Research out of the box


Contextual inquiry is an integral part of our research process, and over the years we have used it across multiple research projects within the consumer, medical and industrial sectors. More recently we have been using it in a clinical setting, which has helped further our understanding of all aspects of using a medical device in the real world. This has given me insight into the research process that I would like to share with you.

I believe that contextual inquiry has huge value in understanding the user in their typical environment. And it is not just me that thinks so: according to the US Food and Drug Administration’s (FDA) Draft Guidance for User Research in Medical Device Design, contextual inquiry “necessitates an understanding of how users interact with the medical device in the actual use environment. This understanding can only come from user input and observation.”

So what is it? Contextual inquiry is a method of research that makes deeper understanding possible. It involves observing users in the environment where they typically carry out the task to gain a realistic understanding of their behaviour.  For example this could range from a surgeon carrying out a procedure in an operating theatre, a person applying mascara in their bathroom or a pilot flying a plane. In short, it allows us to understand the context in which they are carrying out an activity and this in turn helps us to design products and services that fit the user to their environment.

This methodology is also supported and encouraged by the FDA. They recommend contextual enquiry as a valid formative (i.e. early stage) research method. Contextual inquiry can also provide valuable insights which can be used to form the foundations of a use specification, an integral part of a human factors engineering file. Contextual inquiry is particularly valuable during the early stages of a development programme, as it helps designers to better understand their users and the environments where their devices will be used. Understanding these requirements from an early stage also helps to reduce design decisions being made on assumptions and guess work.  

Recently, we have been using contextual inquiry to help inform the development of laparoscopic surgery (keyhole surgery) tools. Whilst clinical training simulation centres and usability testing facilities provide a practical and controlled environment for later formative testing, it was necessary to observe a real life procedure to truly understand the design requirements.  By immersing myself in the surgeons and his operating theatre team’s working environment it became no longer about them demonstrating what they thought I might like to see as a researcher. Rather, it was about how the surgeon and his team interacted with their tools and equipment, and the associated environmental challenges in a truly naturalistic manner.   

Adopting this approach allowed for more longitudinal observations, resulting in a holistic and detailed understanding of the realities of using laparoscopic surgery tools in real use scenarios. For example, we were able to identify postures that could potentially result in repetitive strain injuries for the surgeon. This became apparent when we saw that surgery tools were often held in unsuitable positions for the four hour duration (or more) the procedure took.  There was also time pressure and evidence of fatigue as the procedure continued.  Again, these insights helped our designers and engineers make informed decisions to develop more functional tools suited to their environment.  

Contextual inquiry proved to be an invaluable tool in the development of new laparoscopic surgery tools. Additionally, by involving our clients in the study fieldwork they gained valuable first-hand experience of the considerations and challenges which need to be taken into account when developing initial design concepts.   

Whilst contextual inquiry clearly offers significant value when developing a medical device, the same methodology can also be applied to other tasks and scenarios in the FMCG sector such as understanding how people use shampoo or brush their hair.

In short, if you step outside the box of the usability testing facility and look around the many different environments people are living and working in day to day, you can learn so much more. By achieving a greater understanding of the context that a user lives and works, we can all begin designing products and services that are safer, easier and more enjoyable to use.

Robin Hancock (Senior Human Factors & Usability Researcher)