의료기기 생체적합성 연구 동향 분석

• Published in: Journal of biomedical engineering research Vol. 46; no. 3; pp. 296 - 308
• Main Authors: 김대진, 차인준, 이유정, 장윤영, 전성진, 김태영, 김현수, Dae Jin Kim, In Jun Cha, Yu Jung Lee, Yoonyoung Jang, Sung Jin Jeon, Taeyeung Kim, Hyeon Su Kim
• Format: Journal Article
• Language: Korean
• Published: 대한의용생체공학회 01.06.2025
• Subjects: 의공학; Mechanical properties; Biocompatibility; Medical device; Behavior; ISO 10993
• ISSN: 1229-0807; 2288-9396

This study aims to conduct a bibliometric analysis of research trends in medical device biocompatibility published over the past decade (2015-2024), identify changes and developments in key research keywords, and provide foundational data for the development of future policies related to the safety management of medical devices. A search for biocompatibility-related articles on medical devices was conducted in the Web of Science (WoS) database using predefined keywords. A Bibliometric analysis was conducted using the R-based bibliometrix package and VOSviewer, covering scientific production, citation analysis, trends topic, thematic evolution, factorial analysis, and co-occurrence network analysis. A total of 1,207 articles were included in the analysis, and the volume of research on medical device biocompatibility has shown an average annual growth rate of 8.5% over the past decade. Overall, studies evaluating the mechanical properties and behavior of medical devices have constituted a significant portion of the field. Thematic evolution analysis revealed that, between 2015 and 2018, the focus was primarily on in-vitro tests, such as cytotoxicity assays and ethylene oxide residual testing. However, in more recent years, the research trend has shifted toward evaluating the biocompatibility and performance of advanced materials, including nanoparticles, biodegradable implantable medical devices, and hydrogel-based biomaterials. Since 2020, the co-occurrence network has revealed the emergence of keywords including 'corrosion behavior', 'design', 'microstructure', 'nanoparticles', and 'scaffolds'. The findings of this study may serve as a foundational resource for developing proactive regulatory strategies related to medical device biocompatibility.