Lauren Aquino Shluzas, Larry J. Leifer
Center for Design Research
Department of Mechanical Engineering
Stanford University Stanford, CA 94305
An inductive, multi-case analysis was conducted to examine how design and development practices involving physicians and medical device developers influence outcomes in entrepreneurial medical device companies. The study revealed practices that contributed to the success or failure of rival product pairs across four clinical areas. Practices specific to each phase of technology development were documented, in addition to practices associated with four strategic areas: gaining design and market insight, maximizing product benefits, managing stakeholder expectations, and increasing financial and intellectual property strength. The findings presented in this paper intend to provide future medical device designers and entrepreneurs with insight regarding practices and strategies that influence the acceptance or rejection of medical products. The research aims to advance knowledge and pedagogical methods in the field of user-centered design and to inform future policies regarding physician- developer interaction in the medical device development process.