Too many medical device makers fail to consider what happens once their product is in a patient’s hands, according to longtime U.S. FDA investigator Laureen Geniusz. The human factor tends to be “overlooked and not fully understood,” she warns. “Human factor,” also called “usability,” refers to the ways users–including patients and caregivers–interact with a device. Overlook this element and you jeopardize patient safety. In a recent presentation, she identified seven human-factor problems FDA investigators find when they inspect manufacturing facilities. Read this two-page paper to learn what they are so you’ll be able to improve compliance and enhance patient safety.