Weldon School of Biomedical Engineering, College of Engineering, Purdue University, West Lafayette, Indiana, USA; email:
Department of Public Health, College of Health and Human Sciences, Purdue University, West Lafayette, Indiana, USA.
Annu Rev Biomed Eng. 2023 Jun 8;25:257-280. doi: 10.1146/annurev-bioeng-081922-024834. Epub 2023 Apr 17.
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 () to provide rationale for the need to incorporate meaningful stakeholder analysis and contextual investigation in health technology development and biomedical engineering pedagogy, () to review existing frameworks and human- and equity-centered approaches to stakeholder engagement and contextual investigation for improved adoption of innovative technologies, and () 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.
需要将医疗器械设计的传统技术中心观点转变为以人为中心的观点，以弥合现有的转化差距，提高健康公平性。为了确保医疗技术创新的成功和公平采用，工程师必须超越设备和直接最终用户，并且必须在设计过程的早期就寻求更全面地了解更广泛的利益相关者的需求和预期使用背景。本文的目的是（）提供在医疗技术开发和生物医学工程教学中纳入有意义的利益相关者分析和背景调查的理由，（）综述现有的框架和以人为中心及公平为中心的方法，以改善创新技术的采用，（）提出应用这些方法的医疗器械设计案例研究，以弥合生物医学工程师与设计对象之间的差距。
