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Revolution of Medical Device Distribution Structure by Expanding UDI Code: A Case Study of Edwards Lifesciences in South Korea

KyoSung Kum Primary Contact
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Abstract

The South Korean medical device market is rapidly growing, necessitating a more efficient and reliable system for managing the supply and distribution of medical devices. (1) Background/Purpose: The current ‘Medical Device Supply Reporting’ system, which utilizes the Unique Device Identifier (UDI) code, provides a foundation for tracking medical device supplies but remains limited in scope, covering only certain classes of medical devices. Hospitals, Group Purchasing Organizations (GPOs), and government agencies operate in silos without effective communication, forcing suppliers to adapt to each system separately and imposing substantial manpower burdens. This study aims to analyze the current distribution structure, evaluate the effectiveness of the existing UDI system, and propose a comprehensive framework for expanding and optimizing the UDI code system to revolutionize medical device distribution in South Korea. (2) Study Design/Methodology/Approach: The study employs a combination of qualitative and quantitative methods, including literature review, case analysis of Edwards Lifesciences Korea using ERP system data and customer service interview insights, comparison against international UDI standards (U.S. FDA, EU MDR/IVDR), and stakeholder analysis. (3) Findings: Based on four years of order data (2020–2023), approximately 38% of consignment replenishment orders were received through cold calling and 47% via GPO-operated sites, with CSRs required to manually monitor 71 separate GPO sites daily. The UDI supply reporting system has increased administrative workload without addressing root-cause inefficiencies in the distribution structure. (4) Originality/Value: This paper strongly proposes the introduction of an Electronic Data Interchange (EDI) system integrated with UDI codes to create an automated, unified solution that maximizes supply chain efficiency, enhances medical device management reliability, and ultimately improves patient safety.

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Keywords
UDI code medical device distribution Electronic Data Interchange (EDI) South Korea supply chain management consignment inventory management Group Purchasing Organization (GPO) patient safety Medical Device Act
Details
Section Articles
Issue Vol. 2 No. 6 (2026): Volume 2 Issue 6 (June 2026) Special Issue
Published 2026-06-10
Authors
KyoSung Kum Primary Contact
ELEKTA Ltd
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How to Cite
Revolution of Medical Device Distribution Structure by Expanding UDI Code: A Case Study of Edwards Lifesciences in South Korea. (2026). ASSIST Business Review, 2(6). https://jnl.ampla.page/abr/article/view/99