Journal of Science Policy & Governance
Volume 24, Issue 01 | April 30, 2024

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

Aman Goswami (1), Alok Baveja (2), Benjamin Melamed (2), Fred Roberts (3)
  1. Rutgers University, Department of Supply Chain Management, Newark, New Jersey, USA
  2. Rutgers University, Department of Supply Chain Management, Piscataway, New Jersey, USA
  3. Rutgers University, DIMACS, CCICADA, Piscataway, New Jersey, USA

​Corresponding author: [email protected]​​
Keywords: medical device supply chain; medical device safety and security; cybersecurity; disruptions to medical device supply chains; disruption classification; disruption prevention and mitigation
https://doi.org/10.38126/JSPG240108

​

Executive Summary

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.

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Background header image courtesy of OECD
Aman Goswami is a 4th year PhD candidate at Rutgers University in the Supply Chain Management department. He is a supply chain and operations management researcher, with an interest in empirical research in healthcare operations. Previously, he worked in the industry as a data science manager, solving varied business problems in consulting and analytical domains for close to a decade. He plans to pursue an academic career with a strong interest in research, teaching, service, and leveraging his data science, consulting, and analytical industry experience to make scientific research more accessible and understandable. 
 
Alok Baveja is a Professor of Supply Chain Management at Rutgers University. His expertise is in the use of innovative modeling and technologies for managing operations in public and private sectors. His research has appeared in numerous journals such as Mathematics of Operations Research, IEEE Transactions on SMC, European Journal of Operational Research, California Management Review, including a bestseller reprint in the Harvard Business School’s case series. His research has been funded by grants from the National Science Foundation, the National Institute of Justice, U.S. Department of Transportation, The British Council, and Centers for Disease Control/New Jersey Department of Health. 

Benjamin Melamed is a Distinguished Professor of Supply Chain Management at Rutgers University. His research interests include supply chain management, supply chain financial management, service chain management (including modeling, analysis, simulation, and optimization), general systems modeling and performance evaluation, stochastic processes, traditional and hybrid simulation, and decision support tools. He has authored or co-authored over 120 papers, co-authored two books, and has published in a broad range of scientific journals, including Operations Research, Mathematics of Operations Research, Management Science, J. of Applied Probability, and Annals of Operations Research. He became AT&T Fellow in 1988 and IEEE Fellow in 1994. 
 
Fred Roberts is the Director of the Department of Homeland Security University Center of Excellence CCICADA: Command, Control and Interoperability Center for Advanced Data Analysis, Director Emeritus of DIMACS: Center for Discrete Mathematics and Theoretical Computer Science, and Distinguished Professor of Mathematics at Rutgers University. His research interests include mathematical models in the social, behavioral, biological, epidemiological, and environmental sciences; theory of measurement; and homeland security issues of stadium security, transportation security, natural disasters, maritime cyber security, supply chain disruptions, and global environmental change. He has authored 5 books, edited 26 books, and authored over 215 papers. 
 
Acknowledgements
This project has been funded in whole or in part with Federal funds from the Department of Homeland Security under BOA No. 70RSAT18G000000001, task order no. 70RSAT21FR00000127. The content of this publication does not necessarily reflect the views or policies of the Department of Homeland Security, nor does mention of trade names, commercial products, or organizations imply endorsement by the USA Government.

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