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what we DO
research | design | ENGINEER | test

At HFUX  Research we consider our priority to be the users’ and patients’ advocate. Verbalizing their needs, ensuring their safety, and elevating their user experience through innovative and intuitive human-focused design. 

Human factors isn’t just a regulatory requirement to us; it is our philosophy.

Our goal is to provide customized human factors and usability strategies and solutions tailored to meet each organization's research and development needs. We want to help our clients to achieve their human factors vision and usability goals and empower them to design and develop the safest and most effective products possible.

medical device development human factors engineering

​Whether you are looking to...

... discover our research, design, ENGINEER, and test services below and learn more about how we can help you in realizing your human factors vision and usability goals.

Contact us now to get your human factors project started >


human factors abd user research

research it.

...qualitative and quantitative human factors and usability research methods...

  • ethnographic studies 

  • field observations

  • use scenarios and personas

  • gap analyses

  • contextual inquiry

  • focus groups

  • in-depth interviews

  • surveys and questionnaires


factors & user

From uncovering new market solutions to exploring cutting-edge design solutions, human factors research is the key to understanding user behaviors, needs, and motivations. Identifying the problem your product is looking to solve and discovering unarticulated or unmet needs prior to development beginning, and capturing a complete understanding of the users’ requirements and their environments in the context in which they are intended to use your product, is not only vital to facilitating a safe and satisfying user experience, but essential to the success of your product in the market. 

HFUX  Research can assist and guide you and your team in the identification, planning, and execution of your customized human factors research strategy and solutions, to help you achieve your research goals.

HF Research

...diverse user experience and interface design approaches...

  • wire-frames and user interface low- and high-fidelity prototyping

  • information architecture

  • interaction design 

  • user interface design, structure, and layouts

  • instruction for use (IFU) design, development, and evaluation

  • user interface characteristics

  • design evaluations and recommendations


user experience
& interface

If human factors research is the key to understanding user behaviors, needs, and motivations, then user experience design is the creative process to integrating such into your product design. It requires a cross-discipline perspective that considers and addresses all aspects of your product, interacted with and perceived by the user, with the purpose to create a useful, easy to use, and delightful user experience.


In medical device design, elements of safety, use-related risk mitigation, and regulatory requirements, add to the complexities of great user experience and interface design. This can represent unique challenges to a design team and the development of your product’s optimal user interface (design).


HFUX  Research can assist and guide you and your team in the identification, definition, rendition, and evaluation of your customized user experience design strategy and solutions, to help you enhance your product’s usability and safety, and achieve your design goals. 

design it.


user experience and interface design
UX Design


human factors and usability engineering


...comprehensive human factors and usability engineering...

  • HF/UE strategy, approach, and SOPs

  • HF/UE plan and templates

  • user needs and product requirements

  • task and workflow analyses

  • known use error and use-related risk analysis 

  • use scenarios and tasks, critical & essential 

  • user interface characteristics and specification

  • develop FDA HFE report / EU UE file


factors & usability

By now it has become common knowledge that human factors engineering (HFE), also known as usability engineering (UE), is required as part of most medical device development. But aside from its regulatory use-related risk mitigation and design validation purposes and advantages, HFE/UE is so much more than that. HFE/UE has demonstrated, time and time again, that the application of knowledge about human behavior, abilities, limitations, needs, and motivations leads not only to safer and easier-to-use device usage, but also to increased effectiveness and enhanced user experiences through superior human-focused design (and user interfaces). 


But from FDA guidelines, to ANSI/AAMI/IEC 62366 standards, to MDD/MDR regulations, and their continuous changes, human factors and usability engineering can be mystifying and quite the undertaking. When to human factors and when not? And if so, how, where, and with who? How to fulfill both, US and EU, HFE/UE requirements, and perform parallel design validation. 

Take advantage of our extensive in-depth experience and allow us to demystify the HFE/UE process and its requirements.

HF Engineering

...wide-ranging user and usability testing methods...

  • usability/cognitive walkthroughs

  • heuristic evaluations and expert reviews

  • A/B testing

  • (agile) prototype testing

  • focus groups and F2F interviews

  • benchmark and comparative testing

  • surveys and questionnaires

  • formative and summative usability testing

including: participant recruitment and compensation, test planning and test site logistics, test protocol development, pilot testing, test moderation, data collection, analysis, and synthesis and results and reporting


evaluation &

The term ‘usability’ is a multi-dimensional quality that refers to the ability of a human to interact easily and relatively error-free with a product or system. Understanding the usability of your device comes down to understanding the three key factors: device users, use environments, and device tasks and user interface touchpoints. Usability testing allows you to gather these key insights, enabling you to measure your device's capacity to meet its intended purpose with its (real) intended users.

Whether you are looking to understand how users feel about your device or how your device performs in relation to its competitors, down select your user interface designs, establish users’ preferences, or even perform final design validation/summative usability testing,

You find FDA summative usability testing intimidating? Don’t worry, HFUX Research will guide you through the entire process, and assist you every step of the way, covering all key testing aspects and activities. Together we will ensure that your usability test, approach and method, is the ideal one for you and provides you with the insights you are looking for.


test it.

human factors and usability evaluation and testing


medical device and combination product FDA human factors
Usability Testing
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