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Product Recall Decisions in Medical Device Supply Chains: A Big Data Analytic Approach to Evaluating Judgment Bias

机译:医疗设备供应链中的产品召回决策:评估偏见的大数据分析方法

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摘要

This study investigates judgment bias (under-reaction or over-reaction) in product recall decisions by firms when they respond to adverse event reports generated by users of their products. We develop an integrative theoretical framework for identifying the sources of judgment bias in product recall decisions. We analyze user-generated reports (big and unstructured data) on adverse events related to medical devices, using a combination of econometric and predictive analytic methods. We find that (i) noisy signals in user feedback, that is, high noise-to-signal ratio, are associated with under-reaction likelihood; and (ii) user feedback related to adverse events characterized by high severity is associated with high over-reaction likelihood. We also identify conditions related to the situated context of managers that are associated with under-reaction or over-reaction likelihood. The findings of this study are consequential for firms and government regulatory agencies, in that they shed light on the sources of judgment bias in recall decisions, thereby ensuring that such decisions are made correctly and in a timely manner. Our findings also contribute toward improving the post-launch market surveillance of products (e.g., medical devices) by making it more evidence-based and predictive.
机译:这项研究调查了当企业对产品用户产生的不良事件报告做出响应时,企业在产品召回决策中的判断偏差(反应不足或反应过度)。我们建立了一个综合性的理论框架,用于识别产品召回决策中的判断偏差来源。我们结合计量经济学和预测分析方法,分析与医疗设备相关的不良事件的用户生成报告(大数据和非结构化数据)。我们发现(i)用户反馈中的噪声信号,即高的信噪比与反应不足的可能性有关; (ii)与严重程度高的不良事件相关的用户反馈与过度反应的可能性相关。我们还确定与管理者所处环境相关的条件,这些条件与反应不足或反应过度的可能性有关。这项研究的结果对公司和政府监管机构具有重要意义,因为它们揭示了召回决定中判断偏见的根源,从而确保了正确,及时地做出此类决定。我们的发现还通过使其更加基于证据和更具预测性,从而有助于改善产品(例如医疗设备)的上市后市场监控。

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