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The COVID-19 pandemic placed an unprecedented strain on the global medical device supply chains and supporting microelectronics industry. The objective of this report is to assess and identify high-risk, critical paths in the medical microelectronics supply chain, as well as propose risk mitigation measures for future crisis response efficacy. The analysis used a range of methods, including publicly available data, product information, and device teardowns, to understand supply chain vulnerabilities. Insights from this analysis were used to develop an interview agenda with medical device manufacturers and front-line users to further validate supply chain resilience issues. Observations were organized into a Risk Register, and risk statements were prioritized using a Failure Modes and Effects Analysis (FMEA) framework.

As the study progressed, recurring themes emerged, leading to the creation of Risk Archetypes. These archetypes grouped vulnerabilities into nine categories: National Strategy, Industry “Best Practices”, Data Transparency, Sole/Single Sourcing, Foreign Dependency, Manufacturing Capacity, Technology Limitations, Implementation Limitations, and Human Capital. Each archetype includes associated risk and mitigation recommendations, providing a clear understanding of areas for improvement. For the purpose of the study, the United States region was studied within the context of the global supply chain. The assessment model, based on the FMEA framework, can be adapted to different regions with region-specific risk assessments. Now that the supply chain has largely stabilized post-pandemic, valuable lessons from this period can guide preparations for future disruptions.