• 제목/요약/키워드: Medical device industry

검색결과 166건 처리시간 0.027초

엑스선골밀도측정기의 기술문서 작성을 위한 가이드라인 개발 연구 (A Study on Development of Guideline on Writing Technical Document for Electrical Medical Devices : Bone Absorptiometric X-ray System)

  • 이승열;김재량;김은림;이준호;이창형;박창원
    • 대한방사선기술학회지:방사선기술과학
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    • 제39권2호
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    • pp.263-271
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    • 2016
  • 최근 인구 고령화에 따른 골다공증 환자의 증가 및 의료기기 시장의 성장으로 인해 엑스선골밀도측정기 시장이 커지고 있으며, 이에 따른 의료기기 허가 심사건수가 증가하고 있다. 의료기기 기술문서는 의료기기의 허가 심사 시 가장 기본이 되는 문서로 필수 제출 첨부자료 중 하나이다. 기술문서는 의료기기 관련 법령 및 고시에 그 근거를 두고 있으며, 의료기기 전반적인 항목을 기술해야하는 만큼 작성자의 전문성이 필요한 항목이다. 하지만 최근 부정확한 작성의 증가로 인한 심사자들의 업무부담이 증가되고 있어 민원 처리 효율이 저하되고 있다. 특히 엑스선골밀도측정기의 경우 식품의약품안전처 기준규격이 없어, 의료기기 제조/수입업체 등에서 시험항목을 설정하는 데 많은 어려움을 겪고 있다. 따라서 본 연구에서는 개선된 제도가 반영된, 엑스선골밀도측정기 기술문서 작성 가이드라인 개발을 위해 첫째, 개선된 제도 운영에 대한 조사, 품목별 의료기기의 제도 적용에 따른 문서 작성 방법 검토, 기 허가된 품목에 대한 허가 및 기술문서 검토를 완료하였다. 둘째, 품목별 시장현황 조사, 적용 가능한 국내 외 규격을 조사 분석하여 품목별 국제조화된 안전성 및 성능평가 시험기준 및 방법을 도출하였다. 마지막으로, 산 연 관 전문가협의체 논의를 거쳐 기술문서 작성 가이드라인(안)을 최종 도출하였다.

빅데이터 활용 의학·바이오 부문 사업화 가능 기술 연구 (Research on the development of demand for medical and bio technology using big data)

  • 이봉문;남가영;강병철;김치용
    • 한국멀티미디어학회논문지
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    • 제25권2호
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    • pp.345-352
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    • 2022
  • Conducting AI-based fusion business due to the increment of ICT fusion medical device has been expanded. In addition, AI-based medical devices help change existing medical system on treatment into the paradigm of customized treatment such as preliminary diagnosis and prevention. It will be generally promoted to the change of medical device industry. Although the current demand forecasting of medical biotechnology commercialization is based on the method of Delphi and AHP, there is a problem that it is difficult to have a generalization due to fluctuation results according to a pool of participants. Therefore, the purpose of the paper is to predict demand forecasting for identifying promising technology based on building up big data in medical biotechnology. The development method is to employ candidate technologies of keywords extracted from SCOPUS and to use word2vec for drawing analysis indicator, technological distance similarity, and recommended technological similarity of top-level items in order to achieve a reasonable result. In addition, the method builds up academic big data for 5 years (2016-2020) in order to commercialize technology excavation on demand perspective. Lastly, the paper employs global data studies in order to develop domestic and international demand for technology excavation in the medical biotechnology field.

음파를 이용한 진동운동기구개발 (The vibration exercise device development which uses the sonic wave)

  • 민진영
    • 대한전자공학회:학술대회논문집
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    • 대한전자공학회 2008년도 하계종합학술대회
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    • pp.135-136
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    • 2008
  • By applying sonic wave technology in Vibration Exercise Equipment, we introduced an completely new concept of device into the fitness and medical industry creating a new trend. Sonic Vibration Exercise Equipment which got over the limit of technology will be easily accessible not only by professional athletes but also by ordinary users and even minority groups such as disabled, elderly, children.

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Review of Domestic Sleep Industry Classification Criteria and Aanalysis of characteristics of related companies

  • Yu, Tae Gyu
    • International journal of advanced smart convergence
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    • 제11권1호
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    • pp.111-116
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    • 2022
  • After COVID-19, the number of people with sleep disorders around the world is increasing. In particular, in the flow of the 4th industrial revolution, the differentiation of types and characteristics of the sleep industry is accelerating. Therefore, in this study, the characteristics of each type of sleep-related industry were reclassified from an industrial point of view, and based on this, an attempt was made to review the classification system that can help companies develop sleep products and improve related national systems. Based on the 10th standard industry classification, we compared input cost, value, and usability and analyzed common characteristics, treatments, and preventive effects based on this. A comprehensive taxonomy using matrix analysis was reviewed. As a result, in terms of cost (A), the most common sleeping products are general mattresses and general bedding. It is an IOT device (auxiliary device), and the value aspect (B, B/D) included sleep cafe, bedding rental and management service, and sleep consulting. In terms of utility (A/B), a total of 6 product groups including sleep aids (health functional foods) belong to this category, and in terms of treatment (A/C), a total of 3 product groups including sleep clinics (medical services) belong to this category. As for the product group (A/D) with both properties, it was found that non-insurance sleep treatment medical devices, sleep-related over-the-counter drugs, and some sleep monitoring applications belong to this category. Ultimately, it was found that the sleep industry classification enables the most active product development and composition according to the relative relationship between cost and utility, and treatment and utility. appeared to be necessary.

Strategies for Deriving Strategic Products to Enter the Dementia Industry on SMEs-Focused on AHP Analysis

  • Yu, Tae Gyu
    • International Journal of Internet, Broadcasting and Communication
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    • 제12권1호
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    • pp.61-66
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    • 2020
  • Many SMEs are interested in entering the dementia industry as the national dementia responsibility system begins in earnest. However, it is ambiguous about which technology and field to enter, and accordingly, it is impossible to make a quick judgment and misses the time to enter the market. Therefore, the purpose of this study is to provide a simple but clear information to many SMEs in this situation, which products and related technologies will be able to help product development and market entry in the dementia prevention and diagnosis technology market more easily. In this regard, I would like to suggest the direction through hierarchical analysis (AHP) through conducting with a group of experts who can make professional judgments about the development of dementia medical technology, including the four-year university senior welfare department, nurses, directors and directors of long-term care institutions, medical device workers and experts' opinions on what sectors SMEs can most effectively apply to product development to enter the dementia market.

보건의료산업에서의 전자상거래 가치 및 활성화 전략 (e-Business Strategy of Healthcare Industry)

  • 이견직
    • 보건행정학회지
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    • 제11권3호
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    • pp.102-120
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    • 2001
  • This paper examines the current situation and major impacts of e-business on healthcare industry: hospital, pharmaceutical, medical device and health-related internet sectors. Of the 137 samples collected with mail survey, the utilization rate of B2C e-commerce is 31.4% and B2B is 13.1%. And 74.5% of respondents remains the first development stage which represents the simple advertisement such as the one-way information offering. The key obstacle of expansion of health care e-commerce turns out to be the illogical and outdated medical-related law and institution. Finally, policy recommendations are proposed based on the evaluation of the current policy implemented by government.

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외장형 MDEC을 이용한 CMS 개발 (The Development of the CMS using External MDEC)

  • 정현철;김태군;강동원;장덕형;유재영;진호;김홍삼;박명철
    • 한국컴퓨터정보학회:학술대회논문집
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    • 한국컴퓨터정보학회 2016년도 제53차 동계학술대회논문집 24권1호
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    • pp.335-336
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    • 2016
  • 본 논문에서는 다중 의료장비의 신호를 전송할 수 있는 MDEC과 연동성이 있는 CMS를 개발한다. 주요장비는 환자 감시를 위한 M20과 진단용 심전계 장비인 E40이 대상이 된다. 본 도구는 MDEC의 실효성을 입증하고 환자의 상태를 중앙 집중식으로 모니터링하기 위한 목적으로 개발한다. 먼저, CMS의 기능 구성을 정의하고 MDEC과의 연동성을 위한 프로토콜 정의를 통하여 실제 모니터링 도구를 개발하였다. 향후, 개발된 도구는 CMCIS(Central Monitoring and Cardiology Information System) 기반의 통합 시스템에 적용할 계획이다.

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원주의료기기 클러스터 혁신역량 제고방안 (A Method for Increasing the Promotion of Wonju Cluster)

  • 이우천
    • 한국경제지리학회지
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    • 제11권3호
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    • pp.428-441
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    • 2008
  • 원주클러스터의 역량 제고방안을 제시하기 위해 원주의료기기의 산업현황을 파악하였다. 그리고 설문과 심층면접으로 기업일반현황 및 입지요인, 경영환경, 기업경쟁력, 기업지원제도 등을 조사하였다. 원주클러스터는 '07말 기준 40만 평방미터의 부지에 79개 의료기기 제조업체가 입주하여 연구개발 및 생산중이며 시장점유율은 전국 의료기기 생산액의 9%, 수출액의 11%를 차지하고 있다. 그러나 원주클러스터 업체들의 혁신역량이 보완되기 위해서는 기업들의 지리적 집적, 의료기기 및 전후방 업체육성 및 유치, 고급인력공급, 기술개발지원, 기술 및 정보획득 지원, 주거 교육 등 기반시설 보완, 체계적인 창업보육 시스템구축, 자금조달지원, 마케팅 지원과 경영자의 자질향상 프로그램이 필요함을 알 수 있었다.

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스마트 의료 환경에서 이기종 네트워크 간 연동 기술 설계 (Design of Interworking Technology for Heterogeneous Medical Device Networks in Smart Healthcare Environments)

  • 김민진;이승한;김재수
    • 디지털산업정보학회논문지
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    • 제11권4호
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    • pp.25-31
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    • 2015
  • Smart healthcare environments which merge medical and IT technology are getting ready for the third generation centering EHR from current second generation. As a basic technology for the introduction and activation of EHR systems it requires heterogeneous network interworking techniques between various wired and wireless medical devices. Interworking technology for heterogeneous network among various medical devices is needed to introduce EHR system. The heterogeneous network interworking technology is needed for construction of a reliable data system to convert each of unstructured data into structured data. Therefore, in this paper, we identify the domestic and international trends of smart medical field and analyze the characteristics of wired and wireless communication technology that is used in a heterogeneous network. and also suggest requirements needed for interworking technology and provide interworking technology based on them. we expect that proposed method which is designed for smart healthcare environments would provide a basic architecture needed for third smart medical technology generation.