• 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 the Korean Academic Society of Industrial Cluster
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• v.1 no.1
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• pp.67-86
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• 2007

Wonju Medical Equipment Industry, despite of its short history, poor sales and weak manpower and so on, have shown remarkable outcomes in a relatively short period. At the end of 2007, totally 79 enterprises (only 4.6% of whole enterprises in Korea) made 10% of the nationwide production and 15% of the nationwide exports with an annual average growth rate of 66.7%, contributing domestic medical equipment industry tremendously. In addition, many leading medical equipment enterprises in various fields already moved or plan to move to Wonju, accelerating Wonju Medical Equipment Cluster. Wonju Medical Equipment Industry Cluster now enters into the growth stage, getting out of the initial business setup stage. Especially, the nomination of Wonju cluster project from the government accelerates networking (e.g. the development of the universal parts, the establishment of the mutual collaboration model among enterprises, and the mutual marketing), making a rapid growth in Wonju Medical Equipment Industry. Wonju Medical Equipment Industry Cluster revealed positive outcomes despite of the weakness in investment size and infra-structure comparing with the other medical industry cluster in the advanced country, while many domestic enterprises pursued their own growth models and thus failed to promote the international competitive power. Wonju Medical Equipment Industry has been developed rapidly. However, there are many challenging problems to support enterprises: small R&D investment and thus weak technology power, difficulties in recruiting R&D engineers, and poor marketing capabilities, financial infrastructure & policies, and network architecture. In order to develop a world-competitive medical equipment industry cluster at Wonju, the complement of infrastructures, the technology innovation, the mutual marketing, and the network expansion to support enterprises are further required. Wonju' s experiences in developing medical equipment industry so far suggest that our own flexible cluster model considering the industry structure and maturity for different regions should be developed, and specific action plans from the local and central governments based on their systematic strategies for industry development should be implemented in order to build world-competitive industry clusters in Korea.

• Journal of the Korean institute of surface engineering
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• v.55 no.6
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• pp.390-397
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• 2022

Parylene-C which was mainly used for industries such as electronics, machinery and semiconductors has recently been in the spotlight in the medical field due to its properties such as corrosion resistance and biocompatibility. In this study we intend to derive a plan to improve the bonding strength of Parylene-C coating with the SUS304 base material for medical use which can be applied to various medical fields such as needles, micro needles and in vitro diagnostic device sensors. Through plasma pretreatment the bonding strength between Parylene-C and metal materials was improved. It was confirmed that the coated surface was hydrophobic by measuring the contact angle and the improvement of the surface roughness of the sample manufactured through CNC machining was confirmed by measuring the surface roughness with SEM. Through the above results, it is thought that it will be effective in increasing usability and reducing pain in patients by minimizing friction when inserting medical devices and in contact with skin. In addition it can be applied to various application fields such as human implantable stents and catheters, and is expected to improve the performance and lifespan of medical parts.

• The Proceeding of the Korean Institute of Electromagnetic Engineering and Science
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• v.16 no.3 s.55
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• pp.80-88
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• 2005

본 고에서는 의료 분야의 전자파 장해 사례를 들었으며, 국내 및 국외 의료용 전기 기기의 전자파 적합성 규격에 대하여 간략하게 살펴보았다. 의료 기기 전자파 업무를 수행하는 국내 기관들을 소개하였으며, 주요 국제 규격인 IEC 60101-1-2의 동향을 간략하게 다루었다. 비록 외국이기는 하지만 의료 기기와 전자파 장해에 대한 실례를 들어서 일상생활에 편리한 전자파가 의료기기 동작에도 영향을 끼침을 보았다. 본고를 통하여 정보 통신 및 전기 전자 산업 분야 뿐만 아니라 의료 기기 분야에서도 전자파 적합성 문제가 중요함을 일깨우는 계기가 마련되기를 바란다.

• 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.

• 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.

• 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.

• Journal of Biomedical Engineering Research
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• v.42 no.3
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• pp.125-142
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• 2021

The POCT (point-of-care test) sensing that has been a fast-developing field is expected to be a next generation technology in health care. The POCT sensors for the detection of proteins, small molecules and especially nucleic acids have lately attracted considerable attention. According to the World Health Organization (WHO), the POCT methods are required to follow the ASSURED guidelines (Affordable, Sensitive, Specific, User- friendly, Robust and rapid, Equipment-free, Deliverable to all people who need the test). Recently, several CRISPR (Clustered Regularly Interspaced Short Palindromic Repeats) based diagnostic techniques using the sensitive gene recognition function of CRISPR have been reported. CRISPR/Cas (Cas, CRISPR associated protein) systems based detection technology is the most innovative gene analysis technology that is following the ASSURED guidelines. It is being re-emerged as a powerful diagnostic tool that can detect nucleic acids due to its characteristics that enable rapid, sensitive and specific analyses of nucleic acid. The first CRISPR-based diagnosis begins with the discovery of the additional function of Cas13a. The enzymatic cleavage occurs when the conjugate of Cas protein and CRISPR RNA (crRNA) detect a specific complementary sequence of the target sequence. Enzymatic cleavage occurs on not only the target sequence, but also all surrounding non-target single-stranded RNAs. This discovery was immediately utilized as a biosensor, and numerous sensor studies using CRISPR have been reported since then. In this review, the concept of CRISPR, the characteristics of the Cas protein required for CRISPR diagnosis, the current research trends of CRISPR diagnostic technology, and some aspects to be improved in the future are covered.

• Information and Communications Magazine
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• v.33 no.6
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• pp.47-52
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• 2016

의료기기는 다학제적 융합기술 분야이자 고 부가가치 산업으로 IT 기술의 발전과 초고령화 사회의 본격화로 높은 성장 가능성이 전망된다. 이 중 피부 부착형 (웨어러블) 및 인체 삽입형 (임플랜터블) 소형 의료기기는 포화된 스마트폰 시장에 새로운 성장 원동력으로 작용할 것이다. 따라서 본고에서는 생체삽입형 및 부착형 소형 의료기기 중 생체삽입형 전극 어레이, 스마트 콘택트 렌즈, 피부부착형 헬스 모니터링 디바이스의 개발 사례를 알아보고, 궁극적 소형 의료기기로 손꼽히는 복용형 디바이스에 대한 전망을 알아본다. 또한 각 유형별로 현재 극복해야 할 기술적 한계와 문제점을 짚어본다.

• Journal of Biomedical Engineering Research
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• v.40 no.3
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• pp.105-115
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• 2019

Brain tumor surgery may be difficult, but it is also incredibly important. The technological improvements for traditional brain tumor surgeries have always been a focus to improve the precision of surgery and release the potential of the technology in this important area of the body. The need for precision during brain tumor surgery has led to an increase in Robotic-assisted surgeries (RAS). One of the challenges to the widespread acceptance of RAS in the neurosurgery is to recognize invisible tumor accurately. Therefore, it is important to detect brain tumor size and location because surgeon tries to remove as much tumor as possible. In this paper, we proposed brain tumor detection procedures for MRI (Magnetic Resonance Imaging) system. A method of automatic brain tumor detection is needed to accurately target the location of the lesion during brain tumor surgery and to report the location and size of the lesion. In the qualitative assessment, the proposed method showed better results than those obtained with other brain tumor detection methods. Comparisons among all assessment criteria indicated that the proposed method was significantly superior to the threshold method with respect to all assessment criteria. The proposed method was effective for detecting brain tumor.