개발 동향 분석을 통한 혁신의료기기소프트웨어의 산업 발전 방향 제언
A proposal for industrial development direction of a innovative medical device software through development trends analysis
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초록
Innovative medical devices apply cutting-edge technology to ensure significantly greater safety and effectiveness than other treatments compared to existing medical devices. In relation to this, Innovative medical device-related systems are being implemented not only in Korea but also in various developed countries. Innovative medical device software means that Software as Medical Device (SaMD) has been recognized as an Innovative medical device, and the Korea Ministry of Food and Drug Safety is introducing various related systems. This study aims to provide Korean medical device stakeholders with insight into the direction of industry development by analyzing research trends on Innovative medical device software. Therefore, we analyzed the designation status of innovative medical devices in Korea and analyzed the designation rate of SaMD, purpose, class, application area, and approval of Innovative medical device software. It was found that the rate of SaMD was high in Innovative medical devices, that Innovative medical device software was mainly developed for diagnostic purposes, was divided into class 2 and class 3 medical devices, and mainly targeted organs essential for life support. In the case of licensing, it was investigated that it was obtained at a high rate in Korea, but it was extremely low in the US market. We expect that this study will contribute to strategic decision-making in the medical device industry in the future by providing industry workers with insights such as product trends developed through analysis of the development trends of Innovative medical device software.
Abstract
Innovative medical devices apply cutting-edge technology to ensure significantly greater safety and effectiveness than other treatments compared to existing medical devices. In relation to this, Innovative medical device-related systems are being implemented not only in Korea but also in various developed countries. Innovative medical device software means that Software as Medical Device (SaMD) has been recognized as an Innovative medical device, and the Korea Ministry of Food and Drug Safety is introducing various related systems. This study aims to provide Korean medical device stakeholders with insight into the direction of industry development by analyzing research trends on Innovative medical device software. Therefore, we analyzed the designation status of innovative medical devices in Korea and analyzed the designation rate of SaMD, purpose, class, application area, and approval of Innovative medical device software. It was found that the rate of SaMD was high in Innovative medical devices, that Innovative medical device software was mainly developed for diagnostic purposes, was divided into class 2 and class 3 medical devices, and mainly targeted organs essential for life support. In the case of licensing, it was investigated that it was obtained at a high rate in Korea, but it was extremely low in the US market. We expect that this study will contribute to strategic decision-making in the medical device industry in the future by providing industry workers with insights such as product trends developed through analysis of the development trends of Innovative medical device software.
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