19/12/2025
“The FDA is more of a partner than a roadblock to innovation—early engagement speeds up approvals.”
Kwame Ulmer from MedTech Impact Partners breaks down why most medtech founders underestimate how much evidence matters—and how a proactive regulatory strategy can accelerate both approvals and funding.
Even at the concept stage, having a clear regulatory roadmap—including understanding FDA pathways like 510(k), DeNovo, and 513(g)—positions startups for success. Kwame also emphasizes the importance of realistic capital and schedule buffers, and fluency in regulatory language to attract investors.
A must-watch for medtech innovators looking to navigate complex regulatory pathways efficiently.
🎥 Watch the full interview: https://eu1.hubs.ly/H0qySw10
