In the Season 1 finale, Michelle and Ti challenge the traditional view of regulatory affairs as the “business prevention department.” Instead, they reframe regulators as strategic partners and proactive innovators who can drive compliance and competitive advantage.
From shocking stories of last-minute compliance scrambles to major recalls that reshaped the industry, this episode reveals why being a “regulatory rebel” means understanding intent over letter, pushing back when it matters, and building trust across teams.
Key takeaways:
How proactive vs. reactive compliance impacts company culture and patient safety
Why draft guidance matters (and how to use it to influence FDA thinking)
The ethical and strategic case for regulatory professionals as innovators
What Michelle and Ti would change if they ruled the FDA for a day
Perfect for regulatory pros, quality leaders, and anyone ready to challenge the status quo in medtech.
Season 2 coming soon!