• 대한의용생체공학회:의공학회지
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• 제44권1호
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• pp.41-52
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• 2023

With the international change in the medical device market owing to the development of innovative medical engineering and the use of various raw materials, a systematic and rational medical device classification system is needed to safely manage newly developed medical devices. This study aims to improve the domestic medical device classification system by proposing product establishment and segmentation. It is based on medical device products from the United States and Europe that are only available in foreign systems and are more subdivided than domestic products. This study analyzes and compares the domestic and foreign medical device classification systems by examining laws, guidelines, and analysis reports in Korea, the United States, and Europe. In accordance with product establishment and segmentation criteria, products subject to improvement are presented. This study contributes to safely managing medical devices that do not fit with the current classification system and to solving the confusion caused by the lack of international harmony in product classification systems.

• 대한의용생체공학회:의공학회지
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• 제44권1호
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• pp.73-79
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• 2023

The purpose of this study is to derive medical devices with different management systems through comparison of domestic and overseas medical device product classification systems and to propose management conversion measures for the products. The definitions of medical devices were compared and the scope of medical devices defined by each country was confirmed through surveys of the Medical Device Act, Federal Food, Drug & Cosmetics Act (FD&C) in the U.S., and Medical Device Regulations (MDR) in Europe. Using the Ministry of Food and Drug Safety's regulations on medical device products and grades, 21 CFR part 860-892 and product code classification files in U.S., and EMDN in Europe as basic data to compare medical device products and derive medical devices with different management systems. As a result of comparing the definition and product classification systems of medical devices in Korea, the U.S. and Europe, medical device accessories, prosthetic limbs and aids among assistive devices for persons with disabilities, drugs, quasi-drugs and industrial products that are not managed by medical devices in Korea are managed as medical devices in the U.S. and Europe. This study aims to improve public health by securing systematic product safety management and essential performance under medical device regulations. Management within a single medical device system will increase the efficiency of licensing work of domestic medical device manufacturers and related organizations. It is also expected to help advance the system according to the international harmony of the item classification system and enhance smooth import and export competitiveness.

• 대한의용생체공학회:의공학회지
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• 제39권6호
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• pp.268-277
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• 2018

With drastic change in the market and technology of medical devices, a comparative analysis is necessary in advanced systems internationally in order to prepare domestically applicable plans for improvement in classification and differential grade management for items of medical devices. This research examines and analyzes the differences of definition and legal systems of medical devices among Korea, United States, EU, Japan and China, and investigates classification and grading system of each country to identify disadvantages of classification and grading structures for medical device in Korea. This research suggests ways to supplement the disadvantages of domestic classification and grading system of medical devices, and elicits differential management plans for medical devices.

• 대한안전경영과학회지
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• 제12권3호
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• pp.37-52
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• 2010

This study is aimed at proposing the national policy for medical device control system in Korea as deeply analysed the present status of the system. On 1979, Korean government had started to inspect 24 kinds of the medical devices such as X-ray diagnostic equipments, medical sterilizer and etc. mostly imported from advanced countries which USA, Germany and Japan for the first time according to the Pharmaceutical Affairs Law. However medical devices were becoming consideration as an important partner of diagnosis, curing and alleviation of diseases by medical doctors and also much important keeping the health at home. Furthermore medical devices industry can be designated as a national growth engine industry. So it is necessary not only to harmonize to international standards but also the harmonization of the system including pre-market application and post-market surveillance, is strongly needed by the Korea Food and Drugs Administration(KFDA).

• 대한의용생체공학회:의공학회지
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• 제39권6호
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• pp.256-267
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• 2018

The number of items and the market size of the senior-friendly medical devices are rapidly increasing, and it is necessary to come up with a safety management plan for senior-friendly medical devices. We searched and analyzed the definition and policy of senior-friendly medical device, and classified medical device items of the Ministry of Food and Drug Safety, calculated market sizes and manufacturing export import results by classification, and investigated the current state of senior-friendly industry and the fields of its culture. In order to prepare a safety management plan, we reduce the number of items that need to be managed intensively by extracting 69 items for administration, that are substantially harmful to the elderly. As specific safety management plans of items for administration, we propose plans for introductions of readability-enhanced labeling, QR codes for cautions and manuals, universal design mandatory, UDI code system with considering a balanced viewpoint of the industry development.

• 보건의료산업학회지
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• 제11권4호
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• pp.189-202
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• 2017

Objectives : This study aims to present a new classification system using evaluation standards to ensure the safety of transport ventilators used in Korea. Due to the rapid advancement of technology, various types of ventilators have been developed and as the range of application increases, so does demand. With quick access to information and a growing economy, the technology used in Korean hospitals is equivalent to that of other countries; however, regulatory and safety consciousness are still lagging in Korea. Methods : Based on researching overseas cases, reference data and standards for improving the current system in Korea are proposed. Results : According to the review of transport ventilator use in Korea, it was found that concerns about safety is due to the absence of a standardized classification system for evaluating the safety and effectiveness of transport ventilators. Conclusions : In order to improve the safety of patients and the quality of medical care, it is essential to establish guidelines and assessment standards guaranteeing the safety of transport ventilators in Korea. Clear definitions and classifications for devices must precede the application of such standards. In addition, effective evaluation standards should be developed in order to resolve problems and improve upon the current system through continuous validation.

• 대한의용생체공학회:의공학회지
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• 제44권3호
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• pp.182-189
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• 2023

CT is a medical device that acquires medical images based on Attenuation coefficient of human organs related to X-rays. In addition, using this theory, it can acquire sagittal and coronal planes and 3D images of the human body. Then, CT is essential device for universal diagnostic test. But Exposure of CT scan is so high that it is regulated and managed with special medical equipment. As the special medical equipment, CT must implement quality control. In detail of quality control, Spatial resolution of existing phantom imaging tests, Contrast resolution and clinical image evaluation are qualitative tests. These tests are not objective, so the reliability of the CT undermine trust. Therefore, by applying an artificial intelligence classification model, we wanted to confirm the possibility of quantitative evaluation of the qualitative evaluation part of the phantom test. We used intelligence classification models (VGG19, DenseNet201, EfficientNet B2, inception_resnet_v2, ResNet50V2, and Xception). And the fine-tuning process used for learning was additionally performed. As a result, in all classification models, the accuracy of spatial resolution was 0.9562 or higher, the precision was 0.9535, the recall was 1, the loss value was 0.1774, and the learning time was from a maximum of 14 minutes to a minimum of 8 minutes and 10 seconds. Through the experimental results, it was concluded that the artificial intelligence model can be applied to CT implements quality control in spatial resolution and contrast resolution.

• 경영과정보연구
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• 제36권1호
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• pp.181-213
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• 2017

전 세계적으로 고령화 문제가 대두됨에 따라 최근 의료기기 산업이 미래 유망 산업으로 주목받고 있다. 하지만 의료기기 산업의 높은 성장이 예견됨에도 불구하고 국내외 협소한 내수시장과 영세한 기업구조로 인해 국내 기업들의 자체적인 노력만으로는 성장에 한계가 있다. 따라서 본 연구에서는 국내 의료기기 산업의 효과적인 육성을 위해 다음과 같은 연구를 수행하였다. 첫째, 한국보건산업진흥원의 의료기기 분류체계를 참고하여 의료기기를 중분류, 세분류, 세세분류로 구분했으며, 의료기기 관련 전문가 30명을 대상으로 설문조사를 실시하였다. 둘째, 설문조사 결과를 토대로 AHP 분석과 이를 보완한 Fuzzy-AHP 분석을 수행하였으며, AHP와 Fuzzy-AHP의 분석결과 도출된 Global 가중치를 X축과 Y축으로 하는 포지셔닝 맵을 활용하여 분류별 미래 유망 의료기기 우선순위를 도출하였다. 셋째, 보건산업 통계의 의료기기 생산액과 우선순위를 비교분석하여 핵심 미래 유망 의료기기를 선별하였다. 연구 결과 '치과 재료'의 세분류인 '치과용 임플란트'가 핵심 미래 유망 의료기기로 선정되었으며, 해당 의료기기의 지원 전략을 제시하였다. 의료기기 산업이 미래 유망 산업으로 주목받고 있는 현 시점에서 본 연구를 통해 도출된 핵심 미래 유망 의료기기 및 전략 도출 방법이 국내 의료기기 R&D 개발 및 지원 정책에 활용될 것으로 기대된다.

• 대한의용생체공학회:의공학회지
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• 제44권6호
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• pp.392-403
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• 2023

This study presents a new hybrid fNIRS-EEG system to meet the demand for a lightweight and low-cost sleep pattern monitoring device. For multiple-channel configuration, a six-channel electroencephalogram (EEG) and a functional near-infrared spectroscopy (fNIRS) system with eight photodiodes (PD) and four dual-wavelength LEDs are designed. To enhance the convenience of signal measurement, the device is miniaturized into a patch-like form, enabling simultaneous measurement on the forehead. Due to its fully integrated functionality, the developed system is advantageous for performing sleep stage classification with high-temporal and spatial resolution data. This can be realized by utilizing a two-dimensional (2D) brain activation map based on the concentration changes in oxyhemoglobin and deoxyhemoglobin during sleep stage transitions. For the system verification, the phantom model with known optical properties was tested at first, and then the sleep experiment for a human subject was conducted. The experimental results show that the developed system qualifies as a portable hybrid fNIRS-EEG sleep pattern monitoring device.

• International journal of advanced smart convergence
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• 제11권1호
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• pp.111-116
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• 2022

After COVID-19, the number of people with sleep disorders around the world is increasing. In particular, in the flow of the 4th industrial revolution, the differentiation of types and characteristics of the sleep industry is accelerating. Therefore, in this study, the characteristics of each type of sleep-related industry were reclassified from an industrial point of view, and based on this, an attempt was made to review the classification system that can help companies develop sleep products and improve related national systems. Based on the 10th standard industry classification, we compared input cost, value, and usability and analyzed common characteristics, treatments, and preventive effects based on this. A comprehensive taxonomy using matrix analysis was reviewed. As a result, in terms of cost (A), the most common sleeping products are general mattresses and general bedding. It is an IOT device (auxiliary device), and the value aspect (B, B/D) included sleep cafe, bedding rental and management service, and sleep consulting. In terms of utility (A/B), a total of 6 product groups including sleep aids (health functional foods) belong to this category, and in terms of treatment (A/C), a total of 3 product groups including sleep clinics (medical services) belong to this category. As for the product group (A/D) with both properties, it was found that non-insurance sleep treatment medical devices, sleep-related over-the-counter drugs, and some sleep monitoring applications belong to this category. Ultimately, it was found that the sleep industry classification enables the most active product development and composition according to the relative relationship between cost and utility, and treatment and utility. appeared to be necessary.