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Abstract Incorporating contextual factors into engineering design processes is recommended to develop solutions that function appropriately in their intended use contexts. In global health settings, failing to tailor solutions to their broader context has led to many product failures. Since prior work has thus far not investigated the use of contextual factors in global health design practice, we conducted semi-structured interviews with 15 experienced global health design practitioners. Our analysis identified 351 instances of participants incorporating contextual factors in their previous design experiences, which we categorized into a taxonomy of contextual factors, including 9 primary and 32 secondary classifications. We summarized and synthesized key patterns within all the identified contextual factor categories. Next, this study presents a descriptive model for incorporating contextual factors developed from our findings, which identifies that participants actively sought contextual information and made conscious decisions to adjust their solutions, target markets and implementation plans to accommodate contextual factors iteratively throughout their design processes. Our findings highlight how participants sometimes conducted formal evaluations while other times they relied on their own experience, the experience of a team member or other stakeholder engagement strategies. The research findings can ultimately inform design practice and engineering pedagogy for global health applications. 

A shift in the traditional technocentric view of medical device design to a human-centered one is needed to bridge existing translational gaps and improve health equity. To ensure the successful and equitable adoption of health technology innovations, engineers must think beyond the device and the direct end user and must seek a more holistic understanding of broader stakeholder needs and the intended context of use early in a design process. The objectives of this review article are ( a) to provide rationale for the need to incorporate meaningful stakeholder analysis and contextual investigation in health technology development and biomedical engineering pedagogy, ( b) to review existing frameworks and human- and equity-centered approaches to stakeholder engagement and contextual investigation for improved adoption of innovative technologies, and ( c) to present case studyexamples of medical device design that apply these approaches to bridge the gaps between biomedical engineers and the contexts for which they are designing.