In the first article of this series, we explored how a prevention first mindset strengthens the design of risk controls in medical devices. This second article builds on that foundation by examining how use related risk analysis (URRA) enables teams to anticipate, understand, and prevent use errors long before they reach the hands of patients or clinicians.
“If you want to create a great product, you have to start by understanding the people who will use it.” Don Norman
Understanding how real users interact with a device is central to designing for safety. IEC 623661:2020 formalises this through a structured usability engineering process, beginning with a clear use specification and the identification of user interface characteristics that influence safety. This early groundwork ensures that design decisions are informed by realistic user behaviour rather than assumptions.
Humans, however, are inherently variable. They make mistakes, take shortcuts, and behave unpredictably, especially in stressful clinical environments. For this reason, regulators do not accept “unlikely to occur” as justification for leaving critical risks unmitigated. ISO 14971:2019 is explicit: all risks must be reduced as far as possible, regardless of perceived probability.
Early URRA: Prevention at the Concept Stage
A prevention focused approach requires that URRA begin early, ideally during concept development. At this stage, design teams can explore how users might interact with emerging concepts and identify potential hazards before they become embedded in the design.
Early analysis offers two major advantages:
- It enables inherently safer design. Risks identified early can often be eliminated entirely through design changes rather than controlled through training or labelling.
- It avoids costly redesign. The later a risk is discovered, the more difficult, and expensive, it becomes to address.
Consider a device concept that must be held upright to function correctly. If early URRA reveals that users naturally attempt to operate it horizontally, the design can be adapted before development progresses. This is prevention in action: identifying a foreseeable use error and designing it out before it becomes a problem.
Iterative Risk Analysis: A Living Process
URRA is not a one off exercise. It should evolve throughout development, informed by each round of formative testing, design iteration, and user feedback. IEC 623661:2020 requires that usability evaluations, both formative and summative, validate that risk controls are effective and that the device can be used safely by its intended users.
Each iteration should:
- Document newly identified risks
- Capture refinements to mitigations
- Strengthen the narrative of risk based design evolution
This iterative approach demonstrates to regulators that the design team has systematically and proactively addressed use related risks, rather than reacting to issues late in development.
Thoroughness and Pragmatism
Design teams sometimes dismiss certain use errors as too unlikely to consider. Yet if a scenario is conceivable, and especially if it could lead to harm, it warrants attention. ISO 14971:2019 reinforces this expectation by requiring that all risks, even those perceived as improbable, be addressed.
Including unlikely but plausible scenarios is not only good practice; it also strengthens regulatory submissions by demonstrating thoroughness, realism, and a commitment to prevention.
Conclusion
Early, detailed, and iterative URRA empowers design teams to prevent issues before they arise, rather than relying on reactive measures later in development. It also provides clear evidence of a user centred, risk based design process aligned with ISO 14971:2019 and IEC 623661:2020.
Together, these two articles advocate for a strategic, prevention driven approach to medical device development: one that prioritises inherently safe design, thoughtful risk control, and early analysis. Prevention is not simply a principle; it is a practical, standards aligned pathway to safer, more effective medical devices.