When previously working as a design engineer for a medical device manufacturer I was not always exposed to the end user of the device I was developing. Due to the pressure on resources, time required to arrange testing or the complexity of negotiating hospital access this activity was frequently put on hold. It was also assumed that the upfront user research had already been done from previous usability research / studies from predicate devices or research conducted by business development. However, early exposure to the end user is necessary to understand the context of the device with the appropriate stakeholders; the exposure allows the engineers to understand the effect on the end user of the product being developed. In my own career, attending hospital visits and conducting studies in simulation centres was when I truly understood the value of gaining exposure to the end user. From a Human Factors perspective I have been lucky enough to observe orthopaedic and gynaecology surgeries, a hip replacement, spinal fracture surgery and a hysterectomy, all as delightful as you’d imagine. Nevertheless, those visits not only helped me understand the impact of the work that I was doing but also triggered my interest and formed the basis of my career in Human Factors, sensitising me to the difference that medical technology can make.
Now, as Senior Human Factors Consultant at PDD, interacting with the end user is an essential part of my role. Across ethnographic research, heuristic evaluation, formative / summative studies and clinical observations, end user needs are at the forefront of our work. As interesting and insightful as interacting with the end user can be, there can be logistical issues with any usability study. Currently I’m working across a range of user groups with a variety of medical conditions and each one brings with it a particular set of challenges.
For example, in recent months I have conducted formative usability evaluations, evaluating two different drug delivery devices for two very different user groups. The first user group consisted of self-injecting patients as young as 7 years old and the second, Alzheimer’s patients up to the age of 70 years old. When working with varied user groups a researcher / moderator has to be flexible in the hours or days the studies are conducted; late evenings and weekends, for example, had to be included to evaluate the children outside of school hours. For the Alzheimer’s study the recruitment target was intended to be participants with mild to moderate forms of the Alzheimer’s; it was challenging to recruit participants with a specific condition severity when such a condition can sometimes change on a day to day basis and the professional medical diagnosis may differ slightly on the particular day of the study.
Aside from the initial logistical issues, the main challenge of those particular studies occurred during the evaluation sessions themselves. The first challenge was the fidelity of the drug delivery device being assessed. As expected from a prototype, the device did not perform to its full functionality and some features were difficult for the children to use. In comparison, when assessing what seemed to be a straightforward task during the Alzheimer’s study, I witnessed a live change in some of the patients’ conditions, with some showing signs of severe Alzheimer’s. This affected their ability to compute simple information in the instructions for use and compromised their ability to use the device safely. For both cases as a moderator I had to firstly assess the risk (if any) the prototype device could pose to the user and if needed, provide enough assistance during the study not to disturb the flow but to ensure the participant was safe, felt happy to continue and the outcome of the results are were not affected.
When seeing any person struggle (physically or cognitively) it can be emotionally challenging; however as a moderator it is important to ensure that the participant is happy and comfortable to continue so that the team can continue to gain valuable feedback on the device. As a moderator it can be difficult not to intervene, naturally we want to help the user when they are showing signs of difficulty related to their condition while using the device.
Observing product use, receiving feedback from participants, understanding the root cause of any difficulties or use errors and identifying unanticipated risks are the main goals of a usability study. This information can be fed back to the design team and the design of the device can be adapted to ensure safe and effective use and enhance the user experience.
As a usability consultant I may not have been directly involved in the design of the device but it is still rewarding to be part of a process of bringing a new product to market. As a moderator you have a front line position in terms of receiving feedback regarding the use of the device. It is not always an easy place to be but the outcome is always rewarding. For both formative studies, regardless of any issues that were experienced, both groups (Alzheimer’s patients and self-injecting children) believed that the devices would be an improvement on their current methods and would improve their quality of life while helping them manage their conditions. The work that we do is an essential part of making sure that those particular devices can be brought to market without compromising safety. It is rewarding to observe participants become excited at the prospect that one day the prototype device may be available for actual use and to know that your work contributed to that development.
The next Human Factors blog will discuss further moderator tips by my fellow colleague Hollie Johnston.
For upcoming Human-Centred Design workshop dates visit www.pdd.co.uk/capabilities/#innovation-training.