• THE INTERNATIONAL COMMERCE & LAW REVIEW
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• v.59
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• pp.181-205
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• 2013

This study has analyzed the international trade flow of medical devices in Korea, China, and U.S. more theoretically and systematically through a mutual connection of the medical device export structure of Korea and the import structure of China and U.S. organically, with an intensity approach on the bilateral international trade flow. Also, it is meaningful to find a solution to boost exports of Korea to China and U.S.. Therefore in this study, we recognize the importance of the medical device market in China and U.S., which is the main competition for Korea and its market, and look into the trade situation of these three countries. We also look into the relative market stream and the trade intensity of the main medical devices in Korea, China and U.S., and seek measures for the steady growth of the medical device market in these three countries.

• IEMEK Journal of Embedded Systems and Applications
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• v.16 no.6
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• pp.313-321
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• 2021

The global market for medical devices is huge, and it will continue showing remarkable growth in the future. However, due to the entry barrier to develop medical devices, many domestic companies have technical problems in entering the medical device industry. In this paper, we introduce an open platform that can help with research and development for companies in the healthcare industry. This open platform consists of a hardware part and a software part. A hardware part is combined into CPU, base and other modules that are easy to replace and assemble. A software part is based on application software for development developed by Bionet. We test the performance of the open medical device platform using a biosignal processing algorithm.

• Korea Journal of Hospital Management
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• v.23 no.4
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• pp.15-25
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• 2018

Purposes: The objectives of this study present the direction of the criteria for the separately reimbursement of therapeutic medical device. Methodology: We summarized experts' opinion using Delphi survey and Analytic Hierarchy Process(AHP). 48 experts were gathered from Medical Insurance Review Nurses Association, medical device industry, academy and association, Medical Device Expert Evaluation Committee. Descriptive statistics, consistency index, content validity ratio were analyzed. Findings: Clinical utility, patient safety, infection control, cost-homogeneity, cost-effectiveness showed high feasibility and importance, but market contribution and functional utility showed low feasibility and importance in a relative sense. The results of functional utility differed between clinical and non-clinical experts. Measurability was low across the whole area. Among the criteria for the separately reimbursement of therapeutic medical device. Patient safety/infection control and clinical utility showed the highest relative importance values, analyzed using AHP. Practical Implications: Patient safety and infection control are needed to be considered as one of Value Assessment Criteria. It is important to find out how to improve the measurability of therapeutic medical device.

• 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.

• Journal of Applied Reliability
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• v.16 no.3
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• pp.216-223
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• 2016

Purpose: This paper suggests the procedure to enhance the reliability of the software of the medical device that is to cure, treat, diagnose, and prevent a disease or an abnormal health conditions. Methods: After test requirements are classified by the software requirements specification for safety and backgrounds, reliability assessment methods are suggested. Results: Verification and validation for function and safety can be performed whether the medical device software are implemented as intended. Conclusion: Procedure on the static analysis, unit test, integration test, and system test are provided for the medical device software.

• Current Optics and Photonics
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• v.2 no.6
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• pp.499-507
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• 2018

For the spatiotemporally aligned observation of photothrombosis induction and transient variations of in vivo brain stroke, we developed a novel photothrombosis inducing system compatible to a magnetic resonance imaging (MRI) system using nonmagnetic stereotaxic equipment. From the spatial point of view, the system provides a more reliable level of reproducibility of the photothrombosis in each brain. From the temporal point of view, from T1- and T2-weighted in vivo MR (magnetic resonance) images, the transient variations such as incidence, location, and size of the thrombosis are measured quantitatively. In addition, the final variation is observed in the ex vivo brain by TTC (Triphenyltetrazolium chloride) staining based on histological assay and utilized for the verification of the MR images. From the experimental result of the rat brain, the proposed system shows more reliable characteristics for transient variations of brain strokes.

• Biomedical Science Letters
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• v.14 no.3
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• pp.167-172
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• 2008

We compared the clinical efficacy of LED therapy using 880 nm and 630 nm LED to test collagen accumulations in subcutaneous tissue of mouse after LED irradiation by measuring the quantity of collagen. 880 nm and 630 nm LED was irradiated on the back of ICR mouse given at $10.8J/cm^2$ followed for 30 minutes everyday for 5 weeks. Histological observation was performed by Hematoxylin & Eosin staining and Masson's Trichrome collagen staining. We also used Sircol soluble collagen assay kit for measuring the amounts of collagen in the mouse skin tissue after 1, 3, and 5 weeks post LED irradiation, respectively. Collagen generation was found at subcutaneous tissue, and the quantity of collagen in 880 nm LED group had grown more than that of 630 nm LED group at 5 weeks follow-up later. About 75% more efficacies for collagen generation were found in the group of 5th week of 880nm LED irradiation. The efficacy of 880nm LED could be more useful than 630 nm LED for synthesizing collagens in mouse subcutaneous tissue as time followed.

• International Neurourology Journal
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• v.22 no.4
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• pp.228-236
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• 2018

Neuromodulation was introduced for patients with poor outcomes from the existing traditional treatment approaches. It is well-established as an alternative, novel treatment option for voiding dysfunction. The current system of neuromodulation uses an open-loop system that only delivers continuous stimulation without considering the patient's state changes. Though the conventional open-loop system has shown positive clinical results, it can cause problems such as decreased efficacy over time due to neural habituation, higher risk of tissue damage, and lower battery life. Therefore, there is a need for a closed-loop system to overcome the disadvantages of existing systems. The closed-loop neuromodulation includes a system to monitor and stimulate micturition reflex pathways from the lower urinary tract, as well as the central nervous system. In this paper, we reviewed the current technological status to measure biomarker for closed-loop neuromodulation systems for voiding dysfunction.

• Journal of Internet Computing and Services
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• v.20 no.3
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• pp.69-75
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• 2019

The safety and performance of medical device software is managed through life-cycle processes, which represent the entire process of research and development (R&D). The life-cycle process of medical device software is represented by an international standard called IEC 62304, ISO/IEC 12207. In order to license the product, the manufacturer must have document artifacts that comply with the IEC 62304 standard. However, these standards only describe the content of the activity and do not provide a method or procedure for documentation. Therefore, this paper suggests R&D documentation guidelines that assist medical device software developers to have R&D documents conforming to the standards. For this purpose, this study identifies the requirements related to documentation among the requirements existing in the standard and extracts them in the form of guidelines showing only the core information of the requirements. In addition, through the Web framework implemented based on this research, the developer can evaluate whether the technical documents are written in accordance with the R&D document guidelines. Medical device software manufacturers can efficiently produce high-quality research and development documents through R&D documentation guidelines, and they can have standards-compliantresearch and development documentation required for licensing procedures.

• Physical Therapy Korea
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• v.29 no.3
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• pp.235-240
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• 2022

Background: A spinal extension and intensive rehabilitation program reduced the symptoms and pain of kyphosis, and improved function. Objects: This study aimed to demonstrate the effect of a spine extension device on the degree of thoracic kyphosis and extension angles, confirm reduction of the kyphosis angle and an increase in flexibility. Methods: Thirteen adults were enrolled in the experiment, using the spine extension device, which was set to passively extend the spine. The angle between the spinous process of the first thoracic vertebra and the spinous process of the twelfth thoracic vertebra was measured by dual inclinometer before and after using the spine extension device. Results: In the static posture, the thoracic kyphosis decreased after using the spine extension device in the thoracic extension posture, and there was a significant difference (p < 0.05); thoracic extension angle increased with statistical significance (p < 0.05). Conclusion: In this study, the thoracic kyphosis angle and thoracic extension angle of the subjects before and after using spine extension device was compared and analyzed, which proved that the spine extension device can effectively improve the mobility of spinal extension.