{"@context":{"@vocab":"https://cir.nii.ac.jp/schema/1.0/","rdfs":"http://www.w3.org/2000/01/rdf-schema#","dc":"http://purl.org/dc/elements/1.1/","dcterms":"http://purl.org/dc/terms/","foaf":"http://xmlns.com/foaf/0.1/","prism":"http://prismstandard.org/namespaces/basic/2.0/","cinii":"http://ci.nii.ac.jp/ns/1.0/","datacite":"https://schema.datacite.org/meta/kernel-4/","ndl":"http://ndl.go.jp/dcndl/terms/","jpcoar":"https://github.com/JPCOAR/schema/blob/master/2.0/"},"@id":"https://cir.nii.ac.jp/crid/1390001205296255616.json","@type":"Article","productIdentifier":[{"identifier":{"@type":"DOI","@value":"10.4286/jjmi.79.273"}},{"identifier":{"@type":"NDL_BIB_ID","@value":"10362224"}},{"identifier":{"@type":"URI","@value":"http://id.ndl.go.jp/bib/10362224"}},{"identifier":{"@type":"URI","@value":"https://ndlsearch.ndl.go.jp/books/R000000004-I10362224"}},{"identifier":{"@type":"URI","@value":"http://www.jstage.jst.go.jp/article/jjmi/79/5/79_5_273/_pdf"}},{"identifier":{"@type":"NAID","@value":"110007338941"}},{"identifier":{"@type":"NAID","@value":"130004696007"}},{"identifier":{"@type":"URI","@value":"https://search.jamas.or.jp/link/ui/2009272839"}}],"resourceType":"学術雑誌論文(journal article)","dc:title":[{"@language":"en","@value":"Definition of the Device Lag and Its Measurement"},{"@language":"ja","@value":"デバイスラグの定義と測定"},{"@language":"ja-Kana","@value":"デバイスラグ ノ テイギ ト ソクテイ"}],"dc:language":"ja","description":[{"type":"abstract","notation":[{"@language":"en","@value":"The purpose of this study is to examine the improvement of the Device Lag. In this report, we are defining the Device Lag, after distinguishing sharply to period of time and lag, and we are measuring the Device Lag about medical devices approved on Japan between April 1, 2001 and March 31, 2008. The number of medical devices was 30. As a result of the analysis, it was revealed that \"period of review in U.S.\" was 1.20 year, \"period of review in Japan\" was 2.90 year, \"lag of review between U.S. and Japan\" was 1.70 year, \"lag of file from U.S. to Japan\" was 2.42 year, \"period after approval in Japan until Public Health Insurance cover in Japan\" was 0.65 year, \"period after file in Japan until Clinical Use in Japan\" was 2.92 year, and \"period after file in U.S. until Clinical Use in Japan\" was 5.44 year. Review time in Japan is significantly lengthy compared with Review time in U.S (P<0.01). It was suggested by these analytical results that the Device Lag is solved by reviewers increase, global harmonization of regulation, deregulation of Public Health Insurance cover, and Clinical Trials with the Bayesian Statistics."}],"abstractLicenseFlag":"disallow"}],"creator":[{"@id":"https://cir.nii.ac.jp/crid/1030566608660584323","@type":"Researcher","personIdentifier":[{"@type":"NRID","@value":"9000006035511"},{"@type":"RESEARCHMAP","@value":"https://researchmap.jp/40538609"}],"foaf:name":[{"@language":"en","@value":"Nakano Shohei"},{"@language":"ja","@value":"中野 壮陛"}],"jpcoar:affiliationName":[{"@language":"en","@value":"Graduate School of Engineering Management, Shibaura Institute of Technology"},{"@language":"ja","@value":"芝浦工業大学大学院 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Fumio"},{"@language":"ja","@value":"児玉 文雄"}],"jpcoar:affiliationName":[{"@language":"en","@value":"Graduate School of Engineering Management, Shibaura Institute of Technology"},{"@language":"ja","@value":"芝浦工業大学大学院 工学マネジメント研究科"}]},{"@id":"https://cir.nii.ac.jp/crid/1420845751137482624","@type":"Researcher","personIdentifier":[{"@type":"KAKEN_RESEARCHERS","@value":"20439293"},{"@type":"NRID","@value":"1000020439293"},{"@type":"ORCID","@value":"0000-0002-6625-2644"},{"@type":"NRID","@value":"9000014597721"},{"@type":"NRID","@value":"9000412101404"},{"@type":"NRID","@value":"9000007730158"},{"@type":"NRID","@value":"9000401510327"},{"@type":"NRID","@value":"9000412315382"},{"@type":"NRID","@value":"9000403667389"},{"@type":"NRID","@value":"9000403671469"},{"@type":"NRID","@value":"9000403671513"},{"@type":"NRID","@value":"9000265254957"},{"@type":"NRID","@value":"9000403667640"},{"@type":"NRID","@value":"9000403667522"},{"@type":"NRID","@value":"9000020838519"},{"@type":"NRID","@value":"9000403670821"},{"@type":"NRID","@value":"9000409468753"},{"@type":"NRID","@value":"9000403671133"},{"@type":"RESEARCHMAP","@value":"https://researchmap.jp/shingo-kano"}],"foaf:name":[{"@language":"en","@value":"Kano Shingo"},{"@language":"ja","@value":"加納 信吾"}],"jpcoar:affiliationName":[{"@language":"en","@value":"Graduate School of Engineering Management, Shibaura Institute of Technology"},{"@language":"ja","@value":"芝浦工業大学大学院 工学マネジメント研究科"}]}],"publication":{"publicationIdentifier":[{"@type":"PISSN","@value":"18824978"},{"@type":"LISSN","@value":"18824978"},{"@type":"EISSN","@value":"1884054X"},{"@type":"NDL_BIB_ID","@value":"000009147869"},{"@type":"ISSN","@value":"18824978"},{"@type":"NCID","@value":"AA12291278"}],"prism:publicationName":[{"@language":"en","@value":"Iryou kikigaku (The Japanese journal of medical instrumentation)"},{"@language":"ja","@value":"医療機器学"},{"@language":"en","@value":"JJMI"},{"@language":"en","@value":"The Japanese journal of medical instrumentation"},{"@language":"en","@value":"Iryou kikigaku"},{"@language":"en","@value":"Iryou kikigaku (The Japanese journal of medical instrumentation)"},{"@language":"ja","@value":"医器学"}],"dc:publisher":[{"@language":"en","@value":"Japanese Society of Medical Instrumentation"},{"@language":"ja","@value":"一般社団法人日本医療機器学会"}],"prism:publicationDate":"2009","prism:volume":"79","prism:number":"5","prism:startingPage":"273","prism:endingPage":"285"},"reviewed":"false","url":[{"@id":"http://id.ndl.go.jp/bib/10362224"},{"@id":"https://ndlsearch.ndl.go.jp/books/R000000004-I10362224"},{"@id":"http://www.jstage.jst.go.jp/article/jjmi/79/5/79_5_273/_pdf"},{"@id":"https://search.jamas.or.jp/link/ui/2009272839"}],"availableAt":"2009","project":[{"@id":"https://cir.nii.ac.jp/crid/1040282257441083776","@type":"Project","projectIdentifier":[{"@type":"KAKEN","@value":"19330087"},{"@type":"JGN","@value":"JP19330087"},{"@type":"URI","@value":"https://kaken.nii.ac.jp/grant/KAKENHI-PROJECT-19330087/"}],"notation":[{"@language":"ja","@value":"先端医療分野のレギュレーションギャップ・マネジメントに関する研究"},{"@language":"en","@value":"Regulation Gap Management in Advanced Medicines : A Comparative Institutional Analysis between US and Japan"}]}],"relatedProduct":[{"@id":"https://cir.nii.ac.jp/crid/1363107371176308096","@type":"Article","relationType":["references"],"jpcoar:relatedTitle":[{"@value":"The Dynamics of Technological Change in Medicine"}]},{"@id":"https://cir.nii.ac.jp/crid/1363951793925233152","@type":"Article","relationType":["references"],"jpcoar:relatedTitle":[{"@value":"Innovation In Medical Technology: Reading The Indicators"}]},{"@id":"https://cir.nii.ac.jp/crid/1390001204366033792","@type":"Article","resourceType":"学術雑誌論文(journal article)","relationType":["isCitedBy"],"jpcoar:relatedTitle":[{"@language":"en","@value":"Current issues concerning development, clinical application and<br>commercialization of advanced medical devices"},{"@language":"ja","@value":"先進医療機器の開発・臨床応用・製品化における現在の課題"},{"@value":"Current issues concerning development, clinical application andcommercialization of advanced medical devices"}]},{"@id":"https://cir.nii.ac.jp/crid/1390282680272697728","@type":"Article","resourceType":"学術雑誌論文(journal article)","relationType":["isCitedBy"],"jpcoar:relatedTitle":[{"@language":"en","@value":"Development and Productization of an Innovative Artificial Lung and an ECMO/PCPS System with Potent Thrombo-Resistant Property and Long-Term Durability"},{"@value":"抗血栓性と長期耐久性に優れた次世代型人工肺およびECMO/PCPSシステムの開発と製品化"},{"@language":"ja-Kana","@value":"コウケッセンセイ ト チョウキ タイキュウセイ ニ スグレタ ジセダイガタ ジンコウ ハイ オヨビ ECMO/PCPS システム ノ カイハツ ト セイヒンカ"}]},{"@id":"https://cir.nii.ac.jp/crid/1390282680884825856","@type":"Article","relationType":["isReferencedBy","isCitedBy"],"jpcoar:relatedTitle":[{"@language":"ja","@value":"わが国における先進医療機器の研究開発・臨床応用・製品化に関する諸問題と対策(<特集>医療福祉機器を産業化するまでのステップとその課題)"},{"@language":"en","@value":"Problems and Measures in the Research and Development, Clinical Application and Commercialization of Advanced Medical Devices in 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