• The Journal of the Convergence on Culture Technology
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• v.8 no.5
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• pp.29-37
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• 2022

MDR, a new European medical device regulation newly enacted in 2017, requires that medical device products that have received CE conformity certification through MDD be re-certified by May 2024 in line with the new CE MDR regulation. The new MDR requires more stringent medical device clinical evaluation and clinical investigation than the previous MDD required, and also require the submission of documented post-marketing surveillance data. Korean medical device makers also need to meet the new MDR requirements and obtain conformity certification, but the industry is still confused because they do not understand the new regulations thoroughly. In this study, medical device regulations in Korea, the United States, and Europe are compared, and the European MDR is further compared with the previous European Medical Device Directive MDD to help understand the requirements of the new European Medical Device Act.

• Journal of Biomedical Engineering Research
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• v.38 no.4
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• pp.205-210
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• 2017

The convergence healthcare industry in Korea has been stalled due to conflicts between stakeholders as well as a supplier-centered industry structure. This situation is caused by the structural contradiction in which the Korean industry has a prolonged conflict structure among stakeholders due to a strong regulation and an institutional inertia from the viewpoint of the sociotechnical system. Therefore, it is necessary to identify new system management plan that enhances social acceptability such as laws, customs and ideas while reducing conflicts between stakeholders. In this study, mainly adapting the stakeholder-oriented autopoiesis and focusing on publicness of healthcare, we propose the rationale and direction for policy making to harmonize various systems within the convergence healthcare industry.

• The Korean Journal of Nuclear Medicine Technology
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• v.27 no.1
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• pp.23-28
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• 2023

Carbon materials are widely used in many areas of our lives. A fiber having a carbon content of 90% or more obtained by heating an organic fiber precursor is referred to as a "carbon fiber". Carbon fibers are currently used in the medical market to manufacture radiation transmission device parts, artificial joints, and medical aids, as many developments have been made to utilize carbon fibers' characteristics such as light weight, radiation permeability, biocompatibility, high strength, high heat resistance, thermal conductivity, and electrical conductivity. In order to maintain body temperature and increase immunity in long-lasting nuclear medical examination and treatment through the idea of convergence of carbon materials and radiation technology, the quality of medical services can be improved by utilizing carbon materials. We should be aware of the domestic carbon-based medical device industry and make efforts to contribute to the development of medical devices. As a radiation expert, we should try to use our skills and experience to find items that can be fused with medical devices to develop various nuclear medical examination fields and radiographic examination fields that can be widely applied. We should actively engage in future technology development and carbon material research to strengthen the global competitiveness of the domestic medical device industry and improve the quality of medical services.

• 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.

• Proceedings of the Korea Contents Association Conference
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• 2009.05a
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• pp.1210-1215
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• 2009

The domestic medical device industry compared by advanced nations continues a quick growth, also the level of technique is gradually improving. However, the high import percentage, low investment, shortage of professional manpower and etc. are remained as weaknesses in the competitive circumstance. In this paper I researched world medical device market and industry, and tried to find the development plan of the domestic medical device. The approach could be in mid-long term rather than short-term, The institutional improvement and support of the government, the production complex, the market segmentation and overseas marketing reinforcement and etc. are necessary for export expansion plan.

• Journal of Biomedical Engineering Research
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• v.40 no.5
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• pp.171-178
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• 2019

This study was conducted to observe the differences in perspective of medical device adverse events and report exchange for domestic stakeholders. The post-market surveillance of medical device not only improves the usability and functionality of the device but also identifies new or growing risks caused by the device. APEC (Asia-Pacific Economic Cooperation) have established and operated post-market surveillance systems for medical devices based on IMDRF (International Medical Device Regulators Forum) and GHTF (Global Harmonization Task Force) guidelines. However, there are significant gaps in many aspects. It is essential to apply harmonized guidelines internationally but also to interpret and apply the guidelines consistently to report and exchange medical device adverse event in domestic. This study retrospectively analyzed the results of surveys conducted by providing examples of the adverse events and guidelines for post-market surveillance. The results of the study showed that there was a considerable difference in the judgment on the phase of using medical device for patient. In the case of medical device adverse event, different opinions shown according to knowledge and experience. Education and training are needed to have a harmonized perspective on the reporting and exchanging international guidelines of the adverse event for domestic stakeholders.

• Transactions of the KSME C: Technology and Education
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• v.5 no.1
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• pp.23-52
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• 2017

Bio-fusion and medical device industry is the multidisciplinary engineering application technology industries, which are fused, such as electricity, electronics, machinery, materials. It aims to improve the quality of human life by using bio-fusion and medical devices, and is an important industry recognition and brand power for the product. However, there is a period that is required from the development of products with technology-dependent industries. Therefore, it is necessary to have continuous effort for industrial investment in research and development at the national level including technical support, institutional support, and human resources.

• The Korean Journal of Health Service Management
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• v.11 no.3
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• pp.129-144
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• 2017

Objectives : To review a Tanzanian medical engineering education program and determine improvement measures for the Official Development Assistance (ODA) healthcare projects. Methods : A consultation of the Tanzanian medical engineering education program funded by the National Research Foundation of Korea (NRFK) was reviewed. An on site survey, an environmental analysis, and in-depth interviews were performed. Results : Survey results highlighted a lack of medical device education and the low operating rate of medical equipment. The need to establish educational program was thus confirmed. The expansion of healthcare facilities appeared to be limited within the current medical management system. A master coursework plan for Tanzania medical engineering was developed. Conclusions : The needs of medical engineering education were recognized. A plan and curriculum were developed. The medical engineering education program should be planned and budgeted prior to the ODA healthcare program.

• Journal of Service Research and Studies
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• v.4 no.2
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• pp.1-10
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• 2014

According to recent trends in technological advances and globalization, medical device industry may improve the constitution to meet worldwide medical equipment management system. Also it is holding a strand of mitigation to reach the level of international regulation. In addition, recent legislation tends are to stay limited ranges of industry regulations at least and take as open attitude for integration of new technologies combined medical devices. A greater environmental risk is not likely to work in medical technology, Combinded medical device is used as close to zero risk in most of the human body, which is classified as Class 1. Even medical device such as little or no risk in handling, it is possible to minimize the unnecessary administrative power and a waste of time to occur. For the medical device may be improving people's choices and access, medical equipment operator is expanding to include dealers, because this will be exalted to particular area of the business of the company. In this paper, we investigate the legal prerequisites for the establishment of a medical device. And propose improved regulations in topics in order to facilitate the repair and distribution markets for fair trade.

• Journal of Technology Innovation
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• v.8 no.2
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• pp.1-17
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• 2000

Recently, due to the primary emphasis of health industry and to the restriction of budget, setting the priorities for effective and efficient investment on the medical device and material products has been one of the critical issues in the government sector. This paper shows how an Analytic Hierarchy Process (AHP) model can be used for assessing selected medical device and material products for grant of the Ministry of Health & Welfare. The final results show that unabsorbable suture is the most attractive medical device product among 88 evaluated products, followed by IV cannula, central venous catheter.