• 제목/요약/키워드: Medical Devices Industry

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State and subject of health and sports medical devices industry at oversea

  • Seo, Jung-Hwa;Kim, Se-Jin
    • Journal of Sport and Applied Science
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    • 제1권1호
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    • pp.1-5
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    • 2017
  • 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.

한국 의료기기 산업의 역사와 국제 경쟁력 고찰 (A Study on the History of the Korean Medical Device Industry and its Global Competitiveness)

  • 염호준;정현우;박상수
    • 문화기술의 융합
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    • 제8권5호
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    • pp.1-7
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    • 2022
  • 한국의 의료기기 산업은 1995년부터 시작된 G7 의료공학기술개발사업으로 본격적인 성장과 발전의 기틀을 마련하였으며 2020년 한국 의료기기 생산실적은 2001년에 비하여 8.52배, 수출 실적은 13.94배 성장하였다. 의료기기 국산화 개발 초기에 초음파 의료기기 등 전자 의료기기의 개발이 활발하였던 것과 비교하여 2020년에는 체외진단시약과 치과용 임플랜트의 생산 및 수출 실적이 상위권을 차지하고 있다. 그러나 한국 의료기기 시장에서 수입 의료기기가 차지하는 비중은 60-70%에서 큰 변화가 없는데 이는 한국의 의료기기 산업이 중저가 의료기기를 생산 수출하고, 기술집약적이고 자본집약적인 고가 의료기기는 주로 수입에 의존하고 있기 때문이다. 본 논문에서는 한국과 세계시장의 주요 의료기기 회사들의 생산 품목을 비교하여 한국 의료기기 산업의 세계 시장 진출에 대한 전략을 제시하고자 한다.

주요국의 혁신적 의료기기 관리제도에 대한 비교 연구 (A Comparative Study on Innovative Medical Device Management Systems in Major Countries)

  • 이진수;김수경
    • 대한의용생체공학회:의공학회지
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    • 제43권3호
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    • pp.153-160
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    • 2022
  • As new types of medical devices are emerging through convergence with advanced technology, innovative technologies are becoming hot issues in health policy because of their disruptiveness. This study analyzed the innovative medical device management systems in the US, China and Korea. Innovative medical devices have been defined differently depending on the country's management system, but in common, they are defined as products that do not exist or have dramatically improved performance compare to existing products by applying innovative technologies. Innovative medical devices have been supported by regulatory authorities during product development and approval processes. While the US and China have more than 300 products designated as innovative medical devices with diverse functions, application fields, and manufacturing countries considering the initial situation of the implementation for the system, Korea has only 16 products, mainly radiology and diagnostic devices and made in Korea only as innovative medical device. In addition, Korea shows the highest market approval rate of innovative medical devices compare to the US and China, and it is necessary to prepare the approval process in consideration of product diversity.

의료기기산업의 수출경쟁력 분석 및 강화방안 -강원지역 의료기기산업을 중심으로- (The Analysis and Strengthening Method of Export Competitive Power of Medical Device Industry - With Respect to Medical Device Industry in Gangwon Area)

  • 이강빈
    • 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.

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The Relationship Between Renminbi Exchange Rate Fluctuations and China's Import and Export Trade

  • Renhong WU;Yuantao FANG;Md. Alamgir HOSSAIN
    • 산경연구논집
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    • 제15권5호
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    • pp.17-27
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    • 2024
  • Purpose: The renminbi (RMB) has appreciated alongside the elevation of China's economic status, leading to increased exchange rate volatility. Moreover, China's medical industry saw a surge in import and export trade volume, with trade related to epidemic prevention and control in the medical sector significantly increasing its share. The medical device trade, in particular, occupies a substantial portion of this trade. Research design, data and methodology: This paper focuses on the import and export value of medical devices in the medical industry as a case study to explore the impact of RMB exchange rate fluctuations on the import and export trade of the medical industry during the pandemic. Additionally, it investigates whether the import and export trade of the medical industry can be a contributing factor to the fluctuations in the RMB exchange rate. Results: Through an empirical study on the import and export values of medical devices in the medical industry over the past three years, as well as the RMB exchange rate, this paper establishes a VAR model and conducts a series of tests including stationarity tests and cointegration tests. Conclusions: The conclusion is that fluctuations in the RMB exchange rate have a long-term impact on China's medical industry's import and export trade.

국산 의료기기 사용률과 사용자 및 관리자 인식 조사를 통한 국산 의료기기 개선 방안 (Suggest Improvement for Medical Device Made in Korea by the Investigation of Domestic Medical Device Percentage and Survey of Medical Device Users and Manager)

  • 이정현
    • 재활복지공학회논문지
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    • 제11권4호
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    • pp.299-306
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    • 2017
  • 국산 의료기기 산업에 대한 다양한 투자와 신기술 도입에 따라 국내의료기기 산업은 비약적인 증가를 하고 있으나 국내 대형의료기관의 국산의료기기 사용률은 여전히 저조한 것으로 조사되고 있다. 본 논문에서는 국내 대형병원에서의 국산 의료기기 사용률과 사용자 및 관리자의 인식조사를 수행하여 국산의료기기의 개선점을 제시하였다. 이를 위해 국내 4곳의 국립대학교병원을 대상으로 전체 의료기기의 종류와 국산 의료기기 사용률에 대한 조사를 진행하고 이를 바탕으로 의료기기 중 중점조사 대상 의료기기를 선정하였다. 중점조사대상 의료기를 대상으로 고장통계와 사용자 인식조사를 수행하였으며 이를 통해 중점조사대상 의료기기의 개선사항을 제시하였다.

의료기기산업의 지식자산 평가모형 (The Evaluation Model for Knowledge Assets on Medical Devices Industry)

  • 김만술;이종무
    • 대한안전경영과학회지
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    • 제13권2호
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    • pp.251-258
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    • 2011
  • 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.

고령친화 의료기기의 안전관리방안 연구 (A Study on Safety Management for Senior-Friendly Medical Devices)

  • 임경민;송동진
    • 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.

의료기기 공용기술 활용 촉진을 위한 개방형 의료기기 플랫폼 개발 및 구현 (Development and Implementation of an open Medical Device Platform)

  • 김대관;홍주현;이효진
    • 대한임베디드공학회논문지
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    • 제16권6호
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    • pp.313-321
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    • 2021
  • The global market for medical devices is huge, and it will continue showing remarkable growth in the future. However, due to the entry barrier to develop medical devices, many domestic companies have technical problems in entering the medical device industry. In this paper, we introduce an open platform that can help with research and development for companies in the healthcare industry. This open platform consists of a hardware part and a software part. A hardware part is combined into CPU, base and other modules that are easy to replace and assemble. A software part is based on application software for development developed by Bionet. We test the performance of the open medical device platform using a biosignal processing algorithm.

미용업종사자의 미용기기 사용에 대한 분쟁해결과 정책적 과제 (Conflict resolution and political tasks on the usage of beauty care devices by beauty artists)

  • 김주리
    • 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.