MedTech founders often treat regulation as a hurdle. Malte instead argues it's one of your biggest strategic advantages. In this episode, we cover why regulatory planning should start at ideation, how intended purpose functions as a company-wide strategic tool, and why defining commercial claims late is one of the most dangerous business risks in MedTech.
We also break down risk classification trade-offs, ISO 13485 timing, adaptive AI implications under MDR, and why early notified body engagement dramatically changes your investor risk profile. If you're a medical device founder, CEO, or commercial leader, this episode will reframe your regulatory strategy.
