Towards Crowd-Based Needfinding in Medical Device Development¹

Public and private institutions invest over $100 billion annually in biomedical research [1]. These funds can be misused and the value diminished if the engineers and clinicians are not aligning work with areas of clinical need [2]. As medical device developers have pointed out, “Get (the clinical need) right and you have a chance, get it wrong and all further effort is likely to be wasted” [3, p. 3]. Needfinding is a formal tool within the design cycle used to fully understand the problem, particularly when involving human behavior [4]. While effective when used, these methods are reported to be underutilized in healthcare practice [5–7] due to unique challenges in healthcare [8,9]. This lack of early stage input can lead to unnecessary investment in new projects already destined to fall short of the potential clinical improvements...