mobility aid showcasing great product UX design
summary
Good usability can be seamless. Poor usability can lead to user frustration, unsafe or ineffective use.
Human Factors (HF) refers to the ways in which a user interacts with a product. HF teams work to develop products that are inclusive and meet user needs, creating devices that are easier and safer to use. Drawing on psychology, anthropometrics and usability engineering, the principals of human factors influence a wide variety of high-risk sectors. From the perspective of compliance, regulations define how the risk of use errors is managed to ensure the safe operation of devices. Integrating analysis throughout the development cycle is key to preventing serious injuries or even fatalities linked to product use.

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Team exploring ideas and conducting user research
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Exploration and User Research
User research provides the foundation for the identification of risks and opportunities for refinement in the interactions.

The exploration and user research phase involves the HF team identifying and empathising with the end-users (and other stakeholders) of the device. The exploratory research can typically include; user journey mapping, persona creation, in-depth interviews, and focus groups. This research can also identify weaknesses in existing products, helping to shape more effective and innovative solutions due to an in depth understanding of the users’ pain points.

It’s important to start this phase with a clear product concept to drive the direction of research through thorough task analysis.

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Iterative Development Testing
Taking on the findings of the research, HF teams iteratively build and test concepts, continuously identifying possible directions for refinement. Bridging both physical and digital design, the development stage should cover all aspects of the product interaction.

Armed with the ability to empathise with users, internal design evaluation can be completed utilising rapid, low-fidelity prototyping. HF teams can quickly simulate product usage to identify usability issues, inefficiencies, and areas of potential confusion, providing the opportunity to further improve the devices ease of use, user satisfaction, and performance.

Testing early and efficiently allows HF teams to develop a deep understanding of the problems faced, furthering the drive towards innovative solutions.

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Formative and Summative User Studies
Formative (to inform design direction) and Summative (to validate design decision) studies are formal processes of gathering real-user feedback through simulated product use, as outlined in IEC-62366-1.

Our HF team are experienced in designing and executing complex usability testing simulations. Working alongside a network of trusted partners for recruitment and facilitation, we have successfully delivered studies across a diverse range of high-risk sectors.

Formative studies are expected to result in observed use errors. It’s important to invest the time in consolidating and categorising these errors before conducting thorough root-cause analysis to inform the direction of design iteration. Complex devices often need multiple formative studies to understand and mitigate risks.

User studies can also be a useful mechanism for evaluating point-of-care devices against CLIA certificate of waiver requirements (US only), ensuring that designs meet the highest standards for usability and safety in clinical environments.

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Packaging, Labelling, and Instructions for Use (IFU)
Packaging, labelling and use instructions play a crucial role in supporting users’ interactions with the device. These can include; instructions for use, quick reference guides, and user manuals, as well as the deliberate application of colour, material, finish and graphics, and should be developed in parallel with the rest of the design.

HF teams are experienced in designing all the instructional material required for usability testing, ensuring they remain on path to production and market release.

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HF Regulatory Requirements
HF teams are required to adhere to critical standards, including IEC 62366-1 and ISO 14971. When submitting a device file to the relevant approvals body, it is essential to provide traceable evidence of the insights and learnings gained from research and formative evaluations. This information constitutes a vital component of the Human Factors and Usability Engineering (HF/UE) file submission.

It’s important to clearly define the target market prior to starting development. HF teams provide support in preparing HF documentation from HFE plans, protocols and HFE reports for regulatory submissions in the US, UK, and EU.

OPD is also accredited to ISO13485 Quality Management standard.

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