Integrating Human Computer Interaction Testing into the Medical Device Approval Process

Abstract

Medical devices that utilize computer software are becoming common place in today’s health care environment. In this paper we examine device failures in the area of the human computer interaction—a failure of the interface between the hardware/software in the medical device, and the person using the device. We make the case that human computer interaction testing—starting early on in the product development life cycle—should be required before medical devices are approved by the FDA. Use of human computer interaction testing of medical devices can improve device quality and user experience, and most importantly, has the potential to reduce serious health care outcomes