• Journal of radiological science and technology
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• v.39 no.4
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• pp.651-660
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• 2016

Due to recent population aging, the number of check-up for senior citizens has increased steadily. According to this trend, the market size of dental X-ray equipment and the number of approval and review for these devices have simultaneously increased. The technical document of medical device is required for approval and review for medical device, and medical device companies needs to have work comprehension and expertise, as the document needs to include the overall contents such as performances, test criteria, etc.. Yet, since most of domestic manufacturers or importers of medical devices are small businesses, it is difficult for them to recruit professional manpower for approval of medical devices, and submission of inaccurate technical documents has increased. These problems lead to delay of the approval process and to difficulties in quick entering into the market. Especially, the Ministry of Food and Drug safety (MFDS) standards of a dental extra-oral X-ray equipment, a dental intra-oral X-ray equipment, an arm-type computed tomography, and a portable X-ray system have been recently enacted or not. this guideline of dental X-ray equipment adjusting revised standards was developed to help relative companies and reviewers. For this study, first, the methods to write technical document have been reviewed with revised international and domestic regulations and system. Second, the domestic and foreign market status of each item has been surveyed and analyzed. Third, the contents of technical documents already approved by MFDS have been analyzed to select the correct example, test items, criteria, and methods. Finally, the guideline has been developed based on international and domestic regulation, through close review of a consultative body composed of academic, industrial, research institute and government experts.

• International Journal of Internet, Broadcasting and Communication
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• v.12 no.1
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• pp.61-66
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• 2020

Many SMEs are interested in entering the dementia industry as the national dementia responsibility system begins in earnest. However, it is ambiguous about which technology and field to enter, and accordingly, it is impossible to make a quick judgment and misses the time to enter the market. Therefore, the purpose of this study is to provide a simple but clear information to many SMEs in this situation, which products and related technologies will be able to help product development and market entry in the dementia prevention and diagnosis technology market more easily. In this regard, I would like to suggest the direction through hierarchical analysis (AHP) through conducting with a group of experts who can make professional judgments about the development of dementia medical technology, including the four-year university senior welfare department, nurses, directors and directors of long-term care institutions, medical device workers and experts' opinions on what sectors SMEs can most effectively apply to product development to enter the dementia market.

• International journal of advanced smart convergence
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• v.8 no.3
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• pp.87-94
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• 2019

IoT-based services are being released in accordance with the aging population and the demand for well-being pursuit needs. In addition to medical device companies, companies with ideas ranging from global ICT companies to startup companies are accelerating their market entry. The areas where these services are most commonly applied are health/medical, life/safety, city/energy, automotive and transportation. Furthermore, by expanding IoT technology convergence into the area of life care services, it contributes greatly to the development of service models in the public sector. It also provides an important opportunity for IoT-related companies to open up new markets. By addressing the problems of life care services that are still insufficient. We are providing opportunities to pursue the common interests of both users and workers and improve the quality of life. In order to establish IoT-based digital life care services, it is necessary to develop convergence technologies using cloud computing systems, big data analytics, medical information, and smart healthcare infrastructure.

• Proceedings of the KIEE Conference
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• 2007.04a
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• pp.380-382
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• 2007

As the society changes more to the aging society in future, many healthcare product are developed and distributed more on the market. The digital wrist band tye blood pressure device for home use are popular already in the market. It is useful for checking blood pressure level at home and control of hypertension. Especially. It is very essential home device to check the health condition of blood circulation disease. Nowadays many product types are available. But the measurement accuracy of blood pressure is not enough compared to the mechanical type. It needs to be upgraded to assure the precise health data enough to use in the hospital. The structure, feature and output signal of capacitor type pressure sensors are analyzed. An improved design fa capacitor sensor is suggested. It shows more precise health data after use on a wrist band type health unit. They can be applied for remote u-health medical service.

• The Journal of the Convergence on Culture Technology
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• v.6 no.4
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• pp.803-806
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• 2020

The body shape measurement method using 3D images has been widely used due to the recent development of 3D measurement cameras and algorithms. Existing 3D imaging devices are expensive devices, and there is a limit to their universalization. Due to the recent spread of inexpensive 3D cameras and the development of various measurement methods, various possibilities are being shown. It is expected to have a great impact on the medical device market that requires accurate data collection. Various medical device products using artificial intelligence are emerging, and accurate data collection is the most important to develop accurate artificial intelligence algorithms. Collection equipment using 3D cameras is expected to act as a major factor in the development of artificial intelligence algorithms using 3D images.

• Journal of the Korea Society for Simulation
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• v.22 no.2
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• pp.21-31
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• 2013

There is a high demand for the diagnostic medical blood analyzer in the global medical device market. The domestic market is in infant stage, but expected to grow very fast. In this study, we attempt to provide several ways for production improvement in order to secure price competitiveness of domestic medical blood analyzer. For this purpose we identify the problems of current production process using ARENA simulation and suggest several alternatives for productivity improvement.. Five steps of TOC (Theory of Constraints) and ARENA simulation are employed to predict productivity of each alternative and to suggest further improvement.

• The Journal of Korean Institute of Communications and Information Sciences
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• v.39C no.10
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• pp.896-908
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• 2014

The electrical medical device market have been expanded since the public interest in healthy living that has deepened together with the global health trend of the aging population. The external hand-held ultrasonic probe is a frequently approved medical device and it is commonly used in the clinical field. However, there is no obvious standard or a guideline in Korea on regarding evaluation of performance of such external hand-held ultrasonic probe for approval and quality management. In this study, local and foreign reference standards were reviewed to propose performance test standards and methods after conducting characteristic of probe, market, and permission status. In addition, such proposed test items were validated to develop a draft guideline that is internationally harmonized for performance evaluation. This study is expected not only improve the quality and performance of the external hand-held ultrasonic probe but also contribute to securing consistency of permission and evaluation works for approval.

• Journal of Biomedical Engineering Research
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• v.41 no.5
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• pp.210-218
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• 2020

Vessel sealing is a medical device that converts electrical or ultrasonic energy into thermal energy and leads to seal, coagulate, and cut the vessel by protein modification within the walls or surrounding connective tissues. As most of surgeries have recently been conducted with minimally invasive surgery, the demand and market for vessel sealing are expected to get bigger. However, there is a problem that electrosurgical or ultrasonic surgical is applied and we have a high risk to evaluate the strength of seal, because the collateral and particular standards currently in force follows have not been establish. Therefore, in this study, we investigated some papers studied on the efficacy and safety of the device, the guidance of FDA and test papers previously conducted from 3 individual subject device made in Korea. We found there is a relationship between burst pressure and the performance of the device, therefore, we propose the vascular bursting pressure test for evaluating the safety and performance of the vessel sealing.

• International Journal of Precision Engineering and Manufacturing
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• v.7 no.4
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• pp.40-46
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• 2006

The market of programmable implantable pumps has bound to a monopolistic situation, inducing high device costs, thus making them inaccessible to most patients. Micro-mechanical and medical innovations allow improved performances by reducing the dimensions. This affects the consumption and weight, and, by reducing the number of parts, the cost is also affected. This paper presents the procedure followed to design an innovative implantable drug delivery system. This drug delivery system consists of a low flow pump which shall be implanted in the human body to relieve pain. In comparison to classical known solutions, this pump presents many advantages of high interest in both medical and mechanical terms. The first section of the article describes the specifications which would characterize a perfect delivery system from every points of view. This concerns shape, medication, flow, autonomy, biocompatibility, security and sterilization ability. Afterwards, an overview of existing systems is proposed in a decisional tree. Positive displacement motorized pumps are classified into three main groups: the continuous movement group, the fractioned translation group and the alternative movement group. These systems are described and the different problems which are specific to these mechanisms are presented. Since none of them fully satisfy the specifications, an innovation is justified.. The decisional tree is therefore extended by adding new principles: fractioned refilling and fractioned injection within the fractioned translation movement group, spider guiding system within the alternative translation movement group, rotational bearing guided device and notch hinge guided device in the alternative rotation movement group.

• Proceedings of the Korean Society of Precision Engineering Conference
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• 2005.10a
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• pp.509-513
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• 2005

In order to increase productivity in conventional stereolithography. Microstereolithography using a digital micramirror device $(DMD^{TM})$ as a dynamic patter generator is proposed The deviation from a level of clear optical images to a level of a photopolymer surface is a key for the fabrication of an accurate 3D structure. so this deviation is minimized by controlling the viscosity of FA1260T with organic solvents. After finding the appropriate process valuables (exposure time of optical images. layer thickness of each layer). the feasibility of microstructures such as a microgear and a microsphere is then demonstrated. Microstereolithography wi th $DMD^{TM}$ might eventually replace conventional laser induced microstereolithography market such as in the manufacturing of jewels and medical parts.