Prevention and Mitigation of Disruptions in Medical Device Supply Chains: A Policy Perspective

Abstract

New technologies and their connectivity to the internet render medical devices and their supply chains a target for worldwide criminal attacks. Disruptions to a medical device supply chain (MDSC), including cybersecurity attacks, have increased rapidly, with some sophisticated attacks compromising the availability and operation of life-critical devices. Understanding the impact of disruptions on MDSCs is difficult due to the attendant supply chain complexity. The lack of a systematic classification of disruptions to MDSCs limits the transferability of mitigation strategies. Thus, there is a need for evidence-based, actionable policy guidance for corporations and government agencies that address disruption risks to MDSCs. This paper first presents a disruption classification scheme based on historical and anticipated disruptions to MDSCs. Then, it introduces a model, dubbed the Focal-firm Supply-chain Integrated Model (FSIM), that integrates a focal-firm view of supply chains and attendant disruptions, illustrated through an MDSC example. Based on lessons learned from constructing a disruption classification and creating an FSIM map, we describe the following actionable insights: a) implementing procedures and technologies that enable early-detection of disruptions, b) accurate and timely information flows, c) continual monitoring of physical inventory levels and comparing them with digital data, d) enhanced and repeated testing at various supply chain testing sites, e) standardized metrics that measure the impact of disruptions, f) developing in advance a preparedness strategy and a planning process to allocate resources effectively, equitably, and transparently during disruptions, and g) the need for a common framework that bridges the medical device regulatory gaps across countries. These insights can guide MDSC stakeholders, including manufacturers, suppliers, service providers, healthcare providers, policymakers, and government agencies.