전 세계적인 코로나19의 확산으로 인해, 진단시약 등과 같은 감염병 의료 및 의료기기 신제품이 비약적으로 개발·출시되고 있으며, 이의 빠른 수급을 위해 각 국가들은 수입규제를 완화하거나 신속한 인·허가를 위한 정책을 펼치고 있다(NIDS, 2020). 반면, 신종감염병과 관련 없는 신개발 의료기기의 경우 오히려 시험검사 등 지연 및 취소되는 사례가 발생하고 있는 등 여전히 엄격한 인·허가규제를 통해 시장에 진출하고 있다. 이에 본 연구는 의료기기신제품이 시장에 진출하면서 마주하게 되는 정부소관법률에 특화하여 규제강도 영향요인을 도출하고 규제강도를 분석하여 규제대응 프레임워크를 제안하였다. 연구방법은 문헌연구, Failure Mode and Effects Analysis(FMEA)기법 적용, 전문가인터뷰(1차):아이디어수집, 전문가인터뷰(2차) : 타당성검증의 방법으로 진행하였으며, FMEA기법의 적용프로세스를 통해 우선 규제단계별 영향요인의 발생영향도와 규제사무 유형별 부담영향도를 곱하여 규제요인의 중요도를 구하고, 규제영향 심각도를 곱하는 방식으로 규제강도 정량화방법을 제시하였다. 시사점은 최근 해외 주요 국가들 및 우리나라 정부가 코로나19에 따른 신개발의료기기의 신속한 인·허가를 위한 특별규제정책 및 완화정책을 펼치며 적극적으로 대응하고 있는 시점에 본 연구에서 제안된 프레임워크를 통해 향후 기존 의료기기 신제품의 인·허가 정책 규제프로세스에도 보다 적극적이며 선제적인 대응이 될 수 있도록 규제의 개선방향과 규제대응 방안이 이루어지길 기대한다.

This paper investigated relationship among internal as well as external motive to receive the ISO 13485 certification, countermeasure to the certification examination, active reception/execution level of the certification, and operational as well as financial performance of the medical device related enterprises in South Korea which received and are maintaining the ISO 13485 certification. SEM (structural equation model) and related analyses using AMOS 21.0 and SPSS 21.0 have been applied to verify the hypotheses of the research. Result of the research showed that internal as well as external motive for certification positively(+) affects active reception/execution level of the certification as well as countermeasure to the certification examination. The reception/execution level of the certification also positively(+) affects on the operational as well as financial performance of the certified enterprises. However, countermeasure to the certification examination was found out to negatively(-) affects the active reception/execution level of the certification and we can interpret that relatively more countermeasure to the certification examination burdens the employees of the enterprise, causing them to be less active on the reception/execution level of the certification. This research found that an enterprise’s operational/financial performance improves when an enterprise introduces the ISO 13485 certification standard spontaneously on the purpose of improving its system and the certification system is applied to the enterprise actively, not passively. This research emphasizes the need to recognize the difference of the level of active reception implication among members of an enterprise according to the motive of introduction of the certification system.

Patent management activities are considered to play a key role for technology-based firms under the recent knowledge-based economies. This is because intellectual property, including patents, can act as a system for continuous profit generation by protecting firms’ products, processes and services. In Korea, healthcare industry is now regarded as one of the promising next generation industries. Despite the promise of healthcare industry, Korean healthcare product manufacturers are faced with turbulent business changes, such as market opening. Even though there are various industrial studies on the effect of patent management activities on firm outcome, previous studies have hardly paid attention to Korean healthcare product manufacturing firms. For this reason, this study identifies the effect of patent management activities, such as patenting activeness, technical excellence and cooperation degree, on firm outcomes, including financial profitability and firm growth, with respect to the Korean healthcare product manufacturers. In this study, we located 86 Korean healthcare manufacturing firms from KORCHAMBIZ and DART, and then collected the data of their patenting activities and outcomes between 2001 and 2013. By applying factor analysis and regression analysis, our empirical study found that firms’ patenting activeness has the significant positive relationship on firms’ financial profitability, and firms’ patenting activeness and technical excellence have the significant positive relationship on firms’ financial growth. Our study is an initial attempt to identify the effect of patent management activities on firm outcome within Korean healthcare product manufacturing industry, and thus its results can be used as the basis to formulate national policies for Korean healthcare product industry.

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.

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).

고령 인구의 증가와 고도의 산업화에 따른 환경 질환 및 생활 습관성 질병의 증가, 산업 재해 및 교통 재해의 꾸준한 증가에 따라 지속적인 의료산업 시장의 확대가 예상되고 있다. 그에 따라 인공 스텐트, 촬영장비, 인공 관절 등 대규모 개발 프로젝트가 국내 많은 업체에서 이루어지고 있다. 대규모 개발 프로젝트가 수행됨에 따라 프로젝트에 내재된 위험요인들이 기하급수적으로 증가하게 되고 그러한 위험요인을 사전에 파악하고 대응하지 못함으로 인하여 많은 프로젝트 들이 중지되거나 실패로 끝나는 사례들이 실제로 많이 발생하고 있다. 이러한 의료기기 개발 프 로젝트의 실패율을 줄일 수 있는 한 가지 방법은 프로젝트 이해 당사자들이 직면하여 있는 주요 위험 요인들을 정의하여 인식하고, 일정한 허용 한계 내에서 적절히 관리하는 것이다. 본 연구는 국내 의료기기 개발 프로젝트의 성패의 열쇠를 쥐고 있는 위험요소에 관한 연구로서 PMBOK의 위험 관리의 정의를 명확히 하고, 기존 문헌을 통하여 프로젝트에 영향을 미치는 위험요소에 대하여 파악하고 의료기기 개발 프로젝트에 영향을 미치는 위험요소를 확인하고 그 우선순위를 파 악하여 프로젝트 전 단계에 걸쳐 파악된 위험요소를 실제 개발에 적용하여 위험으로 인한 프로젝트의 실패 확률을 줄이는 데에 그 목적이 있다.

The health industry is highly value-added, compared to other industries. The reason is that increase of income growth and the expanded human life expectancy bring about positively needs of products at health industry. This is related with increase in expenses of health care and R&D investment of health industry. After 1995, the share of GDP at drug & biomedical industry is increased. Especially, the share of GDP at biomedical is 0.12% in 1995 1st quarter, but 0.17% in 2002 3rd quarter, 0.24% in 2008. Biomedical's contribution about GDP growth is to jump into 6.01% in 2008. The share of GDP at drug will continuously expand, compared to other manufacture industries. Also, drug's contribution about GDP growth will increase, compared with before. Conclusionally, total shares of GDP at drug St biomedical industry are to increase, compared with before. Also, this health industry's contribution is to expand as value-added industry and increase of sales.