Medical devices should be designed to provide the best possible user experience, while reducing the risk of errors that can result in harm, injury, or compromised medical care. To do this, 21 CFR 820:30 states that “…when designing a device, the manufacturer should conduct appropriate human factors studies, analyses, and tests from the early stages of the design process until that point in development at which the interfaces with the medical professional and the patient are fixed…”
However, in an interview with MD+DI, Gia Rozells, director of user experience design at Becton, Dickinson, and Co. (BD) said “many medical devices in use today were developed prior to these human factors guidelines and other regulations. Some of those devices may still exhibit human factors deficiencies that would be eliminated in products designed using current standards and requirements. Advances in medical technology, improvements in human factors engineering guidance, and more stringent requirements all serve to reduce the potential for use errors.”
Rozells will be speaking in the MD&M West 2020 session, "10 Ways to Design Error-Resistant Medical Devices," on Wednesday, February 12, from 2:05 to 3:00 p.m. in Room 210A/B.
Additionally, Rozells said, “Although some devices may have human factors deficiencies, the consequences of use errors can be benign. Other devices may be well designed to eliminate most errors, but the potential harm could be more significant,” she continued, “It’s important to realize that often multiple factors contribute to use errors.”
To reduce or eliminate use errors, Rozells explained “designers at BD employ processes that effectively consider the type of users, their workflow, the environment in which the product is used, and other potential influences. The design of devices used in complex systems with many interrelated factors should be most carefully designed for effectiveness and safety.”
Rozells added that “using proven design principles is one way to reduce errors and increase safety. These principles for medical device design are available from various sources. We’ve gathered 10 into a set of heuristics that will help attendees create good designs and spot designs that can cause use errors.”
She explained that some of the heuristics are fairly simple, but powerful. “For example, be sure it is obvious what state the device is in. Is it on or off? No matter what the device is doing, there should be a clear indicator to the user.” Other heuristics are not as obvious to designers, she said, such as Recall vs. Recognition. “The design should not rely on the memory of a busy user; instead, give users prompts and choices with the information they need when they need it.”
The session will also include interactive examples to allow participants to hone their skills at recognizing error-prone areas of their designs.
When asked what she would like attendees to take away from the session, Rozells said, “I hope they leave understanding that having a strong human factors/user experience process as part of product development will reduce use errors and improve the usability of devices.”
In this session, Rozells will be joined with Tim Goldsmith, a staff human factors engineer and user experience designer at Illumina; and Tressa Daniels, global director of human factors, Teleflex.
The MD&M West 2020 session, "10 Ways to Design Error-Resistant Medical Devices," will be held on Wednesday, February 12, from 2:05 to 3:00 p.m. in Room 210A/B.