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User experience design (UxD) has been applied in other industries for a very long time, especially on sectors like transportation and e-commerce. However, in other sectors, it has been seen as an expense. That was the case of the medical devices industry. Traditionally, the focus was on fulfilling the device’s purpose and getting it faster to the market.

Many manufacturers know now that user experience is not something to be underestimated and are taking steps to strengthen their focus on user experience (UX), embracing UxD and feedback-driven processes to deliver safer products.

Dangers of underestimating UX

Bad UX, for most, means something like a frustrating tab that will not go away while browsing an app or website, which is typically nothing major, resulting in an eye-roll or an inpatient screen tap. However, a poorly thought user experience can have quite a different impact when it comes to critical systems, including medical devices. UxD is part of much more vital systems and, here, bad UxD can be a matter of life or death.

For example, Jenny was a young cancer patient struggling with her disease for quite a long time when she started taking new medication at a hospital. This new treatment was so aggressive that she required pre- and post-hydration cycles for three days through intravenous fluids. The nurses looking after Jenny were responsible for entering the information into a corresponding software application. Sadly, however, the nurses missed critical information about Jenny’s three-day hydration requirements on the app’s interface. Jenny died of toxicity and dehydration the day after her treatment. The experienced nurses made this critical error because they were too distracted, trying to understand the app’s interface. The analysis found that the interface, overloaded with information, made it difficult to extract useful insights. Colour choices were not the wisest and drew attention to the wrong parts of the app. Even worse, some critical information was not visible on the app’s main interface at all.

The above example shows us one of the problems that might arise upon poor planning of UxD. In Jenny’s case, specialists overestimated human cognitive abilities. The information overload in the app’s interface did not allow the nurses to focus on what was crucial, and the system buried vital information.

UX at the front of medical device software development

Developing software responsible for the treatment and lives of patients is quite a challenge, and as we have seen before, design issues can generate devastating consequences. This means UxD needs to be part of the device development since an early stage. It is easy to understand how doing so could lead to less error-prone products. By addressing actual requirements from medical professional and patients, UxD enhances usability and helps manufacturers avoid unsafe and inefficient products that are difficult to use.

Effective UX not only increases safety but can also be a compelling selling point while decreasing the chance for recalls and therefore protecting manufacturers reputation and avoiding loss of revenue.

Still, many manufacturers look at UxD as a nice-to-have or just another way to delay and complicate software development. However, contrary to common belief, including UxD from an early stage decreases development times better defines priorities and makes adjustments early in the process, avoiding a redesign of the product on later stages.

If creating safer, more efficient and profitable products is not enough reason to include UxD at the centre of product development, regulation could do the trick.

All eyes on UX

Regulators are not indifferent to the impact that poor user experience can have and to the fact that more and more medical professionals and patients seek devices that mimic the kind of experience they have with their devices.

Naturally, authorities have developed regulatory frameworks when it comes to medical devices’ UX, including guidance documents from the US Food and Drug Administration (FDA), the upcoming Medical Devices Regulation (MDR) and the International Electrotechnical Commission (IEC) 62366-1 standard.

MDR’s General Safety and Performance Requirements state that a manufacturer should eliminate or reduce risks that are related to error use, implementing measurements that take account of the intended purpose, users and environmental conditions. Each device’s technical documentation should include information associated with usability activities, user feedback and any post-market surveillance follow-up.

The FDA chose a different approach; they have yet to create a standard but rather a guide with lists of requirements, regulations and activities that should be taken into consideration to ensure error-prone usability on medical devices.

Finally, IEC 62366 standard also focus on usability for medical devices by describing the device development process, including validation and testing activities of the user interface design.

How we do it at Critical Software

Many of the highest-profile and costliest system failures have poorly anticipated how users would respond to, understand, and use the system in question. We cannot look at operations and only consider their hardware and software aspects – we must also consider the users as part of that system. One needs to assess how people use critical processes to reduce operational errors, ensure safety and security, and optimise performance.

Understanding a design problem in its various facets and creating a valid and effective solution is a wide-ranging task. At Critical, we make this happen through discovery workshops based on design-thinking techniques. This process includes specifying goals and anti-goals, which means that we not only plan the things we want to incorporate into the design of a system, but we also organise the things we should avoid. We know that systems are often made up not only of hardware and software but the people that actually use them. Complex critical systems need to be built with how people use them in mind and therefore account for the use environment with a 360º contextual approach to design, as well as taking into account the realities of human cognitive abilities to avoid overloading users with information during critical processes.

To learn more about how to get UxD for critical systems right, we put together a pocket guide on the topic. Download it for free here.