Solving problems is simple. Understanding which problems should be solved is immensely challenging. Medical device design projects frequently begin with a search for solutions rather than a clear appraisal of needs. Understanding clinical needs, user needs, unmet needs and the differences between them is crucial. Through a process of filtering research into an array of needs the author prescribes a method to aid the designer in defining the overarching problem. This array can create a clear path to problem solutions while utilizing a methodology that fits in the context of a regulated design process. For medical device startups, design consulting firms, and corporate manufacturers, a clear understanding of the problem can mark the difference between a misguided solution and a solution that benefits physicians and patients.