Published online by Cambridge University Press: 26 May 2022
Numerous and complex sequence of activities in medical device development often result in time consuming and expensive engineering processes. In this study, patient and designer requirements were identified and integrated within a novel framework which supports medical device design through a consolidated understanding of user-experience whilst directly coalescing the applicable regulatory requirements in terms of product compliance and certification. This assists in the development of safe and reliable products which reflect the need for increased usability considerations during design.