• 센서학회지
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• 제19권4호
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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.

• 대한예방한의학회지
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• 제28권1호
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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.

• 전자통신동향분석
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• 제32권6호
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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.

• 재활복지공학회논문지
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• 제11권4호
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• pp.299-306
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• 2017

국산 의료기기 산업에 대한 다양한 투자와 신기술 도입에 따라 국내의료기기 산업은 비약적인 증가를 하고 있으나 국내 대형의료기관의 국산의료기기 사용률은 여전히 저조한 것으로 조사되고 있다. 본 논문에서는 국내 대형병원에서의 국산 의료기기 사용률과 사용자 및 관리자의 인식조사를 수행하여 국산의료기기의 개선점을 제시하였다. 이를 위해 국내 4곳의 국립대학교병원을 대상으로 전체 의료기기의 종류와 국산 의료기기 사용률에 대한 조사를 진행하고 이를 바탕으로 의료기기 중 중점조사 대상 의료기기를 선정하였다. 중점조사대상 의료기를 대상으로 고장통계와 사용자 인식조사를 수행하였으며 이를 통해 중점조사대상 의료기기의 개선사항을 제시하였다.

• 대한의용생체공학회:의공학회지
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• 제30권5호
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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.

• 동의신경정신과학회지
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• 제31권2호
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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.

• 전자공학회논문지SC
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• 제49권2호
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• pp.55-62
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• 2012

정보기술과 의료기기의 융합에 의해 혈당을 집에서 측정하거나 운동 시에 심박수를 측정하는 것과 같이 건강관련 정보를 언제 어디서나 측정할 수 있게 되었고, 이에 따라 의료를 장소에 구애받지 않고 쉽게 접근할 수 있게 되었다. 최근에 유헬스케어 의료기기 시장이 빠르게 성장하고 있으나 이러한 기기의 안전성과 유효성을 평가하는 가이드라인이 아직 마련되지 않은 실정이다. 이를 위해 식약청, ISO/IEEE, CE 등 국내외의 유헬스케어 관련 규정을 조사하고, 이 중 유헬스케어 의료기기에 관련된 안정성 및 성능 평가에 대한 시험 방법과 항목을 제안하였다. 유헬스케어 의료기기의 가장 큰 특성인 무선 데이터 통신에 있어 데이터 무결성과 기기 사용환경이 다양하기 때문에 환경 요인이 기기에 미치는 영향을 평가하였다. 이를 바탕으로 휴대형 유헬스케어 의료기기의 평가 가이드라인을 제안하였다. 제안하는 지침을 기반으로 휴대형 유헬스케어 기기를 개발한다면 사용자들에게 보다 안전성과 신뢰도 높은 기기를 제공할 수 있을 것으로 기대된다.

• 한국정밀공학회지
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• 제26권12호
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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.

• 대한기계학회논문집 C: 기술과 교육
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• 제5권1호
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• pp.23-52
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• 2017

바이오융합 및 의료기기 산업은 의학과 전기, 전자, 기계, 재료 등 공학이 융합되는 다학제간 응용기술 산업분야이다. 바이오 융합 및 의료기기를 이용해 인간의 삶의 질 향상을 목표로 하고 있으며 제품에 대한 인지도와 브랜드 파워가 매우 중요한 산업이다. 그러나, 자본/기술 의존형 산업으로 제품의 개발부터 생산까지 소요되어지는 기간이 길고 개별 제품의 시장 규모가 작고 수명주기가 짧다고 할 수 있다. 따라서 연구개발에 대한 지속적인 투자가 요구되어지는 산업으로 국가적인 차원에서 바이오벤처 기업들을 위해 기술적 지원, 제도적 뒷받침, 인력 양성 등의 산업생태계 전반을 활성화하고자 하는 노력이 필요하다.

• Korean Journal of Acupuncture
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• 제40권4호
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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.