Medical Device Development: Prototypes, Stakeholders, and Settings. Poster #81 POSTER INNOVATION Friday 14 December 2018 Medical Device Development: Prototypes, Stakeholders, and Settings. Authors: Marianna J. Coulentianos1, Ilka Rodriguez-Calero1, Jocelyn Burridge2, Dr. Shanna Daly3, Dr. Kathleen H. Sienko2,3 1Design Science, 2Biomedical Engineering, 3Mechanical Engineering – University of Michigan Contact: Marianna Coulentianos mjcoul@umich.edu 1 3 Counts per person DEEP GO/NOGO TECH MAINTENANCE 1.4 1.4 RELIABILITY 1.1 1.1 FUNCTION 1.0 0.9 PERFORMANCE 0.9 0.8 USABILITY 0.6 0.8 Findings Motivation Although the medical device design process has well established methods for stakeholder engagement using prototypes including usability testing (1), the front-end phases of the process lack clear guidelines for stakeholder engagement with prototypes. The aim of this research study is to describe, in companies developing mechanical and electromechanical medical devices, the various prototypes used by design practitioners to engage stakeholders in front-end design, the stakeholders engaged, and the engagement setting Prototypes used for stakeholder engagement in the front-end of medical device design 2 Methods Companies Total medical device companies: 17 Global health companies: 9 Multinational companies: 8 Stakeholders engaged in the front-end of medical device design Participants 24 interview respondents 4 Conclusions Design practitioners in our study: Used both 2D and 3D prototypes with various levels of fidelity in front-end design. Emphasized the use of prototypes with end users, but also leveraged prototypes with a variety of other stakeholder types and set distinct goals to achieve with these other stakeholders. Incorporated prototypes into interviews and short design activities with little resource investment into the setting. Findings indicate no one right prototype type, stakeholder group, and usage context, supporting the idea that these choices should be made strategically to align with articulated goals. Acknowledgements We thank all study participants. This work was supported by the EAGER NSF grant number 1745866. References Wiklund ME, Kendler J, Strochlic AY. Usability testing of medical devices. Boca Raton, Fl.a: CRC Press; 2011. 374 p.Privitera, M. B., Evans, M., & Southee, D. (2017). Human factors in the design of medical devices – Approaches to meeting international standards in the European Union and USA. Applied Ergonomics, 59, 251–263. https://doi.org/10.1016/j.apergo.2016.08.034 Settings for stakeholder engagement in the front-end of medical device design (neutral room) Hospital (operation or patient room) Disclaimer: The presentation of this material does not imply any endorsement or recommendation by WHO. WHO disclaims any and all liability and responsibility whatsoever for any injury, death, loss, damage, use of personal data, or other prejudice of any kind whatsoever that may arise as a result of, or in connection with the procurement, distribution and/or use of any technology presented in the 4th WHO Global Forum on Medical Devices.