Human factors in healthcare software: what it is, and why it matters
Gideon Awolesi ·
Human factors is the study of how people interact with a system, and how to design the system so they can use it safely and effectively. In healthcare software, it's the discipline that asks what happens when a tired nurse, an interrupted pharmacist, or a patient at home uses your product, and makes sure a predictable mistake doesn't turn into harm. In the US, it's usually called human factors engineering. In Europe and in IEC 62366-1, it's usually called usability engineering. They mean the same work.
01How it differs from UX
UX design asks if people can use a product easily and if they want to. Human factors asks if they can use it safely, every time, under the conditions they actually work in. The methods overlap a lot: task analysis, prototype testing, and observation. The difference is that human factors work has to produce evidence you can trace and keep, because a regulator will ask for it.
02Where it applies
It applies to software that's a medical device in its own right, and to software that's part of one, like the interface of a patient monitor or an infusion pump. It's also good practice for healthcare software that isn't regulated, like scheduling or clinical documentation, because a confusing screen in a hospital can still lead to a wrong decision.
03The standards and guidance
In the EU and in a lot of other markets, IEC 62366-1 sets out the usability engineering process, alongside ISO 14971 for risk management. In the US, the FDA's guidance on applying human factors and usability engineering to medical devices describes the process, and its guidance on the content of human factors information in marketing submissions, final since 29 May 2026, sets out what to submit.
04What a human factors study involves
- Describe who uses the product, where, and for what.
- Break the work into tasks, and find the ones where a use error could cause harm, called critical tasks.
- Design and test prototypes with representative users while you can still change them. That's formative evaluation.
- At the end, test the final design with representative users to show it can be used safely. That's summative or validation testing, and the FDA expects at least 15 participants from each distinct user group.
05What it looks like in practice
In a medical device project we worked on for Philips, a new clinical parameter was going onto its bedside monitors. Before any screen was final, we turned the clinical and engineering requirements into 14+ use scenarios, five safety decisions, and uFMEA inputs, so the clinical, risk, and engineering teams could review how the parameter should behave.
If you're preparing a submission, our Usability Review checks your usability engineering file against IEC 62366-1 and the FDA's guidance, clause by clause, in four weeks from €6,000.