Areas of expertise
Topics
The areas of medical device human factors I work in and write about, each with the full set of related articles.
Best practices
Good human factors work is mostly a set of habits: involving users early, writing use-related risk properly, and keeping usability engineering and risk management talking to each other. These pieces describe the practices that consistently produce defensible files.
8 articles
Regulation
Regulatory expectations for human factors move faster than most quality systems do. These pieces track what FDA, the EU MDR and the harmonised standards actually require of a submission, what changed recently, and how to prepare evidence that survives review.
7 articles
Concepts
Human factors carries a lot of vocabulary: use error, hazardous situation, critical task, use specification. These pieces define the concepts precisely, because imprecise definitions are where submissions and safety arguments start to fail.
6 articles
Process
Human factors fails most often for process reasons, not technical ones. These pieces cover how usability engineering fits into development planning, design controls and design history files.
2 articles
Summative
Validation is where every earlier decision is tested. These pieces cover summative study design, simulated versus actual use, participant numbers, root cause analysis of use errors, and how to report results credibly.
2 articles