10 years ago, while human factors were important in consumer products, they were not necessarily a common point of emphasis in the design of a product or medical device. In layman’s terms, a company or person could create something that was utterly uncomfortable, but because it was super cool, people really liked it. Increasingly both in the consumer market and in the medical device market, human factors have become more and more important to how a product functions and feels.

People get a little bit less patient when they can’t figure something out. One great example to point to is from the 1990s. Do you remember trying to program your VCR? Imagine trying to do that today to catch the finale of Game of Thrones! Nobody could program their VCR correctly. Versus today, we are all well equipped to record something or watch it on demand at our leisure. We are all in possession of very advanced cell phones which are driving our culture and that has spilled over into the medical device field.

Users today, in some cases, literally have their lives depend on whether or not they can actually use a device. Whether that is a patient-driven device where the patient takes it home with them or it’s at the hospital and the device is part of the critical care of patients. One of the big differences that have evolved between the consumer world and the medical device world is that doing human factors in the medical device world is now mandatory. Human factors are not an option.

Comparatively to the consumer market, where demand is not just driven by life or death use cases, but also “coolness” and “newness,” a developer can get by with a little bit less human factors. Perhaps it is not less, but human factors in the consumer space are not scrutinized to the degree that it is in the medical field. To be clear, it is not that they’re less important, the higher the risk, the more scrutiny it should have and does have. When viewed from the FDA, there are national and international standards in regards to human factors that have to be considered in medical devices that are not necessary for consumer products.

At HS Design, Mary Beth Privitera, serves as a Principal of Human Factors and Co-Chairs the AAMI Human Engineering Committee. Her background is as an industrial designer and she holds a PhD in Design with a focus on medical devices. Mary Beth explains that Human Factors are, “really about how users interact with products and systems, how do we interact with ourselves? It gets down to when we’re doing our work, it’s the tools, it’s tasks, it’s the environment and taking that all into consideration so that we have a little easier time doing our everyday tasks or when we’re on the job or our jobs, the tasks that we have to do related to our job.”

The relationship between patient safety and human factors in medical device design has a role in how devices are developed. There is considerable thought, effort, and energy that goes into how the devices fit into an overall system or platform that the practice of medicine goes into. In other words, if a designer is focused solely on the singular device of an anesthesia cart, how does that anesthesia cart speak to the phlebotomist cart so when they go on bypass they are actually talking to one another and is the overall system taken into consideration?

Mary Beth thinks that “In regard to promoting patient safety, that has also been a branch of human factors that has split a little bit. There are human factors as it relates to device design, but then there’s also the human factors that contribute to patient safety and literature that’s come out about the system to design. How can we identify and remove hazards of the design while it’s of the system overall? How do I handoff a patient from the OR to the recovery unit into the floor.”

In those types of situations, if you can avoid an obstacle, then understanding what the strategies to mitigate what the impacts are can help make the system or platform resilient, support adaptability, and improve the flexibility of human interaction. If you look at your cell phone, for example, the beautiful part of it is that you can make it your own. How can I make my work environment my own and enable those users to detect, adapt to recover from disruptions, disturbances, errors, hazards? That’s really the crux on human factors is to design systems and devices that are flexible and that enable the users to back out when they do have a problem.

“When you appropriately apply the Human Factors principles, you’re going to enable value-based care with the products and systems,” Mary Beth emphasizes. She continues to explain, “you’re going to end up with something that is desirable and that’s the key point here, the agency (FDA) just says it has to be safe and effective. Well, what about making it usable? What about making it desirable? I think when you start to look at the principles of human factors, it’s really about increasing the overall value and mastering that market to be efficient, to have fewer cuppers after it’s been released.”