What’s your favorite regulatory pitfall? I know that’s a strange question, but if you’ve spent much time in the medical device industry, there are likely a few that come to mind. People reach out to me all the time asking how to break into the medical device industry—and I love those conversations. But here’s what I tell them: This industry is not for the faint of heart.

Most folks start out energized and motivated to save lives while bringing something meaningful to market. But it doesn’t take long for regulatory hurdles to get in the way, and that’s where a lot of good ideas stall out.

After working with dozens of startups, I’ve seen the same five mistakes trip up product teams again and again. These aren’t just small oversights; they’re pitfalls that derail timelines, drain budgets, and exhaust entire teams.

Let’s walk through each one—and how to avoid them.

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