{"id":8346,"date":"2020-09-25T14:32:16","date_gmt":"2020-09-25T14:32:16","guid":{"rendered":"https:\/\/www.kolabtree.com\/blog\/?p=8346"},"modified":"2021-03-12T09:21:02","modified_gmt":"2021-03-12T09:21:02","slug":"medical-device-development-and-design-a-definitive-guide","status":"publish","type":"post","link":"https:\/\/www.kolabtree.com\/blog\/ja\/medical-device-development-and-design-a-definitive-guide\/","title":{"rendered":"\u533b\u7642\u6a5f\u5668\u306e\u958b\u767a\u30fb\u8a2d\u8a08\u306e\u305f\u3081\u306e\u6c7a\u5b9a\u7248\u30ac\u30a4\u30c9"},"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-69f18bd0de29f\" 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-69f18bd0de29f\"><\/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-and-design-a-definitive-guide\/#1_What_does_usability_mean_for_medical_devices\" title=\"1.\u533b\u7642\u6a5f\u5668\u306b\u304a\u3051\u308b\u30e6\u30fc\u30b6\u30d3\u30ea\u30c6\u30a3\u3068\u306f\u4f55\u304b\uff1f\">1.\u533b\u7642\u6a5f\u5668\u306b\u304a\u3051\u308b\u30e6\u30fc\u30b6\u30d3\u30ea\u30c6\u30a3\u3068\u306f\u4f55\u304b\uff1f<\/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-and-design-a-definitive-guide\/#2_Why_are_human_factors_important_in_medical_device_design\" title=\"2.\u533b\u7642\u6a5f\u5668\u306e\u8a2d\u8a08\u306b\u304a\u3044\u3066\u30d2\u30e5\u30fc\u30de\u30f3\u30d5\u30a1\u30af\u30bf\u30fc\u304c\u91cd\u8981\u306a\u306e\u306f\u306a\u305c\u3067\u3059\u304b\uff1f\">2.\u533b\u7642\u6a5f\u5668\u306e\u8a2d\u8a08\u306b\u304a\u3044\u3066\u30d2\u30e5\u30fc\u30de\u30f3\u30d5\u30a1\u30af\u30bf\u30fc\u304c\u91cd\u8981\u306a\u306e\u306f\u306a\u305c\u3067\u3059\u304b\uff1f<\/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-and-design-a-definitive-guide\/#3_Common_errors_while_designing_a_medical_device\" title=\"3.\u533b\u7642\u6a5f\u5668\u8a2d\u8a08\u6642\u306e\u30b3\u30e2\u30f3\u30a8\u30e9\u30fc\">3.\u533b\u7642\u6a5f\u5668\u8a2d\u8a08\u6642\u306e\u30b3\u30e2\u30f3\u30a8\u30e9\u30fc<\/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-and-design-a-definitive-guide\/#4_The_biggest_mistake_you_can_make_in_medical_device_development\" title=\"4.\u533b\u7642\u6a5f\u5668\u958b\u767a\u3067\u9665\u308a\u3084\u3059\u3044\u6700\u5927\u306e\u30df\u30b9\">4.\u533b\u7642\u6a5f\u5668\u958b\u767a\u3067\u9665\u308a\u3084\u3059\u3044\u6700\u5927\u306e\u30df\u30b9<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-5\" href=\"https:\/\/www.kolabtree.com\/blog\/ja\/medical-device-development-and-design-a-definitive-guide\/#5_How_to_focus_on_delivery\" title=\"5.\u30c7\u30ea\u30d0\u30ea\u30fc\u306b\u6ce8\u529b\u3059\u308b\u65b9\u6cd5\u00a0\">5.\u30c7\u30ea\u30d0\u30ea\u30fc\u306b\u6ce8\u529b\u3059\u308b\u65b9\u6cd5\u00a0<\/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=MDDev\">\u30b7\u30e5\u30ea\u30cb\u30fc\u30c9\u30fb\u30b8\u30e7\u30b7<\/a>\u3001\u30d5\u30ea\u30fc\u30e9\u30f3\u30b9 <a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/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> \u306eKolabtree\u3067\u306f\u3001\u533b\u7642\u6a5f\u5668\u306e\u958b\u767a\u30fb\u8a2d\u8a08\u306b\u95a2\u3059\u308b\u6c7a\u5b9a\u7684\u306a\u30ac\u30a4\u30c9\u3092\u63d0\u4f9b\u3057\u3066\u304a\u308a\u3001\u30d7\u30ed\u30bb\u30b9\u3092\u5186\u6ed1\u304b\u3064\u5bb9\u6613\u306b\u3059\u308b\u305f\u3081\u306b\u7559\u610f\u3059\u3079\u304d\u70b9\u3092\u5f37\u8abf\u3057\u3066\u3044\u307e\u3059\u3002\u00a0<\/em><\/p>\n<p>\u533b\u7642\u6a5f\u5668\u958b\u767a\u306e\u65c5\u306b\u51fa\u308b\u524d\u306b\u3001\u533b\u7642\u6a5f\u5668\u306e\u958b\u767a\u306f\u9577\u304f\u3066\u8907\u96d1\u306a\u30d7\u30ed\u30bb\u30b9\u3067\u3042\u308b\u3053\u3068\u3092\u3054\u5b58\u77e5\u3067\u3057\u3087\u3046\u304b\u3002\u6700\u8fd1\u3067\u306f\u3001FDA\u3084EU\u306a\u3069\u3001\u4e16\u754c\u7684\u306b\u898f\u5236\u304c\u5f37\u5316\u3055\u308c\u3066\u304a\u308a\u3001\u305f\u3060\u3067\u3055\u3048\u9ad8\u984d\u306a\u958b\u767a\u8cbb\u304c\u3055\u3089\u306b\u9ad8\u984d\u306b\u306a\u3063\u3066\u3044\u307e\u3059\u3002\u958b\u767a\u30d7\u30ed\u30b8\u30a7\u30af\u30c8\u304c\u3046\u307e\u304f\u9032\u307e\u306a\u3044\u3068\u3001\u30b3\u30b9\u30c8\u3068\u6642\u9593\u304c\u8d85\u904e\u3057\u3001\u6700\u7d42\u7684\u306b\u306f\u4e2d\u6b62\u305b\u3056\u308b\u3092\u5f97\u306a\u304f\u306a\u308a\u3001\u83ab\u5927\u306a\u91d1\u92ad\u7684\u30fb\u6a5f\u4f1a\u7684\u30b3\u30b9\u30c8\u304c\u767a\u751f\u3057\u307e\u3059\u3002\u4e2d\u5c0f\u4f01\u696d\u3084\u30b9\u30bf\u30fc\u30c8\u30a2\u30c3\u30d7\u4f01\u696d\u306b\u3068\u3063\u3066\u306f\u3001\u4f1a\u793e\u5168\u4f53\u306e\u5c06\u6765\u3092\u8105\u304b\u3059\u3053\u3068\u306b\u3082\u306a\u308a\u304b\u306d\u307e\u305b\u3093\u3002\u6280\u8853\u7cfb\u306e\u30b9\u30bf\u30fc\u30c8\u30a2\u30c3\u30d7\u3067\u306f\u4e00\u822c\u7684\u306a\u30a2\u30b8\u30e3\u30a4\u30eb\u958b\u767a\u624b\u6cd5\u306f\u3001\u533b\u7642\u6a5f\u5668\u306e\u5206\u91ce\u3067\u306f\u5fc5\u305a\u3057\u3082\u6a5f\u80fd\u3057\u307e\u305b\u3093\u3002\u533b\u7642\u6a5f\u5668\u306e\u5206\u91ce\u3067\u306f\u3001\u88fd\u54c1\u3092\u5e02\u5834\u306b\u51fa\u3057\u305f\u308a\u3001\u30e6\u30fc\u30b6\u30fc\u3068\u30c6\u30b9\u30c8\u3057\u305f\u308a\u3059\u308b\u524d\u306b\u3001\u898f\u5236\u306b\u3088\u3063\u3066\u3059\u3079\u3066\u306e\u8a73\u7d30\u3084\u6587\u66f8\u304c\u5fc5\u8981\u306b\u306a\u308a\u307e\u3059\u3002<\/p>\n<blockquote><p>\u30d2\u30e5\u30fc\u30de\u30f3\u30d5\u30a1\u30af\u30bf\u30fc\u3068\u30e6\u30fc\u30b6\u30d3\u30ea\u30c6\u30a3\u306f\u975e\u5e38\u306b\u91cd\u8981\u3067\u3042\u308a\u3001\u533b\u7642\u6a5f\u5668\u958b\u767a\u306b\u4fa1\u5024\u3092\u3082\u305f\u3089\u3057\u307e\u3059\u3002COVID-19\u306e\u30d1\u30f3\u30c7\u30df\u30c3\u30af\u306e\u969b\u3001\u591a\u304f\u306e\u533b\u7642\u6a5f\u5668\u306e\u30b9\u30bf\u30fc\u30c8\u30a2\u30c3\u30d7\u4f01\u696d\u306f\u3001\u898f\u5236\u5f53\u5c40\u306b\u300c\u5b9f\u7528\u7684\u306a\u88fd\u54c1\u304c\u3067\u304d\u305f\u306e\u3067\u3001\u8fc5\u901f\u306a\u898f\u5236\u5f53\u5c40\u306e\u627f\u8a8d\u3092\u5f97\u308b\u3053\u3068\u304c\u3067\u304d\u306a\u3044\u3060\u308d\u3046\u304b\u300d\u3068\u3044\u3046\u5358\u7d14\u306a\u8cea\u554f\u3092\u3057\u3066\u3001\u5e02\u5834\u3078\u306e\u9032\u51fa\u3092\u6025\u3054\u3046\u3068\u3057\u3066\u3044\u307e\u3059\u3002FDA\u3092\u306f\u3058\u3081\u3068\u3059\u308b\u4e16\u754c\u4e2d\u306e\u898f\u5236\u5f53\u5c40\u306f\u3001\u3053\u306e\u524d\u4f8b\u306e\u306a\u3044\u30cb\u30fc\u30ba\u306b\u5fdc\u3048\u308b\u305f\u3081\u306b\u3001\u7dca\u6025\u4f7f\u7528\u8a31\u53ef\uff08EUA<strong>).\u3057\u304b\u3057\u3001\u591a\u304f\u306e\u5834\u5408\u3001\u898f\u5236\u8981\u4ef6\u306e\u898b\u76f4\u3057\u306b\u3088\u308a\u3001\u533b\u7642\u6a5f\u5668\u306e\u6839\u672c\u7684\u306a\u518d\u8a2d\u8a08\u304c\u5fc5\u8981\u3067\u3042\u308b\u3053\u3068\u304c\u3059\u3050\u306b\u5224\u660e\u3057\u3001\u533b\u7642\u6a5f\u5668\u30e1\u30fc\u30ab\u30fc\u306f\u958b\u767a\u306e\u591a\u304f\u3092\u3084\u308a\u76f4\u3055\u306a\u3051\u308c\u3070\u306a\u3089\u306a\u3044\u3053\u3068\u306b\u6c17\u4ed8\u304d\u307e\u3059\u3002<\/strong><\/p><\/blockquote>\n<p>\u533b\u7642\u6a5f\u5668\u898f\u5236\u306f\u3069\u306e\u56fd\u306b\u304a\u3044\u3066\u3082\u5b8c\u74a7\u3067\u306f\u3042\u308a\u307e\u305b\u3093\u304c\u3001\u307b\u3068\u3093\u3069\u306e\u898f\u5236\u5f53\u5c40\u306f\u3001\u67d4\u8edf\u6027\u304c\u3042\u308a\u3001\u6027\u80fd\u30d9\u30fc\u30b9\u3067\u3001\u89e3\u91c8\u304c\u53ef\u80fd\u306a\u898f\u5236\u3092\u610f\u56f3\u7684\u306b\u7b56\u5b9a\u3057\u3066\u3044\u307e\u3059\u3002\u3053\u306e\u3088\u3046\u306b\u3057\u3066\u3001\u898f\u5236\u306f\u6642\u3068\u3068\u3082\u306b\u9069\u5fdc\u3057\u7d9a\u3051\u3001\u5e45\u5e83\u3044\u6280\u8853\u3084\u7528\u9014\u306b\u9069\u7528\u3055\u308c\u307e\u3059\u3002\u533b\u7642\u6a5f\u5668\u306e\u30b9\u30bf\u30fc\u30c8\u30a2\u30c3\u30d7\u4f01\u696d\u3084\u4e2d\u5c0f\u4f01\u696d\u306f\u3001\u3053\u306e\u89b3\u70b9\u3092\u5341\u5206\u306b\u7406\u89e3\u3057\u305f\u4e0a\u3067\u3001\u3053\u306e\u70b9\u3092\u6709\u5229\u306b\u6d3b\u7528\u3059\u308b\u3053\u3068\u304c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class=\"ez-toc-section\" id=\"1_What_does_usability_mean_for_medical_devices\"><\/span><strong>1.\u533b\u7642\u6a5f\u5668\u306b\u304a\u3051\u308b\u30e6\u30fc\u30b6\u30d3\u30ea\u30c6\u30a3\u3068\u306f\u4f55\u304b\uff1f<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>\u30b8\u30e7\u30f3\u30ba\u30fb\u30db\u30d7\u30ad\u30f3\u30b9\u5927\u5b66\u306e\u6700\u8fd1\u306e\u7814\u7a76\u306b\u3088\u308b\u3068\u3001\u7c73\u56fd\u3067\u306f\u6bce\u5e7425\u4e07\u4eba\u4ee5\u4e0a\u306e\u4eba\u304c\u533b\u7642\u30df\u30b9\u306b\u3088\u3063\u3066\u6b7b\u4ea1\u3057\u3066\u304a\u308a\u3001\u533b\u7642\u30df\u30b9\u306f\u4e16\u754c\u3067\u6700\u3082\u6df1\u523b\u306a\u554f\u984c\u3067\u3059\u3002 <a href=\"https:\/\/www.cnbc.com\/2018\/02\/22\/medical-errors-third-leading-cause-of-death-in-america.html?__source=sharebar|email&amp;par=sharebar\">\u6b7b\u4ea1\u539f\u56e0\u306e\u7b2c3\u4f4d<\/a> \u5fc3\u81d3\u75c5\u3084\u764c\u306e\u5f8c <strong>[1]<\/strong>To err is human: Building a saferent health system <strong>[2]<\/strong>.WHO\uff08\u4e16\u754c\u4fdd\u5065\u6a5f\u95a2\uff09\u306e\u30a6\u30a7\u30d6\u30b5\u30a4\u30c8\u306b\u3088\u308b\u3068\u3001\u30e8\u30fc\u30ed\u30c3\u30d1\u306e\u533b\u7642\u30b7\u30b9\u30c6\u30e0\u306b\u3082\u540c\u69d8\u306e\u50be\u5411\u304c\u898b\u3089\u308c\u3001\u5165\u9662\u306e8\u301c12\uff05\u304c\u6709\u5bb3\u4e8b\u8c61\u3092\u4f34\u3046\u3068\u63a8\u5b9a\u3055\u308c\u3001\u6700\u5927\u3067 <a href=\"https:\/\/www.who.int\/news-room\/fact-sheets\/detail\/patient-safety\">\u60a3\u8005\u306e18\uff05\u304c<\/a> \u533b\u7642\u30df\u30b9\u306b\u3088\u308b\u554f\u984c\u3092\u7d4c\u9a13\u3057\u305f\u3053\u3068\u304c\u3042\u308b\u3068\u7b54\u3048\u305f\u4eba <strong>[3]<\/strong>.\u82f1\u56fd\u3067\u306f\u3001\u75c5\u9662\u611f\u67d3\u3078\u306e\u4ecb\u5165\u306b\u304b\u304b\u308b\u30b3\u30b9\u30c8\u3060\u3051\u3067\u3082\u5e74\u9593200\u4e07\u30dd\u30f3\u30c9\u3068\u63a8\u5b9a\u3055\u308c\u3066\u3044\u307e\u3059\u3002\u904e\u53bb20\u5e74\u9593\u306b\u767a\u751f\u3057\u305f\u6709\u5bb3\u4e8b\u8c61\u3067\u306f\u3001\u533b\u7642\u6a5f\u5668\u306e\u30e6\u30fc\u30b6\u30fc\u30a4\u30f3\u30bf\u30fc\u30d5\u30a7\u30fc\u30b9\uff08UI\uff09\u306b\u95a2\u3059\u308b\u8a2d\u8a08\u4e0a\u306e\u554f\u984c\u306b\u8d77\u56e0\u3059\u308b\u5e02\u8ca9\u5f8c\u306e\u30a4\u30d9\u30f3\u30c8\u304c\u6c17\u306b\u306a\u308b\u50be\u5411\u306b\u3042\u308a\u307e\u3059\u3002\u8f38\u6db2\u30dd\u30f3\u30d7\u3001\u81ea\u52d5\u96fb\u5b50\u9664\u7d30\u52d5\u5668\u3001\u4eba\u5de5\u547c\u5438\u5668\u3001\u304a\u3088\u3073\u85ac\u5264\u81ea\u52d5\u6ce8\u5165\u5668\u3001\u5438\u5165\u5668\u3001\u30b9\u30da\u30fc\u30b5\u30fc\u88c5\u7f6e\u306a\u3069\u306e\u7d44\u307f\u5408\u308f\u305b\u88fd\u54c1\u306f\u3001\u4f7f\u7528\u306b\u95a2\u9023\u3057\u305f\u8a2d\u8a08\u4e0a\u306e\u554f\u984c\u306b\u3088\u308a\u3001\u904e\u91cf\u6295\u4e0e\u3001\u4e0d\u9069\u5207\u306a\u6cbb\u7642\u306e\u63d0\u4f9b\u3001\u8aa4\u3063\u305f\u8a3a\u65ad\u3001ER\u8a2a\u554f\u3001\u304a\u3088\u3073\u6cbb\u7642\u306e\u5371\u967a\u306a\u9045\u5ef6\u304c\u767a\u751f\u3057\u305f\u7d4c\u7def\u304c\u3042\u308a\u307e\u3059\u3002\u898f\u5236\u6a5f\u95a2\u306b\u3088\u308b\u30a8\u30e9\u30fc\u524a\u6e1b\u306e\u305f\u3081\u306e\u4f53\u7cfb\u7684\u306a\u30d7\u30ed\u30bb\u30b9\u306e\u4e00\u74b0\u3068\u3057\u3066\u3001\u7c73\u56fd\u304a\u3088\u3073EU\u306e\u533b\u7642\u6a5f\u5668\u4f01\u696d\u306f\u3001\u30d2\u30e5\u30fc\u30de\u30f3\u30d5\u30a1\u30af\u30bf\u30fc\u304a\u3088\u3073\u30e6\u30fc\u30b6\u30d3\u30ea\u30c6\u30a3\u30a8\u30f3\u30b8\u30cb\u30a2\u30ea\u30f3\u30b0\u306e\u5206\u91ce\u3092\u5c0e\u5165\u3057\u307e\u3057\u305f\u3002\u30e6\u30fc\u30b6\u30d3\u30ea\u30c6\u30a3\u306e\u7d4c\u9a13\u306f\u300160\u5e74\u4ee5\u4e0a\u306b\u308f\u305f\u3063\u3066\u81ea\u52d5\u8eca\u3001\u822a\u7a7a\u5b87\u5b99\u3001\u901a\u4fe1\u696d\u754c\u3067\u9069\u7528\u3055\u308c\u3066\u304d\u307e\u3057\u305f\u304c\u3001\u533b\u7642\u696d\u754c\u3067\u9069\u7528\u3055\u308c\u308b\u3088\u3046\u306b\u306a\u3063\u305f\u306e\u306f\u3054\u304f\u6700\u8fd1\u306e\u3053\u3068\u3067\u3059\u3002\u30d2\u30e5\u30fc\u30de\u30f3\u30d5\u30a1\u30af\u30bf\u30fc\u3068\u30e6\u30fc\u30b6\u30d3\u30ea\u30c6\u30a3\u306f\u3001\u4eba\u9593\u306e\u80fd\u529b\u3068\u9650\u754c\u306b\u95a2\u3059\u308b\u77e5\u8b58\u3092\u9069\u7528\u3057\u3001\u30e6\u30fc\u30b6\u30fc\u3068\u30b7\u30b9\u30c6\u30e0\u306e\u30d1\u30d5\u30a9\u30fc\u30de\u30f3\u30b9\u306b\u95a2\u3059\u308b\u30c6\u30b9\u30c8\u3068\u8a55\u4fa1\u3092\u884c\u3046\u3053\u3068\u3067\u3001\u4eba\u9593\u306e\u64cd\u4f5c\u8005\u3001\u307e\u305f\u306f\u30b7\u30b9\u30c6\u30e0\u3092\u4f7f\u7528\u3059\u308b\u30e6\u30fc\u30b6\u30fc\u3068\u305d\u306eUI\u306e\u76f8\u4e57\u52b9\u679c\u306b\u7126\u70b9\u3092\u5f53\u3066\u307e\u3059\u3002\u307e\u305f\u3001\u30d2\u30e5\u30fc\u30de\u30f3\u30d5\u30a1\u30af\u30bf\u30fc\u306f\u3001\u30c7\u30a3\u30b9\u30d7\u30ec\u30a4\u3001\u30b3\u30f3\u30c8\u30ed\u30fc\u30eb\u3001\u305d\u306e\u4ed6\u306eUI\u306e\u8a2d\u8a08\u306b\u304a\u3044\u3066\u3001\u65e2\u77e5\u306e\u539f\u5247\u3068\u30d9\u30b9\u30c8\u30d7\u30e9\u30af\u30c6\u30a3\u30b9\u3092\u9069\u7528\u3057\u3001\u4f7f\u7528\u3092\u6700\u9069\u5316\u3057\u3001\u4f7f\u7528\u306b\u95a2\u9023\u3059\u308b\u30ea\u30b9\u30af\u3092\u6392\u9664\u307e\u305f\u306f\u5236\u9650\u3057\u307e\u3059\u3002 <strong>[4]<\/strong>.<\/p>\n<p>\u30e6\u30fc\u30b6\u30d3\u30ea\u30c6\u30a3\u306f\u3001\u533b\u7642\u6a5f\u5668\u306e\u88fd\u54c1\u8981\u6c42\u4ed5\u69d8\u66f8\uff08PRS\uff09\u306b\u6cbf\u3063\u305f\u3082\u306e\u3067\u306a\u3051\u308c\u3070\u306a\u308a\u307e\u305b\u3093\u3002PRS\u306f\u3001\u88fd\u54c1\u306e\u3059\u3079\u3066\u3092\u5b9a\u7fa9\u3057\u307e\u3059\u3002\u958b\u767a\u306e\u6700\u521d\u304b\u3089\u6700\u5f8c\u307e\u3067\u95a2\u308f\u308b\u305f\u3081\u3001\u304a\u305d\u3089\u304f\u958b\u767a\u5168\u4f53\u3067\u6700\u3082\u91cd\u8981\u306a\u30c9\u30ad\u30e5\u30e1\u30f3\u30c8\u3068\u306a\u308a\u307e\u3059\u3002\u898f\u5236\u306e\u89b3\u70b9\u304b\u3089\u3082\u975e\u5e38\u306b\u91cd\u8981\u3067\u3059\u304c\u3001\u5546\u696d\u7684\u30fb\u5b9f\u7528\u7684\u306a\u89b3\u70b9\u304b\u3089\u3082\u6b20\u304b\u305b\u307e\u305b\u3093\u3002\u88fd\u54c1\u4ed5\u69d8\u304c\u30e6\u30fc\u30b6\u30d3\u30ea\u30c6\u30a3\u3092\u5ff5\u982d\u306b\u7f6e\u3044\u3066\u5b9a\u7fa9\u3055\u308c\u3066\u3044\u306a\u3044\u5834\u5408\u3001\u30d7\u30ed\u30b8\u30a7\u30af\u30c8\u9045\u5ef6\u306e\u6700\u5927\u306e\u539f\u56e0\u3068\u306a\u308b\u53ef\u80fd\u6027\u304c\u3042\u308a\u307e\u3059\uff08\u30c1\u30fc\u30e0\u5185\u306e\u554f\u984c\u3082\u540c\u69d8\u3067\u3059\uff09\u3002\u305d\u306e\u305f\u3081\u3001\u3053\u306e\u6587\u66f8\u3092\u6b63\u3057\u304f\u7406\u89e3\u3057\u3001\u30d3\u30b8\u30cd\u30b9\u5168\u4f53\u3067\u5408\u610f\u3092\u5f97\u3066\u3001\u305d\u308c\u3092\u7dad\u6301\u3059\u308b\u3053\u3068\u304c\u3001\u6210\u529f\u3059\u308b\u65b0\u3057\u3044\u533b\u7642\u6a5f\u5668\u306e\u8fc5\u901f\u306a\u958b\u767a\u3092\u53ef\u80fd\u306b\u3059\u308b\u305f\u3081\u306b\u91cd\u8981\u3067\u3059\u3002\u30e6\u30fc\u30b6\u30d3\u30ea\u30c6\u30a3\u30fb\u30b9\u30bf\u30f3\u30c0\u30fc\u30c9\u3002 <a href=\"https:\/\/www.iso.org\/standard\/63179.html\">IEC 62366<\/a>\u307e\u305f\u3001\u300c\u30e6\u30fc\u30b6\u30d3\u30ea\u30c6\u30a3\u300d\u3068\u306f\u3001\u300c\u6709\u52b9\u6027\u3001\u52b9\u7387\u6027\u3001\u304a\u3088\u3073\u30e6\u30fc\u30b6\u306e\u6e80\u8db3\u5ea6\u3092\u78ba\u7acb\u3059\u308bUI\u306e\u7279\u6027\u300d\u3068\u5b9a\u7fa9\u3055\u308c\u3066\u3044\u307e\u3059\u3002\u305d\u306e\u305f\u3081\u3001\u30e6\u30fc\u30b6\u306e\u30df\u30b9\u3084\u4f7f\u7528\u4e0a\u306e\u30ea\u30b9\u30af\u3092\u6700\u5c0f\u9650\u306b\u6291\u3048\u308b\u305f\u3081\u306b\u306f\u3001\u30e6\u30fc\u30b6\u30d3\u30ea\u30c6\u30a3\u30a8\u30f3\u30b8\u30cb\u30a2\u30ea\u30f3\u30b0\uff08UE\uff09\u30d7\u30ed\u30bb\u30b9\u3092\u7528\u3044\u3066\u3001\u5408\u7406\u7684\u306a\u30e6\u30fc\u30b6\u30d3\u30ea\u30c6\u30a3\u3092\u5b9f\u73fe\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002 <a href=\"https:\/\/www.iso.org\/standard\/62780.html\">(IEC 62366:2007\u304a\u3088\u3073A1:2014<\/a>).<\/p>\n<p>FDA\u306b\u3088\u308b\u3068\u3001\u30d2\u30e5\u30fc\u30de\u30f3\u30d5\u30a1\u30af\u30bf\u30fc\/\u30e6\u30fc\u30b6\u30d3\u30ea\u30c6\u30a3\u30a8\u30f3\u30b8\u30cb\u30a2\u30ea\u30f3\u30b0\u3092\u533b\u7642\u6a5f\u5668\u306b\u9069\u7528\u3059\u308b\u3053\u3068\u3067\u5f97\u3089\u308c\u308b\u5177\u4f53\u7684\u306a\u6709\u76ca\u306a\u6210\u679c\u306f\u4ee5\u4e0b\u306e\u901a\u308a\u3067\u3059\u3002<\/p>\n<ul>\n<li>\u3088\u308a\u4f7f\u3044\u3084\u3059\u3044\u30c7\u30d0\u30a4\u30b9<\/li>\n<li>\u6a5f\u5668\u306e\u90e8\u54c1\u3084\u4ed8\u5c5e\u54c1\uff08\u96fb\u6e90\u30b3\u30fc\u30c9\u3001\u30ea\u30fc\u30c9\u7dda\u3001\u30c1\u30e5\u30fc\u30d6\u3001\u30ab\u30fc\u30c8\u30ea\u30c3\u30b8\u306a\u3069\uff09\u3092\u3088\u308a\u5b89\u5168\u306b\u63a5\u7d9a\u3059\u308b\u3053\u3068\u304c\u3067\u304d\u308b\u3002<\/li>\n<li>\u3088\u308a\u898b\u3084\u3059\u3044\u64cd\u4f5c\u7cfb\u3068\u8868\u793a\u7cfb\u3002<\/li>\n<li>\u6a5f\u5668\u306e\u72b6\u614b\u3084\u64cd\u4f5c\u65b9\u6cd5\u306b\u95a2\u3059\u308b\u30e6\u30fc\u30b6\u30fc\u306e\u7406\u89e3\u304c\u6df1\u307e\u308b\u3002<\/li>\n<li>\u60a3\u8005\u3055\u3093\u306e\u73fe\u5728\u306e\u75c5\u72b6\u306b\u5bfe\u3059\u308b\u30e6\u30fc\u30b6\u30fc\u306e\u7406\u89e3\u304c\u6df1\u307e\u308b\u3002<\/li>\n<li>\u3088\u308a\u52b9\u679c\u7684\u306a\u30a2\u30e9\u30fc\u30e0\u4fe1\u53f7<\/li>\n<li>\u30c7\u30d0\u30a4\u30b9\u306e\u30e1\u30f3\u30c6\u30ca\u30f3\u30b9\u3084\u4fee\u7406\u304c\u5bb9\u6613\u306b\u306a\u308a\u307e\u3059\u3002<\/li>\n<li>\u30e6\u30fc\u30b6\u30fc\u306e\u30de\u30cb\u30e5\u30a2\u30eb\u3078\u306e\u4f9d\u5b58\u5ea6\u3092\u4f4e\u6e1b\u3002<\/li>\n<li>\u30e6\u30fc\u30b6\u30fc\u30c8\u30ec\u30fc\u30cb\u30f3\u30b0\u3084\u518d\u6559\u80b2\u306e\u5fc5\u8981\u6027\u304c\u6e1b\u5c11<\/li>\n<li>\u4f7f\u7528\u30df\u30b9\u306e\u30ea\u30b9\u30af\u3092\u4f4e\u6e1b\u3002<\/li>\n<li>\u6709\u5bb3\u4e8b\u8c61\u306e\u30ea\u30b9\u30af\u3092\u4f4e\u6e1b\u3057\u3001\u304b\u3064<\/li>\n<li>\u88fd\u54c1\u30ea\u30b3\u30fc\u30eb\u306e\u30ea\u30b9\u30af\u3092\u4f4e\u6e1b\u3002<\/li>\n<\/ul>\n<p>\u306a\u304a\u3001\u30e6\u30fc\u30b6\u30d3\u30ea\u30c6\u30a3\u898f\u683c\u3067\u3042\u308bEN 62366:2008\u304a\u3088\u3073NF EN 62366-1:2015\u3067\u306f\u3001\u30e6\u30fc\u30b6\u30d3\u30ea\u30c6\u30a3\u30a8\u30f3\u30b8\u30cb\u30a2\u30ea\u30f3\u30b0\u3068\u30d2\u30e5\u30fc\u30de\u30f3\u30d5\u30a1\u30af\u30bf\u30fc\u30a8\u30f3\u30b8\u30cb\u30a2\u30ea\u30f3\u30b0\u3068\u3044\u3046\u8a00\u8449\u304c\u540c\u7fa9\u306b\u6271\u308f\u308c\u3066\u3044\u307e\u3059\u3002 <strong>[5]<\/strong>\u307e\u305f\u3001\u7c73\u56fdFDA\u306e \"Introduction to Human Factors in Medical Devices \"\u306b\u3088\u308b\u3068\u3001\"Human Factor Engineering\"\u3001\"Usability Engineering\"\u3001\"Ergonomics \"\u3068\u3044\u3046\u8a00\u8449\u306f\u3001\u4f7f\u3044\u52dd\u624b\u306e\u826f\u3044\u6a5f\u5668\u3092\u5b9f\u73fe\u3059\u308b\u305f\u3081\u306e\u30d7\u30ed\u30bb\u30b9\u3068\u3057\u3066\u3001\u540c\u3058\u610f\u5473\u3067\u4f7f\u308f\u308c\u3066\u3044\u307e\u3059\u3002<\/p>\n<p>\u3057\u304b\u3057\u3001\u30d2\u30e5\u30fc\u30de\u30f3\u30d5\u30a1\u30af\u30bf\u30fc\u3068\u306f\u3001\u300c\u30e6\u30fc\u30b6\u30fc\u96c6\u56e3\u306e\u80fd\u529b\u306b\u9069\u5408\u3057\u305f\u30cf\u30fc\u30c9\u30a6\u30a7\u30a2\u304a\u3088\u3073\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u306e\u8a2d\u8a08\u306b\u3088\u308a\u3001\u6a5f\u5668\u306e\u4f7f\u7528\u306b\u304a\u3051\u308b\u4eba\u9593\u306e\u30d1\u30d5\u30a9\u30fc\u30de\u30f3\u30b9\u3092\u5411\u4e0a\u3055\u305b\u3088\u3046\u3068\u3059\u308b\u5b66\u554f\u300d\u3068\u5b9a\u7fa9\u3055\u308c\u3066\u3044\u308b\uff08US FDA, An Introduction to Human Factors in Medical Devices, Dec. 1996\uff09\u3002 <strong>[6]<\/strong>.<\/p>\n<p>\u4e00\u8a00\u3067\u8a00\u3048\u3070\u3001\u88fd\u54c1\u958b\u767a\u306b\u306f\u3042\u308b\u7a0b\u5ea6\u306e\u59a5\u5354\u304c\u5fc5\u8981\u306a\u5834\u5408\u304c\u3042\u308a\u307e\u3059\u3002\u53ef\u80fd\u306a\u9650\u308a\u6210\u529f\u3057\u305f\u88fd\u54c1\u3092\u4f5c\u308b\u305f\u3081\u306b\u306f\u3001\u30e6\u30fc\u30b6\u30d3\u30ea\u30c6\u30a3\u3001\u3064\u307e\u308a\u300c\u7406\u60f3\u7684\u306a\u30e6\u30fc\u30b6\u30fc\u4f53\u9a13\u300d\u3092\u5b9a\u7fa9\u3059\u308b\u3053\u3068\u304c\u4e0d\u53ef\u6b20\u3067\u3059\u3002\u3057\u304b\u3057\u3001\u5546\u696d\u7684\u307e\u305f\u306f\u6280\u8853\u7684\u306a\u5236\u7d04\u306e\u305f\u3081\u306b\u3001\u7406\u60f3\u7684\u306a\u30e6\u30fc\u30b6\u30fc\u4f53\u9a13\u3092\u5b9f\u73fe\u3067\u304d\u306a\u3044\u5834\u5408\u304c\u3042\u308a\u307e\u3059\u3002\u3057\u304b\u3057\u3001\u7406\u60f3\u3092\u5b9a\u7fa9\u3059\u308b\u3053\u3068\u3067\u3001\u533b\u7642\u6a5f\u5668\u306e\u30b9\u30bf\u30fc\u30c8\u30a2\u30c3\u30d7\u306f\u3001\u30e6\u30fc\u30b6\u30fc\u4f53\u9a13\u306b\u60aa\u5f71\u97ff\u3092\u4e0e\u3048\u308b\u8981\u7d20\u3092\u7406\u89e3\u3057\u3001\u88fd\u9020\u30d7\u30ed\u30bb\u30b9\u3001\u6280\u8853\u3001\u30b3\u30b9\u30c8\u3001\u304a\u3088\u3073\u898f\u5236\u306e\u5236\u7d04\u306e\u4e2d\u3067\u3001\u53ef\u80fd\u306a\u9650\u308a\u6700\u9ad8\u306e\u30e6\u30fc\u30b6\u30fc\u4f53\u9a13\u3092\u5f97\u3089\u308c\u308b\u3088\u3046\u306b\u3059\u308b\u3053\u3068\u304c\u3067\u304d\u307e\u3059\u3002\u3053\u306e\u3053\u3068\u306f\u3001\u958b\u767a\u5168\u4f53\u306b\u5f53\u3066\u306f\u307e\u308a\u3001\u5fc5\u8981\u306a\u5909\u66f4\u306b\u95a2\u3059\u308b\u6c7a\u5b9a\u306f\u3001\u5e38\u306b\u30e6\u30fc\u30b6\u30fc\u306b\u3068\u3063\u3066\u4f55\u304c\u30d9\u30b9\u30c8\u304b\u3092\u5ff5\u982d\u306b\u7f6e\u3044\u3066\u884c\u308f\u308c\u307e\u3059\u3002\u3053\u306e\u3088\u3046\u306a\u30a2\u30d7\u30ed\u30fc\u30c1\u306f\u3001\u9577\u671f\u7684\u306b\u3082\u30e1\u30ea\u30c3\u30c8\u304c\u3042\u308a\u307e\u3059\u3002\u6280\u8853\u306f\u6642\u9593\u3068\u3068\u3082\u306b\u767a\u5c55\u3057\u3001\u5b89\u4fa1\u306b\u306a\u3063\u3066\u3044\u304d\u307e\u3059\u3002\u5927\u6210\u529f\u3092\u53ce\u3081\u305f\u30c7\u30d0\u30a4\u30b9\u3067\u3082\u3001\u3088\u308a\u512a\u308c\u305f\u65b0\u3057\u3044\u30d0\u30fc\u30b8\u30e7\u30f3\u306b\u53d6\u3063\u3066\u4ee3\u308f\u3089\u308c\u307e\u3059\u3002\u6700\u826f\u306e\u88fd\u54c1\u3068\u306f\u3069\u306e\u3088\u3046\u306a\u3082\u306e\u304b\u3092\u30a4\u30e1\u30fc\u30b8\u3057\u3066\u304a\u304f\u3053\u3068\u3067\u3001\u65b0\u3057\u3044\u6280\u8853\u3084\u7d20\u6750\u3001\u30d7\u30ed\u30bb\u30b9\u304c\u3082\u305f\u3089\u3059\u30c1\u30e3\u30f3\u30b9\u3092\u898b\u6975\u3081\u3001\u5e02\u5834\u306b\u6b21\u306e\u30a4\u30ce\u30d9\u30fc\u30b7\u30e7\u30f3\u3092\u8fc5\u901f\u306b\u751f\u307f\u51fa\u3059\u3053\u3068\u304c\u3067\u304d\u307e\u3059\u3002<\/p>\n<h2><span class=\"ez-toc-section\" id=\"2_Why_are_human_factors_important_in_medical_device_design\"><\/span><strong>2.\u533b\u7642\u6a5f\u5668\u306e\u8a2d\u8a08\u306b\u304a\u3044\u3066\u30d2\u30e5\u30fc\u30de\u30f3\u30d5\u30a1\u30af\u30bf\u30fc\u304c\u91cd\u8981\u306a\u306e\u306f\u306a\u305c\u3067\u3059\u304b\uff1f<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>\u822a\u7a7a\u5b87\u5b99\u3001\u539f\u5b50\u529b\u3001\u77f3\u6cb9\u5316\u5b66\u3001\u30a8\u30cd\u30eb\u30ae\u30fc\u3001\u8f38\u9001\u306a\u3069\u306e\u5371\u967a\u6027\u306e\u9ad8\u3044\u7523\u696d\u3067\u306f\u3001\u6f5c\u5728\u7684\u306a\u30ea\u30b9\u30af\u3092\u6700\u5c0f\u9650\u306b\u6291\u3048\u308b\u305f\u3081\u306b\u4eba\u7684\u8981\u56e0\u306e\u539f\u5247\u304c\u9577\u5e74\u306b\u308f\u305f\u3063\u3066\u9069\u7528\u3055\u308c\u3066\u304d\u307e\u3057\u305f\u3002\u6700\u8fd1\u3067\u306f\u3001\u30e9\u30a4\u30d5\u30b5\u30a4\u30a8\u30f3\u30b9\u696d\u754c\u306b\u304a\u3051\u308b\u30d2\u30e5\u30fc\u30de\u30f3\u30d5\u30a1\u30af\u30bf\u30fc\u3082\u91cd\u8981\u306a\u30c6\u30fc\u30de\u3068\u3057\u3066\u8a8d\u8b58\u3055\u308c\u308b\u3088\u3046\u306b\u306a\u3063\u3066\u304d\u307e\u3057\u305f\u3002\u4eba\u9593\u5de5\u5b66\u306f\u3001\u4ee5\u524d\u306f\u8907\u96d1\u306a\u30e6\u30fc\u30b6\u30fc\u30a4\u30f3\u30bf\u30fc\u30d5\u30a7\u30fc\u30b9\u3092\u6301\u3064\u96fb\u6c17\u533b\u7642\u6a5f\u5668\u306b\u306e\u307f\u5fc5\u8981\u3068\u3055\u308c\u3066\u3044\u307e\u3057\u305f\u304c\u3001\u73fe\u5728\u3067\u306f\u4e16\u754c\u4e2d\u306e\u533b\u7642\u88fd\u54c1\u306e\u5927\u534a\u306e\u958b\u767a\u306b\u5fc5\u8981\u3068\u3055\u308c\u308b\u5fc5\u9808\u306e\u8a2d\u8a08\u9805\u76ee\u306b\u307e\u3067\u767a\u5c55\u3057\u3066\u3044\u307e\u3059\u3002<\/p>\n<p>\u591a\u304f\u306e\u533b\u7642\u6a5f\u5668\u304c\u60a3\u8005\u306e\u91cd\u8981\u306a\u30e2\u30cb\u30bf\u30ea\u30f3\u30b0\u306b\u4f7f\u7528\u3055\u308c\u3066\u3044\u307e\u3059\u304c\u3001\u60a3\u8005\u306b\u5371\u5bb3\u3092\u52a0\u3048\u308b\u3088\u3046\u306a\u4f7f\u7528\u4e0a\u306e\u30a8\u30e9\u30fc\u306f\u3001\u30e1\u30fc\u30ab\u30fc\u3068\u60a3\u8005\u306e\u53cc\u65b9\u306b\u3068\u3063\u3066\u5927\u304d\u306a\u554f\u984c\u3068\u306a\u3063\u3066\u304d\u3066\u3044\u307e\u3059\u3002\u3053\u306e\u3088\u3046\u306a\u30a8\u30e9\u30fc\u306e\u539f\u56e0\u306f\u3001\u7279\u306b\u8907\u96d1\u306a\u30e6\u30fc\u30b6\u30fc\u30b7\u30b9\u30c6\u30e0\u304c\u5b58\u5728\u3059\u308b\u5834\u5408\u3001\u6a5f\u5668\u306e\u30e6\u30fc\u30b6\u30fc\u30a4\u30f3\u30bf\u30fc\u30d5\u30a7\u30fc\u30b9\u306e\u8a2d\u8a08\u4e0d\u826f\u306b\u8d77\u56e0\u3059\u308b\u3053\u3068\u304c\u591a\u3044\u3002<\/p>\n<p>\u8f38\u6db2\u30dd\u30f3\u30d7\u3001\u4eba\u5de5\u547c\u5438\u5668\u3001\u81ea\u52d5\u96fb\u5b50\u9664\u7d30\u52d5\u5668\u3001\u304a\u3088\u3073\u85ac\u5264\u3068\u30c7\u30d0\u30a4\u30b9\u306e\u7d44\u307f\u5408\u308f\u305b\u88fd\u54c1\uff08\u81ea\u52d5\u6ce8\u5c04\u5668\u306a\u3069\uff09\u306f\u3001\u904e\u5270\u6295\u4e0e\u3084\u85ac\u5264\u6295\u4e0e\u306e\u5371\u967a\u306a\u9045\u5ef6\u3084\u56f0\u96e3\u306a\u3069\u306e\u6df1\u523b\u306a\u5371\u967a\u3092\u3082\u305f\u3089\u3059\u53ef\u80fd\u6027\u306e\u3042\u308b\u30e6\u30fc\u30b6\u30fc\u30a4\u30f3\u30bf\u30fc\u30d5\u30a7\u30fc\u30b9\u95a2\u9023\u306e\u554f\u984c\u3092\u62b1\u3048\u3066\u3044\u308b\u3068\u8a8d\u8b58\u3055\u308c\u3066\u3044\u307e\u3059\u3002\u533b\u7642\u6a5f\u5668\u306e\u6a5f\u80fd\u306f\u307e\u3059\u307e\u3059\u591a\u69d8\u5316\u3057\u3066\u304a\u308a\u3001\u65b0\u305f\u306a\u6c17\u6674\u3089\u3057\u3084\u5c02\u9580\u7684\u306a\u30c8\u30ec\u30fc\u30cb\u30f3\u30b0\u3092\u5fc5\u8981\u3068\u3059\u308b\u591a\u5fd9\u306a\u74b0\u5883\u3067\u4f7f\u7528\u3055\u308c\u308b\u983b\u5ea6\u304c\u9ad8\u304f\u306a\u3063\u3066\u3044\u307e\u3059\u3002\u60a3\u8005\u306e\u30b1\u30a2\u304c\u9032\u5316\u3057\u3001\u500b\u4eba\u5b85\u3084\u516c\u5171\u306e\u5834\u306b\u79fb\u3055\u308c\u3066\u3044\u304f\u4e2d\u3067\u3001\u60a3\u8005\u3084\u4ecb\u8b77\u8005\u3092\u542b\u3080\u3001\u3042\u307e\u308a\u719f\u7df4\u3057\u3066\u3044\u306a\u3044\u3001\u3042\u308b\u3044\u306f\u719f\u7df4\u3057\u3066\u3044\u306a\u3044\u30e6\u30fc\u30b6\u30fc\u304c\u3001\u3053\u308c\u3089\u306e\u8907\u96d1\u306a\u6a5f\u5668\u3092\u5b89\u5168\u306b\u4f7f\u7528\u3067\u304d\u308b\u3088\u3046\u306b\u3057\u306a\u3051\u308c\u3070\u306a\u308a\u307e\u305b\u3093\u3002<\/p>\n<p>UI\u306b\u8d77\u56e0\u3059\u308b\u6709\u5bb3\u4e8b\u8c61\u304c\u5897\u52a0\u3057\u3066\u3044\u308b\u3053\u3068\u304b\u3089\u3001FDA\u3067\u306f\u3001\u5e02\u5834\u524d\u627f\u8a8d\u30d7\u30ed\u30bb\u30b9\u306e\u4e00\u74b0\u3068\u3057\u3066\u3001CDRH\uff08Center for Devices and Radiological Health\uff09\u306e\u30c7\u30d0\u30a4\u30b9\u8a55\u4fa1\u5c40\uff08Office of Device Evaluation\uff09\u306b\u304a\u3044\u3066\u3001HF\/UE\uff08Human Factor\/User Experience\uff09\u30ec\u30d3\u30e5\u30fc\u3092\u5b9a\u671f\u7684\u306b\u5b9f\u65bd\u3059\u308b\u3088\u3046\u306b\u306a\u308a\u307e\u3057\u305f\u3002 <strong>[7]<\/strong>.<\/p>\n<p>\u540c\u69d8\u306b\u3001\u56fd\u969b\u7684\u306a\u898f\u5236\u5f53\u5c40\u306f\u3001\u3053\u306e\u3088\u3046\u306a\u72b6\u6cc1\u3092\u8e0f\u307e\u3048\u3066 <a href=\"https:\/\/www.iso.org\/standard\/63179.html\">IEC 62366, \u533b\u7642\u6a5f\u5668 - \u30e6\u30fc\u30b6\u30d3\u30ea\u30c6\u30a3\u30a8\u30f3\u30b8\u30cb\u30a2\u30ea\u30f3\u30b0\u306e\u533b\u7642\u6a5f\u5668\u3078\u306e\u9069\u7528<\/a>\u307e\u305f\u3001\u7c73\u56fd\u4ee5\u5916\u306e\u56fd\u3067\u306f\u3001\u627f\u8a8d\u30d7\u30ed\u30bb\u30b9\u306e\u4e00\u90e8\u3068\u3057\u3066\u4f7f\u7528\u3055\u308c\u3066\u3044\u307e\u3059\u3002FDA \u306e HF\/UE \u30ac\u30a4\u30c0\u30f3\u30b9\u304a\u3088\u3073 IEC 62366 \u306f\u3001\u6a5f\u5668\u306e\u958b\u767a\u671f\u9593\u4e2d\u306e\u6d3b\u52d5\u3092\u542b\u3080\u30d7\u30ed\u30bb\u30b9\u306e\u6982\u8981\u3092\u793a\u3057\u3066\u304a\u308a\u3001\u6700\u7d42\u7684\u306b\u306f\u3001\u6700\u7d42\u7684\u306a UI \u30c7\u30b6\u30a4\u30f3\u3092\u4f7f\u7528\u74b0\u5883\u3092\u30b7\u30df\u30e5\u30ec\u30fc\u30c8\u3057\u3066\u691c\u8a3c\u30c6\u30b9\u30c8\u3092\u884c\u3044\u307e\u3059\u3002HF\/UE\u306e\u6d3b\u52d5\u306f\u3001\u5927\u304d\u304f3\u3064\u306e\u30d5\u30a7\u30fc\u30ba\u306b\u5206\u985e\u3055\u308c\u307e\u3059\u3002<\/p>\n<ul>\n<li>\u4e88\u5099\u7684\u306a\u5206\u6790\u3002<\/li>\n<li>\u30e6\u30fc\u30b6\u30fc\u30a4\u30f3\u30bf\u30fc\u30d5\u30a7\u30fc\u30b9\u306e\u8a2d\u8a08\u30fb\u8a55\u4fa1\u3092\u884c\u3044\u307e\u3059\u3002<\/li>\n<li>\u7591\u4f3c\u4f7f\u7528\u30c6\u30b9\u30c8\uff08\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\uff09\u3002<\/li>\n<\/ul>\n<p>\u8aad\u8005\u306e\u7686\u69d8\u306b\u306f\u3001\u4ee5\u4e0b\u306e\u3088\u3046\u306a\u8ffd\u52a0\u30ea\u30bd\u30fc\u30b9\u3092\u3054\u6848\u5185\u3057\u307e\u3059\u3002 <a href=\"https:\/\/my.aami.org\/aamiresources\/previewfiles\/he75_1311_preview.pdf\">AAMI HE75:2009, \u30d2\u30e5\u30fc\u30de\u30f3\u30d5\u30a1\u30af\u30bf\u30fc\u30a8\u30f3\u30b8\u30cb\u30a2\u30ea\u30f3\u30b0 - \u533b\u7642\u6a5f\u5668\u306e\u8a2d\u8a08<\/a>\u3068\u3057\u3066\u3044\u307e\u3059\u3002 <a href=\"https:\/\/www.greenlight.guru\/glossary\/iso-14971\">ISO 14971<\/a> <strong>[8]<\/strong>.<\/p>\n<h2><span class=\"ez-toc-section\" id=\"3_Common_errors_while_designing_a_medical_device\"><\/span>3.\u533b\u7642\u6a5f\u5668\u8a2d\u8a08\u6642\u306e\u30b3\u30e2\u30f3\u30a8\u30e9\u30fc<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><span style=\"font-size: 14px;\">\u533b\u7642\u6a5f\u5668\u4f1a\u793e\u304c\u4e0d\u78ba\u5b9f\u6027\u306e\u8981\u7d20\u3092\u8003\u616e\u3057\u5fd8\u308c\u3066\u3057\u307e\u3046\u3068\u3001\u533b\u7642\u6a5f\u5668\u306e\u8a2d\u8a08\u306f\u9053\u304b\u3089\u5916\u308c\u3001\u8ff7\u8d70\u3057\u3066\u3057\u307e\u3046\u3053\u3068\u304c\u3042\u308a\u307e\u3059\u3002\u4e0d\u78ba\u5b9f\u6027\u306f\u30ea\u30b9\u30af\u306b\u3064\u306a\u304c\u308b\u305f\u3081\u3001\u30ea\u30b9\u30af\u3092\u6e1b\u3089\u3059\u305f\u3081\u306b\u306f\u3001\u30d7\u30ed\u30b8\u30a7\u30af\u30c8\u306e\u3067\u304d\u308b\u3060\u3051\u65e9\u3044\u6bb5\u968e\u3067\u4e0d\u78ba\u5b9f\u6027\u306e\u9818\u57df\u3092\u7279\u5b9a\u3057\u3001\u7b54\u3048\u3092\u5f97\u308b\u3053\u3068\u304c\u91cd\u8981\u3067\u3059\u3002\u305d\u306e\u305f\u3081\u306b\u306f\u3001\u6b21\u306e\u3088\u3046\u306a\u8cea\u554f\u3092\u3059\u308b\u306e\u304c\u6700\u3082\u52b9\u679c\u7684\u3067\u3059\u3002<\/span><\/p>\n<ol>\n<li>\u307e\u3060\u77e5\u3089\u306a\u3044\u3053\u3068\u304c\u3042\u308b\u306e\u3067\u306f\uff1f<\/li>\n<li>\u73fe\u5728\u3001\u4e00\u822c\u7684\u306b\u884c\u308f\u308c\u3066\u3044\u308b\u3053\u3068\u3068\u306f\u7570\u306a\u308b\u3053\u3068\u3092\u8a08\u753b\u3057\u3066\u3044\u307e\u3059\u3002<\/li>\n<\/ol>\n<p>\u4f8b\u3048\u3070\u3001\u6700\u8fd1\u3001\u79c1\u306e\u30af\u30e9\u30a4\u30a2\u30f3\u30c8\u304b\u3089\u3001\u547c\u5438\u5668\u7cfb\u75be\u60a3\u306e\u305f\u3081\u306e\u5438\u5165\u5668\u306e\u30c7\u30b6\u30a4\u30f3\u3092\u4f9d\u983c\u3055\u308c\u307e\u3057\u305f\u3002\u3053\u306e\u30af\u30e9\u30a4\u30a2\u30f3\u30c8\u306f\u3001\u91cd\u8981\u306a\u8cea\u554f\u3092\u3059\u308b\u3068\u3044\u3046\u6226\u7565\u306b\u3088\u3063\u3066\u3001\u76ee\u7684\u3092\u7d20\u65e9\u304f\u9054\u6210\u3059\u308b\u3053\u3068\u304c\u3067\u304d\u307e\u3057\u305f\u3002\u3053\u3053\u3067\u91cd\u8981\u306a\u306e\u306f\u3001\u30d7\u30ed\u30b8\u30a7\u30af\u30c8\u306e\u30d3\u30b8\u30e7\u30f3\u3092\u898b\u308b\u3053\u3068\u304b\u3089\u59cb\u3081\u308b\u3053\u3068\u3067\u3059\u3002\u3053\u306e\u8cea\u554f\u306e\u7b54\u3048\u3092\u30c8\u30c3\u30d7\u30ec\u30d9\u30eb\u306e\u30d3\u30b8\u30e7\u30f3\u30fb\u30b9\u30c6\u30fc\u30c8\u30e1\u30f3\u30c8\u306b\u5165\u308c\u307e\u3059\u3002\u305d\u306e\u30af\u30e9\u30a4\u30a2\u30f3\u30c8\u306e\u5834\u5408\u3001\u3053\u306e\u7c21\u5358\u306a\u30a8\u30af\u30b5\u30b5\u30a4\u30ba\u3067\u6b21\u306e\u3088\u3046\u306a\u3082\u306e\u304c\u5f97\u3089\u308c\u305f\u3002<\/p>\n<p>\u300c\u3082\u3057\u3001\u5e02\u5834\u306b\u51fa\u56de\u3063\u3066\u3044\u308b\u307b\u3068\u3093\u3069\u306e\u85ac\u306b\u9069\u5408\u3059\u308b\u5438\u5165\u5668\u3092\u4f5c\u308b\u3053\u3068\u304c\u3067\u304d\u308c\u3070\u3001\u307e\u305f\u3001\u65e2\u5b58\u306e\u304b\u3055\u3070\u308b\u30b9\u30da\u30fc\u30b5\u30fc\u88c5\u7f6e\u3092\u7f6e\u304d\u63db\u3048\u308b\u3053\u3068\u304c\u3067\u304d\u308c\u3070\u3001\u6a5f\u80fd\u3092\u5b9a\u7fa9\u3057\u3001\u4fa1\u683c\u3092\u78ba\u5b9a\u3057\u300112\u30f6\u6708\u4ee5\u5185\u306b\u7c73\u56fd\u5e02\u5834\u3067\u8ca9\u58f2\u3059\u308b\u3053\u3068\u304c\u3067\u304d\u308c\u3070\u3001\u5e74\u9593\u3067\u4f55\u53f0\u3082\u8ca9\u58f2\u3059\u308b\u3053\u3068\u304c\u3067\u304d\u308b\u3068\u8003\u3048\u3066\u3044\u307e\u3059\u300d\u3068\u8ff0\u3079\u3066\u3044\u307e\u3059\u3002<\/p>\n<p>\u3053\u308c\u306b\u3088\u308a\u3001\u3044\u304f\u3064\u304b\u306e\u91cd\u8981\u306a\u7591\u554f\u304c\u751f\u3058\u305f\u3002<\/p>\n<ol>\n<li>\u547c\u5438\u5668\u7cfb\u306e\u60a3\u8005\u3055\u3093\uff08\u30bf\u30fc\u30b2\u30c3\u30c8\u30e6\u30fc\u30b6\u30fc\uff09\u304c\u3001\u3053\u306e\u4ed5\u4e8b\u3092\u3059\u308b\u305f\u3081\u306e\u30c7\u30d0\u30a4\u30b9\u3092\u671b\u3093\u3067\u3044\u308b\u3068\u78ba\u4fe1\u3057\u3066\u3044\u308b\u306e\u304b\uff1f<\/li>\n<li>\u30b9\u30da\u30fc\u30b5\u30fc\u88c5\u7f6e\u3068\u73fe\u5728\u306e\u5438\u5165\u5668\u3092\u4f7f\u3044\u7d9a\u3051\u308b\u3053\u3068\u3092\u5e0c\u671b\u3059\u308b\u304b\uff1f<\/li>\n<li>\u305d\u306e\u3088\u3046\u306a\u30c7\u30d0\u30a4\u30b9\u306b\u5bfe\u3057\u3066\uff08\u3082\u3057\u305d\u306e\u3088\u3046\u306a\u30c7\u30d0\u30a4\u30b9\u3092\u671b\u3080\u306e\u3067\u3042\u308c\u3070\uff09\u3001\u3069\u306e\u304f\u3089\u3044\u306e\u91d1\u984d\u3092\u652f\u6255\u3046\u899a\u609f\u304c\u3042\u308b\u306e\u3060\u308d\u3046\u304b\uff1f<\/li>\n<li>\u5438\u5165\u5668\u3068\u30b9\u30da\u30fc\u30b5\u30fc\u306e\u7d44\u307f\u5408\u308f\u305b\u306f\u7c21\u5358\u3067\u3059\u304b\uff1f<\/li>\n<li>\u30e6\u30cb\u30d0\u30fc\u30b5\u30eb\u306a\u5438\u5165\u5668\u3092\u4f5c\u308b\u3053\u3068\u304c\u3067\u304d\u308b\u6280\u8853\u3067\u3059\u304b\uff1f<\/li>\n<li>\u5e02\u5834\u898f\u6a21\u306f\u3069\u306e\u304f\u3089\u3044\u3067\u3059\u304b\uff1f<\/li>\n<\/ol>\n<p>So, rather than start designing, the first phase of work for this client was focused on answering these questions which naturally led to a <a href=\"https:\/\/www.kolabtree.com\/blog\/ja\/ensuring-reproducibility-in-ai-driven-research-how-freelance-experts-can-help-in-biotech-and-healthcare\/\">\u30ea\u30b5\u30fc\u30c1<\/a> program with target users and healthcare professionals for planning new developments and initiation of activities for FDA approval. The result was that the current technologies couldn&#8217;t reliably deliver more than 5-10percent of the medications to the target areas and even with a spacer device, the best possible dug delivery is not more than 20 percent. The research identified that combining them in a single device along with improvement in the drug delivery aspect can deliver more than 45 percent of the drug to the target region of the lungs and can drastically improve the performance of the device.<\/p>\n<p>\u307e\u3068\u3081\u308b\u3068\u3001\u958b\u767a\u30d7\u30ed\u30bb\u30b9\u3092\u963b\u5bb3\u3059\u308b\u6700\u5927\u306e\u8ab2\u984c\u306f\u3001\u9069\u5207\u306a\u7279\u8a31\u8abf\u67fb\u3084\u30ec\u30d3\u30e5\u30fc\u306b\u3088\u308b\u7af6\u5408\u4ed6\u793e\u306eIP\u306e\u56de\u907f\u306a\u3069\u4f55\u3067\u3082\u3088\u3044\u306e\u3067\u3059\u304c\u3001\u91cd\u8981\u306a\u30ea\u30b9\u30af\u9818\u57df\u306f\u3001\u30e6\u30fc\u30b6\u30fc\u30d9\u30fc\u30b9\u3001\u6280\u8853\u30d9\u30fc\u30b9\u3001\u30b3\u30b9\u30c8\u30d9\u30fc\u30b9\u306e\u7d44\u307f\u5408\u308f\u305b\u306b\u306a\u308a\u307e\u3059\u3002<\/p>\n<h2><span class=\"ez-toc-section\" id=\"4_The_biggest_mistake_you_can_make_in_medical_device_development\"><\/span><strong>4. <\/strong><strong>\u533b\u7642\u6a5f\u5668\u958b\u767a\u3067\u9665\u308a\u3084\u3059\u3044\u6700\u5927\u306e\u30df\u30b9<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>\u4e00\u822c\u7684\u306a\u533b\u7642\u6a5f\u5668\u306e\u958b\u767a\u3067\u306f\u3001\u30ad\u30c3\u30af\u30aa\u30d5\u304b\u3089\u5e02\u5834\u3067\u306e\u627f\u8a8d\u3001\u767a\u58f2\u307e\u3067\u306b1\u5e74\u304b\u30894\u5e74\u304b\u304b\u308b\u3068\u8a00\u308f\u308c\u3066\u3044\u307e\u3059\u3002\u5e02\u5834\u6295\u5165\u307e\u3067\u306e\u6642\u9593\u3092\u77ed\u7e2e\u3059\u308b\u3053\u3068\u306f\u3001\u7af6\u4e89\u4e0a\u306e\u512a\u4f4d\u6027\u3092\u751f\u307f\u51fa\u3059\u3053\u3068\u306b\u3064\u306a\u304c\u308b\u305f\u3081\u3001\u5e38\u306b\u958b\u767a\u671f\u9593\u306e\u77ed\u7e2e\u3092\u6c42\u3081\u308b\u5727\u529b\u304c\u304b\u304b\u308a\u307e\u3059\u3002\u65b0\u88fd\u54c1\u306e\u958b\u767a\u30b5\u30a4\u30af\u30eb\u3092\u77ed\u7e2e\u3059\u308b\u3053\u3068\u306f\u53ef\u80fd\u3067\u3059\u304c\u3001\u5275\u9020\u6027\u3092\u767a\u63ee\u3059\u308b\u6642\u9593\u3092\u524a\u3089\u306a\u3044\u3088\u3046\u306b\u3059\u308b\u3053\u3068\u304c\u91cd\u8981\u3067\u3059\u3002\u30b3\u30f3\u30bb\u30d7\u30c8\u30fb\u30b8\u30a7\u30cd\u30ec\u30fc\u30b7\u30e7\u30f3\u306e\u6bb5\u968e\u3067\u306f\u3001\u88fd\u54c1\u304c\u5f62\u4f5c\u3089\u308c\u3001\u30a4\u30ce\u30d9\u30fc\u30b7\u30e7\u30f3\u3084\u4ed8\u52a0\u4fa1\u5024\u306e\u3042\u308b\u6a5f\u80fd\u304c\u751f\u307f\u51fa\u3055\u308c\u307e\u3059\u3002\u8a2d\u8a08\u8005\u304c\u30e6\u30fc\u30b6\u30fc\u306e\u771f\u306e\u30cb\u30fc\u30ba\u3092\u660e\u3089\u304b\u306b\u3057\u3001\u7406\u60f3\u7684\u306a\u30e6\u30fc\u30b6\u30fc\u4f53\u9a13\u3092\u5b9a\u7fa9\u3057\u3001\u305d\u306e\u30cb\u30fc\u30ba\u306b\u6700\u9069\u306a\u65b9\u6cd5\u3067\u5fdc\u3048\u308b\u30c7\u30b6\u30a4\u30f3\u3092\u751f\u307f\u51fa\u3059\u305f\u3081\u306e\u6642\u9593\u3092\u78ba\u4fdd\u3059\u308b\u3053\u3068\u304c\u91cd\u8981\u3067\u3059\u3002\u3053\u308c\u306f\u901a\u5e38\u3001\u30d7\u30ed\u30b8\u30a7\u30af\u30c8\u306e\u6700\u521d\u306e1\u301c2\u30f6\u6708\u3067\u884c\u308f\u308c\u3001\u958b\u767a\u5168\u4f53\u306e\u65b9\u5411\u6027\u3092\u6c7a\u5b9a\u3057\u307e\u3059\u3002\u3053\u308c\u3092\u6025\u3050\u3042\u307e\u308a\u3001\u8aa4\u3063\u305f\u5224\u65ad\u3092\u3057\u305f\u308a\u3001\u6a5f\u4f1a\u3092\u9003\u3057\u305f\u308a\u3059\u308b\u3068\u3001\u30d7\u30ed\u30b8\u30a7\u30af\u30c8\u306e\u6b8b\u308a\u306e\u671f\u9593\u3084\u88fd\u54c1\u306e\u4e00\u751f\u306b\u5f71\u97ff\u3092\u53ca\u307c\u3057\u307e\u3059\u3002\u300c\u958b\u767a\u3092\u52a0\u901f\u3059\u308b\u305f\u3081\u306b\u3001\u3044\u304f\u3064\u304b\u306e\u6d3b\u52d5\u3092\u4e26\u884c\u3057\u3066\u884c\u3044\u3001\u88fd\u54c1\u306e\u30d3\u30b8\u30e7\u30f3\u3068\u30c7\u30b6\u30a4\u30f3\u30b3\u30f3\u30bb\u30d7\u30c8\u304c\u5408\u610f\u3055\u308c\u308c\u3070\u3001\u533b\u7642\u6a5f\u5668\u306e\u958b\u767a\u3092\u5168\u901f\u529b\u3067\u9032\u3081\u308b\u3053\u3068\u304c\u3067\u304d\u307e\u3059\u3002<\/p>\n<p>\u533b\u7642\u6a5f\u5668\u306e\u30a4\u30ce\u30d9\u30fc\u30b7\u30e7\u30f3\u306b\u306f\u30012\u7a2e\u985e\u306e\u8ca1\u52d9\u4e0a\u306e\u8ab2\u984c\u304c\u3042\u308a\u307e\u3059\u30021\u3064\u306f\u3001\u30a4\u30ce\u30d9\u30fc\u30b7\u30e7\u30f3\u306e\u958b\u767a\u8cc7\u91d1\u3092\u8abf\u9054\u3059\u308b\u3053\u3068\u3001\u3082\u30461\u3064\u306f\u3001\u30a4\u30ce\u30d9\u30fc\u30b7\u30e7\u30f3\u306b\u3088\u3063\u3066\u5f97\u3089\u308c\u305f\u88fd\u54c1\u3084\u30b5\u30fc\u30d3\u30b9\u306b\u5bfe\u3057\u3066\u8ab0\u304c\u3069\u308c\u3060\u3051\u652f\u6255\u3046\u304b\u3092\u6c7a\u5b9a\u3059\u308b\u3053\u3068\u3067\u3059\u3002\u4e00\u3064\u76ee\u306e\u554f\u984c\u306f\u3001\u65b0\u3057\u3044\u533b\u7642\u6a5f\u5668\u306e\u958b\u767a\u306b\u306f\u9577\u3044\u6295\u8cc7\u671f\u9593\u304c\u5fc5\u8981\u306a\u3053\u3068\u3067\u3059\u3002<a href=\"https:\/\/www.fda.gov\/medical-devices\/premarket-submissions\/de-novo-classification-request\">\u30c7\u30fb\u30ce\u30dc<\/a> \u307e\u305f\u306f <a href=\"https:\/\/www.accessdata.fda.gov\/scripts\/cdrh\/cfdocs\/cfpmn\/pmn.cfm\">510 (k)<\/a>)\u3067FDA\u306e\u627f\u8a8d\u304c\u5fc5\u8981\u306a\u3082\u306e <strong>[9]<\/strong>.IT\u95a2\u9023\u306e\u30d9\u30f3\u30c1\u30e3\u30fc\u4f01\u696d\u3092\u652f\u63f4\u3059\u308b\u30d9\u30f3\u30c1\u30e3\u30fc\u30ad\u30e3\u30d4\u30bf\u30eb\u306f\u30012\u301c3\u5e74\u3067\u8cc7\u91d1\u3092\u5f97\u308b\u3053\u3068\u304c\u3067\u304d\u307e\u3059\u304c\u3001\u533b\u7642\u6a5f\u5668\u4f01\u696d\u306e\u6295\u8cc7\u5bb6\u306f\u3001\u533b\u7642\u6a5f\u5668\u306e\u30af\u30e9\u30b9\u306b\u3088\u3063\u3066\u306f\u3001\u88fd\u54c1\u304c\u627f\u8a8d\u3055\u308c\u308b\u304b\u3069\u3046\u304b\u3092\u77e5\u308b\u305f\u3081\u306b\u3055\u3048\u30011\u301c4\u5e74\u5f85\u305f\u306a\u3051\u308c\u3070\u306a\u308a\u307e\u305b\u3093\u3002\u3082\u3046\u4e00\u3064\u306e\u554f\u984c\u306f\u3001\u5f93\u6765\u306e\u8cc7\u91d1\u63d0\u4f9b\u8005\u306e\u591a\u304f\u304c\u533b\u7642\u696d\u754c\u306b\u7cbe\u901a\u3057\u3066\u3044\u306a\u3044\u305f\u3081\u3001\u6295\u8cc7\u5bb6\u3092\u898b\u3064\u3051\u308b\u306e\u304c\u96e3\u3057\u304f\u3001\u307e\u3057\u3066\u3084\u9769\u65b0\u8005\u306b\u6709\u76ca\u306a\u30a2\u30c9\u30d0\u30a4\u30b9\u3092\u3057\u3066\u304f\u308c\u308b\u6295\u8cc7\u5bb6\u3092\u898b\u3064\u3051\u308b\u306e\u3082\u96e3\u3057\u3044\u3068\u3044\u3046\u3053\u3068\u3067\u3059\u3002\u3053\u306e\u3088\u3046\u306a\u8cc7\u91d1\u8abf\u9054\u306e\u8ab2\u984c\u306f\u3001\u30a4\u30ce\u30d9\u30fc\u30b7\u30e7\u30f3\u306b\u5f71\u97ff\u3092\u4e0e\u3048\u308b\u53ef\u80fd\u6027\u304c\u3042\u308b\u305f\u3081\u3001\u533b\u7642\u6a5f\u5668\u30e1\u30fc\u30ab\u30fc\u306f\u3001\u958b\u767a\u30d7\u30ed\u30bb\u30b9\u5168\u4f53\u3092\u59a8\u3052\u308b\u53ef\u80fd\u6027\u306e\u3042\u308b\u8cc7\u91d1\u8abf\u9054\u306e\u8ab2\u984c\u306b\u5bfe\u5fdc\u3059\u308b\u305f\u3081\u306e\u30ea\u30bd\u30fc\u30b9\u3092\u7279\u5b9a\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002<\/p>\n<h2><span class=\"ez-toc-section\" id=\"5_How_to_focus_on_delivery\"><\/span><strong>5.\u30c7\u30ea\u30d0\u30ea\u30fc\u306b\u6ce8\u529b\u3059\u308b\u65b9\u6cd5\u00a0<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>\u88fd\u54c1\u306e\u30d3\u30b8\u30e7\u30f3\u304c\u5b9a\u7fa9\u3055\u308c\u3001\u30ea\u30b9\u30af\u304c\u7406\u89e3\u3055\u308c\u3066\u8efd\u6e1b\u3055\u308c\u3001\u30c7\u30b6\u30a4\u30f3\u30b3\u30f3\u30bb\u30d7\u30c8\u304c\u8996\u899a\u5316\u3055\u308c\u3066\u9078\u629e\u3055\u308c\u308b\u3068\u3001\u3059\u3079\u3066\u306e\u95a2\u4fc2\u8005\u306f\u958b\u767a\u8a08\u753b\u306b\u30b3\u30df\u30c3\u30c8\u3057\u3001\u5408\u610f\u3055\u308c\u305f\u88fd\u54c1\u3092\u63d0\u4f9b\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002\u3053\u306e\u6642\u70b9\u3067\u306f\u3001\u88fd\u54c1\u3092\u767a\u58f2\u3059\u308b\u307e\u3067\u306b\u5b8c\u4e86\u3057\u306a\u3051\u308c\u3070\u306a\u3089\u306a\u3044\u3059\u3079\u3066\u306e\u6d3b\u52d5\u306b\u96c6\u4e2d\u3057\u306a\u3051\u308c\u3070\u306a\u308a\u307e\u305b\u3093\u3002\u30d7\u30ed\u30b8\u30a7\u30af\u30c8\u8a08\u753b\u306f\u5b9a\u671f\u7684\u306b\u898b\u76f4\u3057\u3001\u66f4\u65b0\u3057\u3001\u6f5c\u5728\u7684\u306a\u9045\u5ef6\u306e\u539f\u56e0\u3092\u7279\u5b9a\u3057\u3001\u7de9\u548c\u7b56\u3092\u8a08\u753b\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002\u610f\u601d\u6c7a\u5b9a\u306e\u9045\u308c\u306f\u975e\u5e38\u306b\u4e00\u822c\u7684\u306a\u554f\u984c\u3067\u3042\u308a\u3001\u7279\u306b\u4e2d\u5c0f\u4f01\u696d\u3084\u65b0\u8208\u4f01\u696d\u3067\u306f\uff08\u4f01\u696d\u74b0\u5883\u3067\u3042\u3063\u3066\u3082\uff09\u3001\u3059\u3079\u3066\u306e\u95a2\u4fc2\u8005\u304c\u51fa\u5e2d\u3067\u304d\u308b\u4f1a\u8b70\u3092\u30b9\u30b1\u30b8\u30e5\u30fc\u30eb\u3059\u308b\u3068\u3001\u6570\u9031\u9593\u306e\u9045\u308c\u304c\u751f\u3058\u308b\u3053\u3068\u304c\u3042\u308a\u307e\u3059\u3002\u6570\u30f6\u6708\u524d\u306b\u4f1a\u8b70\u3092\u4e8b\u524d\u306b\u4e88\u7d04\u3057\u305f\u308a\u3001\u4ee3\u7406\u306e\u4eba\u3092\u914d\u7f6e\u3059\u308b\u3053\u3068\u3067\u3001\u3053\u306e\u3088\u3046\u306a\u9045\u5ef6\u3092\u6291\u3048\u308b\u3053\u3068\u304c\u3067\u304d\u307e\u3059\u3002<\/p>\n<p>\u3053\u306e\u6bb5\u968e\u3067\u306f\u3001\u30d7\u30ed\u30b8\u30a7\u30af\u30c8\u3092\u63a8\u9032\u3059\u308b\u30c1\u30fc\u30e0\u306e\u4e3b\u8981\u30e1\u30f3\u30d0\u30fc\u306f\u3001\u30d7\u30ed\u30b8\u30a7\u30af\u30c8\u306b\u96c6\u4e2d\u3057\u306a\u3051\u308c\u3070\u306a\u308a\u307e\u305b\u3093\u3002\u65e5\u3005\u306e\u6d3b\u52d5\u306b\u8ffd\u308f\u308c\u3066\u3044\u308b\u30b9\u30bf\u30c3\u30d5\u306f\u3001\u3069\u3046\u3057\u3066\u3082\u30d7\u30ed\u30b8\u30a7\u30af\u30c8\u304b\u3089\u96e2\u308c\u3066\u3057\u307e\u3044\u3001\u5fc5\u7136\u7684\u306b\u9045\u308c\u3066\u3057\u307e\u3046\u3002\u3053\u306e\u3088\u3046\u306a\u6bb5\u968e\u3067\u306f\u3001\u30c1\u30fc\u30e0\u30e1\u30f3\u30d0\u30fc\u3092\u8ffd\u52a0\u3057\u3066\u8a08\u753b\u3092\u52a0\u901f\u3055\u305b\u308b\u3053\u3068\u304c\u3067\u304d\u308b\u5834\u5408\u304c\u3042\u308a\u307e\u3059\u3002\u305d\u306e\u969b\u306b\u306f\u3001\u65b0\u6a5f\u7a2e\u306e\u958b\u767a\u306b\u7279\u5316\u3057\u305f\u30e1\u30f3\u30d0\u30fc\u3092\u52a0\u3048\u308b\u306e\u304c\u7406\u60f3\u3067\u3059\u3002\u4e07\u304c\u4e00\u3001\u958b\u767a\u306b\u554f\u984c\u304c\u767a\u751f\u3057\u305f\u5834\u5408\u3067\u3082\u3001\u30d7\u30ed\u30b8\u30a7\u30af\u30c8\u306e\u30d3\u30b8\u30e7\u30f3\u3092\u5b9f\u73fe\u3059\u308b\u3053\u3068\u306b\u5c02\u5ff5\u3057\u3066\u3044\u308b\u30c1\u30fc\u30e0\u306f\u3001\u3088\u308a\u732e\u8eab\u7684\u3067\u3001\u56f0\u96e3\u3092\u89e3\u6c7a\u3059\u308b\u305f\u3081\u306e\u8fc5\u901f\u306a\u30a2\u30af\u30b7\u30e7\u30f3\u30d7\u30e9\u30f3\u3092\u4f5c\u6210\u3059\u308b\u3053\u3068\u304c\u3067\u304d\u307e\u3059\u3002\u732e\u8eab\u7684\u3067\u3084\u308b\u6c17\u306e\u3042\u308b\u30c1\u30fc\u30e0\u306f\u3001\u30d0\u30e9\u30d0\u30e9\u3067\u6c17\u306e\u629c\u3051\u305f\u30c1\u30fc\u30e0\u304c2\u5e74\u9593\u3067\u9054\u6210\u3059\u308b\u3088\u308a\u3082\u30011\u5e74\u9593\u3067\u3088\u308a\u591a\u304f\u306e\u3053\u3068\u3092\u9054\u6210\u3059\u308b\u3053\u3068\u304c\u3067\u304d\u307e\u3059\u3002<\/p>\n<p>\u7d50\u8ad6\u304b\u3089\u8a00\u3046\u3068<\/p>\n<ul>\n<li>\u30e6\u30fc\u30b6\u30d3\u30ea\u30c6\u30a3\u3068\u30d2\u30e5\u30fc\u30de\u30f3\u30d5\u30a1\u30af\u30bf\u30fc\u306f\u3001\u533b\u7642\u6a5f\u5668\u306e\u4f7f\u3044\u3084\u3059\u3055\u3068\u5b89\u5168\u6027\u3092\u78ba\u4fdd\u3059\u308b\u305f\u3081\u306b\u3001\u88fd\u54c1\u958b\u767a\u30d7\u30ed\u30bb\u30b9\u306e\u91cd\u8981\u306a\u4e00\u90e8\u3068\u306a\u3063\u3066\u3044\u307e\u3059\u3002<\/li>\n<li>\u4e16\u754c\u4e2d\u306e\u898f\u5236\u6a5f\u95a2\u306f\u3001\u30e1\u30fc\u30ab\u30fc\u304c\u30e6\u30fc\u30b6\u30d3\u30ea\u30c6\u30a3\u30a8\u30f3\u30b8\u30cb\u30a2\u30ea\u30f3\u30b0\u898f\u683c\u306b\u6e96\u62e0\u3057\u3066\u3044\u308b\u304b\u3069\u3046\u304b\u3092\u4f53\u7cfb\u7684\u306b\u76e3\u8996\u304a\u3088\u3073\u30ec\u30d3\u30e5\u30fc\u3059\u308b\u30d7\u30ed\u30bb\u30b9\u3092\u958b\u59cb\u3057\u307e\u3057\u305f\u3002FDA\uff08\u7c73\u56fd\u98df\u54c1\u533b\u85ac\u54c1\u5c40\uff09\u306e\u5e02\u8ca9\u524d\u306e\u6a5f\u5668\u5be9\u67fb\u30d7\u30ed\u30bb\u30b9\u3067\u306f\u3001\u4eba\u7684\u8981\u56e0\u306b\u3088\u308b\u30ea\u30b9\u30af\u8a55\u4fa1\u3068\u3001\u610f\u56f3\u3057\u305f\u30e6\u30fc\u30b6\u30fc\u306b\u3088\u308b\u6a5f\u5668\u306eUI\u306e\u691c\u8a3c\u30c6\u30b9\u30c8\u304c\u5b9a\u671f\u7684\u306b\u884c\u308f\u308c\u3066\u3044\u307e\u3059\u3002<\/li>\n<li>\u30a4\u30ce\u30d9\u30fc\u30b7\u30e7\u30f3\u3001\u9ad8\u5468\u6ce2\u3001\u304a\u3088\u3073UE\u306e\u6d3b\u52d5\u306f\u3001\u4e88\u5099\u7684\u306a\u30bf\u30b9\u30af\u304a\u3088\u3073\u30ea\u30b9\u30af\u5206\u6790\u3001UI\u306e\u8a2d\u8a08\u304a\u3088\u3073\u8a55\u4fa1\u3001\u6700\u7d42\u7684\u306a\u30b7\u30df\u30e5\u30ec\u30fc\u30b7\u30e7\u30f3\u306b\u3088\u308b\u7dcf\u62ec\u7684\u306a\u691c\u8a3c\u30c6\u30b9\u30c8\u306a\u3069\u3001\u30c7\u30d0\u30a4\u30b9\u306e\u8a2d\u8a08\u304a\u3088\u3073\u958b\u767a\u306e\u3059\u3079\u3066\u306e\u6bb5\u968e\u3067\u5b9f\u65bd\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002<\/li>\n<li>\u7126\u70b9\u306f\u3001\u533b\u7642\u6a5f\u5668\u4f01\u696d\u306e\u30d3\u30b8\u30e7\u30f3\u30fb\u30b9\u30c6\u30fc\u30c8\u30e1\u30f3\u30c8\u3068\u4e00\u81f4\u3055\u305b\u308b\u305f\u3081\u306e\u91cd\u8981\u306a\u8cea\u554f\u3092\u3059\u308b\u3053\u3068\u3067\u3059\u3002<\/li>\n<\/ul>\n<p>\u6b21\u56de\u306f\u3001\u533b\u7642\u6a5f\u5668\u958b\u767a\u306e\u91cd\u8981\u306a\u67f1\u3067\u3042\u308b\u533b\u7642\u6a5f\u5668\u306e\u6982\u8981\u3068\u898f\u5236\u306b\u3064\u3044\u3066\u3054\u7d39\u4ecb\u3057\u307e\u3059\u3002<\/p>\n<blockquote><p><strong>\u533b\u7642\u6a5f\u5668\u306e\u958b\u767a\u306b\u30b5\u30dd\u30fc\u30c8\u304c\u5fc5\u8981\u3067\u3059\u304b\uff1fKolabtree\u3067\u30d5\u30ea\u30fc\u30e9\u30f3\u30b9\u306e\u533b\u7642\u6a5f\u5668\u30b3\u30f3\u30b5\u30eb\u30bf\u30f3\u30c8\u3068\u4e00\u7dd2\u306b\u50cd\u304d\u307e\u3057\u3087\u3046\u3002\u00a0<\/strong><\/p><\/blockquote>\n<p><strong>\u8457\u8005\u306e\u63a1\u7528<\/strong><\/p>\n<p><a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/shrinidh-joshi\/?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=MDDev\"><img decoding=\"async\" loading=\"lazy\" class=\"alignleft wp-image-7614\" src=\"https:\/\/www.kolabtree.com\/blog\/wp-content\/uploads\/2020\/05\/Shrinidh_JoshiB.PharmM.PhamPhD-300x300.jpg\" alt=\"\" width=\"215\" height=\"215\" srcset=\"https:\/\/www.kolabtree.com\/blog\/wp-content\/uploads\/2020\/05\/Shrinidh_JoshiB.PharmM.PhamPhD-150x150@2x.jpg 300w, https:\/\/www.kolabtree.com\/blog\/wp-content\/uploads\/2020\/05\/Shrinidh_JoshiB.PharmM.PhamPhD-150x150.jpg 150w, https:\/\/www.kolabtree.com\/blog\/wp-content\/uploads\/2020\/05\/Shrinidh_JoshiB.PharmM.PhamPhD-24x24.jpg 24w, https:\/\/www.kolabtree.com\/blog\/wp-content\/uploads\/2020\/05\/Shrinidh_JoshiB.PharmM.PhamPhD-48x48.jpg 48w, https:\/\/www.kolabtree.com\/blog\/wp-content\/uploads\/2020\/05\/Shrinidh_JoshiB.PharmM.PhamPhD-96x96.jpg 96w, https:\/\/www.kolabtree.com\/blog\/wp-content\/uploads\/2020\/05\/Shrinidh_JoshiB.PharmM.PhamPhD.jpg 500w, https:\/\/www.kolabtree.com\/blog\/wp-content\/uploads\/2020\/05\/Shrinidh_JoshiB.PharmM.PhamPhD-96x96@2x.jpg 192w\" sizes=\"(max-width: 215px) 100vw, 215px\" \/><\/a>Shrinidh Joshi\u306f\u3001\u88fd\u85ac\u3001\u81e8\u5e8a\u3001\u85ac\u4e8b\u3001\u30e1\u30c7\u30a3\u30ab\u30eb\u30e9\u30a4\u30c6\u30a3\u30f3\u30b0\u306e\u5206\u91ce\u306710\u5e74\u4ee5\u4e0a\u306e\u7d4c\u9a13\u304c\u3042\u308a\u307e\u3059\u3002University Health Network\u3001Krembil Research Institute\u3001Sun Pharma\u3001Virgilant\u3001CannTrust\u3001ThermoFisher Scientific\u306a\u3069\u306e\u4f01\u696d\u3067\u3001\u5b66\u754c\u5185\u5916\u3067\u6d3b\u8e8d\u3057\u3066\u304d\u307e\u3057\u305f\u3002\u5c02\u9580\u5206\u91ce\u306f\u3001\u6297\u4f53\u3001\u518d\u751f\u533b\u7642\u3001\u7d30\u80de\u30fb\u907a\u4f1d\u5b50\u6cbb\u7642\u3001\u30a6\u30a4\u30eb\u30b9\u88fd\u54c1\u3001\u304c\u3093\u514d\u75ab\u7642\u6cd5\u3001\u9593\u8449\u7cfb\u30b9\u30c8\u30ed\u30fc\u30de\u7d30\u80de\u3001\u30d0\u30a4\u30aa\u30ea\u30a2\u30af\u30bf\u30fc\u3001\u533b\u7642\u6a5f\u5668\u3001\u8db3\u5834\u3001\u30ab\u30f3\u30ca\u30d3\u30ce\u30a4\u30c9\u306a\u3069\u306e\u533b\u85ac\u54c1\u30fb\u30d0\u30a4\u30aa\u30ed\u30b8\u30af\u30b9\u5e02\u5834\u3002\u30db\u30ef\u30a4\u30c8\u30da\u30fc\u30d1\u30fc\u3001\u30ea\u30b5\u30fc\u30c1\u30da\u30fc\u30d1\u30fc\u3001\u30d6\u30c3\u30af\u30c1\u30e3\u30d7\u30bf\u30fc\u306a\u3069\u3092\u57f7\u7b46\u3057\u3066\u3044\u307e\u3059\u3002<br \/>\n<a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/shrinidh-joshi\/?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=MDDev\">\u30b7\u30e5\u30ea\u30cb\u30fc\u30c9\u30fb\u30b8\u30e7\u30b7\u3092\u96c7\u3046<\/a><\/p>\n<p><strong>\u30ea\u30d5\u30a1\u30ec\u30f3\u30b9\uff06\u30ea\u30bd\u30fc\u30b9<\/strong><\/p>\n<ul>\n<li><a href=\"https:\/\/www.cnbc.com\/2018\/02\/22\/medical-errors-third-leading-cause-of-death-in-america.html?__source=sharebar|email&amp;par=sharebar\">https:\/\/www.cnbc.com\/2018\/02\/22\/medical-errors-third-leading-cause-of-death-in-america.html?__source=sharebar|email&amp;par=sharebar<\/a>)<\/li>\n<li>Kohn, L.T., Corrigan, J.M. and Donaldson, M., (eds.), To err is human: Building a safer health system, (Washington DC, National Academy Press, 2000).<\/li>\n<li><a href=\"https:\/\/www.who.int\/news-room\/fact-sheets\/detail\/patient-safety\">https:\/\/www.who.int\/news-room\/fact-sheets\/detail\/patient-safety<\/a><\/li>\n<li><a href=\"https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/applying-human-factors-and-usability-engineering-medical-devices\">Draft Guidance for Industry and Food and Drug Administration Staff - Applying human factors and usability engineering to optimize medical device design, FDA Center for Devices and Regulatory Health, June 2011<\/a><\/li>\n<li><a href=\"https:\/\/lne-america.com\/library\/news\/medical-device-usability-highlights-of-european-regulations-and-standards\">https:\/\/lne-america.com\/library\/news\/medical-device-usability-highlights-of-european-regulations-and-standards<\/a><\/li>\n<li>\u533b\u7642\u6a5f\u5668\u306e\u4f7f\u7528-\u5b89\u5168\u6027\u3002\u30ea\u30b9\u30af\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u306b\u30d2\u30e5\u30fc\u30de\u30f3\u30d5\u30a1\u30af\u30bf\u30fc\u30a8\u30f3\u30b8\u30cb\u30a2\u30ea\u30f3\u30b0\u3092\u53d6\u308a\u5165\u308c\u308b\u3001FDA\u30c7\u30d0\u30a4\u30b9\u30fb\u898f\u5236\u4fdd\u5065\u30bb\u30f3\u30bf\u30fc\u30012000\u5e747\u6708<\/li>\n<li><a href=\"https:\/\/www.federalregister.gov\/documents\/2000\/07\/18\/00-18061\/guidance-for-industry-and-fda-reviewers-on-medical-device-use-safety-incorporating-human-factors\">https:\/\/www.federalregister.gov\/documents\/2000\/07\/18\/00-18061\/guidance-for-industry-and-fda-reviewers-on-medical-device-use-safety-incorporating-human-factors<\/a><\/li>\n<li><a href=\"https:\/\/www.greenlight.guru\/glossary\/iso-14971\">https:\/\/www.greenlight.guru\/glossary\/iso-14971<\/a><\/li>\n<li><a href=\"https:\/\/www.yakar-eng.co\/2018\/04\/15\/differences-between-510k-and-de-novo-submission\/\">https:\/\/www.yakar-eng.co\/2018\/04\/15\/differences-between-510k-and-de-novo-submission\/<\/a><\/li>\n<\/ul>\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=MDDev\">\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=MDDev\">\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=MDDev\">\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=MDDev\">\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=MDDev\">\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=MDDev\">\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, freelance medical device consultant on Kolabtree, provides a definitive guide to medical device development and design, stressing on important things to keep in mind to make the process smoother and easier.\u00a0 Before we embark on the journey of medical device development as you might know that developing a medical device is a long and complex process. During recent times, tightening regulatory requirements globally from agencies such as the FDA and EU mean this already expensive process is becoming even more costly. Badly run development projects can overrun on cost and time and may ultimately have to be aborted with huge financial and opportunity costs. For small businesses and<\/p>\n<div class=\"read-more\"><a href=\"https:\/\/www.kolabtree.com\/blog\/ja\/medical-device-development-and-design-a-definitive-guide\/\" title=\"\u7d9a\u304d\u3092\u8aad\u3080\">\u7d9a\u304d\u3092\u8aad\u3080<\/a><\/div>","protected":false},"author":12,"featured_media":8357,"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 and Design: A Definitive Guide<\/title>\n<meta name=\"description\" content=\"A definitive guide to medical device development and design. Includes the role of human factors, usability, and common errors to avoid.\" \/>\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-and-design-a-definitive-guide\/\" \/>\n<meta property=\"og:locale\" content=\"ja_JP\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Medical Device Development and Design: A Definitive Guide\" \/>\n<meta property=\"og:description\" content=\"A definitive guide to medical device development and design. Includes the role of human factors, usability, and common errors to avoid.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.kolabtree.com\/blog\/ja\/medical-device-development-and-design-a-definitive-guide\/\" \/>\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=\"2020-09-25T14:32:16+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2021-03-12T09:21:02+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/www.kolabtree.com\/blog\/wp-content\/uploads\/2020\/09\/shutterstock_1596653908-scaled.jpg\" \/>\n\t<meta property=\"og:image:width\" content=\"2560\" \/>\n\t<meta property=\"og:image:height\" content=\"1707\" \/>\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=\"15\u5206\" \/>\n<!-- \/ Yoast SEO Premium plugin. -->","yoast_head_json":{"title":"Medical Device Development and Design: A Definitive Guide","description":"A definitive guide to medical device development and design. 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