Get Answers to Your Usability Testing Questions

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+DI that 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.” Allison Strochlic headshot copy.jpg Strochlic (shown at right) says that medical device manufacturers with limited HFE experience “might consider usab...
Source: MDDI - Category: Medical Devices Authors: Tags: MD & M East (New York) Design Source Type: news