Question 1

Usability testing

Accepted Answer

How will your technology be used in real clinical practice, and what risks emerge when it is placed in the hands of real users? Usability testing answers these questions by examining how users interact with a device in realistic contexts of use, identifying where use errors may occur and how they can be prevented.

We apply a range of usability testing and simulation methods to replicate real-world use, allowing us to observe user behaviour, interactions, and potential failure points. Our work is underpinned by structured risk management aligned with ISO 14971, incorporating Use Error Analysis and Human Factors FMEA (HFMEA). Errors are analysed across Perception, Action, and Cognition to understand root causes and inform robust risk minimisation strategies, supporting safe use, regulatory compliance, and confident adoption.

Question 2

User Research and Clinical Workflow

Accepted Answer

Have you clearly defined who your users are and what they need from your technology? User research is the foundation of any successful medical device. Understanding user needs, expectations, and real-world behaviour is central to human-centred design and essential for safe and effective use.

We conduct user research to define intended users, use environments, and clinical workflows in line with IEC 62366. Through ethnographic studies, stakeholder interviews, and workflow mapping, we capture both physical and cognitive interactions to ensure designs reflect real clinical practice.
We then analyse user interactions, critical tasks, and use scenarios to identify usability gaps and safety-critical issues. Gap analysis against IEC 62366 and AAMI/ANSI HE75 highlights where design improvements or risk controls are required to meet regulatory expectations and support safe adoption.

Question 3

Usability Engineering

Accepted Answer

Usability engineering is central to regulatory compliance and risk control in medical device development. We plan and deliver formative usability evaluations and simulation studies to identify and mitigate use-related risks early, using usability testing, heuristic evaluation, and realistic clinical scenarios to inform iterative design improvements and strengthen regulatory readiness.

We also design and execute summative usability evaluations to demonstrate that devices can be used safely and effectively by intended users under expected conditions of use. These studies are mandatory for FDA submissions and strongly recommended by the MHRA as evidence of compliance with IEC 62366. We produce complete human factors documentation, including usability engineering files, study reports, and clear traceability between identified risks, mitigation measures, and validation evidence, aligned with IEC 62366, ISO 14971, and relevant standards such as IEC 60601.

Human Factors, Usability and Regulatory Readiness