• 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.

• Science of Emotion and Sensibility
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• v.17 no.3
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• pp.129-142
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• 2014

Due to the increase of the aged population and population of the disabled today, there is a growing demand for rehabilitation medical instruments. Furthermore, there is a growing demand for evaluation indices for services that should be provided for uses of the rehabilitation medical instruments. In order to evaluate rehabilitation medical instrument designs in this study, the basic index for design evaluations shall be identified to search for assessment plans. Through this, new evaluation indices will be deduced through discussions and analysis of rehabilitation medical experts, biomedical engineers, and designers. The results of this study are summarized as follows. First, the existing design evaluation indices were collected and analyzed to construct 10 rehabilitation medical instrument design evaluation indices and 44 sub-evaluation items. These will be important evaluation standards for designing rehabilitation medical instruments in the future. Second, the design evaluation indices that must be taken into consideration when developing health care rehabilitation medical instruments are the 10 design evaluation indices of usability, cognition, safety, learning, motility, durability, economic feasibility, space, aesthetics and environmental aspects. Third, design evaluation indices of environment, space, cognition, usability, economic feasibility and aesthetics are indices that must be taken into consideration for product design, while learning, safety, motility and durability are factors that must be given special consideration for rehabilitation medical instrument design evaluation indices. Fourth, if existing product design evaluation indices placed importance on environment, space, cognition, usability, economic feasibility and aesthetics of products for design evaluation indices, rehabilitation medical instrument design evaluation indices placed importance on learning, safety, motility and durability on top of usability and economic feasibility, which are the differences between the design evaluation indices of rehabilitation medical instrument and other product designs. The 10 rehabilitation medical device design evaluation indices and 44 sub-evaluation items were carried out in this study. This research is only on the overall rehabilitation medical device design evaluation indices. In future research, the evaluation indices will be applied in the actual rehabilitation medical design device through production of prototypes, while making revisions and supplementations where necessary.

• The Journal of Economics, Marketing and Management
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• v.6 no.4
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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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• v.45 no.1
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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.

• Proceedings of the Korean Society of Precision Engineering Conference
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• 2007.11a
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• pp.161-162
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• 2007

• Journal of Biomedical Engineering Research
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• v.39 no.6
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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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• v.48 no.4
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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.

• KIISE Transactions on Computing Practices
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• v.20 no.10
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• pp.561-566
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• 2014

There are growing demands for improving the patient safety and the effectiveness of medical services through device connectivity and interoperability. However, integration through networking might greatly increase the complexity of the system if it is not properly designed, jeopardizing patient safety. In this paper, we codify safe medical device interaction patterns, and exploit them for the low complexity design and safety analysis of networked supervisory medical systems. We implement the proposed approach as a plug-in of Architecture Analysis and Description Language (AADL). Our implementation enables the modeling and safety analysis of medical devices and their interactions before actual development.

• Journal of information and communication convergence engineering
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• v.10 no.1
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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.

• The Korean Society of Law and Medicine
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• v.15 no.2
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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.