• Journal of Biomedical Engineering Research
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• v.44 no.3
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• pp.190-203
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• 2023

The purpose of this study is to provide basic data to ensure the safety and essential performance of a Lower Extremity robotic assisted gait training system and to provide advanced technology and technical basis to the industry handling the system. Based on IEC 60601-1:2012/AMD2:2020 (Medical Electrical Equipment - General requirements for basic safety and essential performance of medical electrical equipment), IEC 62366-1:2015/AMD1:2020 (Medical devices - Part 1: Application of usability engineering to medical devices) and EN ISO 14971:2019 (Medical devices - Application of risk management to medical devices), the requirements for ensuring the safety and essential performance of the Lower Extremity robotic assisted gait training system were derived. Through the Delphi survey method and scenario analysis, which reflects the opinions and knowledge of experts in the fields of development, testing and review of technical documents, and quality assurance of medical devices, validity and reliability were conducted and obtained results with adequate content validity ratio (CVR; 0.7≤) and excellent reliability (Cronbach's α; 0.9≤). As a result, it was confirmed that the reliability and validity of the risk management process to ensure the safety and essential performance of the Lower Extremity robotic assisted gait training system are required a model can be established to provide measures to reduce risks according to the level of risk exposure caused by usage.

• Journal of the Korean Medical Association
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• v.61 no.12
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• pp.765-775
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• 2018

With growing interest in novel digital healthcare devices, such as artificial intelligence (AI) software for medical diagnosis and prediction, and their potential impacts on healthcare, discussions have taken place regarding the regulatory approval, coverage, and clinical implementation of these devices. Despite their potential, 'digital exceptionalism' (i.e., skipping the rigorous clinical validation of such digital tools) is creating significant concerns for patients and healthcare stakeholders. This white paper presents the positions of the Korean Society of Radiology, a leader in medical imaging and digital medicine, on the clinical validation, regulatory approval, coverage decisions, and clinical implementation of novel digital healthcare devices, especially AI software for medical diagnosis and prediction, and explains the scientific principles underlying those positions. Mere regulatory approval by the Food and Drug Administration of Korea, the United States, or other countries should be distinguished from coverage decisions and widespread clinical implementation, as regulatory approval only indicates that a digital tool is allowed for use in patients, not that the device is beneficial or recommended for patient care. Coverage or widespread clinical adoption of AI software tools should require a thorough clinical validation of safety, high accuracy proven by robust external validation, documented benefits for patient outcomes, and cost-effectiveness. The Korean Society of Radiology puts patients first when considering novel digital healthcare tools, and as an impartial professional organization that follows scientific principles and evidence, strives to provide correct information to the public, make reasonable policy suggestions, and build collaborative partnerships with industry and government for the good of our patients.

• Journal of Korean Society of Industrial and Systems Engineering
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• v.46 no.4
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• pp.74-92
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• 2023

The computer system validation consulting industry is growing as domestic GMP companies' overseas exports or advancements increase, and computer system validation has been mandatory in Korea since the 2010s, but domestic CSV consulting companies are small in size and have a short history, revealing many shortcomings in terms of service quality and customer satisfaction when conducting consulting. Research related to consulting has been mainly focused on management consulting and IT consulting, and research related to computer system validation is very insufficient. This study confirmed the effect of consultant competency and service quality on consulting performance, customer satisfaction, and intention to renew contract when performing computer system validation through empirical research on food, pharmaceutical, cosmetics, and medical device companies, which are representative companies in the GMP industry. As a result, it was confirmed that consultant competency and service quality had a significant effect on consulting performance, customer satisfaction, and intention to renew contract. In addition, it was confirmed that the reputation and expertise of consulting companies had a moderating effect on the relationship between consultant competency and consulting performance.

• Journal of Chest Surgery
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• v.46 no.6
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• pp.391-401
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• 2013

Mechanical circulatory support (MCS) in the pediatric heart failure population has a limited history especially for infants, and neonates. It has been increasingly recognized that there is a rapidly expanding population of children diagnosed and living with heart failure. This expanding population has resulted in increasing numbers of children with medically resistant end-stage heart failure. The traditional therapy for these children has been heart transplantation. However, children with heart failure unlike adults do not have symptoms until they present with end-stage heart failure and therefore, cannot safely wait for transplantation. Many of these children were bridged to heart transplantation utilizing extracorporeal membranous oxygenation as a bridge to transplant which has yielded poor results. As such, industry, clinicians, and the government have refocused interest in developing increasing numbers of MCS options for children living with heart failure as a bridge to transplantation and as a chronic therapy. In this review, we discuss MCS options for short and long-term support that are currently available for infants and children with end-stage heart failure.

• The Korean Journal of Health Service Management
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• v.5 no.1
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• pp.125-132
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• 2011

In this study investigated what buyers want and expect from medical equipment industry. In this study we found as fellows, (a) The quality of instrument is the most important factors that lead to customer purchase intent and brand image follwed by reliability and efficiency in order; (b) Customers perception of company did not show any meaningful relationship with brand image suggesting company positive image perceived by the customers would not necessarily have a positive impact on brand image. Rather, if brand image customer perceived gets higher, considerably higher purchase intention was observed. Therefore, the findings from the present study suggest that medical instrument manufactures need to focus more on providing a long-term high quality of service marketing strategy to increase customer satisfaction and purchase intent in this competitive business environment.

• Journal of Korea Society of Digital Industry and Information Management
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• v.10 no.4
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• pp.109-116
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• 2014

In recent, ISM (Industrial Scientific Medical) band that is 2.4GHz band authorized free of charge is being widely used for smart phone, notebook computer, printer and portable multimedia devices. Accordingly, studies have been continuously conducted on the possibility of coexistence among nodes using ISM band. In particular, the interference of IEEE 802.11b based Wi-Fi device using overlapping channel during communication among IEEE 802.15.4 based wireless sensor nodes suitable for low-power, low-speed communication using ISM band causes serious network performance deterioration of wireless sensor networks. This paper examined a method of identifying channel status to avoid interference among wireless communication devices using IEEE 802.11b (Wi-Fi) and other ISM bands during communication among IEEE 802.15.4 based wireless sensor network nodes in ISM band. To identify channels occupied by Wi-Fi traffic, various studies are being conducted that use the RSSI (Received Signal Strength Indicator) value of interference signal obtained through ED (Energy Detection) feature that is one of IEEE 802.15.4 transmitter characteristics. This paper examines an algorithm that identifies the possibility of using more accurate channel by mixing utilization of interference signal and RSSI mean value of interference signal by wireless sensor network nodes. In addition, it verifies such algorithm by using OPNET Network verification simulator.

• Journal of Arbitration Studies
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• v.27 no.2
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• pp.83-105
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• 2017

In contemporary society interest in and consumption of beauty treatment are increasing, raising interest in health and beauty. However, beauty-related laws are becoming factors of hindrance of beauty development. Currently the Public Health Control Act plays a basic role in the beauty art business in Korea, However the contents are in discord with international laws and its definition is not clear. Therefore it is causing conflicts of different occupations and job associations which are similar to art business. Especially, because neither definitions nor policies on beauty care devices exist in the Public Health Control Act, beauty care devices using in foreign countries cannot be used in Korea due to classification as medical devices. Under this circumstance, therefore, beauty care device uses by beauty artists violate the law. The government has tried to solve these irrational regulations. Recently, the Small and Medium Business Administration announced 'the improvement plan of small business and young founders site regulation for public economy recovery' in a ministerial meeting on December 28, 2016. Regulations on policy preparation for skincare devices were inclusive in this announcement. It is the question whether the regulations will be executed or not. Even though beauty industrial competitiveness was presented in the 18th Presidential Council on National Competitiveness in 2009, it was not practiced. The proposal bills for beauty law improvement have been put forth several times since 2000 including an improvement plan for regulating beauty care devices. However, so far there have been no improvements. The damage on the regulation classifying beauty devices as medical devices is not only restricted to skincare. This develops beauty devices and the beauty industry which imports and exports beauty devices. When beauty devices are exported, complicated procedures are unavoidable and when beauty devices are imported, irrational problems like reregistration procedures and costs occur. The reason why an improvement plan has not gone into practice is the resistance of the dermatologists' association. Dermatologists tend to stand positively against harming public health by saying that beauty devices used by beauty artists cause people to suffer side effects. In contrast, anyone who has a licence to use beauty devices is able to use them in foreign countries. It is not only infringement of one's right as a beauty artist but also people's right to receive beauty care services. With this reason, Korean's current law under which beauty devices are ruled as medical devices should be revised with accordance to domestic surroundings. Therefore in order to advance and globalize the beauty industry, the support and cooperation of the Korean government and relevant associations is needed to legislate and revise the beauty devices laws. The relevant associations abandon regional self-centeredness and cooperate to define ranges, size and management of beauty devices for safe use. If no collaboration exists, an arbitration agency should be established to solve the problem.

• Proceedings of the Korean Institute of Electrical and Electronic Material Engineers Conference
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• 2004.07b
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• pp.1062-1065
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• 2004

The importance of display is becoming increasingly important due to the development of information and industry where it leads to diverse and abundant information in today's society. The demand and application range for FPD(Flat Panel Display), specifically represented by LCD(Liquid Crystal Display) and PDP(Plasma Display Panel), have been rapidly growing for its outstanding performance and convenience amongst many other forms of display. The current focus has been on OLED(Organic Light Emitting Diode) in the mobile form, which has just entered into mass production amid the different types of FPD. Many studies are being conducted in regards to device, vacuum evaporation, encapsulation, and drive circuits with the development of device as a matter of the utmost concern. This study develops a new type of light-emitting materials by synthesizing medical polymer organic chitosan and phosphor material CuS. Chitosan itself satisfies the Pool-Frenkel Effect, an I-V specific curve, with a thin film under $20{mu}m$, and demonstrates production possibility for a living body sensors solely with the thin film. Furthermore, it enables production possibility for EML of organic EL device(Emitting Layer) with liquid Green light emitting and Blue light emitting as a result of synthesis with phosphor material.

• Journal of Sasang Constitutional Medicine
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• v.22 no.4
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• pp.20-29
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• 2010

1. Objectives Our goal is to observe the feasibility of constitution discrimination from computing quantitative roughness index from dynamic friction coefficients and their gradients with the measurement device of skin friction with 3-Axis load cell sensor. 2. Methods In the traditional Korean medicine, skin diagnosis is one of the examination methods to discriminate Sasang constitution since it was known that Tae-eumin has rough skin, and Soyangin has smooth one. It is based on the skin roughness on the back of one's hand for the discrimination. The measurement device of skin friction with 3-axis load cell sensor has been developed in order to provide quantitative skin roughness through dynamic friction coefficients. The effective interval of the coefficients is obtained from the automatic sampling algorithm to use their curvature and slope. Then, Fisher's discriminant function of them makes the discrimination. 3. Results The success rate of extracting the effective interval was about 90% and the discriminant accuracy between Tae-eumin and Soyangin was 70% and 68% for men and women, respectively. The entire methods showed the possibility to distinguish between Tae-eumin and Soyangin by using stochastic properties of roughness index, which can make the entire system to include the measurement, the computation of the roughness index and the discrimination of constitution automatical. 4. Conclusions The measurement device, the automatic sampling algorithm of dynamic friction coefficients and the constitution discrimination algorithm were developed, respectively, and their combination can become the serial and automatic procedure for quantitative and objective skin diagnosis, which mimics the movement of the Oriental medical doctors' skin diagnosis. It can be applied to healthcare as well as the diagnosis of constitution in a u-Health system soon.

• Journal of Korea Technology Innovation Society
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• v.17 no.2
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• pp.421-447
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• 2014

Traditional medicine has been integrated into the national health system in many countries such as Korea, China, Taiwan, etc. Korea and China are most representative among them. The purpose of this study is to compare the policies on traditional medicine in Korea and China focusing on where it came from and where it is headed. In this regard, the study suggested the first analysis tool in the world for analyzing the policy of traditional medicine. The results of the study are as follows: First of all, the development process of Korean Medicine (KM) and Traditional Chinese Medicine (TCM) shows the same pattern, that is, both are influenced by its own national policies. Secondly, the difference between the two countries is due to the gap in the development status or the different aspects in national heath system. TCM is more vitalized in health system and has larger category, and stays ahead in globalization compared to KM. TCM covers Chinese medicine, integrative medicine and ethno-medicine. Korea emphasizes the role of KM in the declining birthrate and aging society, and promotes the overseas patient invitation strategy. China, on the other hand, establishes the medical system for emergency medical treatment and preventive treatment of major diseases and promotes overseas expansion of TCM service. In addition, Korea stressed the safety and distribution of herbal medicine, and China emphasizes production technologies. Korea has a strong medical device industry along with the government's fostering policy; however, in China, medical devices are in the R&D stage yet. Even though both countries promotes the drug development from natural products, Korea focuses on developing herbal cosmetics in application industry, but China shows weakness in policies on application industry. China shores up the foundation for culture and theory of traditional medicine, while Korea doesn't have related policy. Korea places emphasis on promoting collaboration with international organizations and medical volunteer programs, whereas China is more interested in mutual cooperation and real trade with other countries.