The user experience (UX) should be the starting point of designing any product, according to Dorothy Shamonsky, Ph.D., chief UX strategist at Integrated Computer Solutions Inc., in an interview with MD+DI.  “Although some product ideas are born because a new technology is developed, ideally the process then switches to focusing on the user experience,” she said. “It still happens all too often that a product is designed by engineers and then once 90% complete, the user experience is considered—too late to make any significant changes.” Shamonsky will be speaking about medical device UX design challenges in the upcoming MD&M BIOMEDigital virtual event presentation, "The Complex World of Usability in Next-Gen Devices and Medical Robotics."

Shamonsky said that from a user’s perspective, UX is important because it means users can effectively reap the benefits of the device. “There is less training time, more ease of use and satisfaction, optimal device use, fewer errors in use, they are safer, and there are better outcomes from device use.”

From the product owner’s perspective, Shamonsky said, UX makes their product more effective with users and more saleable. This leads to better patient outcomes, preempts device complaints, reduces product liability, and facilitates the regulatory approval process.

However, there are some challenges manufacturers can face when trying to make their products more intuitive. The session’s other speaker, Milton Yarberry, director of medical programs, PMP, at ICS Inc., said that one challenge is that UX can be undervalued. “Some manufacturers think they know best how to meet the user’s needs and they undervalue the external view of the product, which, ironically, can be representative of their user base,” he said.

Another mistake some manufacturers can make is that they see usability as a soft topic, Yarberry said. However, he said that UX in the medical device sector is principally concerned with safety. “It is centered on how to avoid use errors rather than a feel-good user experience,” he explained.

Shamonsky said that undervaluing and misunderstanding UX design can lead to companies hiring young, inexperienced designers, “on the belief that it’s just about creating some pretty graphics or that it’s about bringing some cool, trendy ideas to the design. In the end, they don’t get much value from the work and it substantiates their belief that UX is not necessary or worth much.”

Many manufacturers have a conception of an intuitive product, but they have little experience in that type of design, Yarberry said. Some markers of intuitiveness are consistency of design from screen to screen; using industry norms for navigation, messaging, and colors; and work flows that are familiar to the intended users, Yarberry said, noting that an external perspective is better at balancing that.

The session will also present examples of successful incorporation of UX design. Yarberry described one such product that he is currently working on—an IVD automated test machine for diseases such as HIV, RVP, and COVID-19. He said the user interface (UI) was completely designed in an industry standard tool, Figma, and the UI was tested with stakeholders, and adjustments were made and iterated until it was mature. “Starting development with a very mature UI eliminates ripples of change late in the product and simultaneously aligns the development group, enabling them to implement quickly,” Yarberry said. “Basically, a front-loaded UX design saves redesign later in the project.”

When asked what they would like attendees to take away from their session, Yarberry said, “I hope that they see their product challenges as normative in the industry, and that there are known and productive solutions that are available that can meet standards like ISO 13485 and IEC 62304 and IEC 62366, while simultaneously saving them development time.” Shamonsky added that she would like to see attendees gain an overview of the process of product design.

While all are welcome, Yarberry and Shamonsky said their session will be especially useful for product owners, technical managers, product engineers, product stakeholders, and CEOs.

"The Complex World of Usability in Next-Gen Devices and Medical Robotics," will be presented at MD&M BIOMEDigital on April 7, from 9:30 to 10 a.m.