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Abstract Stakeholder engagement with prototypes during the front-end phases of medical device design can support problem identification, problem definition, and early concept generation. This study examined what prototypes were leveraged to engage specific types of stakeholders during front-end medical device design. Analysis of semi-structured interviews with 22 design practitioners in the medical device industry revealed some common associations of prototype choice for particular stakeholders. A few associations are highlighted: designers engaged users with physical three-dimensional (3D) prototypes, financial decision-makers with physical 3D and two-dimensional (2D) prototypes, government and regulatory stakeholders with 2D prototypes, and expert advisors with digital 3D prototypes. The rationale provided by practitioners revealed the intentional selection of prototype form for specific stakeholder engagements. 

Abstract 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.