• 제목/요약/키워드: Medical Device Industry

검색결과 164건 처리시간 0.028초

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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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.

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.

Fuzzy-AHP를 활용한 미래유망 의료기기 우선순위 도출 (A Study on the Prioritization of Medical Device using Fuzzy-AHP)

  • 이창섭;윤재웅;전재헌;이석준
    • 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.

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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.

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.

Exploratory Study on the Success Factors of Rehabilitation Medical Device Cluster

  • Kim, Sung-Jin;Kim, Gyu-Bae
    • 융합경영연구
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    • 제6권4호
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    • pp.17-27
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    • 2018
  • Purpose - As Korea is reaching a post-aged society, the number of chronic illness is increasing, and the demand for rehabilitation medical device is growing. Although there is high potential for the growth in rehabilitation industry, because most of the related companies in Korea are relatively small, lacking capital or R&D resource, it is difficult for them to create an innovative product, and currently most of the high-tech equipments are imported. Therefore a medical device cluster, where business, research, medical institutes and universities may work cooperatively to enhance research development and solve issues is necessary for future development. Research design, data, methodology - In this method we have done a literature review of the rehabilitation industry and industrial cluster. Based on the studies, we have conducted an exploratory factor analysis by studying examples of foreign and domestic medical clusters and drawing success factors in forming a medical cluster. Next based on the studies we have conducted a survey to domestic medical device companies to find their difficulties and needs to form a successful medical device cluster. Results - This paper provides both theoretic review on success factors of forming a medical device cluster and practical analysis using case study and survey. Conclusion - The significance of this paper is that based on the literature review, we have compared actual examples of domestic/foreign medical clusters and drawn difference and coincidence between literature and actual cluster success factor. We were also able to conduct a survey on actual medical device companies and through the results we were able to search difficulties and necessities of medical device companies.

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.

글로벌 의료기기산업의 시장동향 및 주요 수출국의 의료기기 관련 규제에 관한 연구 (A Study on Global Medical Device Market Trends and Regulation of Medical Equipment in Major Countries)

  • 이우천;박세훈
    • 무역상무연구
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    • 제75권
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    • pp.159-177
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    • 2017
  • In this paper, we examined trends and regulations of the global medical equipment industry through literature search. The medical equipment industry is attracting attention as a new growth engine in the Fourth Industrial revolution. However, the medical device industry is a highly competitive field due to product diversity, short product life cycle and technological advances. In addition, Medical equipment are related to human health and safety. Therefore, it can only be exported if it is approved by national or international standards. Therefore, from the development stage of the product, the medical equipment should designate the country to be exported and develop a medical equipment that meets the requirements for licensing the medical equipment in the country. Therefore, In this paper, In this paper, we will present the practical considerations of the medical equipment exporting company by examining the global medical equipment market trends and the regulations related to medical equipment in major countries.

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ISO 국제표준의 비교 연구를 통한 국내 의료기기 GMP 제도의 효과적인 운영 방안 (Comparative Study of ISO Standards for an Effective Implementation of the Domestic Medical Device GMP System)

  • 정영아;김영진
    • 품질경영학회지
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    • 제46권2호
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    • pp.211-224
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    • 2018
  • Purpose: It can easily be understood that more rules and regulations need to be imposed on the medical device industry due to its impact on public health and hygiene. Domestic medical device manufacturers are thus required to comply with the requirements specified in the good manufacturing practice (GMP) system, and it is essential to abide by the international standards as well to sustain their global competitiveness. The main purpose of this study is to review the guidelines of the medical device GMP system in Korea and propose future directions for further enhancement of the GMP system. Methods: Specific requirements prescribed in international standards, such as ISO 9001:2015, ISO 13485:2016, ISO 14971:2012, and ISO 14155:2011, are analyzed and compared with the domestic GMP system. Results: It has been observed that the generic international standard related to quality management system, ISO 9001:2015, lays out the foundations for the development of quality management system relevant to medical device industry, ISO 13485:2003, with which the domestic GMP system is fully compatible. Further, several important aspects of risk management and clinical trials of medical devices are also recognized and included in the domestic medical device GMP system. Conclusion: Even though specific requirements of individual ISO standards are slightly different from each other, their overall structure and framework may contribute to the development and enhancement of globally competitive GMP system of the domestic medical device industry.