• Title/Summary/Keyword: Medical device market

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Implementation of Urinary Incontinence Therapy Device with Wireless Bluetooth Communication (무선 요실금 치료기의 구현)

  • Lee, Seung-Jik;Kim, Kyung-Ah;Lee, Tae-Soo;Kim, Wun-Jae;Cha, Eun-Jong
    • Journal of Biomedical Engineering Research
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    • v.27 no.4
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    • pp.197-202
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    • 2006
  • Devices in current market to perform electrical stimulation therapy of the urinary incontinence frequent in aging women are very much impractical to us ε due to the wired configuration. The present study implemented new wireless device to enhance self as well as in-hospital therapy with the easiest and the most convenient application. The therapy system consisted of two modules, called 'master' and 'slave', communicating with each other by the wireless Bluetooth protocol. The patient controls therapy processes on the master module in hand, transmitting the required informations to operate the slave module placed within her pants with the viginal electrode connected, delivering appropriate electrical stimulation. Wireless communication enabled self therapy with clothes on, leading to a great convenience for the patient. The stimulation output signal was comparable to commercialized products in both waveform and stimulation capacity.

Evaluation Method of Portable Handheld U-healthcare Medical Devices (휴대형 유헬스케어 의료기기 평가방법)

  • Nam, Myung-Hyun;Kim, Soo-Chan;Kim, Jang-Su;Lee, Kap-No;Kim, San;Cha, Ji-Hun;Hur, Chan-Hoi;Park, Ki-Jung
    • Journal of the Institute of Electronics Engineers of Korea SC
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    • v.49 no.2
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    • pp.55-62
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    • 2012
  • Convergence of information technology (IT) and medical devices enables people to measure health-related information ubiquitously, such as measuring blood glucose at home and checking cardiac signals during exercise and it allows us to access to medical care anywhere and anytime. Nowadays, the market for U-healthcare medical devices is growing rapidly, but guidelines for the evaluation of safety and effectiveness of such devices remain to be formulated. We performed a study on the development of safety and performance evaluation method for portable, hand-held, U-healthcare medical devices. We reviewed current guidelines and standards for home-health devices from the Korea Food and Drug Administration (KFDA) and related international committees such as the ISO/IEEE and CE. We summarized the test methods and items for the evaluation of safety and performance related to U-healthcare medical devices from the above guidelines and standards. We defined requirements for a U-healthcare medical device to demonstrate good performance. In conclusion, we propose an evaluation method for U-healthcare medical devices, which will help improve the safety and reliability of these devices.

Development of Standards of Tattoo Machine for Safety and Performance Evaluation (의료용 표시기의 안전성 및 성능 평가를 위한 시험 항목 및 시험방법(안)연구)

  • Kim, Y.G.;Cho, S.K.;Lee, T.W.;Yeo, C.M.;Jung, B.J.;Kwon, Y.M.;Cha, J.H.;Hur, C.H.;Park, K.J.;Kim, D.S.;Kim, H.S.
    • Journal of Biomedical Engineering Research
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    • v.32 no.2
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    • pp.151-157
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    • 2011
  • Tattooing is a performance for decorative and cosmetic marking by placing permanent ink into the skin. As the cultural meaning of tattoo in Korea is changing, the tattoo machines are widely spread n permanent cosmetic market. Though the use of the tattoo machine was increased, the evaluation standards of tattoo machine were not existed. Korea Food and Drug Association regulated the electrical and mechanical safety standards which were founded on the IEC 601-1 second edition. Also they regulated he biological safety standards which were derived from the ISO 10993 series, however, these general valuations of common medical device were insufficient for evaluating tattoo machine. We developed the standards of tattoo machine for safety and performance evaluation for tattoo machine by preliminary hazard analysis in ISO 14971. The evaluation criteria of tattoo machines are focused on the mechanical invasion. We suggested the additional evaluation items of the needle speed, length, vibration with general valuation criteria of common medical device. We anticipate that this research may be a primary stage to figure a standard regulation and evaluation for tattoo machine.

Performance assessment and improvement plan of the regulatory management system of veterinary medical devices in Korea (국내 동물용 의료기기 관리실태 평가 및 개선방안 연구)

  • An, Hyo-Jin;Yoon, Hyang-Jin;Kim, Chung-Hyun;Wee, Sung-Hwan;Moon, Jin-San
    • Korean Journal of Veterinary Research
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    • v.55 no.2
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    • pp.97-103
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    • 2015
  • In this study, the Korean veterinary medical devices management system was evaluated relative to systems in the USA, EU, and Japan. Veterinary medical devices are regulated in Korea based on the Medical Appliance Act of 1997. This was initially supervised by the Ministry of Agriculture, Food and Rural Affairs and Korea Animal Health Products Association, and subsequently by the Animal and Plant Quarantine Agency (QIA) in 2000. These devices were classified approximately 1,400 categories as instruments, supplies, artificial insemination apparatus, and other categories. Each of these devices was assigned to four regulatory grades by the QIA in 2007. The ranking system for veterinary medical devices was implemented in 2014 with 820 products from 162 companies registered by that year. However, in vitro diagnostic devices (IVDDs) for animals were managed as medical devices and biological medicine. In vitro diagnostic reagents for treating infection diseases are not subjected to either a classification or grading system. Veterinary medical devices are currently exempt from good manufacturing practices (GMP) and device tracking requirements. Due to gradual growth of the domestic veterinary medical devices market since 2008, regulation of these devices should be improved with re-examination of IVDDs and GMP certification for the effective operating system.

Development of a Smartphone-based Pupillometer

  • Kim, Tae-Hoon;Youn, Jong-In
    • Journal of the Optical Society of Korea
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    • v.17 no.3
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    • pp.249-254
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    • 2013
  • In ophthalmology, a pupillometer, a device to measure the diameter of the pupil of the eye, can provide information on the function of the autonomic nervous system. The current pupillometers on the market are either too large to be a handheld instrument, or relatively expensive. In this study, a pupillometer based on a smartphone was designed. Both white and infrared LEDs and a 3M pixel camera of a smartphone were applied for the visual stimuli to an eye and for the acquisition of the eye images, respectively. Contrary to the existing method of pupil measurement that usually observe the variation of pupil diameter, the proposed algorithm in this study was applied to calculate the constriction ratio of the pupillary area in response to pupillary light reflex. The results showed that the constriction ratio of the pupillary area were all in the normal range (above 4.0) from the sixteen healthy participants. It is believed that the approach to pupil measurement used in this study is suitable for a mobile interface, and this system can be applied to clinical research, home-use healthcare, and distributed to some areas which suffer from problems like a lack of medical support.

Iot Based Vision and Remote Control a Compact Mobile Robot System (IoT 기반의 비전 및 원격제어 소형 이동 로봇 시스템)

  • Jeon, Yun Chae;Choi, Hyeri;Yoon, Ki-Cheol;Kim, Gwang Gi
    • Journal of Korea Multimedia Society
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    • v.24 no.2
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    • pp.267-273
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    • 2021
  • Recently, the small-size mobile robots with remote-control are rapidly growth which market of mobile is increased in the world. Especially, the smart-phones are widely used for interface device in the small size of a mobile robot. The research goal is control system design which is applied to miniaturization of a mobile robot using smart-phone and it can be confirmed performance for designed system. Meanwhile, the fabrication of mini-mobile robot can also be remote-control operation through the WIFI performance of a smart-phone. The smart-phone is used to remote-control for robot operation which control data transmit to robot via the WIFI network. To drive the robot, we can observe by the smart-phone screen and it can easily adjust the robot drive condition and direction by smart-phone button. Consequentially, there was no malfunction and images were printed out well. However, in drive, because of blind spot, robot was bumped into obstacle. Therefore, the additional test is necessary to sensor for blind spot which sensor can be equipment to mobile robot. In addition, the experiment with robot object recognition is needed.

A study about development of hand-piece for orthopedic surgery drived by battery (배터리 구동방식 정형외과용 핸드피스 개발에 대한 연구)

  • Son, Chang-Woo;Jang, Sung-Hui;Jang, Young-Ju;Seo, Tae-Il
    • Design & Manufacturing
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    • v.9 no.1
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    • pp.31-35
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    • 2015
  • Recently, life expectancy increased in the development of medicine, the need for health has increased. Market for medical equipment is growing rapidly to an increase in the interest in health and aging worldwide. It is a device intended for ultra sensitive cleavage process of bone during joint replacement surgery on a technical advanced surgery, finishing, and hole. Domestic demand of the hand piece is a necessary condition on an ongoing basis. However, hand piece was made on the basis of the experience of many years in the country Japan, Germany, and the United States has spread to more than 90% domestic market. Feel the need for the development of the hand piece in the country, many companies are trying to in-house production hand piece. In an attempt to solve the problems with the hand piece of the present, in this paper, it was supposed to be a study of rechargeable hand piece to replace the existing pneumatic.

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A Study on Trends in Scalp Condition Based on Use of Customized Shampoo (맞춤형샴푸 사용에 따른 두피상태 변화 추이 연구)

  • Eun Ji Lee;Jeong Hyun Lee
    • Fashion & Textile Research Journal
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    • v.26 no.3
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    • pp.273-278
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    • 2024
  • Consumer preferences for food are influenced by personal values and personalities. Social, economic, and cultural developments in modern society have influenced consumer lifestyles and brought about multiple changes in consumption patterns. In the beauty market, consumers are now more interested in specialized offerings, and an increasing number of people are opting for customized products in a market structure where mass production has led to mass consumption. Hair products are now manufactured as functional cosmetics designed to maintain and improve scalp health and hair growth by removing waste from the scalp and adding fragrance for cleanliness, breaking away from the concept of general cosmetics. Many studies have focused on personalized products in the cosmetics industry. This study aimed to accurately determine scalp types and further diagnose individual scalp conditions using a scalp diagnostic device. Based on the diagnoses, it recommended and provided personalized shampoos in order to understand how these shampoos improved scalp health. By objectively analyzing and comparing scalp conditions before and after using customized shampoos, the study demonstrated a significant effect on scalp health. The results of this study confirmed the perception and effectiveness of personalized shampoos.

Review of Research Topics on Abdominal Examination (복진(腹診)에 대한 국내 연구동향 분석 및 연구방향 제안)

  • Kim, Jihye;Park, Jeong Hwan;Kim, Keun Ho
    • The Journal of Korean Medicine
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    • v.37 no.3
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    • pp.1-12
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    • 2016
  • Objectives: The abdominal examination is a diagnosis method for determining a morbid condition of the chest and abdomen by touching and pressing. This study reviewed research trends concerning the abdominal examination and suggested of future research directions for quantification of abdominal examination. Methods: A systematic literature search was carried out for relevant articles published between 2000 and 2016 in five databases such as Korean studies Information Service System(KISS), Oriental Medicine Advanced Searching Integrated System(OASIS), DataBase Periodical Information Academic (DBpia), National Digital Science Library and PubMed based on the Keywords 'abdominal examination'. Results: 128 articles were collected for analysis. Overview on the abdominal examination based on selected 17 articles. Then selected articles have been reclassified by diseases of clinical research and parameters for diagnosis of abdominal examination. Conclusions: Taken together, instrument for quantitative evaluation of abdomen characteristic fit to the traditional Korean Medicine have not yet developed. It is suggested that in order to dominate the market about abdominal examination in advance, more concern should be paid to establishing appropriate development of quantitative criteria and instrument. This review will help researcher to systematically understand and to develop Korean medical device as globally competitive device.

A Study on the Development Methodology of Intelligent Medical Devices Utilizing KANO-QFD Model (지능형 메디컬 기기 개발을 위한 KANO-QFD 모델 제안: AI 기반 탈모관리 기기 중심으로)

  • Kim, Yechan;Choi, Kwangeun;Chung, Doohee
    • Journal of Intelligence and Information Systems
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    • v.28 no.1
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    • pp.217-242
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    • 2022
  • With the launch of Artificial Intelligence(AI)-based intelligent products on the market, innovative changes are taking place not only in business but also in consumers' daily lives. Intelligent products have the potential to realize technology differentiation and increase market competitiveness through advanced functions of artificial intelligence. However, there is no new product development methodology that can sufficiently reflect the characteristics of artificial intelligence for the purpose of developing intelligent products with high market acceptance. This study proposes a KANO-QFD integrated model as a methodology for intelligent product development. As a specific example of the empirical analysis, the types of consumer requirements for hair loss prediction and treatment device were classified, and the relative importance and priority of engineering characteristics were derived to suggest the direction of intelligent medical product development. As a result of a survey of 130 consumers, accurate prediction of future hair loss progress, future hair loss and improved future after treatment realized and viewed on a smartphone, sophisticated design, and treatment using laser and LED combined light energy were realized as attractive quality factors among the KANO categories. As a result of the analysis based on House of Quality of QFD, learning data for hair loss diagnosis and prediction, micro camera resolution for scalp scan, hair loss type classification model, customized personal account management, and hair loss progress diagnosis model were derived. This study is significant in that it presented directions for the development of artificial intelligence-based intelligent medical product that were not previously preceded.