Medical devices are used by a multiplicity of users and in a variety of environments. Manufacturers of these devices will therefore need to be aware of differences in skills, needs, abilities and preferences among users, as well as the requirements that pertain to different contexts of use, whether they are in the hospital or the home.
It is well established that medical devices should be designed to fulfil the requirements of the user. Recent research has demonstrated the clear links between the design of medical devices, poor usability, human error and patient safety. As a result of this, it is now a legal requirement for medical device manufacturers to address the usability of their products before they can be placed on the US and European markets. Manufacturers have to provide evidence, through compliance with standards such as ISO/IEC 62366 and HE75 that they have applied ‘human factors engineering’ (also known as user-centred design (UCD), ergonomics or usability engineering) throughout development.
However, as well as improving safety, a user-centred approach to development can have many additional benefits, such as improved effectiveness, ease of use and learning or training, fulfilling hygiene requirements and addressing maintenance, servicing, storage and labelling. In addition, attention to factors such as comfort, aesthetics and portability will improve the patient experience and may improve adherence to treatment regimes. In this article we discuss the crucial role of the end-user in the medical device product pathway, and describe how to conduct practical yet meaningful user research at each stage of development.
Craven, M., & Martin, J. (2011). Ergonomically sound. [Magazine article and Webpage http://www.samedanltd.com/magazine/11/issue/158/article/3028]