Earticle

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.

According to the aging, the medical device industry is focused as a future promising industry. However, Korea medical device industry is not enough market competitiveness due to a narrow domestic market and a small company structure. This study aims at evaluating medical device priorities following 3 steps. First, we classify the medical device into three hierarchy categories and AHP survey was conducted on 30 experts in order to extract medical device priorities. Second, priority scores of medical device are analysed using AHP and Fuzzy-AHP. Third, a most important medical device is selected by comparing the volume of medical device manufacture and priority scores. As a result, ‘dental implant’ is the most import medical device, and we suggest a strategy based on a positioning map. The proposed methodology will provide a inspiration for establish of R&D and support policy in the medical device industry.

The purpose of this study is to derive medical devices with different management systems through comparison of domestic and overseas medical device product classification systems and to propose management conversion measures for the products. The definitions of medical devices were compared and the scope of medical devices defined by each country was confirmed through surveys of the Medical Device Act, Federal Food, Drug & Cosmetics Act (FD&C) in the U.S., and Medical Device Regulations (MDR) in Europe. Using the Ministry of Food and Drug Safety's regulations on medical device products and grades, 21 CFR part 860-892 and product code classification files in U.S., and EMDN in Europe as basic data to compare medical device products and derive medical devices with different management systems. As a result of comparing the definition and product classification systems of medical devices in Korea, the U.S. and Europe, medical device accessories, prosthetic limbs and aids among assistive devices for persons with disabilities, drugs, quasi-drugs and industrial products that are not managed by medical devices in Korea are managed as medical devices in the U.S. and Europe. This study aims to improve public health by securing systematic product safety management and essential performance under medical device regulations. Management within a single medical device system will increase the efficiency of licensing work of domestic medical device manufacturers and related organizations. It is also expected to help advance the system according to the international harmony of the item classification system and enhance smooth import and export competitiveness.

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.