What Should Engineers Know About User-Centered Design?

Before you get started on any medical device design engineering project, it is essential to understand user needs, explains Philip Remedios, CEO and director of design & development for BlackHägen Design. The company and MEDevice Boston exhibitor is a multidisciplinary human factors engineering and product design firm that works with start-ups as well as large multinational medical device companies. 

Human factors engineering is an important and rapidly growing discipline, Remedios tells Design News. “Fifteen years ago, FDA began taking a serious view that use-error is a serious safety issue for patients. Previously, a user-error risk-management approach placed the burden on clinicians to mitigate operational errors, which was not particularly effective as devices often were difficult to use in a safe manner. The adoption of a use-error approach placed the responsibility on manufacturers to demonstrate that they designed devices that were more intuitive and easy to use, which enhanced operational safety” he says.

“Currently, human factors engineering is a design-controls requirement for Class III devices and many Class II,” he continues. Manufacturers need to “understand the end-user and evaluate through task analyses and user-evaluation testing that the device is as simplistic to operate as possible in all intended use-cases.”

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User needs are typically gathered during a contextual needs study or inquiry (CI), Remedios explains, whereby researchers observe user:device interaction in their typical work environment. "This 'contextual' element provides a more holistic and real-world understanding of user challenges, including adverse influence from the workplace and from adjacent devices," he says. While product designers might not always be directly involved in such “discovery” studies, the results of those studies "provide robust design inputs to guide the development process from its inception."

Understanding product use by observing users during CI research is a powerful and insightful tool. “Observation allows creative research beyond what study leaders are told,” Remedios says. “By observing user-implemented workaround solutions to poor or incomplete device design, professional designers can find a better way to solve the problem.” 

Focusing on user needs and user-centered design may also present an opportunity for innovation. “Don’t start on an incumbent design or competitive product that just focuses on the current state of the art,” he says. “Focus on what does or doesn’t work for users. Ask why it doesn’t work and explore how to improve operational performance.”

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It also helps to find out “what users wish for,” he adds. "Understanding user aspirations often drives new features and processes that define next-generation designs."

It is important for design engineers to examine the findings from such user research. “If you don’t know what the problems are, you could make a brand-new product just as bad as the product you may be trying to improve,” he says.

Design engineers may also find it helpful to collaborate with firms like BlackHägen, which works with companies to conduct human factors engineering studies and support R&D teams develop superior and insightful design inputs and concepts.

Such collaboration among engineers from multiple disciplines and functions encourages the “cross pollination of ideas," which is a great way to generate real innovation, Remedios says. Without other perspectives, “you may be too close to your product and industry legacy practices to see something different, distinctive, and, frankly, better.

“How much evolution do you want?” he asks. “If you want disruptive innovation, bring new people in. Be open to new ideas from new employees, marketing, and outside help,” he says. “The best engineers say, ‘I do the best that I can but embrace the strategy of bringing in outside help to help me meet project design goals more effectively.’ ”

Remedios adds that, by design, industrial designers frequently “come up with five or more discrete ways to do something while not falling in love with any one solution. They merge good ideas from different concepts into a final, better product, avoiding a serial, iterative development process that usually lacks creativity.”

To learn more about user-centered design, visit BlackHägen at the upcoming MEDevice Boston, an MD&M event, September 25-26 at Booth #432.