Human factors engineering isn't just a regulatory checkbox—it's the difference between a device that gets used correctly and one that ends up in an incident report. After working with dozens of medical device companies, we see the same mistakes repeatedly. Here's how to avoid them.
The most expensive human factors mistake is waiting until design verification to discover fundamental usability issues. By then, your engineering team has locked in decisions that are costly to change.
The fix: Conduct formative usability studies early and often. Low-fidelity prototypes can reveal critical issues before you've committed to tooling. A $15,000 formative study can prevent a $500,000 redesign.
Your engineering team is not representative of your intended users. Neither are the clinicians who helped design the device. Yet companies routinely conduct usability studies with convenient participants rather than actual end users.
The fix: Define your intended user populations clearly and recruit accordingly. If nurses in busy ERs will use your device, test with nurses in busy ERs—not medical affairs staff in a quiet conference room.
A device that works perfectly in a controlled lab setting may fail in the chaos of actual clinical use. Interruptions, poor lighting, gloved hands, time pressure—these factors dramatically impact usability.
The fix: Simulate realistic use conditions. Add distractions. Test with gloves. Create time pressure. Your summative study environment should mirror real-world conditions as closely as possible.
Human factors issues are the leading cause of FDA 510(k) delays and post-market complaints. Investing in proper usability engineering upfront isn't just good practice—it's the fastest path to market.
Need help building a human factors strategy that satisfies FDA requirements? Let's talk.