• Journal of Sensor Science and Technology
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• v.19 no.4
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• pp.259-270
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• 2010

MEMS(micro electro mechanical systems) is a technology for the manufacture hyperfine structure, as a micro-sensor and a driving device, by a variety of materials such as silicon and polymer. Many study for utilizing the MEMS applications have been performed in variety of fields, such as light devices, high frequency equipments, bio-technology, energy applications and other applications. Especially, the field of Bio-MEMS related with bio-technology is very attractive, because it have the potential technology for the miniaturization of the medical diagnosis system. Bio-MEMS, the compound word formed from the words 'Bio-technology' and 'MEMS', is hyperfine devices to analyze biological signals in vitro or in vivo. It is extending the range of its application area, by combination with nano-technology(NT), Information Technology(IT). The LOC(lab-on-a-chip) in Bio-MEMS, the comprehensive measurement system combined with Micro fluidic systems, bio-sensors and bio-materials, is the representative technology for the miniaturization of the medical diagnosis system. Therefore, many researchers around the world are performing research on this area. In this paper, the application, development and market trends of Bio-MEMS are investigated.

• Journal of Society of Preventive Korean Medicine
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• v.28 no.1
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• pp.31-42
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• 2024

Objective : In order to understand the changes in domestic approval regulations applicable to traditional Korean medical device companies, this article will explain the major amendments 「Regulation on Medical Device Approval Report Review, etc.」 from 2005 to the present on a year-by-year basis, and provide a counter plan to the recent changes in approval regulations. Methods : We analysed the changes in approval regulatory amendments related to the traditional Korean medical devices from 2005 to the present. Results : The Ministry of Food and Drug Safety is continuously improving medical device approval regulations to ensure the global competitiveness of domestic medical devices and contribute to the improvement of public health. Recent major approval regulatory amendments include the establishment of a review system for software medical devices and digital therapeutics, the recognition of real world evidence materials, the introduction of a biological evaluation of medical devices within a risk management process and a medical device approval licence renewal system. Conclusions : It is expected that the range of medical devices available to Korean medicine doctors will continue to expand in the future through the provision of non-face-to-face medical services and the development of advanced and new medical devices, as well as wearable medical devices and digital therapeutics. In order to increase the market entry potential of traditional Korean medical devices that incorporate advanced technologies such as digital technology and AI-based diagnosis and prediction technology, it is urgent that the government provide significant support to traditional Korean medical device companies to improve approval regulatory compliance.

• Electronics and Telecommunications Trends
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• v.32 no.6
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• pp.27-39
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• 2017

A variety of medical devices are utilized to repair or help injured body functions after accidental injury(such as a traffic accident), population aging, or disease. Such medical devices are being actively researched and developed in portable form, skin patchable type, and further, implantable form. In the future, active implantable medical devices for neuro and brain sciences are expected to be developed. Active implantable medical devices that detect brain signals and control neurology for a wider understanding of human cognition and nerve functions, and for an understanding and treatment of various diseases, are being actively pursued for future use. In this paper, the core elements of implantable devices that can be applied to neuro and brain sciences are classified into electrode technologies for bio-signal acquisition and stimulation, analog/digital circuit technologies for signal processing, human body communication technologies, wireless power transmission technologies for continuous device use, and device integration technologies to integrate them. In each chapter, the latest technology development trends for each detailed technology field are reviewed.

• Journal of rehabilitation welfare engineering & assistive technology
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• v.11 no.4
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• pp.299-306
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• 2017

The Korean medical device industry has increased dramatically due to various investments in the domestic medical device industry and the introduction of new technologies, but the domestic medical device usage rate in great hospital is still low. In this paper, improvement point for domestic medical device was suggested by domestic medical device usage rate and user and manager's perception survey in great hospitals in Korea. To do this, a survey on the types of medical devices and domestic medical device usage rates were conducted at four national university hospitals in Korea. From this results, the priority survey medical devices were selected. Improvements of Korean medical devices were suggested by failure mode analysis and user awareness surveys for the priority survey medical devices.

• Journal of Biomedical Engineering Research
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• v.30 no.5
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• pp.438-443
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• 2009

Nebulizer is designed to atomize medicinal fluid for patient with small particles(0.5-$5{\mu}m$) and also able to deliver particles from devices to the lungs when patient inhales air. Several particle size measurements are currently used to size aerosol particles. The most commonly used test is the cascade impactor method in as a standard. But, other methods for comparative particle size distribution data such as the particle size range and reproducibility are acceptable. Therefore, in this study a new test methode is suggested for nonventilatory nebulizer evaluation equipment.

• Journal of Oriental Neuropsychiatry
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• v.31 no.2
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• pp.89-99
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• 2020

Objectives: The purpose of this study was to identify the needs of bio-signal devices for the diagnosis, assessment, and analysis of neurocognitive disorder in Korean medicine (KM) hospitals and clinics. Methods: A questionnaire was developed to survey the current status of medical device use, and diagnosis and interventions for patients with cognitive disorders in KM hospitals and clinics. November 11~December 2, 2019, 114 responses (71.9% completed) were collected by internet-based questionnaires from the members of the Korean society of Oriental Neuropsychiatry. Results: The clinical requests were in the descending order of hematology analyzer, ultrasound imaging system, and electroencephalography among the 15 most commonly used devices of which research would support for their clinical usability. The biosignal-based devices showed the highest research demands for patients with mild cognitive impairment rather than more severe stages of cognitive impairment. Prevention rather than diagnosis, or several treatment regimens was the strongest clinical area of the KM for patients with neurodegenerative cognitive impairment. Many responded that five to 10 minutes of test duration and 20,000 won to 30,000 won of cost would be appropriated for a new device to be developed. Conclusions: There were strong demands for the development of bio-signal devices for neurocognitive disorders among the KM doctors. Specifically, it showed high needs for the technology that can be used in the prevention area of cognitive disorders. Additionally, new medical devices to assess cognitive functions and to obtain KM pattern-related information were the high needs.

• 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.

• Journal of the Korean Society for Precision Engineering
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• v.26 no.12
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• pp.138-145
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• 2009

Custom medical treatment is being widely adapted to lots of medical applications. A technology for 3D modeling is strongly required to fabricate medical implants for individual patient. Needs on true 3D CAD data of a patient is strongly required for tissue engineering and human body simulations. Medical imaging devices show human inner section and 3D volume rendering images of human organs. CT or MRI is one of the popular imaging devices for that use. However, those image data is not sufficient to use for medical fabrication or simulation. This paper mainly deals how to generate 3D geometry data from those medical images. A new image processing technology is introduced to reconstruct 3D geometry of a human body vacancy from the medical images. Then a surface geometry data is reconstructed by using Marching cube algorithm. Resulting CAD data is a custom 3D geometry data of human vacancy. This paper introduces a novel 3D reconstruction process and shows some typical examples with implemented software.

• Transactions of the KSME C: Technology and Education
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• v.5 no.1
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• pp.23-52
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• 2017

Bio-fusion and medical device industry is the multidisciplinary engineering application technology industries, which are fused, such as electricity, electronics, machinery, materials. It aims to improve the quality of human life by using bio-fusion and medical devices, and is an important industry recognition and brand power for the product. However, there is a period that is required from the development of products with technology-dependent industries. Therefore, it is necessary to have continuous effort for industrial investment in research and development at the national level including technical support, institutional support, and human resources.

• Korean Journal of Acupuncture
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• v.40 no.4
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• pp.156-168
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• 2023

Objectives : This study aimed to determine the status of thermal stimulation devices approved in Korea for medical applications over the past 10 years, and based on this, to obtain insight for future thermal treatment in Korean medical institutions. Methods : We searched the item classification list entitled "Regulations on Medical Device Items and Rating by Item" from the Ministry of Food and Drug Safety Notice No. 2021-24, 2021 (Enforced March 19, 2021; www.mfds.go.kr) for individually licensed heaters using the terms "heat" and "heating". Results : We identified 17 items of thermal stimulation product group, of which 1,308 devices were licensed by February 4, 2022, and 53.2% of them (n=696) were devices with valid permits for distribution in Korea. Among the licensed devices, heating pad systems under/overlay (electric, home use) were approved the most, but combinational stimulator (for medical use, home use; Grade 2) accounted for the highest percentage among the current valid permission. Moxibustion apparatuses were licensed separately for electrical use and non-electrical use, and occupied a low percentage of the total devices. We analyzed 307 devices that were accompanied by technical documents and found that the heat sources were wires in 145 (47.2%), infrared rays in 44 (14.3%) and ultrasonic waves in 42 (13.7%) devices. Most (83.1%) devices were used for pain relief, while other applications included beauty, cancer treatment, maintenance of infant body temperature, and healing fractures. Conclusions : Thermal stimulation devices accounted for about 0.9% of all medical devices, and among them, combinational stimulators and heating pad systems under/overlay had the most valid permits. Thermal stimulation devices using heating wires and infrared rays were the most prevalent, and most were used to relieve pain. In order to develop a range of thermal stimulation devices that can be utilized in Korean medical institutions, it is imperative that they have potential applications beyond pain management, addressing various medical purposes. To achieve this, foundational research is necessary to effectively apply diverse heat sources based on medical objectives.