{"id":8882,"date":"2021-03-11T15:23:06","date_gmt":"2021-03-11T15:23:06","guid":{"rendered":"https:\/\/www.kolabtree.com\/blog\/?p=8882"},"modified":"2021-03-12T09:19:37","modified_gmt":"2021-03-12T09:19:37","slug":"medical-device-development-3-tips-for-success","status":"publish","type":"post","link":"https:\/\/www.kolabtree.com\/blog\/ja\/medical-device-development-3-tips-for-success\/","title":{"rendered":"\u533b\u7642\u6a5f\u5668\u958b\u767a\u3002\u6210\u529f\u306e\u305f\u3081\u306e3\u3064\u306e\u30d2\u30f3\u30c8"},"content":{"rendered":"<div id=\"ez-toc-container\" class=\"ez-toc-v2_0_45_1 counter-flat ez-toc-counter ez-toc-grey ez-toc-container-direction\">\n<div class=\"ez-toc-title-container\">\n<p class=\"ez-toc-title\">table of contents<\/p>\n<span class=\"ez-toc-title-toggle\"><a href=\"#\" class=\"ez-toc-pull-right ez-toc-btn ez-toc-btn-xs ez-toc-btn-default ez-toc-toggle\" area-label=\"ez-toc-toggle-icon-1\"><label for=\"item-69f2cc33d5ba1\" aria-label=\"Table of Content\"><span style=\"display: flex;align-items: center;width: 35px;height: 30px;justify-content: center;direction:ltr;\"><svg style=\"fill: #999;color:#999\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" class=\"list-377408\" width=\"20px\" height=\"20px\" viewbox=\"0 0 24 24\" fill=\"none\"><path d=\"M6 6H4v2h2V6zm14 0H8v2h12V6zM4 11h2v2H4v-2zm16 0H8v2h12v-2zM4 16h2v2H4v-2zm16 0H8v2h12v-2z\" fill=\"currentColor\"><\/path><\/svg><svg style=\"fill: #999;color:#999\" class=\"arrow-unsorted-368013\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"10px\" height=\"10px\" viewbox=\"0 0 24 24\" version=\"1.2\" baseprofile=\"tiny\"><path d=\"M18.2 9.3l-6.2-6.3-6.2 6.3c-.2.2-.3.4-.3.7s.1.5.3.7c.2.2.4.3.7.3h11c.3 0 .5-.1.7-.3.2-.2.3-.5.3-.7s-.1-.5-.3-.7zM5.8 14.7l6.2 6.3 6.2-6.3c.2-.2.3-.5.3-.7s-.1-.5-.3-.7c-.2-.2-.4-.3-.7-.3h-11c-.3 0-.5.1-.7.3-.2.2-.3.5-.3.7s.1.5.3.7z\"\/><\/svg><\/span><\/label><input  type=\"checkbox\" id=\"item-69f2cc33d5ba1\"><\/a><\/span><\/div>\n<nav><ul class='ez-toc-list ez-toc-list-level-1' ><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-1\" href=\"https:\/\/www.kolabtree.com\/blog\/ja\/medical-device-development-3-tips-for-success\/#Medical_Device_Development_From_Product_to_Discovery_Phase\" title=\"\u533b\u7642\u6a5f\u5668\u958b\u767a\u3002\u88fd\u54c1\u304b\u3089\u958b\u767a\u6bb5\u968e\u307e\u3067\u00a0\">\u533b\u7642\u6a5f\u5668\u958b\u767a\u3002\u88fd\u54c1\u304b\u3089\u958b\u767a\u6bb5\u968e\u307e\u3067\u00a0<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-2\" href=\"https:\/\/www.kolabtree.com\/blog\/ja\/medical-device-development-3-tips-for-success\/#1_Product_Ideation_and_Conceptualization\" title=\"1.\u5546\u54c1\u306e\u30a2\u30a4\u30c7\u30a2\u3068\u30b3\u30f3\u30bb\u30d7\u30c8\u306e\u7b56\u5b9a\">1.\u5546\u54c1\u306e\u30a2\u30a4\u30c7\u30a2\u3068\u30b3\u30f3\u30bb\u30d7\u30c8\u306e\u7b56\u5b9a<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-3\" href=\"https:\/\/www.kolabtree.com\/blog\/ja\/medical-device-development-3-tips-for-success\/#2_Device_Classification\" title=\"2.\u30c7\u30d0\u30a4\u30b9\u306e\u5206\u985e\">2.\u30c7\u30d0\u30a4\u30b9\u306e\u5206\u985e<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-4\" href=\"https:\/\/www.kolabtree.com\/blog\/ja\/medical-device-development-3-tips-for-success\/#3_Discovery_Phase\" title=\"3.\u30c7\u30a3\u30b9\u30ab\u30d0\u30ea\u30fc\u30fb\u30d5\u30a7\u30fc\u30ba\">3.\u30c7\u30a3\u30b9\u30ab\u30d0\u30ea\u30fc\u30fb\u30d5\u30a7\u30fc\u30ba<\/a><\/li><\/ul><\/nav><\/div>\n<p><em><a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/shrinidh-joshi\/?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=MDDevTips\">\u30b7\u30e5\u30ea\u30cb\u30fc\u30c9\u30fb\u30b8\u30e7\u30b7<\/a>, <a href=\"https:\/\/www.kolabtree.com\/industry\/medical-device\/?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=MDDevTips\">\u30e1\u30c9\u30c6\u30c3\u30af\u30fb\u30b3\u30f3\u30b5\u30eb\u30bf\u30f3\u30c8<\/a> \u306eKolabtree\u3067\u306f\u3001\u533b\u7642\u6a5f\u5668\u958b\u767a\u3092\u6210\u529f\u3055\u305b\u308b\u305f\u3081\u306e3\u3064\u306e\u30d2\u30f3\u30c8\u3092\u7d39\u4ecb\u3057\u3066\u3044\u307e\u3059\u306e\u3067\u3001\u305c\u3072\u3054\u89a7\u304f\u3060\u3055\u3044\u3002\u00a0<\/em><\/p>\n<p><span style=\"font-weight: 400;\">\u65b0\u3057\u3044\u533b\u7642\u6a5f\u5668\u3092\u958b\u767a\u3059\u308b\u305f\u3081\u306e\u30a2\u30a4\u30c7\u30a2\uff08\u300c\u30ca\u30d7\u30ad\u30f3\u300d\u306e\u88cf\u306b\u66f8\u3044\u305f\u3082\u306e\u3067\u3082\u3001\u307e\u3060\u30d6\u30ec\u30a4\u30f3\u30b9\u30c8\u30fc\u30df\u30f3\u30b0\u4e2d\u306e\u3082\u306e\u3067\u3082\u53ef\uff09\u3092\u601d\u3044\u3064\u3044\u305f\u3068\u304d\u3001\u305d\u306e\u30a2\u30a4\u30c7\u30a2\u304c\u300c\u4ed6\u306b\u306f\u306a\u3044\u300d\u7834\u58ca\u7684\u306a\u3082\u306e\u3067\u3042\u308a\u3001\u533b\u7642\u306b\u5927\u304d\u306a\u5f71\u97ff\u3092\u4e0e\u3048\u308b\u53ef\u80fd\u6027\u304c\u975e\u5e38\u306b\u9ad8\u3044\u3067\u3059\u3002\u307e\u305f\u3001\u3042\u306a\u305f\u306e\u88fd\u54c1\u304c\u73fe\u5728\u306e\u8ab2\u984c\u3092\u89e3\u6c7a\u3059\u308b\u53ef\u80fd\u6027\u3082\u3042\u308a\u307e\u3059\u3002\u4f8b\u3048\u3070\u3001\u643a\u5e2f\u578b\u306e\u30b9\u30d1\u30a4\u30ed\u30e1\u30fc\u30bf\u30fc\u30c7\u30d0\u30a4\u30b9\u304c\u767a\u898b\u3055\u308c\u308b\u307e\u3067\u306f\u3001\u30b9\u30d1\u30a4\u30ed\u30e1\u30fc\u30bf\u30fc\u30c7\u30d0\u30a4\u30b9\u306e\u300c\u30d5\u30a9\u30fc\u30e0\u30d5\u30a1\u30af\u30bf\u30fc\u300d\u3084\u300c\u304b\u3055\u3070\u308a\u300d\u304c\u5927\u304d\u306a\u8ab2\u984c\u3067\u3057\u305f\u3002\u540c\u69d8\u306b\u3001\u8840\u7cd6\u5024\u30e2\u30cb\u30bf\u30fc\u306e\u767a\u898b\u306f\u3001\u4f55\u767e\u4e07\u4eba\u3082\u306e\u7cd6\u5c3f\u75c5\u60a3\u8005\u306b\u3068\u3063\u3066\u3001\u3053\u308c\u307e\u3067\u306b\u306a\u3044\u5909\u9769\u3092\u3082\u305f\u3089\u3057\u307e\u3057\u305f\u3002\u00a0\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u975e\u65e5\u5e38\u6027\u3084\u7834\u58ca\u6027\u306e\u3042\u308b\u533b\u7642\u6a5f\u5668\u3092\u8a2d\u8a08\u3059\u308b\u5fc5\u8981\u306f\u306a\u304f\u3001\u65e2\u5b58\u306e\u30e6\u30fc\u30b6\u30fc\u306b\u4ed8\u52a0\u4fa1\u5024\u3092\u4e0e\u3048\u3089\u308c\u308b\u533b\u7642\u6a5f\u5668\u3067\u3042\u308c\u3070\u3001BlueStar\u306e\u3088\u3046\u306a\u533b\u7642\u6a5f\u5668\u3068\u3057\u3066\u306e\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u306e\u3088\u3046\u306b\u3001\u30e6\u30fc\u30b6\u30fc\u306b\u30e1\u30ea\u30c3\u30c8\u3092\u63d0\u4f9b\u3067\u304d\u308b\u53ef\u80fd\u6027\u304c\u3042\u308a\u307e\u3059\u3002 <\/span><a href=\"https:\/\/www.welldoc.com\/health-plans\/\"><span style=\"font-weight: 400;\">[1] <\/span><\/a><span style=\"font-weight: 400;\">\u306f\u3001\u7cd6\u5c3f\u75c5\u60a3\u8005\u306e\u751f\u6d3b\u7fd2\u6163\u3084\u85ac\u306e\u7ba1\u7406\u3092\u30b5\u30dd\u30fc\u30c8\u3059\u308b\u88fd\u54c1\u3067\u3059\u3002\u533b\u7642\u6a5f\u5668\u30e1\u30fc\u30ab\u30fc\u306b\u3068\u3063\u3066\u6700\u5927\u306e\u30b8\u30ec\u30f3\u30de\u306f\u3001\u81ea\u793e\u306e\u533b\u7642\u6a5f\u5668\u304c\u5e02\u5834\u3067\u53ce\u76ca\u6027\u306e\u9ad8\u3044\u30b7\u30a7\u30a2\u3092\u7372\u5f97\u3067\u304d\u308b\u304b\u3069\u3046\u304b\u3067\u3059\u3002\u591a\u304f\u306e\u5834\u5408\u3001\u3053\u306e\u554f\u984c\u306f\u533b\u7642\u6a5f\u5668\u306e\u54c1\u8cea\u7ba1\u7406\u3084\u6709\u52b9\u6027\u3001\u3042\u308b\u3044\u306f\u533b\u7642\u6a5f\u5668\u3092\u5e02\u5834\u306b\u6295\u5165\u3059\u308b\u969b\u306e\u8907\u96d1\u3055\u306b\u8d77\u56e0\u3057\u307e\u3059\u3002\u533b\u7642\u6a5f\u5668\u306e\u30b9\u30bf\u30fc\u30c8\u30a2\u30c3\u30d7\u4f01\u696d\u306b\u3068\u3063\u3066\u3001\u30d7\u30ed\u30bb\u30b9\u5168\u4f53\u3092\u6307\u5c0e\u3059\u308b\u5c02\u9580\u5bb6\u304c\u3044\u306a\u3051\u308c\u3070\u3001\u3069\u3061\u3089\u3082\u30d7\u30ed\u30b8\u30a7\u30af\u30c8\u306e\u9813\u632b\u306b\u3064\u306a\u304c\u308b\u3068\u8a00\u3048\u308b\u3067\u3057\u3087\u3046\u3002\u5834\u5408\u306b\u3088\u3063\u3066\u306f\u3001\u5e02\u5834\u3092\u7834\u58ca\u3057\u3001\u65b0\u3057\u3044\u6cbb\u7642\u6cd5\u3092\u3082\u305f\u3089\u3059\u53ef\u80fd\u6027\u306e\u3042\u308b\u533b\u7642\u6a5f\u5668\u3092\u8a2d\u8a08\u3057\u3066\u3044\u3066\u3082\u3001\u305d\u306e\u3088\u3046\u306a\u6a5f\u5668\u304c\u6301\u3064\u898f\u5236\u8981\u4ef6\u3092\u8003\u3048\u3066\u3044\u306a\u304b\u3063\u305f\u308a\u3001\u898f\u5236\u5f53\u5c40\u304c\u305d\u306e\u6a5f\u5668\u3092\u5206\u985e\u3067\u304d\u306a\u304b\u3063\u305f\u308a\u3059\u308b\u3053\u3068\u304c\u3042\u308a\u307e\u3059\u3002\u79c1\u306f\u3042\u308b\u4f01\u696d\u3068\u63d0\u643a\u3057\u3066\u3044\u307e\u3057\u305f\u304c\u3001\u305d\u306e\u4f01\u696d\u306f\u6cbb\u7642\u6a5f\u5668\u3068\u8a3a\u65ad\u6a5f\u5668\u3092\u7d44\u307f\u5408\u308f\u305b\u3066\u30a8\u30f3\u30c9\u30e6\u30fc\u30b6\u30fc\u306b\u30a8\u30f3\u30c9\u30c4\u30fc\u30a8\u30f3\u30c9\u306e\u30e1\u30ea\u30c3\u30c8\u3092\u63d0\u4f9b\u3059\u308b\u3068\u3044\u3046\u7d20\u6674\u3089\u3057\u3044\u30a2\u30a4\u30c7\u30a2\u3092\u6301\u3063\u3066\u3044\u307e\u3057\u305f\u304c\u3001\u898f\u5236\u5f53\u5c40\u306f\u305d\u306e\u6a5f\u5668\u3092\u533b\u85ac\u54c1\u3068\u3057\u3066\u5be9\u67fb\u3059\u308b\u304b\u3001510(k)\u3067\u8a3a\u65ad\u6a5f\u5668\u3068\u3057\u3066\u5be9\u67fb\u3059\u308b\u304b\u3067\u6df7\u4e71\u3057\u3066\u3044\u307e\u3057\u305f\u3002\u3057\u305f\u304c\u3063\u3066\u3001\u8a2d\u8a08\u306e\u59a5\u5f53\u6027\u3001\u54c1\u8cea\u7ba1\u7406\u3001\u898f\u5236\u306e\u67a0\u7d44\u307f\u306e\u3059\u3079\u3066\u306e\u5074\u9762\u3092\u8003\u616e\u3057\u305f\u7dcf\u5408\u7684\u306a\u30a2\u30d7\u30ed\u30fc\u30c1\u304c\u3001\u5fc5\u8981\u306a\u3068\u304d\u306b\u5fc5\u8981\u306a\u3060\u3051\u53d6\u308a\u7d44\u3080\u3088\u308a\u3082\u8ce2\u660e\u306a\u65b9\u6cd5\u3067\u3059\u3002\u305d\u306e\u305f\u3081\u306b\u306f\u3001\u88fd\u54c1\u306e\u30a2\u30a4\u30c7\u30a2\u51fa\u3057\u304b\u3089\u8a2d\u8a08\u30fb\u958b\u767a\u3001\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u3001\u8a66\u9a13\u3001\u30b9\u30b1\u30fc\u30eb\u30a2\u30c3\u30d7\u3001\u30de\u30fc\u30b1\u30c6\u30a3\u30f3\u30b0\u306b\u81f3\u308b\u307e\u3067\u3001\u3059\u3079\u3066\u306e\u6bb5\u968e\u3067\u6b63\u78ba\u3055\u304c\u6c42\u3081\u3089\u308c\u307e\u3059\u3002<\/span><\/p>\n<p><span 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400;\">\u4eca\u56de\u306f\u3001\u533b\u7642\u6a5f\u5668\u306e\u958b\u767a\u30d7\u30ed\u30bb\u30b9\u306e\u3046\u3061\u3001\u300c\u8a2d\u8a08\u30fb\u958b\u767a\u300d\u306e\u6bb5\u968e\u3092\u3054\u7d39\u4ecb\u3057\u307e\u3059\u3002\u3053\u306e\u6bb5\u968e\u306f\u3001\u533b\u7642\u6a5f\u5668\u306e\u30e9\u30a4\u30d5\u30b5\u30a4\u30af\u30eb\u306e\u4e2d\u3067\u6700\u3082\u91cd\u8981\u306a\u6bb5\u968e\u3060\u3068\u601d\u308f\u308c\u307e\u3059\u3002\u533b\u7642\u6a5f\u5668\u306e\u30b9\u30bf\u30fc\u30c8\u30a2\u30c3\u30d7\u4f01\u696d\u3068\u3057\u3066\u3001\u533b\u7642\u6a5f\u5668\u306e\u5b9a\u7fa9\u3084\u8a2d\u8a08\u306b\u304a\u3044\u3066\u91cd\u8981\u306a\u30b9\u30c6\u30c3\u30d7\u3092\u7701\u3044\u3066\u3057\u307e\u3046\u3068\u3001\u898f\u5236\u6a5f\u95a2\u3078\u306e\u4e0d\u9069\u5408\u306e\u30ea\u30b9\u30af\u304c\u3042\u308a\u3001\u533b\u7642\u6a5f\u5668\u3092\u5e02\u5834\u306b\u51fa\u3059\u3053\u3068\u304c\u3067\u304d\u306a\u304f\u306a\u308a\u307e\u3059\u3002\u5b9a\u7fa9\u3084\u8a2d\u8a08\u304c\u4e0d\u5341\u5206\u306a\u533b\u7642\u6a5f\u5668\u306f\u3001\u898f\u5236\u306e\u30cf\u30fc\u30c9\u30eb\u3092\u56de\u907f\u3059\u308b\u3053\u3068\u306b\u6210\u529f\u3057\u305f\u3068\u3057\u3066\u3082\u3001\u6700\u7d42\u7684\u306b\u306f\u3001\u4f7f\u7528\u76ee\u7684\u3084\u3001\u5148\u884c\u8005\u3084\u7af6\u5408\u4ed6\u793e\u306b\u5bfe\u3059\u308b\u5229\u70b9\u306a\u3069\u306e\u4e3b\u5f35\u3092\u5b9f\u73fe\u3059\u308b\u3053\u3068\u304c\u3067\u304d\u306a\u3044\u304b\u3082\u3057\u308c\u307e\u305b\u3093\u3002\u4e00\u65b9\u3001\u3057\u3063\u304b\u308a\u3068\u5b9a\u7fa9\u30fb\u8a2d\u8a08\u3055\u308c\u305f\u88fd\u54c1\u306f\u3001\u5e02\u5834\u3092\u6df7\u4e71\u3055\u305b\u3001\u6700\u7d42\u7684\u306b\u306f\u5e02\u5834\u306b\u63a1\u7528\u3055\u308c\u308b\u53ef\u80fd\u6027\u3092\u591a\u304f\u79d8\u3081\u3066\u3044\u307e\u3059\u3002\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u533b\u85ac\u54c1\u3067\u3042\u308c\u533b\u7642\u6a5f\u5668\u3067\u3042\u308c\u3001\u3059\u3079\u3066\u306e\u30d8\u30eb\u30b9\u30b1\u30a2\u88fd\u54c1\u3068\u540c\u69d8\u306b\u3001\u9867\u5ba2\u306e\u8981\u6c42\u3092\u6e80\u305f\u3059\u9069\u5207\u306a\u30bd\u30ea\u30e5\u30fc\u30b7\u30e7\u30f3\u3092\u63d0\u4f9b\u3059\u308b\u305f\u3081\u306b\u306f\u3001\u304b\u306a\u308a\u306e\u52aa\u529b\u3068\u7d30\u5fc3\u306e\u6ce8\u610f\u304c\u5fc5\u8981\u3067\u3059\u3002\u533b\u7642\u6a5f\u5668\u30e1\u30fc\u30ab\u30fc\u306e\u30b9\u30bf\u30fc\u30c8\u30a2\u30c3\u30d7\u4f01\u696d\u3068\u3057\u3066\u306f\u3001\u88fd\u54c1\u306e\u30b9\u30b3\u30fc\u30d7\u3001\u6210\u679c\u7269\u3001\u5b9a\u7fa9\u3001\u4ed5\u69d8\u3001\u30c7\u30b6\u30a4\u30f3\u3001\u30d5\u30a9\u30fc\u30e0\u30d5\u30a1\u30af\u30bf\u3001\u30ea\u30b9\u30af\u8efd\u6e1b\u6226\u7565\u3001\u898f\u5236\u8981\u4ef6\u306a\u3069\u306b\u3064\u3044\u3066\u3001\u3059\u3079\u3066\u306e\u95a2\u4fc2\u8005\u304c\u4e00\u81f4\u3057\u3066\u3044\u308b\u3053\u3068\u3092\u78ba\u8a8d\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002\u57fa\u672c\u7684\u306b\u306f\u3001\u4e0a\u8a18\u306e\u3059\u3079\u3066\u306e\u52aa\u529b\u304c\u3001\u533b\u7642\u6a5f\u5668\u306e\u6700\u9ad8\u306e\u54c1\u8cea\u306b\u5411\u3051\u3066\u63a8\u9032\u3055\u308c\u308b\u3079\u304d\u3067\u3059\u3002\u00a0<\/span><\/p>\n<h2><span class=\"ez-toc-section\" id=\"Medical_Device_Development_From_Product_to_Discovery_Phase\"><\/span><b>\u533b\u7642\u6a5f\u5668\u958b\u767a\u3002\u88fd\u54c1\u304b\u3089\u958b\u767a\u6bb5\u968e\u307e\u3067\u00a0<\/b><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<h3><span class=\"ez-toc-section\" id=\"1_Product_Ideation_and_Conceptualization\"><\/span><b>1.\u5546\u54c1\u306e\u30a2\u30a4\u30c7\u30a2\u3068\u30b3\u30f3\u30bb\u30d7\u30c8\u306e\u7b56\u5b9a<\/b><span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p><span style=\"font-weight: 400;\">The first step in medical device innovation is to analyze and identify the medical device market. As mentioned above, you are analyzing to see if your device is meeting unmet medical needs like early diagnosis of a difficult to cure disease or it is providing a more efficient way to manage a chronic disease. The problem statement for your medical device could be a novel or a better way to monitor adherence to the treatment regimen, monitoring ailment and health, improving drug delivery minimizing the drug requirements and adverse drug events, using <a href=\"https:\/\/www.kolabtree.com\/blog\/ja\/ensuring-reproducibility-in-ai-driven-research-how-freelance-experts-can-help-in-biotech-and-healthcare\/\">\u4eba\u5de5\u77e5\u80fd<\/a>, machine learning, deep learning, or real-world insights etc. Innovative software can also be defined and approved as a medical device under a software as a medical device (SaMD) category.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u9700\u8981\u306e\u3042\u308b\u30cb\u30fc\u30ba\u3092\u7279\u5b9a\u3059\u308b\u3053\u3068\u306f\u3001\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u306b\u5bfe\u5fdc\u3059\u308b\u3053\u3068\u3068\u306f\u5225\u306b\u3001\u533b\u7642\u6a5f\u5668\u3092\u63d0\u4f9b\u3059\u308b\u305f\u3081\u306e\u4e3b\u8981\u306a\u30b9\u30c6\u30c3\u30d7\u3067\u3059\u3002\u3053\u308c\u304c\u6210\u529f\u3059\u308b\u304b\u3069\u3046\u304b\u306f\u30012\u3064\u306e\u3053\u3068\u306b\u5927\u304d\u304f\u5de6\u53f3\u3055\u308c\u307e\u3059\u3002<\/span><\/p>\n<ol>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">\u30bf\u30fc\u30b2\u30c3\u30c8\u5e02\u5834\u306e\u30cb\u30fc\u30ba\u3068\u3001\u533b\u7642\u6a5f\u5668\u958b\u767a\u8005\u304c\u8a8d\u8b58\u3057\u3066\u3044\u308b\u30cb\u30fc\u30ba\u3068\u306e\u30ae\u30e3\u30c3\u30d7\u3067\u3042\u308a\u3001\u30ae\u30e3\u30c3\u30d7\u304c\u5c11\u306a\u3044\u307b\u3069\u88fd\u54c1\u5b9a\u7fa9\u306e\u305f\u3081\u306e\u30a4\u30f3\u30d7\u30c3\u30c8\u306b\u306a\u308b\u3002<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">\u5e02\u5834\u306e\u30cb\u30fc\u30ba\u3092\u5206\u6790\u3059\u308b\u3053\u3068\u3067\u3001\u5f37\u529b\u306a\u88fd\u54c1\u5b9a\u7fa9\u304c\u62bd\u51fa\u3055\u308c\u307e\u3059\u3002<\/span><\/li>\n<\/ol>\n<p><span style=\"font-weight: 400;\">\u533b\u7642\u6a5f\u5668\u306e\u958b\u767a\u30d7\u30ed\u30bb\u30b9\u306e\u5168\u4f53\u50cf\u306f\u3001\u4e0b\u56f31\u306e\u3088\u3046\u306b\u7c21\u7565\u5316\u3059\u308b\u3053\u3068\u304c\u3067\u304d\u307e\u3059\u3002\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u533b\u7642\u6a5f\u5668\u306e\u30b9\u30bf\u30fc\u30c8\u30a2\u30c3\u30d7\u4f01\u696d\u3068\u3057\u3066\u306f\u3001\u79d1\u5b66\u7684\u30fb\u5de5\u5b66\u7684\u306a\u30a4\u30ce\u30d9\u30fc\u30b7\u30e7\u30f3\u3092\u3001\u898f\u5236\u5f53\u5c40\u306e\u6c7a\u5b9a\u30d7\u30ed\u30bb\u30b9\u3092\u6c34\u5e73\u65b9\u5411\u306b\u7d20\u65e9\u304f\u79fb\u52d5\u3059\u308b\u305f\u3081\u306e\u654f\u6377\u6027\u3067\u88cf\u4ed8\u3051\u308b\u3053\u3068\u304c\u91cd\u8981\u3067\u3042\u308a\u3001\u3053\u308c\u306f\u533b\u7642\u6a5f\u5668\u958b\u767a\u30d7\u30ed\u30bb\u30b9\u306e\u5404\u6bb5\u968e\u306b\u6226\u7565\u7684\u306a\u30c1\u30a7\u30c3\u30af\u30dd\u30a4\u30f3\u30c8\u3092\u8a2d\u3051\u308b\u3053\u3068\u3067\u5b9f\u73fe\u3067\u304d\u307e\u3059\u3002\u88fd\u54c1\u306e\u30e9\u30a4\u30d5\u30b5\u30a4\u30af\u30eb\u306e\u89b3\u70b9\u304b\u3089\u8003\u3048\u308b\u3068\u3001\u30a2\u30a4\u30c7\u30a2\u306e\u7740\u60f3\u304b\u3089\u5e02\u5834\u6295\u5165\u3001\u85ac\u4e8b\u627f\u8a8d\u304b\u3089\u5e02\u5834\u5c0e\u5165\u306b\u81f3\u308b\u307e\u3067\u3001\u5e38\u306b\u8ab2\u984c\u306b\u76f4\u9762\u3059\u308b\u3053\u3068\u306b\u306a\u308a\u307e\u3059\u3002\u3064\u307e\u308a\u3001\u8ab2\u984c\u3068\u533b\u7642\u6a5f\u5668\u958b\u767a\u306f\u7d50\u3073\u3064\u3044\u3066\u3044\u3066\u3001\u305d\u308c\u3092\u89e3\u304d\u307b\u3050\u3059\u552f\u4e00\u306e\u65b9\u6cd5\u306f\u3001\u958b\u767a\u5074\u3067\u306f\u79d1\u5b66\u7684\u30fb\u6280\u8853\u7684\u306a\u30e2\u30e1\u30f3\u30bf\u30e0\u3001\u627f\u8a8d\u5074\u3067\u306f\u79d1\u5b66\u7684\u6839\u62e0\u306b\u57fa\u3065\u304f\u898f\u5236\u5f53\u5c40\u306e\u610f\u601d\u6c7a\u5b9a\u3067\u3059\u3002\u00a0<\/span><\/p>\n<h2><span class=\"ez-toc-section\" id=\"2_Device_Classification\"><\/span><b>2.\u30c7\u30d0\u30a4\u30b9\u306e\u5206\u985e<\/b><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><span style=\"font-weight: 400;\">\u88fd\u54c1\u306e\u30a2\u30a4\u30c7\u30a2\u3068\u7279\u6027\u306e\u5b9a\u7fa9\u304c\u7d42\u308f\u3063\u305f\u3089\u3001\u6b21\u306e\u30b9\u30c6\u30c3\u30d7\u306f\u3001\u6a5f\u5668\u306e\u30ea\u30b9\u30af\u30d9\u30fc\u30b9\u306e\u898f\u5236\u4e0a\u306e\u5206\u985e\u3092\u78ba\u8a8d\u3059\u308b\u3053\u3068\u3067\u3059\u3002\u88fd\u54c1\u306b\u95a2\u9023\u3059\u308b\u30ea\u30b9\u30af\u3092\u660e\u78ba\u306b\u3057\u3001\u53c2\u5165\u3059\u308b\u898f\u5236\u5e02\u5834\u306b\u57fa\u3065\u3044\u3066\u9069\u5207\u306a\u30af\u30e9\u30b9\u3092\u9078\u629e\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002\u3053\u306e\u6bb5\u968e\u3067\u306f\u3001\u6a5f\u5668\u306e\u4f7f\u7528\u76ee\u7684\u304c\u660e\u78ba\u306b\u5b9a\u7fa9\u3055\u308c\u3066\u3044\u308b\u3053\u3068\u3092\u78ba\u8a8d\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002\u3053\u308c\u306f\u975e\u5e38\u306b\u91cd\u8981\u306a\u3053\u3068\u3067\u3001510(k)\u3092\u8a08\u753b\u3057\u3066\u3044\u308b\u5834\u5408\u306f\u3001\u6a5f\u5668\u306e\u4f7f\u7528\u76ee\u7684\u304c\u30d7\u30ec\u30c7\u30a3\u30b1\u30fc\u30c8\u6a5f\u5668\u3068\u4e00\u81f4\u3057\u3066\u3044\u308b\u3053\u3068\u3092\u78ba\u8a8d\u3057\u3066\u304f\u3060\u3055\u3044\u3002\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u7c73\u56fd\u3084\u6b27\u5dde\u59d4\u54e1\u4f1a\u306a\u3069\u3001\u3069\u306e\u5730\u57df\u3067\u533b\u7642\u6a5f\u5668\u3092\u7533\u8acb\u3057\u3088\u3046\u3068\u3057\u3066\u3044\u308b\u304b\u306b\u3088\u3063\u3066\u3001\u533b\u7642\u6a5f\u5668\u5206\u985e\u30d1\u30cd\u30eb\uff08Medical Device Classification Panel\uff09\u306b\u3088\u308b\u5206\u985e\u304c\u5fc5\u8981\u306b\u306a\u308a\u307e\u3059\u3002<\/span><a href=\"https:\/\/www.fda.gov\/medical-devices\/classify-your-medical-device\/device-classification-panels\"><span style=\"font-weight: 400;\">\u7c73\u56fdFDA\u306e\u533b\u7642\u6a5f\u5668\u5206\u985e<\/span><\/a><span style=\"font-weight: 400;\">)\u307e\u305f\u306fMEDDEV 2.4\/1 Rev.9 (<\/span><a href=\"https:\/\/ec.europa.eu\/docsroom\/documents\/10337\/attachments\/1\/translations\"><span style=\"font-weight: 400;\">EN\u30ac\u30a4\u30c0\u30f3\u30b9 MEDDEV<\/span><\/a><span style=\"font-weight: 400;\">)\u3092\u305d\u308c\u305e\u308c\u4f5c\u6210\u3057\u307e\u3059\u3002\u63d0\u51fa\u7269\u306e\u4e2d\u3067\u6700\u3082\u5927\u304d\u306a\u90e8\u5206\u3092\u5360\u3081\u308b\u306e\u304c\u3001\u533b\u7642\u6a5f\u5668\u5206\u985e\u306e\u30bb\u30af\u30b7\u30e7\u30f3\u3067\u3059\u3002\u3053\u306e\u30bb\u30af\u30b7\u30e7\u30f3\u3067\u306f\u3001\u304a\u5ba2\u69d8\u306e\u6a5f\u5668\u306b\u5bfe\u3059\u308b\u898f\u5236\u8981\u4ef6\u3092\u5b9a\u7fa9\u3057\u307e\u3059\u3002\u9078\u629e\u3057\u305f\u533b\u7642\u6a5f\u5668\u30af\u30e9\u30b9\u306b\u5fdc\u3058\u3066\u3001\u898f\u5236\u5f53\u5c40\u304c\u767a\u884c\u3057\u305f\u65e2\u5b58\u306e\u30ac\u30a4\u30c0\u30f3\u30b9\u6587\u66f8\u3092\u78ba\u8a8d\u3059\u308b\u3053\u3068\u3092\u304a\u52e7\u3081\u3057\u307e\u3059\u3002\u4f8b\u3048\u3070\u3001\u7c73\u56fd\u3067\u306f\u3001FDA\u304c\u3059\u3067\u306b\u30ac\u30a4\u30c0\u30f3\u30b9\u6587\u66f8\u3092\u767a\u884c\u3057\u3066\u3044\u308b\u53ef\u80fd\u6027\u304c\u3042\u308a\u307e\u3059\u304c\u3001\u305d\u306e\u534a\u5206\u306f\u3042\u306a\u305f\u306e\u30a2\u30d7\u30ea\u30b1\u30fc\u30b7\u30e7\u30f3\u306b\u95a2\u9023\u3057\u3066\u3044\u307e\u3059\u3002\u3053\u306e\u3088\u3046\u306a\u30ac\u30a4\u30c0\u30f3\u30b9\u306f\u3001\u8fc5\u901f\u306a\u5be9\u67fb\u30b5\u30a4\u30af\u30eb\u3084\u6700\u521d\u306e\u7533\u8acb\u3067\u306e\u627f\u8a8d\u306e\u53ef\u80fd\u6027\u3092\u9ad8\u3081\u308b\u305f\u3081\u306e\u53c2\u8003\u8cc7\u6599\u3068\u306a\u308a\u307e\u3059\u3002\u3053\u308c\u3089\u306e\u30ac\u30a4\u30c0\u30f3\u30b9\u6587\u66f8\u306f\u3001\u8cb4\u793e\u306e\u3088\u3046\u306a\u9769\u65b0\u7684\u306a\u533b\u7642\u6a5f\u5668\u4f01\u696d\u3068\u3001FDA\u306e\u5be9\u67fb\u5b98\u306e\u4e21\u65b9\u306b\u3001\u7533\u8acb\u306e\u8fc5\u901f\u306a\u5be9\u67fb\u3092\u6307\u5c0e\u3059\u308b\u305f\u3081\u306b\u767a\u884c\u3055\u308c\u3066\u3044\u307e\u3059\u3002\u307e\u305f\u3001\u63d0\u6848\u3055\u308c\u305f\u30a2\u30a4\u30c7\u30a2\u3084\u985e\u4f3c\u3057\u305f\u3082\u306e\u306b\u95a2\u3059\u308b\u65e2\u5b58\u306e\u77e5\u7684\u8ca1\u7523\u304c\u306a\u3044\u304b\u3069\u3046\u304b\u3092\u78ba\u8a8d\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002\u767a\u898b\u6bb5\u968e\u3092\u5b8c\u5168\u306b\u9042\u884c\u3059\u308b\u305f\u3081\u306b\u306f\u3001\u5f37\u529b\u306a\u958b\u767a\u30c1\u30fc\u30e0\u304c\u4e0d\u53ef\u6b20\u3067\u3059\u3002\u7d4c\u9a13\u8c4a\u5bcc\u306a\u30c1\u30fc\u30e0\u3067\u306a\u3044\u3068\u3001\u3053\u308c\u304c\u843d\u3068\u3057\u7a74\u306b\u306a\u308b\u304b\u3082\u3057\u308c\u307e\u305b\u3093\u3002\u3044\u305a\u308c\u306b\u3057\u3066\u3082\u3001\u793e\u5185\u306e\u30c1\u30fc\u30e0\u3001\u30b3\u30f3\u30b5\u30eb\u30bf\u30f3\u30c8\u3001\u533b\u7642\u6a5f\u5668\u30a8\u30f3\u30b8\u30cb\u30a2\u30ea\u30f3\u30b0\u4f1a\u793e\u306e\u3044\u305a\u308c\u304b\u3092\u9078\u629e\u3059\u308b\u3053\u3068\u306b\u306a\u308a\u307e\u3059\u3002<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u4f01\u696d\u304c\u793e\u5185\u306e\u30b3\u30f3\u30b5\u30eb\u30bf\u30f3\u30c8\u3084\u5916\u90e8\u306e\u4eba\u6750\u3092\u63a2\u3059\u969b\u306b\u8003\u616e\u3059\u308b\u30dd\u30a4\u30f3\u30c8\u306f <a href=\"https:\/\/www.kolabtree.com\/industry\/medical-device\/?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=MDDev\">\u533b\u7642\u6a5f\u5668\u30b3\u30f3\u30b5\u30eb\u30bf\u30f3\u30c8<\/a> \u306f\u3001\u6b21\u306e\u3088\u3046\u306a\u5206\u91ce\u306e\u5c02\u9580\u77e5\u8b58\u3092\u6301\u3063\u3066\u3044\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002<\/span><\/p>\n<ol>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">\u30a8\u30f3\u30b8\u30cb\u30a2\u30ea\u30f3\u30b0\u3068\u30c7\u30b6\u30a4\u30f3<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">\u30d2\u30e5\u30fc\u30de\u30f3\u30d5\u30a1\u30af\u30bf\u30fc\u3068\u30e6\u30fc\u30b6\u30d3\u30ea\u30c6\u30a3\u30fc\u30a8\u30f3\u30b8\u30cb\u30a2\u30ea\u30f3\u30b0<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">\u533b\u7642\u696d\u754c\u306e\u81e8\u5e8a\u7684\u30fb\u79d1\u5b66\u7684\u77e5\u8b58<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">\u85ac\u4e8b\u30fb\u54c1\u8cea\u4fdd\u8a3c<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">\u77e5\u7684\u8ca1\u7523\u6cd5<\/span><\/li>\n<\/ol>\n<h3><span class=\"ez-toc-section\" id=\"3_Discovery_Phase\"><\/span><b>3.\u30c7\u30a3\u30b9\u30ab\u30d0\u30ea\u30fc\u30fb\u30d5\u30a7\u30fc\u30ba<\/b><span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p><span style=\"font-weight: 400;\">\u767a\u898b\u6bb5\u968e\u3067\u306f\u3001\u30a2\u30a4\u30c7\u30a2\u3092\u521d\u671f\u8a2d\u8a08\u6bb5\u968e\u306b\u79fb\u3057\u3001\u30c7\u30d0\u30a4\u30b9\u306e\u30d7\u30ed\u30c8\u30bf\u30a4\u30d7\u3092\u958b\u767a\u3057\u307e\u3059\u3002\u3053\u306e\u6bb5\u968e\u3067\u306f\u3001\u30a8\u30f3\u30b8\u30cb\u30a2\u3001\u8a2d\u8a08\u30b3\u30f3\u30b5\u30eb\u30bf\u30f3\u30c8\u3001\u30c1\u30fc\u30e0\u30e1\u30f3\u30d0\u30fc\u3068\u306e\u30d6\u30ec\u30fc\u30f3\u30b9\u30c8\u30fc\u30df\u30f3\u30b0\u3092\u7e70\u308a\u8fd4\u3057\u3001\u30b7\u30df\u30e5\u30ec\u30fc\u30b7\u30e7\u30f3\u3084\u30b3\u30f3\u30d4\u30e5\u30fc\u30bf\u652f\u63f4\u8a2d\u8a08\u306b\u3088\u308b3D\u30d7\u30ed\u30c8\u30bf\u30a4\u30d7\u3092\u4f5c\u6210\u3057\u3001\u305d\u308c\u3089\u306e\u30d7\u30ed\u30c8\u30bf\u30a4\u30d7\u3092\u30c6\u30b9\u30c8\u3057\u3066\u6982\u5ff5\u5b9f\u8a3c\u3092\u884c\u3044\u307e\u3059\u3002\u307e\u305f\u3001FDA\u306e\u30ac\u30a4\u30c0\u30f3\u30b9\u6587\u66f8\u3092\u898b\u3066\u3001\u81ea\u793e\u306e\u30c7\u30d0\u30a4\u30b9\u306b\u95a2\u9023\u3059\u308b\u91cd\u8981\u306a\u6a5f\u80fd\u30c6\u30b9\u30c8\u3092\u898b\u3064\u3051\u51fa\u3057\u3001\u30c7\u30d0\u30a4\u30b9\u306e\u7406\u60f3\u7684\u306a\u30c7\u30b6\u30a4\u30f3\u3092\u6700\u7d42\u7684\u306b\u6c7a\u5b9a\u3059\u308b\u305f\u3081\u306e\u5224\u65ad\u6750\u6599\u3068\u3057\u3066\u4f7f\u7528\u3057\u59cb\u3081\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002\u307e\u3060\u8cc7\u91d1\u7e70\u308a\u306b\u82e6\u52b4\u3057\u3066\u3044\u308b\u30b9\u30bf\u30fc\u30c8\u30a2\u30c3\u30d7\u4f01\u696d\u306b\u3068\u3063\u3066\u3001\u30ac\u30a4\u30c0\u30f3\u30b9\u6587\u66f8\u306b\u5f93\u3063\u3066\u3059\u3079\u3066\u306e\u8a66\u9a13\u3092\u5b9f\u65bd\u3059\u308b\u3053\u3068\u306f\u30b3\u30b9\u30c8\u7684\u306b\u96e3\u3057\u3044\u306e\u3067\u3001\u3080\u3057\u308d\u6700\u3082\u95a2\u9023\u6027\u306e\u9ad8\u3044\u8a66\u9a13\u30921\u3064\u304b2\u3064\u9078\u3073\u3001\u8a2d\u8a08\u306e\u6700\u9069\u5316\u306b\u4f7f\u7528\u3059\u308b\u3053\u3068\u3092\u304a\u52e7\u3081\u3057\u307e\u3059\u3002\u533b\u7642\u6a5f\u5668\u306e\u30b3\u30f3\u30bb\u30d7\u30c8\u3068\u30c7\u30b6\u30a4\u30f3\u304c\u6700\u9069\u5316\u3055\u308c\u305f\u3089\u3001\u898f\u5236\u5f53\u5c40\u306e\u627f\u8a8d\u3068\u5546\u696d\u5316\u306b\u5411\u3051\u3066\u9032\u3080\u3053\u3068\u304c\u3067\u304d\u307e\u3059\u3002  \u3053\u3053\u3067\u6ce8\u76ee\u3059\u3079\u304d\u306f\u3001\u7c73\u56fdFDA\u306e\u30af\u30ea\u30c6\u30a3\u30ab\u30eb\u30fb\u30d1\u30b9\u30fb\u30a4\u30cb\u30b7\u30a2\u30c1\u30d6\u306f\u3001\u3088\u308a\u512a\u308c\u305f\u6bd2\u6027\u5b66\u3001\u30d0\u30a4\u30aa\u30de\u30fc\u30ab\u30fc\u3001\u81e8\u5e8a\u8a66\u9a13\u306e\u6539\u5584\u3001\u500b\u5225\u5316\u533b\u7642\u3068\u3044\u3063\u305f\u958b\u767a\u306e\u79d1\u5b66\u306b\u7126\u70b9\u3092\u5f53\u3066\u3066\u3044\u307e\u3057\u305f\u304c\u3001\u3053\u306e\u30a4\u30cb\u30b7\u30a2\u30c1\u30d6\u306f\u30011990\u5e74\u4ee3\u306e\u30ea\u30a8\u30f3\u30b8\u30cb\u30a2\u30ea\u30f3\u30b0\u30fb\u30a4\u30cb\u30b7\u30a2\u30c1\u30d6\u3084\u6a5f\u5668\u4f7f\u7528\u6599\u306b\u4f34\u3046\u6cd5\u6539\u6b63\u3092\u542b\u3080\u4ed6\u306e\u30a4\u30cb\u30b7\u30a2\u30c1\u30d6\u3068\u540c\u69d8\u306b\u3001\u627f\u8a8d\u30d7\u30ed\u30bb\u30b9\u81ea\u4f53\u306e\u898f\u5236\u69cb\u9020\u3084\u3001\u898f\u5236\u69cb\u9020\u304c\u958b\u767a\u306e\u79d1\u5b66\u306b\u304a\u3051\u308b\u9078\u629e\u3092\u3069\u306e\u3088\u3046\u306b\u6c7a\u5b9a\u3059\u308b\u304b\u306b\u3064\u3044\u3066\u306f\u691c\u8a0e\u3057\u3066\u3044\u307e\u305b\u3093\u3067\u3057\u305f\u3002<\/span><\/p>\n<p><img decoding=\"async\" loading=\"lazy\" class=\"alignnone wp-image-8872 size-large\" src=\"https:\/\/www.kolabtree.com\/blog\/wp-content\/uploads\/2021\/03\/medical-device-development-1-1024x544.png\" alt=\"\" width=\"702\" height=\"373\" srcset=\"https:\/\/www.kolabtree.com\/blog\/wp-content\/uploads\/2021\/03\/medical-device-development-1-1024x544.png 1024w, https:\/\/www.kolabtree.com\/blog\/wp-content\/uploads\/2021\/03\/medical-device-development-1-300x159.png 300w, https:\/\/www.kolabtree.com\/blog\/wp-content\/uploads\/2021\/03\/medical-device-development-1-768x408.png 768w, https:\/\/www.kolabtree.com\/blog\/wp-content\/uploads\/2021\/03\/medical-device-development-1-1080x574.png 1080w, https:\/\/www.kolabtree.com\/blog\/wp-content\/uploads\/2021\/03\/medical-device-development-1.png 1331w\" sizes=\"(max-width: 702px) 100vw, 702px\" \/><\/p>\n<p><b>\u56f31:<\/b><span style=\"font-weight: 400;\"> \u533b\u7642\u6a5f\u5668\u306e\u958b\u767a\u306f\u3001\u5168\u4f53\u7684\u306a\u30d7\u30ed\u30bb\u30b9\u3067\u3059\u3002\u3053\u308c\u306f\u30d5\u30a7\u30fc\u30ba\u3054\u3068\u306e\u30a2\u30d7\u30ed\u30fc\u30c1\u3067\u3042\u308b\u30d7\u30ed\u30bb\u30b9\u306e\u7c21\u6613\u7248\u3067\u3059\u304c\u3001\u7406\u60f3\u7684\u306b\u306f\u3001\u533b\u7642\u6a5f\u5668\u958b\u767a\u306e\u521d\u671f\u6bb5\u968e\u3067\u3001\u3053\u306e\u30d7\u30ed\u30bb\u30b9\u5168\u4f53\u306e\u3059\u3079\u3066\u306e\u30b9\u30c6\u30c3\u30d7\u3092\u30de\u30c3\u30d4\u30f3\u30b0\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\uff08Adapted from<\/span><b> [1,2]<\/b><span style=\"font-weight: 400;\">).<\/span><\/p>\n<p><strong>\u533b\u7642\u6a5f\u5668\u306e\u958b\u767a\u306b\u304a\u56f0\u308a\u3067\u3059\u304b\uff1f\u898b\u308b <a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/medical-device\/?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=MDDevTips\">\u533b\u7642\u6a5f\u5668\u30b3\u30f3\u30b5\u30eb\u30bf\u30f3\u30c8<\/a> \u3092Kolabtree\u306b\u63b2\u8f09\u3057\u307e\u3057\u305f\u3002\u5c02\u9580\u5bb6\u3078\u306e\u554f\u3044\u5408\u308f\u305b\u3084\u30d7\u30ed\u30b8\u30a7\u30af\u30c8\u306e\u6295\u7a3f\u306f\u7121\u6599\u3067\u3059\u3002\u00a0<\/strong><\/p>\n<p>\u3082\u8aad\u3093\u3067\u304f\u3060\u3055\u3044\u3002 <a href=\"https:\/\/www.kolabtree.com\/blog\/how-much-does-it-cost-to-hire-a-medical-device-consultant\/?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=MDDevTips\"><strong>\u533b\u7642\u6a5f\u5668\u306e\u30b3\u30f3\u30b5\u30eb\u30bf\u30f3\u30c8\u3092\u96c7\u3046\u306b\u306f\u3001\u3069\u306e\u304f\u3089\u3044\u306e\u8cbb\u7528\u304c\u304b\u304b\u308a\u307e\u3059\u304b\uff1f\u00a0<\/strong><\/a><\/p>\n<p><strong>\u30ea\u30d5\u30a1\u30ec\u30f3\u30b9<\/strong><\/p>\n<ol>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><a href=\"https:\/\/www.welldoc.com\/health-plans\/\"><span style=\"font-weight: 400;\">https:\/\/www.welldoc.com\/health-plans\/<\/span><\/a><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><a href=\"https:\/\/ec.europa.eu\/docsroom\/documents\/10337\/attachments\/1\/translations\"><span style=\"font-weight: 400;\">https:\/\/ec.europa.eu\/docsroom\/documents\/10337\/attachments\/1\/translations<\/span><\/a><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">FDA, 2005, Total Product Lifecycle, FDA-CDRH Presentation by CDRH Director Dr David Feigal, http:\/\/www.fda.gov\/cdrh\/strategic\/presentations\/ tplc.html.<\/span><\/li>\n<\/ol>\n<p><strong>\u3053\u306e\u30b7\u30ea\u30fc\u30ba\u306e\u5168\u8a18\u4e8b<br \/>\n<\/strong><a href=\"https:\/\/www.kolabtree.com\/blog\/medical-device-development-and-design-a-definitive-guide\/?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=MDDevTips\">\u533b\u7642\u6a5f\u5668\u306e\u958b\u767a\u30fb\u8a2d\u8a08\u306e\u305f\u3081\u306e\u6c7a\u5b9a\u7248\u30ac\u30a4\u30c9<\/a><br \/>\n<a href=\"https:\/\/www.kolabtree.com\/blog\/medical-device-development-3-tips-for-success\/?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=MDDevTips\">\u533b\u7642\u6a5f\u5668\u958b\u767a\u3002\u6210\u529f\u306e\u305f\u3081\u306e3\u3064\u306e\u30d2\u30f3\u30c8<\/a><br \/>\n<a href=\"https:\/\/www.kolabtree.com\/blog\/medical-device-design-the-essential-step-by-step-guide\/?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=MDDevTips\">\u533b\u7642\u6a5f\u5668\u306e\u30c7\u30b6\u30a4\u30f3\u3002The Essential, Step-by-Step Guide<\/a><br \/>\n<a href=\"https:\/\/www.kolabtree.com\/blog\/medical-device-commercialization-9-steps-from-sketch-to-launch\/?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=MDDevTips\">\u533b\u7642\u6a5f\u5668\u306e\u5546\u54c1\u5316\uff1a\u30b9\u30b1\u30c3\u30c1\u304b\u3089\u767a\u58f2\u307e\u3067\u306e9\u3064\u306e\u30b9\u30c6\u30c3\u30d7<\/a><br \/>\n<a href=\"https:\/\/www.biotechnologynewsmagazine.infomeddnews.com\/how-to-overcome-medical-device-commercialization-challenges-best-practices\/\">\u533b\u7642\u6a5f\u5668\u306e\u5546\u696d\u5316\u306e\u8ab2\u984c\u3092\u3069\u3046\u514b\u670d\u3059\u308b\u304b<\/a><br \/>\n<a href=\"https:\/\/www.kolabtree.com\/blog\/medical-device-launch-key-steps-when-taking-product-to-market\/?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=MDDevTips\">\u533b\u7642\u6a5f\u5668\u306e\u30ed\u30fc\u30f3\u30c1\u88fd\u54c1\u3092\u5e02\u5834\u306b\u6295\u5165\u3059\u308b\u305f\u3081\u306e\u91cd\u8981\u306a\u30b9\u30c6\u30c3\u30d7<\/a><br \/>\n<a href=\"https:\/\/www.kolabtree.com\/blog\/a-comprehensive-guide-to-medical-device-post-market-surveillance\/?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=MDDevTips\">\u533b\u7642\u6a5f\u5668\u306e\u5e02\u8ca9\u5f8c\u8abf\u67fb\u3002\u5305\u62ec\u7684\u306a\u30ac\u30a4\u30c9<\/a><\/p>\n<p>&nbsp;<\/p>","protected":false},"excerpt":{"rendered":"<p>Shrinidh Joshi, medtech consultant on Kolabtree, provides 3 tips for successful medical device development that will help take your product to market quickly.\u00a0 When you have an idea (either on a back of a \u2018napkin\u2019 or still brainstorming) for the development of a new medical device, it is very much likely that your idea will be disruptive like \u2018no other\u2019 and it will have a significant impact on the healthcare or it is just another way to look at the things. There is also a possibility that your product will help to resolve some of the current challenges for example \u2018form factor\u2019 and bulkiness of the spirometer device was a<\/p>\n<div class=\"read-more\"><a href=\"https:\/\/www.kolabtree.com\/blog\/ja\/medical-device-development-3-tips-for-success\/\" title=\"\u7d9a\u304d\u3092\u8aad\u3080\">\u7d9a\u304d\u3092\u8aad\u3080<\/a><\/div>","protected":false},"author":12,"featured_media":8890,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":[],"categories":[540],"tags":[],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v20.1 (Yoast SEO v20.1) - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Medical Device Development: 3 Tips for Success - The Kolabtree Blog<\/title>\n<meta name=\"description\" content=\"Tips from an expert on medical device development and design: from the ideation to the discovery phase.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.kolabtree.com\/blog\/ja\/medical-device-development-3-tips-for-success\/\" \/>\n<meta property=\"og:locale\" content=\"ja_JP\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Medical Device Development: 3 Tips for Success\" \/>\n<meta property=\"og:description\" content=\"Tips from an expert on medical device development and design: from the ideation to the discovery phase.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.kolabtree.com\/blog\/ja\/medical-device-development-3-tips-for-success\/\" \/>\n<meta property=\"og:site_name\" content=\"The Kolabtree Blog\" \/>\n<meta property=\"article:publisher\" content=\"https:\/\/www.facebook.com\/kolabtree\" \/>\n<meta property=\"article:published_time\" content=\"2021-03-11T15:23:06+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2021-03-12T09:19:37+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/www.kolabtree.com\/blog\/wp-content\/uploads\/2021\/03\/medical-device-development.jpg\" \/>\n\t<meta property=\"og:image:width\" content=\"702\" \/>\n\t<meta property=\"og:image:height\" content=\"336\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/jpeg\" \/>\n<meta name=\"author\" content=\"Ramya Sriram\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:creator\" content=\"@kolabtree\" \/>\n<meta name=\"twitter:site\" content=\"@kolabtree\" \/>\n<meta name=\"twitter:label1\" content=\"\u57f7\u7b46\u8005\" \/>\n\t<meta name=\"twitter:data1\" content=\"Ramya Sriram\" \/>\n\t<meta name=\"twitter:label2\" content=\"\u63a8\u5b9a\u8aad\u307f\u53d6\u308a\u6642\u9593\" \/>\n\t<meta name=\"twitter:data2\" content=\"8\u5206\" \/>\n<!-- \/ Yoast SEO Premium plugin. -->","yoast_head_json":{"title":"Medical Device Development: 3 Tips for Success - 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