A workaround is often a design requirement that has not been recognized yet.
A workaround is often a design requirement that has not been recognized yet.
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Insights
Everything I publish on medical device human factors, collected here as full text so it can be read, cited and indexed properly.
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Simulated vs. Actual Use Testing
Most human factors validation testing happens under simulated use conditions. Actual use validation is possible, and sometimes necessary, when simulated environments cannot replicate critical user int…
Probability of occurrence. Risk vs HFE interpretation
Probability of occurrence is a common fight between risk management and human factors.
New FDA guidance Human Factors Medical Devices
Human Factors is having a surprisingly active summer at FDA.
Category 2 might expose your lifecycle HF problems
One of my favorite messages from the FDA town hall was this: “Human Factors and usability are aspects of a holistic medical device risk management process.”
The URRA is becoming even more important
One thing that became very clear to me during the recent FDA town hall is that the URRA is going to matter even more under the new submission framework.
We talk a lot about quality maturity in medical device companies. Why don't we talk about Human Factors maturity the same way?
Quality maturity gets a lot of attention in the medical device world. There are full programs and frameworks around it. FDA’s Voluntary Improvement Program is a good example. The idea is that quality…
New FDA guidance marketing authorization decision point D
Decision Point D in the new Human Factors guidance from FDA is not a shortcut. It is a stress test of your Human Factors system.
Sample sizes in HFE
One of the easiest mistakes in Human Factors is treating sample size like a fixed rule instead of a study design decision. There is no single answer, because sample size depends on what you are trying…
FDA guidance in human factors for medical devices from CDRH
You cannot just say “we comply with IEC 62366-1” and assume FDA will accept your Human Factors approach. IEC 62366-1 gives the usability engineering process. It tells you how to analyze, specify, deve…
Affordances in design
Continuing the series on basic Human Factors concepts. This one is about “affordances”.
Summative usability is not a pass or fail event, it is proof you understood and controlled your device’s real risks
Summative usability is not a pass or fail event, it is proof you understood and controlled your device’s real risks.
Defining critical tasks in medical devices
Defining critical tasks early sharpens your usability focus and protects against risk control surprises later.
The concept of Plain language
Plain language is one of those Human Factors concepts that sounds obvious until you start looking at real medical devices.
Cognitive load explanation
Cognitive load is one of those Human Factors concepts that often gets discussed but not always well understood in medical device development.
Critical task definitions
Critical tasks are not defined by difficulty. They are defined by consequence. A task becomes critical when getting it wrong could lead to harm. ISO 14971 gives us the risk management backbone: hazard…
Why summative is not a pass fail activity
Continuing the “Basic Human Factors Concepts for Medical Devices” series, this time I want to talk about why summative evaluation is not a pass/fail activity. Thanks to @Andreas for suggesting the top…
MDR requirements on human factors
MDR does not need a Human Factors chapter to expect Human Factors.
Why mitigating in IFU is not a good idea
Mitigating use-related risks through IFUs or manuals can look like the easiest option. But this is usually a weak control.
HF must understand why users do something
A lot of Human Factors advice in medical devices still stays too close to the method and too far from the user.
Different control measures and how it impacts
A warning is not the same as a design change.
IEC62366 methodologies in human factors
Too many medical device teams rely almost entirely on simulated usability testing.
HF is independent of regulatory categorization
I have lost count of how many times I’ve heard someone say, “We only need Human Factors because our device is Class II” or “That’s just for higher-risk products.” This is one of the most persistent my…
MedTech Human Factors for Everyone - Mental models
Basic Human Factors Concepts for Medical Devices: Mental Models
Different regions different requirements but same goals
One device. Three regions. Three different Human Factors questions. The goal is the same everywhere, safe and effective use by real people. But the way evidence is reviewed, and what counts as “enough…
Consistency in design matters
Consistency in medical device design matters. You cannot make creative interface decisions without understanding the consequences.
Regulators are not the problem for innovation
I see a lot of early MedTech companies blaming regulators on social media for slowing down innovation. I don’t see regulation as the problem. The issue is starting development without really understan…
Timelines in Human Factors
Human factors is one of the top reasons medical devices run into problems with the FDA after an initial submission. Yet many MedTech teams, especially newer companies, still postpone it or treat it as…
Hiring late HF experts
One of the biggest red flags in MedTech startups is hiring Human Factors experts only after the design is already locked. At that stage, the key assumptions have already been made, the workflows are f…
Leading language and biased scripts
Leading language pops up all the time during FDA reviews of the summative protocol. People often call it out as an issue, but it’s actually harder to spot than most expect. I find that the real troubl…
Understanding physical limits of users
I’ve been working in the medical device industry for over a decade, across various device types and sectors. Despite years of regulatory emphasis on understanding users and their use environments, I s…