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Do it by Design: How Usability Brings Value to Risk Controls
Are you still questioning if usability can truly impact medical device design? The answer is yes. Specifically, it plays a crucial role in controlling risks throughout the development process.
Guided by the IEC 62366-1 standard, usability engineering primarily focuses on the risks of use error, in order to design safer, user-centered products.
Enhancing Medical Device Safe Use Through Usability Engineering
Use errors are the primary cause of incidents related to medical devices. To avoid them, it is necessary to pay more attention to human factors and usability. To gain a clearer understanding of the role usability can play in medical device design, let’s take an example of a scenario that could occur in real life.
How could this error have been avoided? By focusing on users and the potential use-related risks when designing the infusion pump. For instance, setting dose limits could have been considered. This is where usability engineering plays a crucial role.
Medical Device Use-Related Risks
User-Centered Design Cycle
How to design for risk control?
Through the example of the infusion pump, we’ve seen how a poorly designed user interface can lead to use-related risks that can negatively impact patient safety. This underscores the need to integrate usability engineering early in the development process, starting from the concept phase of the medical device. Incorporating it too late in the process would significantly reduce its effectiveness in controlling risks.
Creating a checklist for use-related risks
IEC 62366-1 also suggests examining public databases like TPLC (Total Product Life Cycle) to collect information on any recalls that have occurred due to adverse events with similar products.
Applying a risk control approach
Integrating Usability and Risk Management Activities
Applying UX methods
When is it good enough?
This is the approach we take at CLEIO: our expert Human Factors Engineering team and Quality Assurance team work in close coordination. For the medical devices we develop, this means ensuring that risks associated with the user interface are mitigated and that overall residual risks are acceptable. All of this is done with one goal in mind: to create a product that is safe for both the patient and healthcare professional.