• THE INTERNATIONAL COMMERCE & LAW REVIEW
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• v.45
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• pp.191-238
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• 2010

The purpose of this paper is to make research on the trend of the worldwide medical device market, the trend of the medical device market in the major foreign countries, the present status of the medical device industry in Korea and Gangwon area, the present status of export competitive power and the SWOT analysis of competitive power of the medical device industry in Gangwon area, and the strengthening methods of export competitive power of the medical device industry in Gangwon area. As the research method, the questionaire for the strengthening of export competitive power of the medical device industry in Gangwon area was carried out from August 13 to Otober 22, 2009. The worldwide medical device market in 2008 is estimated at USD 210.2 billion, with the United States being the largest market, followed closely by Japan and Western Europe. In 2006, the worldwide export amount of medical devices recorded USD 121.1 billion and the worldwide import amount of medical devices recorded USD 126.3 billion. As of the end of 2008, the number of Korea's medical device manufacturers expanded to 1,726. The production amount of Korea's medical device industry in 2008 recorded 2,525 billion won, and the domestic market volume of medical devices in 2008 recorded 3,618 billion won. Korea's export amount of medical devices in 2008 recorded USD 1,132 million and recorded a 9.67% growth compared to the previous year, and the import amount of medical devices recorded USD 2,123 million and recorded a 1.43% reduction compared to the previous year. As of the end of 2008, the number of Gangwon area's medical device manufacturers expanded to 81. The production amount of Gangwon area's medical industry in 2008 recorded 380 billion won, and Gangwon area's export amount of medical devices recorded USD 269 million and recorded a 0.25% reduction compared to the previous year, and the import amount of medical devices recorded USD 3 million and recorded a 39.63% reduction compared to the previous year. According to the result analysis of the questionaire for the strengthening of export competitive power of medical device industry in Gangwon area(August 13~October 22, 2009), the competing country of the export medical device is the United States being the highest ranking. Comparing to the collective competitive power level 100 of the competing country, the collective competitive level of the export medical device is 60 below and 70-80 below being the highest ranking. Comparing to the quality level 100 of the United States, EU and Japan, the quality level of the export medical device is 80-90 below being the highest ranking. Comparing to the design level 100 of the United States, EU and Japan, the design level of the export medical device is 90-100 below being the highest ranking. Comparing to the technology level 100 of the United States, EU and Japan, the technology level of the export medical device is 80-90 below being the highest ranking. According to the SWOT analysis of competitive power of medical device industry in Gangwon area, the strength is the abundant expert manpower of the medical device in Wonju area. The weakness is the fragility of the brand recognition of the medical device industry. The opportunity is the demand increase of the new medical device owing to the advanced age of population. The threat is the difficulty of entry into overseas market owing to the request of the new specification certification of the medical device. In order to strengthen the export competitive power of the medical device industry in Gangwon area, the following measures should be taken by the government, local self-government body, related organization and medical device industry : the development of new technology and design, the enhancement of brand recognition. the acquisition of the foreign specification certification, the building of overseas distribution channel and after sales service channel, the positive participation in overseas medical device exhibition and opening of medical device exhibition, the training of expert manpower, the strengthening of overseas marketing, and the application of FTA and the establishment of counter measures against FTA. In conclusion, the medical device industry in Gangwon area has the difficulty in the entry into the overseas market owing to the shortage of overseas marketing capability. Therefore, the government and local self-government body should make the intensive and systematical support for overseas marketing of the medical device industry. For the support of overseas marketing, the government and local self-government body should provide positively the support of expenses for the acquisition of foreign specification certification, the support of participation in the overseas medical device exhibition, the despatch of market development mission, the increase of the support amount for R&D investment fund, and the training of expert manpower of medical devices.

• Progress in Medical Physics
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• v.33 no.4
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• pp.53-62
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• 2022

In this study, we have investigated the shielding evaluation methodology for facilities using kV energy generators. We have collected and analysis of safety evaluation criteria and methodology for overseas facilities using radiation generators. And we investigated the current status of shielding evaluation of domestic industrial radiation generators. According to the statistical data from the Radiation Safety Information System, as of 2022, a total of 7,679 organizations are using radiation generating devices. Among them, 6,299 facilities use these devices for industrial purposes, which accounts for a considerable portion of radiation. The organizations that use these devices evaluate whether the exposure dose for workers and frequent visitors is suitable as per the limit regulated by the Nuclear Safety Act. Moreover, during this process, the safety shields are evaluated at the facilities that use the radiation generating devices. However, the facilities that use radiating devices having energy less than or equal to 6 MV for industrial purposes are still mostly evaluated and analyzed according to the National Council on Radiation Protection and Measurements 49 (NCRP 49) report published in 1976. We have investigated the technical standards of safety management, including the maximum permissible dose and parameters assessment criteria for facilities using radiation generating devices, based on the NCRP 49 and the American National Standards Institute/Health Physics Society N.43.3 reports, which are the representative reports related to radiation shielding management cases overseas.

• Journal of rehabilitation welfare engineering & assistive technology
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• v.4 no.1
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• pp.35-41
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• 2010

By the development of medical devices, high-frequency medical devices are becoming widely used. Imaging diagnosis in hospital and clean treatment by high-frequency medical devices and cancer treatment through high-frequency heaters around us, all serve as the examples. However, it still lacks the measures to the problems of the RF(Radio Frequency) mutual interference between the high-frequency devices. In order to prevent the problematic factors for technical and industrial development, a new reasonable and suitable test method is required. In this paper, we study a standard test method for EMC evaluation to solve the RF mutual interference.

• Journal of Biomedical Engineering Research
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• v.39 no.6
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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.

• Korean Journal of Artificial Intelligence
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• v.11 no.2
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• pp.39-44
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• 2023

The creativity of thesis is that the significance of cyber security challenges in blockchain. The variety of enterprises, including those in the medical market, are the targets of cyberattacks. Hospitals and clinics are only two examples of medical facilities that are easy targets for cybercriminals, along with IoT-based medical devices like pacemakers. Cyberattacks in the medical field not only put patients' lives in danger but also have the potential to expose private and sensitive information. Reviewing and looking at the present and historical flaws and vulnerabilities in the blockchain-based IoT and medical institutions' equipment is crucial as they are sensitive, relevant, and of a medical character. This study aims to investigate recent and current weaknesses in medical equipment, of blockchain-based IoT, and institutions. Medical security systems are becoming increasingly crucial in blockchain-based IoT medical devices and digital adoption more broadly. It is gaining importance as a standalone medical device. Currently the use of software in medical market is growing exponentially and many countries have already set guidelines for quality control. The achievements of the thesis are medical equipment of blockchain-based IoT no longer exist in a vacuum, thanks to technical improvements and the emergence of electronic health records (EHRs). Increased EHR use among providers, as well as the demand for integration and connection technologies to improve clinical workflow, patient care solutions, and overall hospital operations, will fuel significant growth in the blockchain-based IoT market for linked medical devices. The need for blockchain technology and IoT-based medical device to enhance their health IT infrastructure and design and development techniques will only get louder in the future. Blockchain technology will be essential in the future of cybersecurity, because blockchain technology can be significantly improved with the cybersecurity adoption of IoT devices, i.e., via remote monitoring, reducing waiting time for emergency rooms, track assets, etc. This paper sheds the light on the benefits of the blockchain-based IoT market.

• Journal of rehabilitation welfare engineering & assistive technology
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• v.11 no.4
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• pp.287-297
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• 2017

This exploratory study aimed to explore the perception (knowledge and attitude) and behaviors of medical personnel regarding medical device safety and to identify the differences in results linked with the type of their task. A questionnaire was administered to medical personnel working at a tertiary care hospital with 900 beds in Incheon, Korea, and 220 completed questionnaires were used for analysis. The results revealed that the majority of the medical personnel perceived the potential risk involved in different types of medical devices they use and stated that they need training programs for safe use of medical devices. Concerning the perception regarding medical devices across different positions within the hospital, it was found that the residents had a low awareness about safety issues, although the medical services they handled involve high risks, thereby calling for safety training. Further nationwide studies are needed to improve the quality and validity of data and eventually to provide important information required by policy makers and academicians to manage medical device safety.

• Journal of Dental Rehabilitation and Applied Science
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• v.36 no.4
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• pp.203-210
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• 2020

By facing the era of the 4th industrial revolution, personalized medical services for patients are expanding with the development of information and communications technology. With these changes, digital medical devices have begun to be used to support diagnosis, patient monitoring, and decision-making of diseases, and recently software medical devices for the purpose of preventing, managing, or treating disorders or diseases have become popular. The aim of this article is to understand the current concept and status of Software as a Medical Device (SaMD), which are actively being carried out in the United States, and to find out what fields can be applied in the future. In addition, it intends to find out the Korean domestic policy trends related to smart healthcare and find out the application of digital software as a medical devices that can be used in dental clinic to keep pace with the upcoming changes in the medical field.

• The Korean Society of Law and Medicine
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• v.24 no.3
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• pp.125-153
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• 2023

The Supreme Court's en banc decision on December 12, 2022 (docket number 2016Do21314) presented a new standard for determining whether the use of diagnostic medical devices by Korean medical doctors constitutes oriental medical doctors constitutes unlicensed medical practice. Based on this standard, it was determined that the use of ultrasound by Korean medical doctors was not an unlicensed medical practice. Supreme Court's Decision 2016Du51405 on August 18, 2023, is the first case in which a new standard was applied to determine that an Korean medical doctor's use of electroencephalography to diagnose Parkinson's disease and dementia was not an unlicensed medical practice. The Supreme Court abolished the previous standard that Western medical knowledge and technology should not be required for Korean medical doctors to use medical devices. However, it was unclear whether Western medical diagnosis of Korean medical doctors using diagnostic medical devices would be viewed as an an auxiliary method of diagnosis. Parkinson's disease and dementia are Western medical diagnoses. The Supreme Court judged that the Western medical diagnosis of Korean medical doctors was not an unlicensed medical practice. This clearly explains what an auxiliary method of diagnosis means. In addition, the Supreme Court excluded the principles of development and production of electroencephalography from its judgment criteria. Automatic extraction and automatic reading of test results were also excluded. The criminal court's view that the meaning of oriental medical practice should be clearly and strictly interpreted from the perspective of an oriental doctor, and it was clarified that diagnostic medical devices were excluded from criminal punishment unless it was clear that they were not related to the principle of oriental medical practice. As a result, the Supreme Court made it clear that the use of diagnostic medical devices is excluded from criminal punishment unless it is clear that they are not related to the principles of Korean medicine.

• 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.

• Journal of Biomedical Engineering Research
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• v.40 no.5
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• pp.197-205
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• 2019

The existing Extracorporeal membrane oxygenation(ECMO) and Cardiopulmonary bypass system(CPB) have been developed and applied to various devices according to their respective indications. However, due to the complicated configuration and difficult usage method, it causes inconvenience to users and there is a risk of an accident. Therefore, smart all-in-one cardiopulmonary circulation device is being developed recently. The smart all-in-one cardiopulmonary assist device consists of a blood pump for cardiopulmonary bypass, a blood oxidizer for cardiopulmonary bypass, a blood circuit for cardiopulmonary bypass, and an artificial cardiopulmonary device. It is an integrated cardiopulmonary bypass device that can be used for a variety of purposes such as emergency, intraoperative, post-operative intensive care, and long-term cardiopulmonary assist, combined with CPB used in open heart surgery and ECMO used when patient's cardiopulmonary function does not work normally. The smart all-in-one cardiopulmonary assist device does not exist as a standard and international standard applicable to advanced medical devices. Therefore, in this study, we will refer to the International Standard for Blood Components, the International Standard for Blood, the Guideline for Blood Products, and prepare applicable performance and safety guidelines to help quality control of medical devices, and contribute to the improvement of the health of people. The guideline, which is the result of conducted a survey of the method of safety and performance test, is based on the principle of all-in-one cardiopulmonary aiding device, related domestic foreign standards, the status of domestic and foreign patents, related literature, blood pump(ISO 18242), blood oxygenator (ISO 7199), and blood circuit (ISO 15676) for cardiopulmonary bypass.The items on blood safety are as follows: American Society for Testing and Materials ASTM F1841-97R17), and in the 2010 Food and Drug Administration's Safety Assessment Guidelines for Medical Assisted Circulatory Devices. In addition, after reviewing the guidelines drawn up through expert consultation bodies including manufacturers / importers, testing inspectors, academia, etc. the final guideline was established through revision and supplementation process. Therefore, we propose guidelines for evaluating the safety and performance of smart all-in-one cardiopulmonary assist devices in line with growing technology.