Insights & Resources

Stay updated with the latest in human factors engineering, FDA regulations, and medical device compliance.

Medical device founders: Here is where you are potentially losing hundreds of thousands of dollars

The FDA has explicitly stated that HF (human factors) validation is required for specific medical devices. Only after this approval can you launch your product and start generating revenue!

TeamSep 5, 2023

5 min read

Best Practices

Formative Study Frenzy: Why These Days Are Crazy-Making for Medical Device Engineering Teams

You'd think designing a user study for a new medical device would be a breeze, right? Just write up a script, ask all the questions, and watch the data roll in. But if you're an engineer...

TeamMar 20, 2026

4 min read

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