Do You Know Your Users?
Human Factors have many definitions around the globe, but the most official one is: “Ergonomics (or Human Factors) is the scientific discipline concerned with the understanding of interactions among humans and other elements of a system, and the profession that applies theory, principles, data and methods to design to optimize human well-being and overall system performance. Ergonomists contribute to the design and evaluation of tasks, jobs, products, environments and systems to make them compatible with the needs, abilities and limitations of people.”
This is easily understandable: Human Factors improve the interaction between people and systems. But who are these people mentioned in the definition?
As we all know, no matter how good a system is, it is impossible that it will fit the needs and expectations of all the people in the world. We are just too different!
When is the moment of designing or evaluating a medical device? And who are these humans that are so important to be part of the very discipline title (HUMAN factors) and mentioned three times in the definition? The answers to these questions are what could differentiate a well-designed/evaluated device from a device that will not be accepted or will suffer major issues (if it ever sees the market at all!!). So, knowing the answer to these questions could solve major issues in the design of the device.
But what are the answers? Well, “It depends”, is the only thing we can say. There is no definitive or generic “human” for medical devices. Take the example of a self-injecting pen, a CT scan and a COVID test. All three are medical devices, all three have different answers to the same questions. A self-injecting pen is used by patients, a CT scan by specialist professionals and a COVID test can be used by both.
So, there it is, easy peasy, you have the answer. Self-injector = patient, CT scan = professional, COVID = both. But who is responsible for teaching patients to use self-injectors? Are the CT scan professionals the same in the USA, Europe and Asia? What happens when a COVID test designed for healthcare professionals are now used by patients? Do the users have different educational backgrounds? Are there differences between different genders? What about height, and age, and children? What about the children, often overlooked!! As we can see the answers are not only vague but it is also very difficult to give one direct answer to each question.
Here at THAY, we perform studies to answer the very important question, “Who are/will be the users?”. We ask this question at every stage of the design process, from the beginning to conducting a summative evaluation (even though with different intentions and priorities) and using different methods, such as interviews, creation of “personas” and contextual inquiries. We can do this in a range of countries and in a variety of languages. To be sure that we can spot cultural or organisational differences that can influence differences in terms of acceptance and even regulatory compliance.
The fact that humans are very important in the Human Factors discipline does not come as a surprise. But that the question, “Who are your users?”, is that difficult to answer, is probably unexpected and, in fairness, many times underestimated.
We feel that knowing your device’s user is as important as knowing your device’s specification, so do not forget to get to know your users!