• Journal of Biomedical Engineering Research
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• v.43 no.3
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• pp.153-160
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• 2022

As new types of medical devices are emerging through convergence with advanced technology, innovative technologies are becoming hot issues in health policy because of their disruptiveness. This study analyzed the innovative medical device management systems in the US, China and Korea. Innovative medical devices have been defined differently depending on the country's management system, but in common, they are defined as products that do not exist or have dramatically improved performance compare to existing products by applying innovative technologies. Innovative medical devices have been supported by regulatory authorities during product development and approval processes. While the US and China have more than 300 products designated as innovative medical devices with diverse functions, application fields, and manufacturing countries considering the initial situation of the implementation for the system, Korea has only 16 products, mainly radiology and diagnostic devices and made in Korea only as innovative medical device. In addition, Korea shows the highest market approval rate of innovative medical devices compare to the US and China, and it is necessary to prepare the approval process in consideration of product diversity.

• Journal of Biomedical Engineering Research
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• v.43 no.4
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• pp.219-229
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• 2022

In this study, we propose a miniaturized micro-ceramic heater device. After screen-printing a silver paste between pre-sintered two aluminum oxide plates to integrate a heating circuit, the device was fabricated through a low-temperature sintering process. In order to configure the optimal heating circuit integration condition, the output current evaluation and heating test were performed according to the number of screen prints of the silver paste at various voltages. A silver paste-based heating circuit printed with a line width of 200 ㎛ and a thickness of 60 ㎛ was successfully integrated on a pre-sintered alumina substrate through a low-temperature sintering process. In the case of the 5 times printed device, the thermal response showed a response rate of 18.19 ℃/sec. To demonstrate feasibility of the proposed device in the medical field, such as bio-tissue suturing and hemostasis, a voltage was applied to pig tissue in the device to test tissue change due to heat generated from the device. These results show the possibility that the proposed small ceramic heater could be used in the medical field based on its excellent temperature response.

• 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.

• Proceedings of the KOSOMBE Conference
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• v.1998 no.11
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• pp.297-298
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• 1998

Prototype portal imaging device (EPID) based on CCD camera, which has a $20\times20cm^2$ field of view (FOV), has been developed and then tested by acquiring phantom images for 6 MV x-ray beam. While, among the captured images, each frame suffered notorious quantum noise, the frame averaging largely enhanced the image quality against quantum noise. Over 60 frames averaging, the signal-to-noise ratio (SNR) was increased by $\sim20$ times and contrast was increased about 2 times in the skull-region of the acquired head-phantom image.

• Journal of Biomedical Engineering Research
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• v.39 no.6
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• pp.268-277
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• 2018

With drastic change in the market and technology of medical devices, a comparative analysis is necessary in advanced systems internationally in order to prepare domestically applicable plans for improvement in classification and differential grade management for items of medical devices. This research examines and analyzes the differences of definition and legal systems of medical devices among Korea, United States, EU, Japan and China, and investigates classification and grading system of each country to identify disadvantages of classification and grading structures for medical device in Korea. This research suggests ways to supplement the disadvantages of domestic classification and grading system of medical devices, and elicits differential management plans for medical devices.

• Design & Manufacturing
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• v.14 no.2
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• pp.34-41
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• 2020

Typical characteristics of medical device parts are that they can not be reused and there are many disposable products. Therefore, there is a need for an injection molding machine having excellent repeatability of molding conditions and a precision injection mold for mass production. Recently, the performance of an injection machine has made a remarkable evolution compared to the past. However, defects such as short-shot, flash, weld line, gas burning, warpage, and deformation, which are typical defects, still do not disappear at all. This is due to the lack of gas ventilation from the product cavities, even if the gas is smoothly vented from the sprue and runner of the mold. For this reason, the internal pressure of the cavity rises and is directly connected to the quality defects. In this study, an active gas vent system was designed to prevent defects due to trapped gas in the cavity. Since it can be easily adjustable in response to the molding conditions and the mold temperature changes, it is expected to improve productivity due to the reduction of the defective ratio.

• 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 Advanced Navigation Technology
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• v.18 no.6
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• pp.625-632
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• 2014

The u-health service is using portable device such as smart device and it consists of small computing device. The u-health service carry out same performance with desktop computer. We designed message structure based on Bluetooth HDP. This message structure is used to transmit patient's biometric data on the smart device of medical team, patient and family over the mobile network environment. ISO/IEEE 11073 PHD standard was defined based on the method of communication between the agent and the manager. And We are confirmed the reliable transmission of biometric data at the smart device by implementing the android OS based patient information monitoring application to check the status of patient for medical team, patient and family.

• Carbon letters
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• v.15 no.3
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• pp.214-217
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• 2014

A filtration-taping method was demonstrated to fabricate carbon nanotube (CNT) emitters. This method shows many good features, including high mechanical adhesion, good electrical contact, low temperature, organic-free, low cost, large size, and suitability for various CNT materials and substrates. These good features promise an advanced field emission performance with a turn-on field of $0.88V/{\mu}m$ at a current density of $0.1{\mu}A/cm^2$, a threshold field of $1.98V/{\mu}m$ at a current density of $1mA/cm^2$, and a good stability of over 20 h. The filtration-taping technique is an effective way to realize low-cost, large-size, and high-performance CNT emitters.

• Progress in Medical Physics
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• v.27 no.3
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• pp.117-124
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• 2016

Intrafractional motion of patients, such as respiratory motion during radiation treatment, is an important issue in image-guided radiotherapy. The accuracy of the radiation treatment decreases as the motion range increases. We developed a control system for a robotic patient immobilization system that enables to reduce the range of tumor motion by compensating the tumor motion. Fusion technology, combining robotics and mechatronics, was developed and applied in this study. First, a small-sized prototype was established for use with an industrial miniature robot. The patient immobilization system consisted of an optical tracking system, a robotic couch, a robot controller, and a control program for managing the system components. A multi speed and position control mechanism with three degrees of freedom was designed. The parameters for operating the control system, such as the coordinate transformation parameters and calibration parameters, were measured and evaluated for a prototype device. After developing the control system using the prototype device, a feasibility test on a full-scale patient immobilization system was performed, using a large industrial robot and couch. The performances of both the prototype device and the realistic device were evaluated using a respiratory motion phantom, for several patterns of respiratory motion. For all patterns of motion, the root mean squared error of the corresponding detected motion trajectories were reduced by more than 40%. The proposed system improves the accuracy of the radiation dose delivered to the target and reduces the unwanted irradiation of normal tissue.