• Journal of rehabilitation welfare engineering & assistive technology
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• v.9 no.3
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• pp.223-230
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• 2015

There is an increasing trend of medical devices and products moving out of hospitals and clinics into community and residual homes for use by the general public due to both the technological developments and demographic changes resulted from the increased life expectancy and decreased birth rate. In Korea, however, the definition of "home medical device" is rather ambiguous and we thus compared the definition of the term used in the global market with that in Korea. FDA definition of "home medical device" includes the devices intended for use in both professional healthcare facilities and home. The KFDA, does not provide the definition for the "home medical device"and the definition has only been inferred from the results of consumer surveys. With a paradigm shift in advent of u-healthcare era, the definition of "home medical device" in Korea should include the medical devices that could be used both at hospitals and at home.

• Journal of Biomedical Engineering Research
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• v.39 no.6
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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.

• THE INTERNATIONAL COMMERCE & LAW REVIEW
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• v.75
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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.

• Asia-Pacific Journal of Business Venturing and Entrepreneurship
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• v.7 no.1
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• pp.67-72
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• 2012

This study describes the environment change of an internal and external medical device market to be entered to European market of an urinary incontinence treatment device, is aimed at suggesting a participation plan analyzing urinary incontinence and treatments, and characteristic of new products & European urinary incontinence market. In conclusion, to sell the urinary incontinence treatment device developed as the world's first in European market, the following strategies are needed. First, the strategies domestic firms make family doctors and urologists heighten awareness of the urinary incontinence treatment device developed in Korea through participation of associations and exhibition being held in Europe to increase a market penetration level are needed. Second, it may be necessary to emphasize the fact that this devices are a characterful products and treatments, and cost-effectiveness treatments reducing infection ratio. Third, the domestic production firms of the urinary incontinence treatment device should suggest quality, delivery, and price consistency through looking for ways to lower the price while maintaining the quality in an increasingly competitive market conditions.

• Journal of Biomedical Engineering Research
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• v.40 no.1
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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.

• Management & Information Systems Review
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• v.36 no.1
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• pp.181-213
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• 2017

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.

• Journal of Biomedical Engineering Research
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• v.43 no.4
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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.

• Journal of the Korea Safety Management & Science
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• v.12 no.3
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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).

• Journal of the Korean Medical Association
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• v.61 no.12
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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.

• Journal of Biomedical Engineering Research
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• v.44 no.1
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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.