• 무역상무연구
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• 제45권
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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.

• 한국의학물리학회지:의학물리
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• 제33권4호
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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.

• 재활복지공학회논문지
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• 제4권1호
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• pp.35-41
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• 2010

의료장비의 발달로 인해 병원에서의 영상진단, 고주파 수술기를 통한 위생적 치료, 고주파 온열기를 통한 암 치료 등 우리 생활에 가까운 곳에서 고주파를 이용한 의료기기들이 넓게 활용되고 있는 시점에 고주파를 이용한 응용기기들 간의 RF상호 간섭 문제에 대한 대책이 미흡한 실정이다. "그러므로 향후기술개발과 고주파응용 의료기기의 산업발전에 문제가 될 수 있는 요인을 방지하기 위하여 고주파응용의료기기의 사용 현장에서 발생될 수 있는 상호 간섭 문제를 합리적이고 적합한 시험방법개발이 필요하다." 본 논문에서는 고주파응용 의료기기에 대한 상호 간섭문제를 해결하기위해 전자파 평가를 위한 표준시험방법을 연구하였다.

• 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.

• 한국인공지능학회지
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• 제11권2호
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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.

• 재활복지공학회논문지
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• 제11권4호
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• pp.287-297
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• 2017

본 연구는 의료기기 안전성에 관한 의료인들의 인식(지식, 태도)과 행동에 관한 기초현황을 파악하여 보고, 직종 간 차이를 평가해보기 위한 탐색적 조사연구이다. 인천광역시에 소재한 900병상 규모의 상급종합병원을 대상으로 설문지를 배포하여 220명의 응답 자료를 분석에 사용하였다. 연구결과, 연구대상 의료인들은 대체적으로 의료기기 종류에 따른 잠재적 위험성에 대한 인식이 갖춰져 있고, 의료기기 안전성 교육의 필요성을 느끼고 있었다. 또한 의료진들의 직종 간 의료기기 안전성에 관한 인식의 차이를 살펴봤을 때, 등급 높은 의료기기를 주로 사용하지만 의료기기 안전에 관한 인식이 가장 낮은 전공의를 대상으로 하는 의료기기 안전교육의 필요성이 크다는 것을 알 수 있었다. 향후 전국규모의 연구를 통하여 자료의 질을 향상하고 결과의 수준을 높이며, 이를 바탕으로 의료기기 안전성 관리에 있어 정책적, 교육적 기반으로 활용할 필요가 있다.

• 구강회복응용과학지
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• 제36권4호
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• pp.203-210
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• 2020

현대사회는 4차 산업혁명 시대를 맞아 정보통신기술의 발달로 환자 개인 맞춤 의료서비스가 확대되고있다. 이러한 변화에 따라 질병의 진단, 환자 감시, 의사결정 지원에 디지털 의료기기가 활용되기 시작했으며 최근엔 장애나 질병예방, 관리 또는 치료하기 위한 목적의 소프트웨어 의료기기가 각광받고 있다. 본 종설은 현재 미국을 중심으로 활발하게 이뤄지고 있는 치료 목적의 소프트웨어에 대한 개념과 현황을 파악하고 앞으로 어떤 분야에서 적용될 수 있는지 알아보고자 한다. 또, 스마트 헬스케어와 관련된 국내 정책 동향을 파악해 다가올 의료계의 변화에 발맞춰 치과 임상에서 가능한 디지털기반 소프트웨어 의료기기의 적용에 대해 알아보고자 한다.

• 의료법학
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• 제24권3호
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• pp.125-153
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• 2023

대법원 2022. 12. 22. 선고 2016도21314 전원합의체 판결은 한의사의 진단용 의료기기 사용이 면허된 것 이외의 의료행위에 해당하는지를 판단하는 새로운 기준을 제시하고, 이 기준에 따라 한의사의 초음파 사용을 무면허 의료행위가 아니라고 판단하였다. 대법원 2023. 8. 18. 선고 2016두51405 판결은 새로운 판단기준을 적용하여 뇌파계를 파킨슨병과 치매 진단에 사용한 행위가 한의사로서 면허된 것 이외의 의료행위에 해당하지 않는다고 판단한 첫 번째 사안이다. 대법원은 판례변경을 통해 의료기기 사용에 서양 의학적 지식과 기술이 필요하지 않아야 한다는 종전 기준을 폐기하였지만, 진단용 의료기기를 사용한 한의사의 서양 의학적 진단행위를 진단의 보조수단으로 볼 것인지는 불투명한 상태였다. 이에 대법원은 뇌파계를 활용하여 파킨슨병과 치매, 즉 서양 의학적 진단을 한 한의사의 행위를 면허된 것 이외의 의료행위가 아니라고 판단함으로써 진단의 보조수단이 가지는 의미를 명확히 정리하였다. 이외에도 대상 판결은 뇌파계의 개발, 제작 원리와 뇌파계 검사 결과의 자동 추출 및 자동 판독 여부 또한 판단기준에서 배제함으로써 한방의료행위의 의미가 수범자인 한의사의 관점에서 명확하고 엄격하게 해석되어야 한다는 죄형법정주의 관점을 더욱 투철하게 적용하고 진단용 의료기기가 한의학적 의료행위 원리와 관련 없음이 명백한 경우가 아닌 한 형사처벌 대상에서 제외됨을 분명히 하였다.

• 한국중재학회지:중재연구
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• 제27권2호
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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.

• 대한의용생체공학회:의공학회지
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• 제40권5호
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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.