer starting point for fundraising.
A question to ask before hiring a regulatory consulting firm: who will develop the strategy and deliver the work?
A perspective on sensing, closed-loop stimulation, and the questions behind more responsive therapy.
As neuromodulation becomes more adaptive, how do we demonstrate that the entire therapy loop is reliable?
Try another topic or category.
Bring your questions. We’ll find a practical place to start.
