By Jean-Marc Bonnaudet, Published: August 7, 2012
A good user experience leads to satisfied users who can use their products in an effective and efficient manner. How does this apply to healthcare? Well, it is great to have physicians and nurses satisfied with the use of medical devices. If additionally their use are efficient too, this is even better: it increases productivity, saves costs, waiting time and... in cases of emergency, efficiency can make the difference between life and death.
Now what about effectivity? According to ISO 9241, effectivity is the accuracy and completeness with which specified users can achieve specified goals in particular environments. That is a must have in healthcare: without accuracy and completeness, diagnostics and treatments would be compromised. Maybe recovering health will be slower. Maybe this will cause injuries, maybe even fatal injuries.
In healthcare, designing the experience is therefore directly linked to risks. Risk management is indeed required in the development of medical devices with the norm IEC 14971. But how to avoid or reduce risks related to use errors? The answer resides in applying the user-centered design process, allowing not only to optimize the usability of the products, but in the case of medical devices, this is the way to recognize, mitigate and eliminate or at least reduce the risks. This process is closely inter-related with the risk management process.
For this reason, following and documenting the usability engineering process is required since 2007 for all medical devices from the international standard ISO/IEC 62366. Following it allows the devices to be compliant with the safety requirements related to use errors of medical devices regulations.
About the author
Jean-Marc Bonnaudet works at Storz Endoskop Produktions GmbH, developing safe, effective, und efficient solutions for minimal invasive surgeries.
(Image: Petr Kratochvil)