The tried-and-true methodology for designing medical devices starts with product ideation and rapid prototyping. But the most vital step starts before product ideation-that is, identifying the unmet clinical need. Starting with clear identification of clinical need may take time to fully elucidate and, importantly, may change over time as clinical practices, medical knowledge, and scientific discoveries change the field. Developing tools to address these unmet needs is the goal for medical device developers. When we start with developing tools that address unmet needs, the tools inherently provide added value.Conversely, tools are often developed to implement new technologies without a clear understanding of the need being addressed.