• 재활복지공학회논문지
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• 제9권3호
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• pp.223-230
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• 2015

기술의 발전과 기대수명의 증가 및 출산율 저하로 인한 인구 고령화로 의료기기와 의료용품들이 병원으로부터 일반인이 사용할 수 있는 가정과 일반 사회로의 이동이 증가하는 추세이다. 그러나 한국에서는 "가정용 의료기기"라는 용어에 대한 정의마저 불명확한 상황이며, 이에 본 연구에서는 글로벌 시장에서의 "가정용 의료기기"의 개념과 한국에서 사용되는 개념을 비교 연구하였다. 미국의 FDA의 가정용 의료기기에 대한 정의는 전문 의료기관과 가정에서 동시에 사용될 수 있는 의료기기를 포함하고 있으나, 한국에서는 식약처가 가정용 의료기기에 대한 정의를 하지 않고 있으며, 소비자를 대상으로 한 조사의 결과로 가정용 의료기기에 대한 정의를 유추하여 왔다. 유헬스케어 시대의 도래로 파라다임이 바뀌고 있는 상황에서, 한국에서도 병원과 가정에서 동시에 사용이 가능한 의료기기를 가정용 의료기기로 포함시켜야 할 것이다.

• 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.

• 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.

• 벤처창업연구
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• 제7권1호
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• pp.67-72
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• 2012

본 연구는 국내 벤처기업에서 세계 최초로 제조된 요실금 치료기기의 유럽시장 진출을 위하여 국내외 의료기기 시장의 환경변화에 대하여 서술하고 요실금과 치료방법, 그리고 신제품의 특성 및 유럽 요실금 치료기기 시장을 분석하여 유럽시장 진출 방안을 제시하였다. 그 결론으로 국내 의료기기 벤처기업에서 세계 최초로 개발된 요실금 치료기기를 유럽시장에 판매하기 위해서는 다음과 같은 전략이 필요하다. 첫째, 시장침투수준을 증가시키기 위하여 국내 업체는 유럽에서 개최되는 관련 학회 및 전시회 참가 등을 통하여 유럽의 가정의와 비뇨기과 의사들에게 국내에서 개발된 요실금 치료 장비에 대한 인식을 높이는 전략이 필요하다. 둘째, 개성 있는 독특한 제품임과 치료방법의 제시, 그리고 감염률을 줄일 수 있는 비용-효과적인 제품이라는 점의 강조가 필요하다. 셋째, 요실금 치료기기 시장의 경쟁이 심화되고 있는 상황에서 국내의 요실금 치료기기 제조업체는 품질을 확보하면서 가격을 낮출 수 있는 방법 모색을 통하여 품질과 배송, 그리고 가격의 일관성을 제시하여야 할 것으로 연구되었다.

• 대한의용생체공학회:의공학회지
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• 제40권1호
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• pp.20-31
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• 2019

Medical device performance management is an activity that allows a device to be safely used and maintained even after it is put on the market. The purpose of this study is to provide procedures and criteria for selection of medical device items that should manage the safety and performance among medical devices in hospital. Investigate the performance management status of medical devices in hospitals and identify the performance management status by domestic and advanced regulatory agencies. Provides selection procedures and test methods for medical devices subject to performance management in hospitals based on medical device risk management and reliability. In addition, a case study on drug infusion pumps was conducted.

• 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.

• 대한의용생체공학회:의공학회지
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• 제43권4호
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• pp.199-213
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• 2022

EN ISO 14971:2012 a risk management standard approved and applied as a European standard in 2012, will be adopted and applied as ISO 14971:2019 published in December 2019, ISO/TR 24971(Guidance) published in June 2020 from May 2022. After that, it is applied to IVDD surveillance and IVDR new and conversion, and the manufacturer is already preparing for application or is starting preparation for application. In addition, 98/78/EEC IVDD applied from 1998 will also be applied as REGULATION (EU) 2017/746 IVDR from May 2022. In particular, in IVDR, the requirements for post-marketing investigations such as Post Market Surveillance (PMS), Summary of safety and performance(SSP), Periodic Safety Update Report(PSUR) and Post Market Performance Follow Up(PMPF), which were not required in the existing IVDD, increased, and the contents were also specified. This study focused on ISO14971:2019 among these strengthened and newly applied regulations, and tried to present a detailed analysis and application plan of Post Market Surveillance (PMS) required by 2017/746 IVDR.

• 대한안전경영과학회지
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• 제12권3호
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• pp.37-52
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• 2010

This study is aimed at proposing the national policy for medical device control system in Korea as deeply analysed the present status of the system. On 1979, Korean government had started to inspect 24 kinds of the medical devices such as X-ray diagnostic equipments, medical sterilizer and etc. mostly imported from advanced countries which USA, Germany and Japan for the first time according to the Pharmaceutical Affairs Law. However medical devices were becoming consideration as an important partner of diagnosis, curing and alleviation of diseases by medical doctors and also much important keeping the health at home. Furthermore medical devices industry can be designated as a national growth engine industry. So it is necessary not only to harmonize to international standards but also the harmonization of the system including pre-market application and post-market surveillance, is strongly needed by the Korea Food and Drugs Administration(KFDA).

• 대한의사협회지
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• 제61권12호
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• pp.702-705
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• 2018

Advances in technology lead to advances in medical devices, and these advances have the positive effect of creating opportunities for beneficial developments in healthcare, such as innovating traditional healthcare processes or expanding opportunities for diagnosing and treating diseases. Nonetheless, device developers, suppliers, users, insurers, and patients all face the challenge of balancing patient safety and health effectiveness with a reasonable profit. In Korea, the New Health Technology Assessment system aims to introduce safe and effective health technology, but this is only effective for the entry of devices onto the healthcare market. This system is not enough for creating a healthy ecosystem in which high-quality technologies and devices survive in the market and naturally exit from the market if not successful. The nation must not lag in the rapid development of medical devices, but the concomitant requirement for patient safety is like two rabbits moving in different directions. There is not enough time to resolve each source of uncertainty for both developers and users. The early adoption of health technologies, including medical devices, offers new opportunities for treatment and diagnosis, but also poses unexpected health risks. Thus, we need to design a plan to generate scientific evidence related to medical devices after they introduced into practice. Additionally, regarding the use of individual medical devices, we believe that the creation of a healthy ecosystem for medical devices by implementing medical device surveillance culture is a way to manage the opportunities and risks of the early introduction of innovative medical devices.

• 대한의용생체공학회:의공학회지
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• 제44권1호
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• pp.41-52
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• 2023

With the international change in the medical device market owing to the development of innovative medical engineering and the use of various raw materials, a systematic and rational medical device classification system is needed to safely manage newly developed medical devices. This study aims to improve the domestic medical device classification system by proposing product establishment and segmentation. It is based on medical device products from the United States and Europe that are only available in foreign systems and are more subdivided than domestic products. This study analyzes and compares the domestic and foreign medical device classification systems by examining laws, guidelines, and analysis reports in Korea, the United States, and Europe. In accordance with product establishment and segmentation criteria, products subject to improvement are presented. This study contributes to safely managing medical devices that do not fit with the current classification system and to solving the confusion caused by the lack of international harmony in product classification systems.