In this study, it was investigated about optical simulation in high brightness and high uniformity direct-type backlight design for medical application. Direct-type backlight has been used high-brightness backlight such as Medical LCD application. The key parameter in designing direct-type backlight was consists of three geometrical dimension such as the distance of two lamps, the gap of lamp and reflection plate and the number of lamps. It has many of variations in optical design and it causes the different properties in backlight system. It shows the best values of above parameters; 26mm of the distance of two lamps, 4.5mm of the gap of lamp and reflection plate and 16 lamps. And we produced the specimen as above condition, and acquired good result in backlight such as the value of the brightness is 6423 nit in center of emission area and less than 5% in brightness uniformity. It shows the effective ways of designing backlight system using optical simulation method for medical LCD application.

전 세계적인 코로나19의 확산으로 인해, 진단시약 등과 같은 감염병 의료 및 의료기기 신제품이 비약적으로 개발·출시되고 있으며, 이의 빠른 수급을 위해 각 국가들은 수입규제를 완화하거나 신속한 인·허가를 위한 정책을 펼치고 있다(NIDS, 2020). 반면, 신종감염병과 관련 없는 신개발 의료기기의 경우 오히려 시험검사 등 지연 및 취소되는 사례가 발생하고 있는 등 여전히 엄격한 인·허가규제를 통해 시장에 진출하고 있다. 이에 본 연구는 의료기기신제품이 시장에 진출하면서 마주하게 되는 정부소관법률에 특화하여 규제강도 영향요인을 도출하고 규제강도를 분석하여 규제대응 프레임워크를 제안하였다. 연구방법은 문헌연구, Failure Mode and Effects Analysis(FMEA)기법 적용, 전문가인터뷰(1차):아이디어수집, 전문가인터뷰(2차) : 타당성검증의 방법으로 진행하였으며, FMEA기법의 적용프로세스를 통해 우선 규제단계별 영향요인의 발생영향도와 규제사무 유형별 부담영향도를 곱하여 규제요인의 중요도를 구하고, 규제영향 심각도를 곱하는 방식으로 규제강도 정량화방법을 제시하였다. 시사점은 최근 해외 주요 국가들 및 우리나라 정부가 코로나19에 따른 신개발의료기기의 신속한 인·허가를 위한 특별규제정책 및 완화정책을 펼치며 적극적으로 대응하고 있는 시점에 본 연구에서 제안된 프레임워크를 통해 향후 기존 의료기기 신제품의 인·허가 정책 규제프로세스에도 보다 적극적이며 선제적인 대응이 될 수 있도록 규제의 개선방향과 규제대응 방안이 이루어지길 기대한다.

The purpose of this study was to review regulatory management of the classification system and scope of veterinary medical devices in Korea. In Korea, the four categories of the classification system for veterinary medical devices (instruments, supplies, artificial insemination apparatus, and others) is somewhat differently than that for human medical devices (instruments, supplies, dental materials, and reagents for in vitro diagnostics). In 2013, veterinary medical devices were classified into approximately 1,400 items, whereas, human medical devices were classified into approximately 2,200 items. Dissimilar to human medical devices, veterinary medical devices have no individual identification codes for effective market management. In conclusion, it is necessary to introduce a device identification code system and re-examine scope of the classification system for veterinary medical devices in Korea.

The existing evaluation systems based on financial performance summarize the information about past results and focus on short-term performance, and so they have the limits to explain the future value of firms and to make a long-term strategic performance. By this reason, as a way to increase the future value, the development of the integrated performance evaluation system with which we may manages financial performance and knowledge assets together has been required recently. This study puts together various researches for the evaluation of knowledge assets, and analyzes the existing studies for the domestic medical devices industry and the tendency of introduction for business practice. Under this analysis, this study develops the knowledge asset evaluation indexes for medical devices industry by using the Balanced Score Card (BSC) of Kaplan & Norton(1992), and then presents the evaluation model by applying the Analytic Hierarchy Process (AHP) of Saaty(1980) to get the weight for each index. With the final evaluation model, we can calculate the evaluation score combined with both the quantitative indexes and the qualitative indexes at once.

Most of people do not remind of 'Who is domestic medical device business?' A lot of people that Johnson and Johnson, GE and Philips and other foreign companies belong to medical device company. In fact, local enterprises small place based on world market. Local medical device industry's production has grown up rapidly last 10 years. Sales increased nearly 3 times from trillion and 500 billion KRW in 2004 to 4 trillion and 600 billion KRW in 2014. The production record constantly increased owing to safety and good quality of domestic medical devices. As many as 59% of medical devices made in Korea is exported to 198 countries in the world. Currently, medical device industry in the world has been given considerable attention. Cognition and awareness are very much low. Medical device industry, high income creating industry, is said to next generation industry to increase scale, and Korea does not follow world flow. The industry is given support from the government that is not enough. Korean enterprises have small scale among a lot of global enterprises. Being interested in development of medical devices, the author selected department of IT at college.