A Primer on Human Factors and Usability Engineering in Healthcare

May 13, 2019

Human factors (HF) and usability engineering (UE) are fields that focus on optimizing the safety and efficacy of product use. Ideally applied early in the product development process, this focus spans the physical, sensory, emotional, and intellectual capabilities of humans. HF and UE specialists are trained to recognize and understand human behavior, and trained to be aware of and identify behaviors that come with the introduction and adoption of new technology. When applied in a clinical setting, HF methods are necessary because regulatory agencies are requiring UE as part of the design process in order to prevent serious injuries and fatalities related to inadequate design and improper use.


Adapted from FDA’s, “Applying Human Factors and Usability Engineering to Medical Devices.

The healthcare industry is fast-paced and constantly growing. It is an incubator for innovation. Healthcare professionals are some of the most highly trained and perceptive minds in the world, but they are still human and thus prone to error. The clinical use environment can be extremely challenging due to rapidly changing patient conditions and significant differences in user preferences and training. The ability to foresee all possible scenarios and accommodate every unique user’s habits is nearly impossible. Using a combination of detailed interviews and thorough observations, we can better characterize and understand the range of conditions that affect device use early in the design cycle.

It is important to understand that technology itself is not what drives product success. Any successful new medical product must allow users to perform their jobs more efficiently, safer, and with better clinical outcomes. In many cases, the goal should be to shift the user curve such that the average user can perform at the same level as the most skilled users in their field.

Talking to a range of prospective users with varying degrees of expertise allows for a better understanding of use challenges and allows us to better understand design requirements. The process forms a realistic view of proper, and improper, usage workflows while guiding early project development planning. One of the first steps to facilitating proper use is understanding the people who use the device, their interactions with the device, and the environment the device will be used in. A proven method for structuring this information is conducting a task analysis, essentially a sequencing of typical tasks in the preparation and use of the device. When preparing a task analysis, a picture of who the intended users are and how each will interact with the device starts to become clear. Their different characteristics and their true needs can be better understood. For example, in a surgical procedure, the attending nurse, the physician’s assistant, and the surgeon each have different training, different roles in the procedure, and different interactions with the device. Understanding these differences is a quick method for effectively classifying tasks that are critical to proper use and tasks that may lead to device misuse. Identifying these critical tasks early on will focus planning efforts and drastically reduce the need for costly design changes in late phases of the project. Developing products with an early understanding of foreseeable use conditions allows the project team to address them proactively. More time becomes available to conduct tests and gather feedback. Gating functions and the intuitive and safe use of the device can be refined naturally as development progresses.

As part of the design cycle, it is up to the product development team to mitigate safety issues during intended device use, as well as to identify and address the potential for misuse. Users in the clinical setting are constantly being exposed to new devices and systems, further compounding the need for intuitive devices. It is our obligation as medical product developers to ensure that advances in technology will be safe for both the users and patients receiving treatment.

At Meddux, our philosophy, expertise, and processes support the necessary consideration of the safe and effective use of the devices we work on by getting humans involved early and learning from their experiences often.


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