Successful medical device design entails an understanding of stakeholder-driven requirements early in the process to assure device safety and usability and support successful and positive patient experiences. Prototypes can be used during stakeholder engagement in the design front end to gather information to inform design decisions. However, an understanding of medical device industry practices of front-end stakeholder engagement with prototypes is lacking. Through interviews with medical device design practitioners, this study explored the variety of stakeholder groups engaged by design practitioners, prototype types used during stakeholder engagements, and settings in which engagements took place during front-end design activities. This study describes the 14 types of stakeholders, 14 types of prototypes, and six types of settings described by practitioners as well as patterns across engagement strategies, stakeholders, prototypes, and/or settings in front-end activities. These outcomes can contribute to broadening designers' stakeholder engagement planning and practices.

Prototypes have the potential to provoke discussion and to encourage stakeholders to play an active role during design engagements in the front-end phases of a design process. However, detailed descriptions of stakeholder engagement strategies in front-end design are lacking. The aim of this research study was to understand how design practitioners prepare and manage stakeholders for engagements involving prototypes in the front-end phases of a medical device design process. Design practitioners at companies developing mechanical and electromechanical medical devices for use in low- and middle-income countries were interviewed following a semi-structured interview guide. Interview transcripts were analysed, and inductive codes were developed. The findings suggest that design practitioners manage the group composition of stakeholders, review the project and prototype(s) with stakeholders at the start of the engagement, and show the progress of prototypes to stakeholders over multiple engagements. These strategies shed light on the importance of handling interpersonal relationships during stakeholder engagement with prototypes.