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사용자 중심의 의료기기 광고를 위한 기술문서 심사 변경의 새로운 정책 연구
안대익,류규하,Ahn, Dae Ik,Ryu, Gyu Ha 대한의용생체공학회 2021 의공학회지 Vol.42 No.1
In the case of domestic medical device advertisements, it is possible to proceed with the advertisement after medical device certification, and pre-deliberation is possible based on the medical device technical document. However, there are some medical device advertisements that stakeholders in administrative procedures have no choice but to misunderstand in customs and laws that do not consider users. In addition, medical equipment and the pre-deliberation system were judged to be unconstitutional, and unconstitutional decisions were made in accordance with the principle of prohibiting pre-censorship based on the Constitution. This is because in domestic medical device advertisements, structural contradictions and user damage occur in the central structure of each stakeholder. It is necessary to reestablish stakeholder relationships, increase water solubility from customs and laws, and seek new policy proposals. In this study, we reestablish relationships with stakeholders by applying the Autopoiesis theory, and present the grounds and directions that can prevent hype and misidentified advertisements through the establishment of user-centered policies, and the measures to be taken by the Constitutional Court unconstitutional decision.
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국내 바이오산업의 지역별 분포특성과 혁신 활동 성과에 관한 연구: 수도권과 비수도권 지역을 중심으로
유민정,류규하,Min Jung Yu,Gyu Ha Ryu 대한의용생체공학회 2023 의공학회지 Vol.44 No.4
The study empirically analyzed the differences in industry distribution and innovation activity performance in the metropolitan and non-metropolitan areas of Korea's bio companies, which are highlighted as future growth engines. The main innovation activities of the bio industry, which are focused on science and technology and expressed with high uncertainty, were analyzed, centering on human resources, technology cooperation, and investment promotion. As a result of the analysis, the biomedical industry in the metropolitan area was found to have a high proportion, and bio foods, bio-based chemicals, and energy industries in the non-metropolitan area, respectively. Moreover, the innovation activity performances differed between the two regions. In particular, the notable characteristics included human resources, investment promotion, and technical cooperation with medical institutions in the metropolitan area with a high proportion of biomedical industries, and technology personnel exchange and cooperation with private research institutions in the non-metropolitan area, which has a high proportion of bio foods, bio-based chemicals, and energy industries. This study is significant in that it is the first study to compare and analyze the performance of innovative activities based on the distribution of industries in the bio-industry, focusing on human resources, technology cooperation, and investment promotion. In addition, after investigating the distribution status and competitiveness of the domestic bio-industry by region, it will analyze the status and characteristics of the domestic bio-industry and present policy implications to implement relevant promotion policy more efficiently.
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빅데이터 및 인공지능을 이용한 혁신의료기기 발전 방향: 한국, 미국, 유럽의 사례중심
송윤희,류규하,Yun Hee Song,Gyu Ha Ryu 대한의용생체공학회 2023 의공학회지 Vol.44 No.4
Purpose: The objective is to extract insights that can contribute to the formulation of harmonized international policies and support measures for innovative medical devices and management systems. This study aims to propose effective strategies for future medical device innovation and healthcare delivery. Results: It investigates technological advancements, regulatory approval systems, insurance policies, and successful commercialization cases in South Korea, the United States, and the European Union. In 2018, the FDA implemented insurance coverage for Software as a Medical Device (SaMD) and recognized insurance coverage for Digital Therapeutics (DTx). Germany is a country that ensures permanent reimbursement for healthcare applications since 2020, making it the first country to provide legal health insurance coverage for fostering a digital ecosystem. Conclusion: The findings of this research highlight the importance of cultivating a supportive regulatory and environmental framework to facilitate the adoption of innovative medical devices. Continuous support for research and development (R&D) efforts by companies, along with the validation of clinical effectiveness, is crucial.
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