Innovating Medical Devices in the Midst of a Crisis: Lessons from an Intravenous Electronic Drop Counter in the 2014-2016 Ebola Outbreak

B. Kolko, M. Blank, Chie Kawahara
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Abstract

This paper addresses the challenges associated with innovating in the midst of a crisis, especially in the area of healthcare and medical device development. A case study is presented that follows the progression of a commercialization stage prototype into a validated tool for use during the Ebola outbreak in West Africa in 2014-2016. An electronic drop counter was subjected to usability and environmental testing to adapt it for medication management in Ebola Treatment Units. The case study demonstrates the crucial role that relationships and partnerships play in transitioning technological innovations into clinical environments, how logistical challenges can be mitigated, and the importance of achieving alignment between clinical needs and subsequent technical and contextual validation that prioritizes patient safety and outcomes. As a result of years of work including and following the detailed case study, we conclude by suggesting generalized best-practices and lessons for adapting a technology to disaster preparedness or crisis situations.
危机中的医疗器械创新:2014-2016年埃博拉疫情中静脉电子滴注计数器的经验教训
本文解决了在危机中与创新相关的挑战,特别是在医疗保健和医疗设备开发领域。在2014-2016年西非埃博拉疫情爆发期间,提出了一个案例研究,跟踪商业化阶段的原型发展成为一个经过验证的工具。对电子滴药计数器进行了可用性和环境测试,以使其适应埃博拉治疗单位的药物管理。该案例研究展示了关系和伙伴关系在将技术创新转化为临床环境中发挥的关键作用,如何减轻后勤挑战,以及实现临床需求与后续技术和情境验证之间的一致性的重要性,从而优先考虑患者安全和结果。经过多年的工作,包括详细的案例研究,我们最后提出了使技术适应备灾或危机情况的一般最佳做法和经验教训。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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