You spoke. We listened.
Expert Human Factors Help.
When You Need It. How You Need It.
Flat-Fee Human Factors and Usability Engineering and Regulatory Strategy Services for Medical- and Drug-Device Combination Product Teams - aligned with FDA, IEC 62366, and AAMI HE75.
We created HFUX Clinic for teams under pressure facing — FDA deadlines, internal design reviews, or regulatory audits — with no time to waste. Our flat-fee service packages give you direct access to expert human factors guidance, without the delays, confusion, or scope creep of traditional consulting. Check out our new HFUX Clinic services.
Clinic
about HFUX
HFUX Research is a medical human factors (HF), usability, and user experience (UX) consultancy specialized in MedDev, Pharmaceutical, MedTech, Biological, and Combination product research, design, and development. Founded in 2017, our mission is to empower organizations around the globe, at every budget, knowledge level, and development stage, from medical device and pharmaceutical startup to Fortune 500 leaders, to realize their HFUX visions and goals.
Our customized human factors and usability strategies and solutions are tailored to fit each client’s individual product research and development needs. We are committed to helping our clients design and develop the safest, most effective, and innovative human-focused devices possible, with superior usability and impeccable user experience.
2017
year
established
19
client countries
76
devices
supported
4253
users
interviewed
what we DO
After two decades of integrating human factors science and usability standards into the product research and development process, we realize that there is no one ‘cookie-cutter’ solution for all. That is why we believe in providing customized human factors and usability strategies and solutions tailored to fit every client's individual research and development needs.
research it.
Human Factors
and User Research
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exploratory research
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generative HF research
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real use user research
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observational field research
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contextual inquiry
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focus groups
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use scenarios and personas
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gap analyses
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expert reviews
design it.
User Experience and
Interface Design
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UX, HCI, UID design
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interaction design
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GUI mockups and wireframes
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hi and low fidelity prototyping
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information architecture
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device labeling and packaging, instructions for use, quick reference guides, and prescribing information
engineer it.
Human Factors and
Usability Engineering
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HF and regulatory strategy
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HF plan and use specification
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known use error and use-related risk analyses (URRA)
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task and workflow analyses
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FDA, IEC 62366, and MDR alignment and adherence
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gap and threshold analyses
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HFE FDA and MDR reporting
test it.
Usability Testing
and Validation
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remote usability testing
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formative usability testing
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summative usability validation
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heuristic evaluations
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A/B directional testing
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agile usability testing
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usability benchmark
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comparative use testing
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cognitive walkthroughs
