• 무역상무연구
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• 제45권
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• pp.191-238
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• 2010

The purpose of this paper is to make research on the trend of the worldwide medical device market, the trend of the medical device market in the major foreign countries, the present status of the medical device industry in Korea and Gangwon area, the present status of export competitive power and the SWOT analysis of competitive power of the medical device industry in Gangwon area, and the strengthening methods of export competitive power of the medical device industry in Gangwon area. As the research method, the questionaire for the strengthening of export competitive power of the medical device industry in Gangwon area was carried out from August 13 to Otober 22, 2009. The worldwide medical device market in 2008 is estimated at USD 210.2 billion, with the United States being the largest market, followed closely by Japan and Western Europe. In 2006, the worldwide export amount of medical devices recorded USD 121.1 billion and the worldwide import amount of medical devices recorded USD 126.3 billion. As of the end of 2008, the number of Korea's medical device manufacturers expanded to 1,726. The production amount of Korea's medical device industry in 2008 recorded 2,525 billion won, and the domestic market volume of medical devices in 2008 recorded 3,618 billion won. Korea's export amount of medical devices in 2008 recorded USD 1,132 million and recorded a 9.67% growth compared to the previous year, and the import amount of medical devices recorded USD 2,123 million and recorded a 1.43% reduction compared to the previous year. As of the end of 2008, the number of Gangwon area's medical device manufacturers expanded to 81. The production amount of Gangwon area's medical industry in 2008 recorded 380 billion won, and Gangwon area's export amount of medical devices recorded USD 269 million and recorded a 0.25% reduction compared to the previous year, and the import amount of medical devices recorded USD 3 million and recorded a 39.63% reduction compared to the previous year. According to the result analysis of the questionaire for the strengthening of export competitive power of medical device industry in Gangwon area(August 13~October 22, 2009), the competing country of the export medical device is the United States being the highest ranking. Comparing to the collective competitive power level 100 of the competing country, the collective competitive level of the export medical device is 60 below and 70-80 below being the highest ranking. Comparing to the quality level 100 of the United States, EU and Japan, the quality level of the export medical device is 80-90 below being the highest ranking. Comparing to the design level 100 of the United States, EU and Japan, the design level of the export medical device is 90-100 below being the highest ranking. Comparing to the technology level 100 of the United States, EU and Japan, the technology level of the export medical device is 80-90 below being the highest ranking. According to the SWOT analysis of competitive power of medical device industry in Gangwon area, the strength is the abundant expert manpower of the medical device in Wonju area. The weakness is the fragility of the brand recognition of the medical device industry. The opportunity is the demand increase of the new medical device owing to the advanced age of population. The threat is the difficulty of entry into overseas market owing to the request of the new specification certification of the medical device. In order to strengthen the export competitive power of the medical device industry in Gangwon area, the following measures should be taken by the government, local self-government body, related organization and medical device industry : the development of new technology and design, the enhancement of brand recognition. the acquisition of the foreign specification certification, the building of overseas distribution channel and after sales service channel, the positive participation in overseas medical device exhibition and opening of medical device exhibition, the training of expert manpower, the strengthening of overseas marketing, and the application of FTA and the establishment of counter measures against FTA. In conclusion, the medical device industry in Gangwon area has the difficulty in the entry into the overseas market owing to the shortage of overseas marketing capability. Therefore, the government and local self-government body should make the intensive and systematical support for overseas marketing of the medical device industry. For the support of overseas marketing, the government and local self-government body should provide positively the support of expenses for the acquisition of foreign specification certification, the support of participation in the overseas medical device exhibition, the despatch of market development mission, the increase of the support amount for R&D investment fund, and the training of expert manpower of medical devices.

• 감성과학
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• 제17권3호
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• pp.129-142
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• 2014

오늘날 고령인구의 증가와 장애인 인구의 증가로 인해 재활훈련기의 수요가 증가하고 있고, 재활훈련기와 사용자간의 제공받아야 할 서비스에 대한 평가 요소의 요구가 커지고 있다. 본 연구에서는 재활훈련기 디자인 평가에 있어서 평가 방안을 모색하기 위해 디자인 평가를 위한 기본 요소를 파악하고 이를 통하여 재활의료전문가, 의공학자, 디자이너들의 토의 및 분석, 실험을 통하여 새로운 평가 요소들을 도출하였다. 연구의 결과는 다음과 같이 요약된다. 첫째, 기존 디자인 평가 요소들을 수집, 분석하여 10가지의 재활훈련기 디자인 평가요소와 44개의 세부 평가항목을 구축하였다. 이는 앞으로 재활훈련기를 디자인하는데 있어서 중요한 평가 기준이 될 것이다. 둘째, 헬스케어 재활훈련기 디자인 개발 시 고려해야 할 디자인 평가요소로는 사용성, 인지성, 안전성, 학습성, 운동성, 내구성, 경제성, 공간성, 심미성, 환경성의 10가지 디자인 평가요소가 있다. 셋째, 환경성, 공간성, 인지성, 사용성, 경제성, 심미성의 디자인 평가요소는 제품디자인에서 공통적으로 고려해야 할 요소들이고, 학습성, 안전성, 운동성, 내구성의 요소는 재활훈련기 디자인 평가요소에서 매우 중요하게 고려해야 할 요소이다. 넷째, 재활훈련기 디자인 평가요소는 제품디자인요소에서 중요하게 고려되는 환경성, 공간성, 인지성, 사용성, 경제성, 심미성에 학습성, 안전성, 운동성, 내구성을 의 요소를 더해 중요하게 생각한 것이 기존 제품디자인 평가요소와 재활훈련기 디자인 평가요소의 차이점이다. 본 연구에서는 10개의 재활훈련기 디자인 평가요소와 44개의 세부 평가항목 구축에 대한 연구를 진행하였다. 이는 전체적인 재활훈련기 디자인 평가요소만을 연구한 것으로, 향후연구에서는 시 제품 제작을 통하여 평가요소들을 실제 재활훈련기 디자인에 적용해 보고, 미진한 점들을 수정 보완할 예정이다.

• 융합경영연구
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• 제6권4호
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• pp.17-27
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• 2018

Purpose - As Korea is reaching a post-aged society, the number of chronic illness is increasing, and the demand for rehabilitation medical device is growing. Although there is high potential for the growth in rehabilitation industry, because most of the related companies in Korea are relatively small, lacking capital or R&D resource, it is difficult for them to create an innovative product, and currently most of the high-tech equipments are imported. Therefore a medical device cluster, where business, research, medical institutes and universities may work cooperatively to enhance research development and solve issues is necessary for future development. Research design, data, methodology - In this method we have done a literature review of the rehabilitation industry and industrial cluster. Based on the studies, we have conducted an exploratory factor analysis by studying examples of foreign and domestic medical clusters and drawing success factors in forming a medical cluster. Next based on the studies we have conducted a survey to domestic medical device companies to find their difficulties and needs to form a successful medical device cluster. Results - This paper provides both theoretic review on success factors of forming a medical device cluster and practical analysis using case study and survey. Conclusion - The significance of this paper is that based on the literature review, we have compared actual examples of domestic/foreign medical clusters and drawn difference and coincidence between literature and actual cluster success factor. We were also able to conduct a survey on actual medical device companies and through the results we were able to search difficulties and necessities of medical device companies.

• Applied Microscopy
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• 제45권1호
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• pp.1-8
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• 2015

We have developed a new HD-2700 (Hitachi High-Technologies Corp., Japan) scanning transmission electron microscope (STEM) that includes an automatic aberration correction function, and a large-solid-angle energy-dispersive X-ray spectroscopy detector that enables high-resolution and sensitive analysis. For observation with atomic resolution, using spherical-aberration-corrected STEM, in order that satisfactory performance of the device can be achieved readily, and within a short time, irrespective of the operator's skill level, a spherical-aberration-correction device with an automatic aberration-correction function was developed. This automatic aberration-correction function carries out the entire correction-related process (aberration measurement, selection and correction) automatically, with automatic selection of the aberrations that require correction, and automatic measurement of the appropriate corrections.

• 한국정밀공학회:학술대회논문집
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• 한국정밀공학회 2007년도 추계학술대회 논문집
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• pp.161-162
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• 2007

• 대한의용생체공학회:의공학회지
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• 제39권6호
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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.

• Archives of Plastic Surgery
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• 제48권4호
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• pp.389-391
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• 2021

Solo hand surgery is becoming increasingly common, mostly due to a lack of assistants and dedicated operating theatres. The solo hand surgeon faces challenges of proper hand positioning, elevation, and skin flap/tissue retraction. Most commercially available hand retractors or stands do not address all the relevant problems and are not economically feasible for trainee surgeons. The Jain's hand retractor system and stand, described herein, provides solutions to all these problems, and its simple design helps surgeons to reproduce it easily.

• 정보과학회 컴퓨팅의 실제 논문지
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• 제20권10호
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• pp.561-566
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• 2014

통신기능과 상호연동가능성을 통해 의료기기들을 통합 제어함으로써 의료서비스의 효율과 환자의 안전성을 높이려는 요구가 증가하고 있다. 그러나, 네트워크와 제어컴퓨터를 통한 의료기기의 통합이 체계적이지 못할 경우 시스템의 복잡도를 크게 높이게 되며, 이는 안전사고의 위험성을 높일 가능성이 있다. 본 논문에서는 의료기기간의 안전한 상호작용 형태를 패턴으로 분류하였으며, 이를 이용하여 네트워크 통합형 의료기기의 제어 구조를 계층적으로 설계하고 안전성을 검사하는 방법을 제시한다. 제안된 기법은 Architecture Analysis and Description Language (AADL)의 플러그인으로써 구현되었다. AADL환경에서 의료기기들을 가상으로 통합하고, 이들의 구조적인 안전성 여부를 검사할 수 있게 함으로써, 실제 개발에 앞서 안전성을 검증할 수 있게 된다.

• Journal of information and communication convergence engineering
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• 제10권1호
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• pp.91-95
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• 2012

The photoplethysmography (PPG) signal measured from a mobile healthcare device contains various motion artifacts occurring from a patient’s movements. Recently, to reject the motion artifacts, the method of using an acceleration sensor was suggested, but such sensors are very expensive. Therefore, this study deals with a novel sensor device to replace the acceleration sensor, and evaluated the performance of the proposed sensor experimentally. In the results of the experiments, it is shown that the proposed sensor device can reconstruct the PPG signal despite the occurrence of motion artifacts, and also that the variation rate in heart rate analysis was 1.22%. According to the experimental results, the proposed method can be applied to design a low-cost device.

• 의료법학
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• 제15권2호
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• pp.63-89
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• 2014

In 1976, the Dalkon Shield-intrauterine device injured several thousand women in U.S.A. which caused the changes of medical deivce regulation. The Medical Device Regulation Act or Medical Device Amendments of 1976 (MDA) was introduce. As part of the process of regulating medical devices, the MDA divides medical devices into three categories. The class II, and III devices which have moderate harm or more can use the section 510 (k), premarket notification process if the manufacturer can establish that its device is "substantially equivalent" to a device that was marketed before 1976. In 21 U.S.C. ${\S}$ 360k(a), MDA introduced a provision which expressly preempts competing state laws or regulations. After that, the judicial debates had began over the proper interpretation and application of Section 360(k) In February 2008, the U.S. Supreme Court ruled in Riegel v. Medtronic that manufacturer approved by the Food and Drug Administration (FDA)'s pre-market approval process are preempted from liability, even when the devices have defective design or lack of labeling. But the Supreme Court ruled in Medtronic Inc. v. Lora Lohr that the manufactures which use the section 510 (k) process cannot be preempted and in Bausch v. Stryker Corp. that manufactures which violated the CGMP standard are also liable to the damage of patient at the state courts. In 2009, the Supreme Court ruled in Wyeth v. Levine that patients harmed by prescription drugs can claim damages in state courts. This may cause a double standard between prescription drugs and medical devices. FDA Preemption is the legal theory in the United States that exempts product manufacturers from tort claims regarding Food and Drug Administration approved products. FDA Preemption has been a highly contentious issue. In general, consumer groups are against it while the FDA and pharmaceutical manufacturers are in favor of it. This issues also influences the theory of product liability of U.S.A. Complete immunity preemption is an issue need to be more declared.