Uninformed or resistant project managers might dismiss the practical and regulatory need for usability testing because their tight development schedule does not allow for such an activity. With myriad marketing, design, engineering, and regulatory activities filling the typical medical device development schedule, usability testing can seem like an added and perhaps superfluous burden. However, usability testing should not appreciably affect a medical device development schedule. In fact, it can accelerate schedules for the following reasons:

• Formative usability tests help development teams make design decisions and continue developing the design rather than stalling due to internal disagreements about user interface design issues.