Human Factors: Why it is Critical in Designing Medical Devices

Human factors helps design out  the opportunity for human error

“Most of the time spent wrestling with technologies that don’t quite work yet is just not worth it for end users, however much fun it is for nerds.”  ---Douglas Adams.

This quote hints at the importance of human factors in technology in medical device design and development. Rollin Fairbanks, director, National Center for Human Factors in Healthcare, talked about human factors and its critical role in medical device design at the PDA/FDA Joint Regulatory Conference in Washington D.C., Sept. 12-14, 2016.
Many issues or mishaps involving medical devices can be attributed to human error. However, instead of focusing on discipline, mindfulness and training of end users, Rollin stressed that human error cannot be eliminated, but it can be significantly reduced with the right approach to product design.

Two Approaches to Design


Fairbanks identified two approaches to device design and development: a person approach and a systems approach. With the person approach, emphasis is placed on procedural behavior through more training on procedures and processes. In contrast, the systems approach applies directly to the design and development of devices based on a number of factors obtained from observing how users interact with products and systems in their working environments.

“We don’t redesign humans, we redesign the system within which humans work,” said Fairbanks. The goals for a systems approach is to design out the opportunity for human error, as well as predict inevitable errors and mitigate their impact. Medical devices that require little conscious attention allow users to focus more on the task.

What Is Human Factors?

One of the earliest and most critical steps in the medical device design process is to differentiate between the customers and intended users. These are often different people, which presents the challenge of balancing the needs and requirements of both, but it is a critical delineation to encourage the safest, most usable design.

Human factors is the process of observing and gathering scientific data about human behavior such as learning styles, abilities and limitations and also the environment where the product will be used. “This helps you design products that can be intuitively used by the intended users to complete specific tasks effectively and efficiently,” said Fairbanks.

What Human Factors Is Not

Human factors engineers strive to optimize human performance by designing systems to match the cognitive and physical capabilities of users. This is not achieved with questionnaires, focus groups or simply by having an industry professional such as a physician or nurse on the design team. There’s a gap between how designers believe work is being done and how work is actually done. The purpose of human factors is to bridge that gap.

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Use Real-World Observations

It is obvious that fully understanding what users want and need leads to better, more suitable devices. It seems logical that you could learn what you need to know by simply asking users what they want and how they prefer to perform tasks. However, relying solely on what people say doesn’t always reveal an accurate scenario. As automobile maker Henry Ford once said, “If I had asked people what they wanted, they would have said faster horses.”

What people say often fails to match what they actually do, let alone what they actually will do in some hypothetical situation. You need to observe users in their element. This allows you to ask questions that users can answer from perception rather than memory and pick up on details that the person being observed may not notice. This also reveals which tasks or processes are routine and which ones require more conscious attention from the user.

Incorporating human factors early and often throughout the device design process results in a better, safer and more usable product. In addition, you can proactively avoid the high costs associated with device recalls and making changes to designs late in the development process.

The cost and complexity involved in applying human factors and usability engineering to your product development can be scary and might compel you to overlook this critical component of product development. On the contrary, employing a systems approach to design actually gives you an opportunity to develop a better and more lucrative product.

What is your experience with human factors in product design and manufacturing? Please comment below.

David Jensen is a marketing communication specialist at MasterControl. He has been writing technical, marketing and public relations content in technology, professional development, business and regulated environments for more than two decades. He has a bachelor’s degree in communications from Weber State University and a master’s degree in professional communication from Westminster College.