Mobile Human Factors offers medical human factors consulting and testing services to develop safe and effective products, which in turn can create positive experiences and reduce legal costs. When seeking regulatory clearance or approval (510(k), ANDA, etc.), the FDA requires a human factors evaluation for many class II and class III medical devices and combination products.
What is Human Factors?
Commonly termed "Ergonomics" and often conflated with "User Experience" (UX), Human Factors is creating safe and effective interactions for how people sense, think, and act (also see IEA definition). Can the intended user hear a click, understand an important sentence, or twist a cap hard enough? Human Factors, applied appropriately and early, can answer questions like these before they become a costly problem, and frequently pays for itself in reduced legal fees and better sales.
Already working with a human factors professional?
Mobile Human Factors also provides a mobile facility for studies in a simulated home environment, priced competitively, no consulting service necessary.
- Higher fidelity with fewer study artifacts
- Move with your user population
- Complete with AV equipment
Looking for other services?
Human factors principles apply very broadly across many domains, not just medical devices. Wherever people interact with things, safety and usability are a part of it. Mobile Human Factors strives for flexibility and growth, and is willing to adapt to meet your needs.
Is Human Factors the same as UX?
While there is overlap between the two, human factors and user experience are not necessarily the same. The FDA is focused on the human factors aspect of a design, not the user experience.
Human Factors
Human factors is more concerned with safety and effectiveness, which sometimes may be achieved through design interactions that are intentionally negative, uncomfortable, boring, or bland.
HF and UX
Safe and effective interaction from good human factors work is often positive and marketable.
User Experience
User experience focuses more on creating a positive, marketable experience, which may come from something unsafe and thrilling or that is visually appealing at the cost of being difficult to use.
Can Human Factors fix all usability/safety problems?
The saying in the field is that there is no such thing as a perfect product. There will always be residual risks when a product goes to market. With this in mind, Mobile Human Factors works to:
- Discover the most common and most severe issues and fix them early on
- Inform product labeling to reduce the risk of issues that could not be mitigated through product design
- Prepare the manufacturer so they can make informed statements to the FDA of whether and why the residual risks are acceptable