• Title/Summary/Keyword: History of Korean Medical Device Industry

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A Study on the History of the Korean Medical Device Industry and its Global Competitiveness (한국 의료기기 산업의 역사와 국제 경쟁력 고찰)

  • Yeom, Hojun;Jeong, Hyun-Woo;Park, Sangsoo
    • The Journal of the Convergence on Culture Technology
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    • v.8 no.5
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    • pp.1-7
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    • 2022
  • Korean medical device industry has laid the foundation for full-fledged growth and development with the G7 medical engineering technology development project that started in 1995, and the medical device production in 2020 increased by 8.52 times and the export by 13.94 times, compared to those in 2001. In early years, electronic medical devices such as ultrasound imaging device contributed greatly to Korean medical industry, but top ranks in medical device production and export in Korea has shifted recently to in vitro diagnostic medical devices and dental implants. However, the share of imported medical devices in the Korean medical device market have not changed much; it still ranges in 60 to 70%, as the Korean medical device industry produces and exports mid- to low-priced medical devices, and technology-intensive and capital-intensive high-priced medical devices are mainly imported. In this paper, we compare the leading medical devices produced by major Korean companies and those by global top medical device companies to suggest strategies for the Korean medical device companies to enter the global market.

The registration and approval of Oriental Medical devices for the entry into U.S. market (한방의료기기의 미국 시장 진출을 위한 심사제도 소개)

  • Oh, Ji Yun;Choi, Yu Na;Jo, Su Jeong;Jung, Chan Yung;Cho, Hyun Seok;Lee, Seung Deok;Kim, Kap Sung;Kim, Eun Jung
    • Journal of Acupuncture Research
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    • v.32 no.4
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    • pp.91-102
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    • 2015
  • Objectives : The Oriental medical device industry is expected to continue to experience significant growth. It should increase its global market share rather than focusing on the domestic market. Countries around the world self-regulate their domestic market, so this study aims to aid in the development of a particular overseas market by introducing the U.S.(the largest market) medical device registration and approval process. Methods : For an understanding of the US medical device licensing process, we researched the relevant regulatory organization (FDA), the history, definition and classification of medical devices, the approval and 510(k) submission process related to substantial equivalence, IEC 60601-1 Edition 3, usability tests, and so on. Results : Medical devices in the United States are assigned to one of three regulatory classes: Class I, Class II and Class III, based on the level of control necessary to assure the safety and effectiveness of the device. If a company's device is classified as Class II and if it is not exempt, a 510k will be required for marketing. 1) A 510(k) is a premarket submission made to the FDA to demonstrate that the new device to be marketed is "substantially equivalent" to a legally marketed device (predicate device) 2) The IEC 60601-1 Edition 3 preparation process, which contains information related to usability, is expensive and time-consuming but a critical requirement. Conclusions : Although the U.S. market has high barriers to entry, access to this, large overseas market will encourage development of the Oriental medical device industry and commercial value enhancement is expected.

The Effect of Consultant Competency on Consulting Performance, Customer Satisfaction, and Intention to Renew Contract: Focused on CSV Consulting in the GMP Industry (컨설턴트 역량이 컨설팅 성과, 고객만족, 재계약 의도에 미치는 영향에 대한 연구: GMP 산업의 CSV 컨설팅을 중심으로)

  • Dae-Hyun Park;Dong-Hyun Baek
    • Journal of Korean Society of Industrial and Systems Engineering
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    • v.46 no.4
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    • pp.74-92
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    • 2023
  • The computer system validation consulting industry is growing as domestic GMP companies' overseas exports or advancements increase, and computer system validation has been mandatory in Korea since the 2010s, but domestic CSV consulting companies are small in size and have a short history, revealing many shortcomings in terms of service quality and customer satisfaction when conducting consulting. Research related to consulting has been mainly focused on management consulting and IT consulting, and research related to computer system validation is very insufficient. This study confirmed the effect of consultant competency and service quality on consulting performance, customer satisfaction, and intention to renew contract when performing computer system validation through empirical research on food, pharmaceutical, cosmetics, and medical device companies, which are representative companies in the GMP industry. As a result, it was confirmed that consultant competency and service quality had a significant effect on consulting performance, customer satisfaction, and intention to renew contract. In addition, it was confirmed that the reputation and expertise of consulting companies had a moderating effect on the relationship between consultant competency and consulting performance.

Pediatric Mechanical Circulatory Support

  • Wilmot, Ivan;Lorts, Angela;Morales, David
    • Journal of Chest Surgery
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    • v.46 no.6
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    • pp.391-401
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    • 2013
  • Mechanical circulatory support (MCS) in the pediatric heart failure population has a limited history especially for infants, and neonates. It has been increasingly recognized that there is a rapidly expanding population of children diagnosed and living with heart failure. This expanding population has resulted in increasing numbers of children with medically resistant end-stage heart failure. The traditional therapy for these children has been heart transplantation. However, children with heart failure unlike adults do not have symptoms until they present with end-stage heart failure and therefore, cannot safely wait for transplantation. Many of these children were bridged to heart transplantation utilizing extracorporeal membranous oxygenation as a bridge to transplant which has yielded poor results. As such, industry, clinicians, and the government have refocused interest in developing increasing numbers of MCS options for children living with heart failure as a bridge to transplantation and as a chronic therapy. In this review, we discuss MCS options for short and long-term support that are currently available for infants and children with end-stage heart failure.

A Relationship between Serum Carcinoembryonic Antigen Concentrations and Job Titles of a Shipyard Workers (조선소 근로자의 직종과 혈청 암배아성 항원 농도와의 관련성)

  • Jung, Kap Yeol;Kim, Jung Won;Ye, Byeong Jin
    • Journal of Korean Society of Occupational and Environmental Hygiene
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    • v.23 no.2
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    • pp.41-49
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    • 2013
  • Objectives: The purpose of this study was to clarify the association between serum carcinoembryonic antigen (CEA) and type of work in the shipbuilding industry. Methods: 1,072 final study subjects were admitted to a general hospital from April through July 2010 for the purpose of medical examination. Data on general characteristics such as age, smoking history, alcohol history and exercise habits was gathered through structured self-administered questionnaires. Information on job factors was collected from a medical examination, by interview and through company personnel data. Serum CEA levels were measured after eight hours' fasting and were analyzed by a radioimmunoassay. Results: On univariate analysis, the mean serum CEA level was significantly higher among married (p=0.02), older age (p<0.01), longer work time (p<0.01), smokers (p<0.01), lower education (p<0.01), and indirect and direct exposure groups (p<0.01). On multiple regression analysis, serum CEA level was influenced by smoking (p=0.001), duration of work (p=0.019), and direct exposure group (p<0.001). However, among the direct exposure group, serum CEA level was not significantly different between welding, mounting, electro-device constructive work, grinding and cleaning, and painting. Conclusions: The goal of this research was to determine if there were differences between serum CEA levels according to occupational role among shipyard workers. The direct exposure group of shipyard workers had a relatively higher level of serum CEA than did the indirect exposure group and office workers, most likely due to occupational exposure.

Evaluation of Ergonomic Performance of Medical Smart Insoles

  • Yi, Jae-Hoon;Lee, Jin-Wook;Seo, Dong-Kwon
    • Physical Therapy Rehabilitation Science
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    • v.11 no.2
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    • pp.215-223
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    • 2022
  • Objective: This study was to resolve the limitations of the experimental environment and to solve the shortcomings of the method of measuring human gait characteristics using optical measuring instruments. Design: A cross-sectional study. Methods: Fifteen healthy adults without a history of orthopedic surgery on the lower extremities for the past 6 months were participated. They were analyzed gait variables using the smart guide and the 3D image analysis at the same time, and their results were compared. Visual-3D was used to calculate the analysis variables. Results: The reliability and validity of the data according to the two measuring instruments were found to be very high; gait speed(0.85), cycle time(0.99), stride time of both feet(0.98, 0.97) stride legnth of both feet(0.86, 0.88) stride per minute of both feet(0.99, 0.96), foot speed of both feet(0.90, 0.91), step time of both feet(0.77, 0.71), step per minute(0.72, 0.74), stance time of both feet(0.96, 0.97), swing time of both feet(0.93, 0.79), double step time(0.81), initial double step time(0.84) and terminal step time(0.76). Conclusions: In the case of the smart insole, which measures human gait variables using the pressure sensor and inertial sensor inserted in the insole, the reliability and validity of the measured data were found to be very high. It can be used as a device to replace 3D image analysis when measuring pathological gait.

Wearable Computers

  • Cho, Gil-Soo;Barfield, Woodrow;Baird, Kevin
    • Fiber Technology and Industry
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    • v.2 no.4
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    • pp.490-508
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    • 1998
  • One of the latest fields of research in the area of output devices is tactual display devices [13,31]. These tactual or haptic devices allow the user to receive haptic feedback output from a variety of sources. This allows the user to actually feel virtual objects and manipulate them by touch. This is an emerging technology and will be instrumental in enhancing the realism of wearable augmented environments for certain applications. Tactual displays have previously been used for scientific visualization in virtual environments by chemists and engineers to improve perception and understanding of force fields and of world models populated with the impenetrable. In addition to tactual displays, the use of wearable audio displays that allow sound to be spatialized are being developed. With wearable computers, designers will soon be able to pair spatialized sound to virtual representations of objects when appropriate to make the wearable computer experience even more realistic to the user. Furthermore, as the number and complexity of wearable computing applications continues to grow, there will be increasing needs for systems that are faster, lighter, and have higher resolution displays. Better networking technology will also need to be developed to allow all users of wearable computers to have high bandwidth connections for real time information gathering and collaboration. In addition to the technology advances that make users need to wear computers in everyday life, there is also the desire to have users want to wear their computers. In order to do this, wearable computing needs to be unobtrusive and socially acceptable. By making wearables smaller and lighter, or actually embedding them in clothing, users can conceal them easily and wear them comfortably. The military is currently working on the development of the Personal Information Carrier (PIC) or digital dog tag. The PIC is a small electronic storage device containing medical information about the wearer. While old military dog tags contained only 5 lines of information, the digital tags may contain volumes of multi-media information including medical history, X-rays, and cardiograms. Using hand held devices in the field, medics would be able to call this information up in real time for better treatment. A fully functional transmittable device is still years off, but this technology once developed in the military, could be adapted tp civilian users and provide ant information, medical or otherwise, in a portable, not obstructive, and fashionable way. Another future device that could increase safety and well being of its users is the nose on-a-chip developed by the Oak Ridge National Lab in Tennessee. This tiny digital silicon chip about the size of a dime, is capable of 'smelling' natural gas leaks in stoves, heaters, and other appliances. It can also detect dangerous levels of carbon monoxide. This device can also be configured to notify the fire department when a leak is detected. This nose chip should be commercially available within 2 years, and is inexpensive, requires low power, and is very sensitive. Along with gas detection capabilities, this device may someday also be configured to detect smoke and other harmful gases. By embedding this chip into workers uniforms, name tags, etc., this could be a lifesaving computational accessory. In addition to the future safety technology soon to be available as accessories are devices that are for entertainment and security. The LCI computer group is developing a Smartpen, that electronically verifies a user's signature. With the increase in credit card use and the rise in forgeries, is the need for commercial industries to constantly verify signatures. This Smartpen writes like a normal pen but uses sensors to detect the motion of the pen as the user signs their name to authenticate the signature. This computational accessory should be available in 1999, and would bring increased peace of mind to consumers and vendors alike. In the entertainment domain, Panasonic is creating the first portable hand-held DVD player. This device weight less than 3 pounds and has a screen about 6' across. The color LCD has the same 16:9 aspect ratio of a cinema screen and supports a high resolution of 280,000 pixels and stereo sound. The player can play standard DVD movies and has a hour battery life for mobile use. To summarize, in this paper we presented concepts related to the design and use of wearable computers with extensions to smart spaces. For some time, researchers in telerobotics have used computer graphics to enhance remote scenes. Recent advances in augmented reality displays make it possible to enhance the user's local environment with 'information'. As shown in this paper, there are many application areas for this technology such as medicine, manufacturing, training, and recreation. Wearable computers allow a much closer association of information with the user. By embedding sensors in the wearable to allow it to see what the user sees, hear what the user hears, sense the user's physical state, and analyze what the user is typing, an intelligent agent may be able to analyze what the user is doing and try to predict the resources he will need next or in the near future. Using this information, the agent may download files, reserve communications bandwidth, post reminders, or automatically send updates to colleagues to help facilitate the user's daily interactions. This intelligent wearable computer would be able to act as a personal assistant, who is always around, knows the user's personal preferences and tastes, and tries to streamline interactions with the rest of the world.

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