Even though it’s been a couple years since FDA published its human factors guidance, some medtech developers still wonder exactly how to conduct usability studies. At MD&M East, attendees will get to see such testing performed live at the Medtech Education Hub as the UL LLC human factors consulting team demonstrates a medical device usability test.

Allison Strochlic, research director for UL Human Factors Engineering (HFE), Wiklund R&D, tells MD+DIthat the team will demonstrate typical aspects of a formative test. These include a test session introduction, the presentation of representative “use scenarios,” and follow-up interviews. The test will be of a blood glucose meter, a device with hardware and software user interfaces that, if used incorrectly or misunderstood, could lead to end-user harm.

A formative usability test “is an evaluation that manufacturers should conduct ‘early and often’ during development to reveal a device’s interactive strengths and identify opportunities for improvement,” Strochlic explains. “Attendees will learn about the key characteristics of a formative usability test and how to conduct an effective usability test. We will share best practices for moderating such tests and for asking the questions that will enable you to rigorously evaluate your device.”

Strochlic (shown at right) says that medical device manufacturers with limited HFE experience “might consider usability testing to be a time-consuming, expensive, and daunting task. We will advise attendees on how to conduct quick, lean, and very effective usability tests to collect representative users’ feedback on a device’s evolving design without interfering with other development tasks or timelines.”

Medical device developers can’t afford to let any misconceptions deter them from conducting usability testing, given today’s regulatory environment. “While FDA and international regulators encourage manufacturers to conduct formative usability tests, doing so is not required per se. That said, regulators are increasingly expecting the steady application of HFE throughout device development, including at the early, formative stages,” Strochlic says. “Notably, there is a range of ‘formative evaluation’ activities that are acceptable and effective. We will clarify how manufacturers can scale formative evaluations, including formative usability tests, to best match their development needs.”

During the formative usability test demo, UL HFE team members will role-play as moderator and participant as Strochlic provides real-time commentary and shares tips for test conduct throughout. “After the demonstration, we will encourage attendees to ask questions to ensure we fully dispel any misconceptions about formative usability testing and provide any clarifications needed,” Strochlic says. “Attendees will walk away with an appreciation of how they can conduct formative testing to quickly identify device strengths and—more importantly—opportunities to improve a device’s use-safety, usability, and effectiveness.”

Source: MDDI+Qmed