There are precisely two things that will sink a medtech company: finance and regulatory. Get either one wrong and you're done. Steve Duddy has spent decades in the CEO chair learning this lesson the hard way. In this episode, Steve shares why regulatory strategy must start on day one, what happens when founders try to outsmart the FDA, and why the best regulatory teams are the ones who will tell a CEO no. You'll learn about breakthrough designation and why the bar isn't as high as most founders think, how to salvage a failed pre-submission meeting, and why talking to your board members individually before board meetings prevents disaster. Steve also breaks down the difference between clearance and approval, explains why fast and right are two different things, and shares his perspective on AI in medtech and where the FDA is headed. If you think regulatory strategy can wait until you have a working prototype, this conversation will change your timeline entirely.

Timestamps:

00:04 - Introduction: Why regulatory is as critical as finance 02:00 - The costly mistake of pushing ahead without regulatory strategy

05:08 - Building FDA reputation: Why first impressions matter forever

07:32 - Coming to the regulatory table too late: A cautionary example

09:32 - Understanding the three main FDA pathways: 510(k), PMA, De Novo

12:40 - Breakthrough designation: Lower bar than most founders think

16:00 - Running pre-submissions in parallel with breakthrough applications

16:40 - What goes wrong when founders do pre-subs alone

19:48 - The language trap: Why words matter more than you think

22:28 - Predicate stacking: Taking bites of the elephant instead of swallowing it whole

23:32 - FDA uncertainty: What founders should know right now

26:00 - Compliance vs regulatory: Understanding the difference

29:00 - Quality systems and strategic acquisitions: Why strategics care now

31:40 - What makes a top-notch regulatory team

35:24 - Fast vs right: Maintaining regulatory integrity under pressure

38:12 - Board management: The one-off conversation strategy

39:36 - Commercialization: Why salespeople will make up their own words

44:40 - AI in medtech: Flying the plane while building it

47:56 - Rapid fire: First 90 days, biggest mistakes, FDA predictions

Follow Melita and Steve:

Connect with Melita: 

LinkedIn: https://www.linkedin.com/in/melitaball/

Website: https://www.linkedin.com/in/melitaball/

Connect with Steve: 

LinkedIn: https://www.linkedin.com/in/steveduddy

Website: https://duddyexecutiveservices.com/