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.

1. Skipping the design history file

The design history file (DHF) isn’t just a document you fill out at the end of a project. It’s a map that guides your product development journey, supports your submission, and stands up under audit.

I’ll admit: I was once that project manager who gave myself a few weeks at the end of a schedule to “compile the DHF.” In reality, the compilation should be done in parallel with the documents that are being produced.

The fix: Build your DHF as you go. Ensure traceability beginning with user needs all the way through to design validation. That traceability is what makes the DHF a valuable, navigable document instead of a painful afterthought.

2. Underestimating risk management

If you’re working in the medical device industry, you should be familiar with ISO 14971. If your product development engineers don’t know what those numbers mean, it’s worth taking the time to teach them.

Risk management isn’t just for the safety team; it’s central to how you design your product. And regulators will expect to see documented evidence of a structured process.

The fix: Start early. Document thoroughly. Connect risk controls back to your design inputs and outputs. Make risk management part of your product culture.

3. Forgetting postmarket surveillance

It’s easy to assume regulators are only concerned with what happens before a product hits the market. But that couldn’t be farther from the truth.

Postmarket surveillance (PMS) is critical. It’s how you demonstrate ongoing safety and effectiveness. It’s also your best defense against product liability claims.

The fix: Treat PMS as part of your core regulatory strategy from Day One. Don’t wait until your product is on shelves. Set up a feedback loop that actively collects, reviews, and responds to real-world data.

4. Treating usability as an afterthought

Usability isn’t just for big companies with big budgets. In fact, it can make or break a device, especially in high-risk or high-stress use environments.

Poor usability leads to user errors, and user errors are risks. (See above.)

The fix: Start with standards like IEC 62366-1, and make usability part of your development process. Keep users involved through iterative testing and design refinement. And if you haven’t read The Design of Everyday Things (Basic Books, 2013), now’s a good time.

5. Relying too heavily on predicates

The 510(k) pathway is attractive. It’s familiar. It feels fast. But it’s not always the right choice—and it’s not always faster in the long run.

Sometimes, a De Novo or even a PMA pathway might serve you better. And yes, that Class III “moat” might even give you a strategic edge.

The fix: Let your product guide your regulatory strategy, not the other way around. Evaluate all your options and choose the one that best aligns with your device, your market, and your long-term goals.

The bottom line

Success in this industry doesn’t come from cutting corners. It comes from knowing which obstacles to avoid, which to face head-on, and which to reframe as opportunities.

If you can steer clear of these common pitfalls, you’ll save your team time, money, and a lot of unnecessary frustration.

Published March 27, 2025, by Greenlight Guru.