• THE INTERNATIONAL COMMERCE & LAW REVIEW
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• v.45
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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.

• Journal of Biomedical Engineering Research
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• v.44 no.1
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• pp.1-10
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• 2023

With the announcement of MEDICAL DEVICE REGULATION 2017/745 (MDR) on April 5 2017, medical device manufacturers shall apply ISO 14971:2019 (3^rd) revised in December 2019. However, there is not much related information and guidance available to medical device manufacturers, especially single use medical device. Risk management process basically follow 5 steps which are Risk Analysis, Risk Evaluation, Risk Control, Evaluation of overall residual risk and post-production activities. The purpose of this study is to provide a guidance of from risk analysis with Failure Mode and Effects Analysis (FMEA) table to overall residual risk evaluation for the single use medical device and to reflect it in a Periodic Safety Update Reports (PSUR) to satisfy with MDR requirements with single use medical device which are widely used and manufactured FDA class 2 or CE class IIb as examples. For this study, single use medical device manufacturer can adopt ISO 14971:2019 in accordance with MDR requirements and it can be extended to the PSUR. But there are still limitations to adopt to the all-single use medical device especially high class, private device and implantable device. So, Competent Authority (CA) shall publish more guidance for the single use medical device.

• The Journal of Korea Institute of Information, Electronics, and Communication Technology
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• v.7 no.4
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• pp.159-167
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• 2014

Local device-to-device (D2D) communication between two smart mobile devices is becoming increasingly popular. The first key step in starting a D2D communication is to discover and identify the remote target device to establish a link. However, existing device discovery mechanisms either require users to explicitly identify the ID of the target device or rely on inaccurate beamforming technology. This paper presents two novel device identification algorithms using a variety of embedded sensors. The algorithms only require that users to point two devices towards each other. This paper describes the algorithms, analyzes their accuracy using analytical models, and verifies the results using simulations.

• Journal of Biomedical Engineering Research
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• v.34 no.2
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• pp.69-72
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• 2013

The goal of this study is to develop test method for evaluating the drug eluting properties of drug eluting stents (DES). PBS and the detergent solutions, presented by each DES manufacturer, were used for drug release of DES coated with paclitaxel, zotarolimus and everolimus. The drugs which are coating DES were not released by PBS but released by the detergent solutions, finally paclitaxel 83.38%, zotarolimus 103.85% and everolimus 115.78%. It seems that the use of the detergents is necessary in order to release the drugs because those drugs are extremely hydrophobic. In conclusion, using of detergent solutions presented by each manufacturer were suitable for evaluating the drug eluting property of drug eluting stent.

• Journal of Biosystems Engineering
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• v.19 no.2
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• pp.91-98
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• 1994

Planting, transplanting, and harvesting are important processes for the successful production of farm products in Korea because those require the high labor intensity during limitted period. Recently, many researches of using automatic control with a microcomputer are carried in the agricultural field, but are not much spread to the seeder development. Automatic sowing technology would be much attractive if there was a way to assure that each seed was count accurately in the seed metering device. Thus, an automatic seed metering device was designed and constructed to be controlled by microcomputer. This device could be improved in not only counting the number of seeds in but also sowing seeds between row spacings. Automatic seed metering device consisted of conveyor belt and temporary storage device. Performance of seed metering device depends on the apparatus including sensor, stepping motor and DC-solenoid. Research contents and results are summarized as follows. 1. The seed metering device involving seed hopper, sorter and temporary storage device was designed and constructed. 2. A seed counting system with six photo electric sensors, designed and built for this project, was adequate for tranferring and counting seeds accurately. 3. Operating algorithm for stepping motor and photo electric DC-solenoid was developed. The Seed metering device proved to be a smooth and accurate operating device using the algorithm. 4. The performance of second prototype metering device was examined with five kinds of seeds ; mung beans, red beans, white beans, black beans and corn to transfer and count the seeds. The error ratio of seed metering was less than 3.5%.

• Proceedings of the Korean Society for Technology of Plasticity Conference
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• 2004.05a
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• pp.109-113
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• 2004

Slitting device is equipment to separate spent fuel of 250 mm rod cut pellets and hull in order to supply required $UO_2$ pellets through the dry pulverizing/mixing device. For development of its device, We have analyzed slitting programs so that the existing device is modified an appropriate scale in the advanced spent fuel conditioning process. The results of the analysis, we added the automatic separation function of pellets and hull, After slitting. Also, we have concentrated on reducing the operation time so that the support and the body of a slitting blade could have been established in the single structure to be easily maintained. It is based on a design and manufacture of a testing device and we have performed an efficiency evaluation. We have analyzed the results of efficiency tests of the slitting device and get the specification of the slitting device. we complete the basic design of the slitting device by using of these data. Therefore, We apply to a basic data when manufacturing a slitting device.

• Journal of Information Processing Systems
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• v.11 no.1
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• pp.125-133
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• 2015

The Remote Device Management (RDM) protocol is used to manage the devices in the lighting control networks. RDM provides bi-directional communications between a controller and many lighting devices over the DMX512-A network. In RDM, using a simple binary search scheme, which is based on the 48-bit unique ID (UID) of each device, discovers the lighting devices. However, the existing binary search scheme tends to require a large delay in the device discovery process. In this paper, we propose a novel partition-based discovery scheme for fast device discovery in RDM. In the proposed scheme, all devices are divided into several partitions as per the device UID, and the controller performs device discovery for each partition by configuring a response timer that each device will use. From numerical simulations, we can see that there is an optimal number of partitions to minimize the device discovery time for a given number of devices in the proposed scheme, and also that the proposed partition-based scheme can reduce the device discovery time, as compared to the existing binary search scheme.

• Journal of the Korea Institute of Information and Communication Engineering
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• v.17 no.1
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• pp.151-157
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• 2013

In this paper, a comparative analysis of PBTI induced device degradation in nanowire n-channel junctionless and inversion mode Multiple-Gate MOSFET(MuGFETs) has been performed. It has been observed that the threshold voltage is increased after PBTI stress and the threshold voltage variation of junctionless device is less significant than that of inversion mode device. However the degradation rate of junctionless device is less significant than that of inversion mode device. The activation energy of the device degradation is larger in inversion mode device than junctionless device. In order to analyze the more significant PBTI induced device degradation in inversion mode device than junctionless device, 3-dimensional device simulation has been performed. The electron concentration in inversion mode device is equal to the one in junctionless device but the electric field in inversion mode device is larger than junctionless device.

• 제어로봇시스템학회:학술대회논문집
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• 2004.08a
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• pp.1634-1637
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• 2004

We developed a communication device for person with serious disability to use slight movement. This device is developed mainly for patients suffering from ALS or a cerebral infarction. They often have communication difficulty because of deterioration of muscle functions. A feature of this device is that slight movements of user's finger, eyes or lips can be detected by using a vision sensor. Due to the features of the vision sensor, it is quite easy even for person with serious disability to use a communication device. By the field test it is confirmed that the vision sensors have superior performances as an input device for communication device. Experiments to use an EMG (electromyography) sensor and a rotary sensor are also tested to compare the performances.

• ETRI Journal
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• v.30 no.3
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• pp.394-402
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• 2008

Domain analysis is the process of analyzing related software systems in a domain to find their common and variable parts. In the case of device drivers, they are highly suitable for domain analysis because device drivers of the same domain are implemented similarly for each device and each system that they support. Considering this characteristic, this paper introduces a new approach to the domain analysis of device drivers. Our method uses a code clone detection technique to extract similarity among device drivers of the same domain. To examine the applicability of our method, we investigated whole device drivers of a Linux source. Results showed that many reusable similar codes can be discerned by the code clone detection method. We also investigated if our method is applicable to other kernel sources. However, the results show that the code clone detection method is not useful for the domain analysis of all kernel sources. That is, the applicability of the code clone detection method to domain analysis is a peculiar feature of device drivers.