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You spoke. We listened.

HFUX Research human factors in medical device development

Clinic
 

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.

Medical Human Factors Experts in Medical Device Development

MEDICAL HUMAN FACTORS EXPERTS

IN MEDICAL DEVICE DEVELOPMENT

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.

human factors in medical device development
home - about HFUX

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

  • exploratory research

  • generative HF research

  • real use user research

  • observational field research

  • contextual inquiry

  • focus groups

  • use scenarios and personas

  • gap analyses

  • expert reviews

design it.

User Experience and

Interface Design

  • UX, HCI, UID design

  • interaction design

  • GUI mockups and wireframes

  • hi and low fidelity prototyping

  • information architecture

  • device labeling and packaging, instructions for use, quick reference guides, and prescribing information

engineer it.

Human Factors and

Usability Engineering

  • HF and regulatory strategy 

  • HF plan and use specification

  • known use error and use-related risk analyses (URRA)

  • task and workflow analyses

  • FDA, IEC 62366, and MDR alignment and adherence

  • gap and threshold analyses

  • HFE FDA and MDR reporting

test it.

Usability Testing

and Validation

  • remote usability testing

  • formative usability testing 

  • summative usability validation

  • heuristic evaluations

  • A/B directional testing

  • agile usability testing

  • usability benchmark

  • comparative use testing

  • cognitive walkthroughs

home - what we do
medical device usability testing and evaluation

Have questions on what HFUX  Research can do for you? 

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