{"id":8840,"date":"2021-03-10T12:28:33","date_gmt":"2021-03-10T12:28:33","guid":{"rendered":"https:\/\/www.kolabtree.com\/blog\/?p=8840"},"modified":"2021-03-12T18:46:25","modified_gmt":"2021-03-12T18:46:25","slug":"medical-device-commercialization-9-steps-from-sketch-to-launch","status":"publish","type":"post","link":"https:\/\/www.kolabtree.com\/blog\/ja\/medical-device-commercialization-9-steps-from-sketch-to-launch\/","title":{"rendered":"\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"},"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-69f19d665fc6e\" 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-69f19d665fc6e\"><\/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-commercialization-9-steps-from-sketch-to-launch\/#Medical_device_conceptualization\" title=\"\u533b\u7642\u6a5f\u5668\u306e\u30b3\u30f3\u30bb\u30d7\u30c8\u7acb\u6848\">\u533b\u7642\u6a5f\u5668\u306e\u30b3\u30f3\u30bb\u30d7\u30c8\u7acb\u6848<\/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-commercialization-9-steps-from-sketch-to-launch\/#9-Step_Process_for_Medical_Device_Commercialization\" title=\"\u533b\u7642\u6a5f\u5668\u306e\u5546\u696d\u5316\u306e\u305f\u3081\u306e9\u30b9\u30c6\u30c3\u30d7\u306e\u30d7\u30ed\u30bb\u30b9\">\u533b\u7642\u6a5f\u5668\u306e\u5546\u696d\u5316\u306e\u305f\u3081\u306e9\u30b9\u30c6\u30c3\u30d7\u306e\u30d7\u30ed\u30bb\u30b9<\/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-commercialization-9-steps-from-sketch-to-launch\/#1_Planning_Phase_Sketch\" title=\"1.\u4f01\u753b\u6bb5\u968e\uff08\u30b9\u30b1\u30c3\u30c1\">1.\u4f01\u753b\u6bb5\u968e\uff08\u30b9\u30b1\u30c3\u30c1<\/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-commercialization-9-steps-from-sketch-to-launch\/#2_Patent_Analysis\" title=\"2.\u7279\u8a31\u5206\u6790\">2.\u7279\u8a31\u5206\u6790<\/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-commercialization-9-steps-from-sketch-to-launch\/#3_Market_Relevance\" title=\"3.\u5e02\u5834\u3068\u306e\u95a2\u9023\u6027\">3.\u5e02\u5834\u3068\u306e\u95a2\u9023\u6027<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-6\" href=\"https:\/\/www.kolabtree.com\/blog\/ja\/medical-device-commercialization-9-steps-from-sketch-to-launch\/#4_Regulatory_Compliance\" title=\"4.\u898f\u5236\u9075\u5b88\">4.\u898f\u5236\u9075\u5b88<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-7\" href=\"https:\/\/www.kolabtree.com\/blog\/ja\/medical-device-commercialization-9-steps-from-sketch-to-launch\/#5_Quality_Assurance\" title=\"5.\u54c1\u8cea\u4fdd\u8a3c\">5.\u54c1\u8cea\u4fdd\u8a3c<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-8\" href=\"https:\/\/www.kolabtree.com\/blog\/ja\/medical-device-commercialization-9-steps-from-sketch-to-launch\/#6_Implementation\" title=\"6.\u5b9f\u88c5\">6.\u5b9f\u88c5<\/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=MDComm3a\">\u30b7\u30e5\u30ea\u30cb\u30fc\u30c9\u30fb\u30b8\u30e7\u30b7<\/a>, <a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/medical-device\/?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=MDComm3a\">\u533b\u7642\u6a5f\u5668\u30b3\u30f3\u30b5\u30eb\u30bf\u30f3\u30c8<\/a> Kolabtree\u3067\u306f\u3001\u533b\u7642\u6a5f\u5668\u306e\u5546\u696d\u5316\u306b\u3064\u3044\u3066\u3001\u30b9\u30b1\u30c3\u30c1\u304b\u3089\u767a\u58f2\u307e\u3067\u306e9\u3064\u306e\u30b9\u30c6\u30c3\u30d7\u3067\u8a73\u7d30\u306a\u30ac\u30a4\u30c9\u3092\u63d0\u4f9b\u3057\u3066\u3044\u307e\u3059\u3002\u30a2\u30a4\u30c7\u30a2\u3092\u5546\u696d\u7684\u306b\u5b9f\u73fe\u53ef\u80fd\u306a\u88fd\u54c1\u306b\u5909\u63db\u3059\u308b\u65b9\u6cd5\u3092\u7406\u89e3\u3059\u308b\u305f\u3081\u306b\u304a\u8aad\u307f\u304f\u3060\u3055\u3044\u3002\u00a0<\/em><\/p>\n<p><span style=\"font-weight: 400;\">\u4eca\u56de\u306f\u3001\u533b\u7642\u6a5f\u5668\u306e\u30b9\u30bf\u30fc\u30c8\u30a2\u30c3\u30d7\u3084\u65e2\u5b58\u306e\u4f01\u696d\u304c\u3001\u30ca\u30d7\u30ad\u30f3\u306e\u88cf\u306b\u66f8\u304b\u308c\u305f\u30a2\u30a4\u30c7\u30a2\u3092\u88fd\u54c1\u5316\u3059\u308b\u969b\u306b\u77e5\u3063\u3066\u304a\u304f\u3079\u304d\u3053\u3068\u306b\u3064\u3044\u3066\u304a\u8a71\u3057\u3057\u305f\u3044\u3068\u601d\u3044\u307e\u3059\u3002\u500b\u4eba\u306e\u30a2\u30a4\u30c7\u30a2\u3001\u767a\u660e\u3001\u5927\u5b66\u3084\u56fd\u7acb\u7814\u7a76\u6240\u3001\u75c5\u9662\u3067\u306e\u7814\u7a76\u3001\u3042\u308b\u3044\u306f\u8d77\u696d\u5bb6\u306b\u3088\u308b\u6280\u8853\u306f\u3001\u305d\u306e\u30a2\u30a4\u30c7\u30a2\u3001\u30b3\u30f3\u30bb\u30d7\u30c8\u3001\u6280\u8853\u304c\u5546\u696d\u7684\u306b\u5b9f\u884c\u53ef\u80fd\u306a\u3082\u306e\u306b\u5909\u63db\u3055\u308c\u305f\u3068\u304d\u306b\u3001\u5177\u4f53\u7684\u306a\u88fd\u54c1\u306b\u306a\u308a\u307e\u3059\u3002<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u79c1\u306f\u79d1\u5b66\u8005\u3067\u3042\u308a\u3001\u533b\u7642\u6a5f\u5668\u306e\u30b3\u30f3\u30b5\u30eb\u30bf\u30f3\u30c8\u3067\u3082\u3042\u308a\u307e\u3059\u304c\u3001\u533b\u7642\u6a5f\u5668\u3092\u958b\u767a\u3059\u308b\u305f\u3081\u306e\u30a2\u30a4\u30c7\u30a2\u3084\u30b3\u30f3\u30bb\u30d7\u30c8\u306f\u3001\u3044\u3064\u3067\u3082\u8ab0\u304b\u3089\u3067\u3082\u5f97\u3089\u308c\u308b\u3082\u306e\u3060\u3068\u7406\u89e3\u3057\u3066\u3044\u307e\u3059\u3002\u4f8b\u3048\u3070\u3001\u6700\u521d\u306e\u30d1\u30fc\u30bd\u30ca\u30eb\u30b0\u30eb\u30b3\u30fc\u30b9\u30e2\u30cb\u30bf\u30fc\u306f\u30011956\u5e74\u306bLeland Clark\u306b\u3088\u3063\u3066\u767a\u8868\u3055\u308c[1]\u3001\u305d\u306e\u5f8c1981\u5e74\u306bBayer\u306b\u3088\u3063\u3066\u6539\u826f\u3055\u308c\u307e\u3057\u305f[2]\u3002\u65b0\u3057\u3044\u30c7\u30d0\u30a4\u30b9\u3092\u5e02\u5834\u306b\u6295\u5165\u3067\u304d\u308b\u306e\u306f\u3001\u7d4c\u9a13\u8c4a\u5bcc\u306a\u30a8\u30f3\u30b8\u30cb\u30a2\u3084\u9ad8\u3044\u8a55\u4fa1\u3092\u53d7\u3051\u3066\u3044\u308b\u5916\u79d1\u533b\u3060\u3051\u3067\u3042\u308b\u5fc5\u8981\u306f\u306a\u304f\u3001\u8ab0\u306b\u3067\u3082\u3067\u304d\u308b\u3053\u3068\u306a\u306e\u3067\u3059\u3002\u533b\u7642\u6a5f\u5668\u306e\u5206\u91ce\u3067\u307e\u3060\u65b0\u3057\u3044\u30b9\u30bf\u30fc\u30c8\u30a2\u30c3\u30d7\u4f01\u696d\u306e\u591a\u304f\u306b\u3068\u3063\u3066\u3001\u6700\u5927\u306e\u8ab2\u984c\u306f\u3001\u533b\u7642\u6a5f\u5668\u696d\u754c\u306f\u898f\u5236\u304c\u53b3\u3057\u304f\u3001\u8907\u6570\u306e\u969c\u5bb3\u304c\u3042\u308b\u5206\u91ce\u3060\u3068\u8a8d\u8b58\u3057\u3066\u3044\u308b\u3053\u3068\u3067\u3059\u3002\u3057\u304b\u3057\u3001\u30d7\u30ed\u30bb\u30b9\u3092\u7c21\u7d20\u5316\u3067\u304d\u308b\u5c02\u9580\u5bb6\u3068\u5354\u529b\u3059\u308c\u3070\u3001\u305d\u3093\u306a\u3053\u3068\u306f\u3042\u308a\u307e\u305b\u3093\u3002\u3068\u306f\u3044\u3048\u3001\u8003\u616e\u3059\u3079\u304d\u3053\u3068\u306f\u305f\u304f\u3055\u3093\u3042\u308a\u3001\u3053\u308c\u306f\u5a01\u5727\u7684\u306a\u30d7\u30ed\u30bb\u30b9\u3067\u3082\u3042\u308a\u307e\u3059\u3002\u3057\u304b\u3057\u3001\u6b63\u3057\u3044\u65b9\u6cd5\u3092\u77e5\u3063\u3066\u3044\u308c\u3070\u3001\u975e\u5e38\u306b\u3084\u308a\u304c\u3044\u304c\u3042\u308a\u3001\u8ffd\u6c42\u3059\u308b\u4fa1\u5024\u304c\u3042\u308a\u307e\u3059\u3002\u6700\u8fd1\u767a\u8868\u3055\u308c\u305f\u30c7\u30fc\u30bf\u306b\u3088\u308b\u3068\u3001\u533b\u7642\u6a5f\u5668\u3092\u958b\u767a\u3057\u3066\u3044\u308b\u4f01\u696d\u306e\u3046\u3061\u3001\u7d0488%\u304c\u6295\u8cc7\u5bb6\u306b\u76f8\u5f53\u306aROI\u3092\u63d0\u4f9b\u3067\u304d\u3066\u3044\u306a\u3044\u305d\u3046\u3067\u3059[3]\u3002\u305d\u3053\u3067\u3001\u672c\u8a18\u4e8b\u306e\u7b2c1\u90e8\u3067\u306f\u3001\u533b\u7642\u6a5f\u5668\u306e\u30b9\u30bf\u30fc\u30c8\u30a2\u30c3\u30d7\u4f01\u696d\u3084\u3042\u3089\u3086\u308b\u898f\u6a21\u306e\u533b\u7642\u6a5f\u5668\u4f01\u696d\u306b\u5f79\u7acb\u3064\u3001\u5546\u696d\u5316\u306e\u91cd\u8981\u306a\u30d2\u30f3\u30c8\u3092\u3054\u7d39\u4ecb\u3057\u307e\u3057\u305f\u3002<\/span><\/p>\n<h2><span class=\"ez-toc-section\" id=\"Medical_device_conceptualization\"><\/span>\u533b\u7642\u6a5f\u5668\u306e\u30b3\u30f3\u30bb\u30d7\u30c8\u7acb\u6848<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><span style=\"font-weight: 400;\">\u533b\u7642\u6a5f\u5668\u306e\u5546\u54c1\u5316\u306f\u3001\u30b3\u30f3\u30bb\u30d7\u30c8\u306e\u7acb\u6848\u304b\u3089\u59cb\u307e\u308a\u307e\u3059\u3002\u533b\u7642\u6a5f\u5668\u306e\u30b3\u30f3\u30bb\u30d7\u30c8\u5316\u306e\u4fa1\u5024\u306f\u3001\u30b3\u30f3\u30bb\u30d7\u30c8\u304b\u3089\u305d\u306e\u6a5f\u5668\u306e\u88fd\u9020\u53ef\u80fd\u6027\u3092\u8003\u616e\u3059\u308b\u3053\u3068\u306b\u4e3b\u306b\u95a2\u4fc2\u3057\u3066\u3044\u307e\u3059\u3002 <\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u521d\u65e5\u304b\u3089\u3001\u3069\u306e\u3088\u3046\u306b\u88fd\u9020\u3055\u308c\u308b\u304b\u3092\u691c\u8a0e\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002\u3053\u308c\u304c\u91cd\u8981\u306a\u306e\u306f\u3001\u3044\u304f\u3064\u304b\u306e\u89b3\u70b9\u304b\u3089\u3067\u3059\u3002 <\/span><\/p>\n<ol>\n<li><span style=\"font-weight: 400;\"><strong>\u7d4c\u6e08<\/strong><br \/>\n\u4e00\u3064\u306f\u3001\u533b\u7642\u6a5f\u5668\u306e\u958b\u767a\u306b\u304a\u3044\u3066\u3001\u7d4c\u6e08\u6027\u304c\u898b\u843d\u3068\u3055\u308c\u3066\u3044\u308b\u3053\u3068\u3067\u3059\u3002\u4e3b\u306b\u3001\u5c0f\u898f\u6a21\u306a\u30b9\u30bf\u30fc\u30c8\u30a2\u30c3\u30d7\u4f01\u696d\u3084\u3001\u88fd\u85ac\u3001\u30d0\u30a4\u30aa\u30c6\u30af\u30ce\u30ed\u30b8\u30fc\u3001\u30a2\u30ab\u30c7\u30df\u30a2\u306a\u3069\u306e\u7570\u306a\u308b\u30d0\u30c3\u30af\u30b0\u30e9\u30a6\u30f3\u30c9\u3092\u6301\u3063\u3066\u533b\u7642\u6a5f\u5668\u5206\u91ce\u306b\u53c2\u5165\u3059\u308b\u30af\u30ed\u30b9\u30d5\u30a1\u30f3\u30af\u30b7\u30e7\u30ca\u30eb\u306a\u7d44\u7e54\u3067\u306f\u3001\u7d4c\u6e08\u6027\u304c\u898b\u843d\u3068\u3055\u308c\u3066\u3044\u307e\u3059\u3002\u533b\u7642\u6a5f\u5668\u30e1\u30fc\u30ab\u30fc\u306f\u3001\u7d4c\u6e08\u6027\u306b\u512a\u308c\u3001\u81ea\u793e\u306e\u5b9a\u7fa9\u3059\u308b\u30d3\u30b8\u30cd\u30b9\u30e2\u30c7\u30eb\u306b\u5408\u3063\u305f\u88fd\u54c1\u3092\u8a2d\u8a08\u3057\u306a\u3051\u308c\u3070\u306a\u308a\u307e\u305b\u3093\u3002\u533b\u7642\u6a5f\u5668\u30e1\u30fc\u30ab\u30fc\u304c\u76ee\u6a19\u3068\u3059\u308b\u8ca9\u58f2\u4fa1\u683c\u3092\u8a2d\u5b9a\u3057\u3001\u305d\u306e\u8ca9\u58f2\u4fa1\u683c\u306f\u3001\u5fc5\u8981\u306a\u30de\u30fc\u30b8\u30f3\u3092\u8003\u616e\u3057\u305f\u65b9\u7a0b\u5f0f\u306b\u3088\u3063\u3066\u6c7a\u5b9a\u3055\u308c\u307e\u3059\u304c\u3001\u305d\u308c\u306f\u6a5f\u5668\u306e\u5546\u54c1\u539f\u4fa1\u306b\u623b\u3063\u3066\u304d\u307e\u3059[4, 5]\u3002\u3064\u307e\u308a\u3001\u533b\u7642\u6a5f\u5668\u30e1\u30fc\u30ab\u30fc\u3068\u3057\u3066\u306f\u3001\u30b3\u30f3\u30bb\u30d7\u30c8\u306e\u6bb5\u968e\u304b\u3089\u305d\u306e\u3053\u3068\u3092\u7406\u89e3\u3057\u3066\u304a\u304f\u5fc5\u8981\u304c\u3042\u308a\u3001\u305d\u308c\u306b\u3088\u3063\u3066\u6700\u7d42\u7684\u306b\u306f\u7d4c\u6e08\u7684\u8981\u4ef6\u3092\u6e80\u305f\u3059\u6a5f\u5668\u3092\u88fd\u9020\u3059\u308b\u3053\u3068\u304c\u3067\u304d\u308b\u306e\u3067\u3059\u3002<\/span><\/li>\n<li><strong>\u30d0\u30ea\u30e5\u30fc\u30d7\u30ed\u30dd\u30b8\u30b7\u30e7\u30f3<\/strong><br \/>\nSecond, for a medical device company and medical device to be successful, it needs to deliver a clear value proposition to the various key stakeholders. Beginning with the patient, it\u2019s important to consider whether the problem medical device company is addressing is truly an unmet medical need and whether their technology will profoundly impact patient outcomes or quality of life. If a medical device is intended for the physician\u2019s use (for example a spirometer or a blood-oxygen monitor), it is important to consider whether there is a demand for the product. Sometimes it is crucial to find out whether that demand is sufficiently high to overcome the inertia of practicing medicine traditionally. In recent times when the medical device industry is working diligently to integrate digital health, <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> (AI), Machine Learning (ML), and Big Data to focus critically toward value-based care, real-world data and evidence, a medical device company should be considering the health-economics of a medical device which will draw support from hospital administrators, insurance companies and pharmaceutical\/medical device industry.<\/li>\n<\/ol>\n<p><span style=\"font-weight: 400;\">\u533b\u7642\u6a5f\u5668\u306e\u5546\u54c1\u5316\u306b\u5f71\u97ff\u3092\u4e0e\u3048\u308b\u3082\u3046\u4e00\u3064\u306e\u4fa1\u5024\u306f\u3001\u30c7\u30b6\u30a4\u30f3\u3092\u3069\u3046\u3059\u308b\u304b\u691c\u8a0e\u3057\u3066\u3044\u308b\u9593\u306b <strong>\u30b3\u30f3\u30bb\u30d7\u30c8\u304b\u3089\u88fd\u9020\u53ef\u80fd\u6027\u3092\u8003\u616e\u3057\u305f\u8a2d\u8a08\u3092\u884c\u3046\u3079\u304d\u3067\u3042\u308b<\/strong>. <\/span><\/p>\n<blockquote><p><span style=\"font-weight: 400;\">\u533b\u7642\u6a5f\u5668\u30e1\u30fc\u30ab\u30fc\u306e\u591a\u304f\u304c\u7d4c\u9a13\u3057\u3066\u3044\u308b\u6700\u5927\u306e\u8ab2\u984c\u306f\u3001\u88fd\u54c1\u958b\u767a\u3001\u8a2d\u8a08\u691c\u8a3c\u3001\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\u304b\u3089\u88fd\u9020\u3078\u306e\u79fb\u884c\u3067\u3059\u3002\u591a\u304f\u306e\u5834\u5408\u3001\u88fd\u9020\u306b\u79fb\u884c\u3059\u308b\u969b\u306b\u3001\u88fd\u9020\u3067\u304d\u306a\u3044\u554f\u984c\u304c\u3042\u308b\u305f\u3081\u306b\u9045\u308c\u304c\u751f\u3058\u3001\u8a2d\u8a08\u3092\u4f55\u5ea6\u3082\u3084\u308a\u76f4\u3055\u306a\u3051\u308c\u3070\u306a\u3089\u306a\u3044\u3053\u3068\u304c\u3042\u308a\u307e\u3059\u3002\u3053\u306e\u3088\u3046\u306a\u3053\u3068\u304c\u8d77\u3053\u308b\u3068\u3001\u533b\u7642\u6a5f\u5668\u30e1\u30fc\u30ab\u30fc\u306f\u6642\u9593\u3092\u5931\u3046\u3053\u3068\u306b\u306a\u308a\u3001\u8ab0\u3082\u304c\u88fd\u54c1\u3092\u5e02\u5834\u306b\u6295\u5165\u3059\u308b\u3053\u3068\u3092\u671b\u3093\u3067\u3044\u308b\u305f\u3081\u3001\u6642\u9593\u304c\u554f\u984c\u3068\u306a\u308a\u307e\u3059\u3002<\/span><\/p><\/blockquote>\n<h2><span class=\"ez-toc-section\" id=\"9-Step_Process_for_Medical_Device_Commercialization\"><\/span>\u533b\u7642\u6a5f\u5668\u306e\u5546\u696d\u5316\u306e\u305f\u3081\u306e9\u30b9\u30c6\u30c3\u30d7\u306e\u30d7\u30ed\u30bb\u30b9<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><span style=\"font-weight: 400;\">\u5f93\u6765\u3001\u5546\u54c1\u5316\u306f\u30b9\u30b1\u30c3\u30c1\u304b\u3089\u767a\u58f2\u307e\u3067\u306e9\u3064\u306e\u30b9\u30c6\u30c3\u30d7\u3067\u884c\u308f\u308c\u3066\u3044\u307e\u3057\u305f\u3002\u3053\u308c\u3089\u306e\u30b9\u30c6\u30c3\u30d7\u306b\u306f<\/span><\/p>\n<ul>\n<li><span style=\"font-weight: 400;\">\u00a0<\/span> <span style=\"font-weight: 400;\">\u30b9\u30b1\u30c3\u30c1\uff08\u30ca\u30d7\u30ad\u30f3\u306e\u88cf\u306e\u3088\u3046\u306a\u3082\u306e\u304b\u3089\u3001\u3088\u308a\u6d17\u7df4\u3055\u308c\u305f\u30c7\u30d0\u30a4\u30b9\u306e\u30c7\u30b6\u30a4\u30f3\u307e\u3067\uff09\u3002<\/span><\/li>\n<li><span style=\"font-weight: 400;\">\u00a0<\/span> <span style=\"font-weight: 400;\">\u7279\u8a31\u5206\u6790\u3002<\/span><\/li>\n<li><span style=\"font-weight: 400;\">\u00a0<\/span> <span style=\"font-weight: 400;\">\u5e02\u5834\u3068\u306e\u95a2\u9023\u6027\u3002<\/span><\/li>\n<li><span style=\"font-weight: 400;\">\u00a0<\/span> <span style=\"font-weight: 400;\">\u898f\u5236\u9075\u5b88\u3002<\/span><\/li>\n<li><span style=\"font-weight: 400;\">\u00a0<\/span> <span style=\"font-weight: 400;\">\u54c1\u8cea\u4fdd\u8a3c\u3002<\/span><\/li>\n<li><span style=\"font-weight: 400;\">\u00a0<\/span> <span style=\"font-weight: 400;\">\u30a4\u30f3\u30d7\u30ea\u30e1\u30f3\u30c6\u30fc\u30b7\u30e7\u30f3\u3067\u3059\u3002<\/span><\/li>\n<li><span style=\"font-weight: 400;\">\u00a0<\/span> <span style=\"font-weight: 400;\">\u30d2\u30e5\u30fc\u30de\u30f3\u30d5\u30a1\u30af\u30bf\u30fc\u3068\u30e6\u30fc\u30b6\u30d3\u30ea\u30c6\u30a3\u3002<\/span><\/li>\n<li><span style=\"font-weight: 400;\">\u00a0<\/span> <span style=\"font-weight: 400;\">\u30d3\u30b8\u30cd\u30b9\u958b\u767a\u3068\u30de\u30fc\u30b1\u30c6\u30a3\u30f3\u30b0\u3001\u305d\u3057\u3066<\/span><\/li>\n<li><span style=\"font-weight: 400;\">\u00a0<\/span> <span style=\"font-weight: 400;\">\u6253\u3061\u4e0a\u3052\u3002<\/span><\/li>\n<\/ul>\n<p><span style=\"font-weight: 400;\">\u3053\u308c\u3089\u306e\u30b9\u30c6\u30c3\u30d7\u306f\u5fc5\u305a\u3057\u3082\u9806\u756a\u306b\u884c\u3046\u5fc5\u8981\u306f\u306a\u304f\u3001\u4e26\u884c\u3057\u3066\u884c\u3063\u305f\u308a\u3001\u4e0a\u8a18\u3068\u306f\u7570\u306a\u308b\u9806\u5e8f\u3067\u884c\u3046\u5fc5\u8981\u304c\u3042\u308b\u5834\u5408\u3082\u3042\u308a\u307e\u3059\u3002\u3057\u304b\u3057\u3001\u958b\u767a\u30fb\u5546\u54c1\u5316\u306e\u30d7\u30ed\u30bb\u30b9\u306b\u304a\u3044\u3066\u3001\u3053\u308c\u3089\u306e\u30b9\u30c6\u30c3\u30d7\u304c\u3059\u3079\u3066\u8003\u616e\u3055\u308c\u3066\u3044\u308c\u3070\u3001\u533b\u7642\u6a5f\u5668\u306e\u6210\u529f\u3078\u306e\u9053\u7b4b\u304c\u898b\u3048\u3066\u304d\u307e\u3059\u3002\u8ab2\u984c\u3084\u6539\u5584\u306e\u4f59\u5730\u306f\u5e38\u306b\u3042\u308a\u307e\u3059\u304c\u3001\u4e0a\u8a18\u306e\u30b9\u30c6\u30c3\u30d7\u306f\u3001\u533b\u7642\u6a5f\u5668\u4f01\u696d\u304c\u843d\u3068\u3057\u7a74\u3092\u56de\u907f\u3059\u308b\u305f\u3081\u306e\u30d7\u30ed\u30bb\u30b9\u3092\u69cb\u7bc9\u3059\u308b\u306e\u306b\u5f79\u7acb\u3061\u307e\u3059\u3002\u4f8b\u3048\u3070\u3001\u898f\u5236\u4e0a\u306e\u8ab2\u984c\u306b\u95a2\u9023\u3059\u308b\u843d\u3068\u3057\u7a74\u3001\u88fd\u9020\u6027\u3092\u8003\u616e\u3057\u305f\u8a2d\u8a08\u306b\u95a2\u9023\u3059\u308b\u843d\u3068\u3057\u7a74\u3001\u512a\u308c\u305f\u88fd\u54c1\u3092\u6301\u3063\u3066\u3044\u3066\u3082\u7d4c\u6e08\u7684\u3067\u306f\u306a\u3044\u305f\u3081\u306b\u8ca9\u58f2\u3067\u304d\u306a\u3044\u3068\u3044\u3046\u843d\u3068\u3057\u7a74\u306a\u3069\u3067\u3059\u3002\u5229\u76ca\u304c\u51fa\u306a\u3044\u306e\u3067\u3001\u88fd\u54c1\u304c\u306a\u3044\u306e\u3067\u3059\u3002\u4f8b\u3048\u3070\u3001\u79c1\u304c\u904e\u53bb\u306b\u4ed5\u4e8b\u3092\u3057\u305f\u4f1a\u793e\u3067\u306f\u3001\u4f55\u767e\u4e07\u30c9\u30eb\u3082\u304b\u3051\u3066\u533b\u7642\u6a5f\u5668\u3092\u958b\u767a\u3057\u3001\u305d\u306e\u6a5f\u5668\u306e\u691c\u8a3c\u3082\u7d42\u3048\u3066\u3044\u305f\u306e\u3067\u3059\u304c\u3001\u5f8c\u306b\u306a\u3063\u3066\u88fd\u9020\u30b3\u30b9\u30c8\u304c\u9ad8\u3059\u304e\u308b\u3053\u3068\u304c\u5224\u660e\u3057\u307e\u3057\u305f\u3002\u305d\u306e\u305f\u3081\u3001\u30de\u30fc\u30b8\u30f3\u3092\u53d6\u308b\u3053\u3068\u304c\u3067\u304d\u305a\u3001\u958b\u767a\u3092\u4e2d\u6b62\u3059\u308b\u304b\u3001\u4ed6\u306e\u65b9\u6cd5\u3067\u88fd\u9020\u3059\u308b\u304b\u3092\u691c\u8a0e\u3057\u306a\u3051\u308c\u3070\u306a\u3089\u306a\u3044\u72b6\u6cc1\u306b\u306a\u3063\u3066\u3044\u307e\u3057\u305f\u3002\u73cd\u3057\u3044\u3053\u3068\u3067\u306f\u3042\u308a\u307e\u305b\u3093\u304c\u3001\u9069\u5207\u306a\u8a08\u753b\u3068\u5b9f\u884c\u306b\u3088\u3063\u3066\u56de\u907f\u3067\u304d\u305f\u306f\u305a\u306e\u8ab2\u984c\u3067\u3059\u3002<\/span><\/p>\n<h3><span class=\"ez-toc-section\" id=\"1_Planning_Phase_Sketch\"><\/span>1.\u4f01\u753b\u6bb5\u968e\uff08\u30b9\u30b1\u30c3\u30c1<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p><span style=\"font-weight: 400;\">\u533b\u7642\u6a5f\u5668\u30e1\u30fc\u30ab\u30fc\u306f\u3001\u4f01\u753b\u6bb5\u968e\u306b\u591a\u304f\u306e\u6642\u9593\u3092\u5272\u304f\u3079\u304d\u3067\u3059\u3002\u3057\u304b\u3057\u3001\u3053\u306e\u30d5\u30a7\u30fc\u30ba\u306f\u3001\u958b\u767a\u30d5\u30a7\u30fc\u30ba\u307b\u3069\u9577\u304f\u3059\u3079\u304d\u3067\u306f\u3042\u308a\u307e\u305b\u3093\u3002\u8a08\u753b\u6bb5\u968e\u306e\u4e3b\u306a\u76ee\u7684\u306f\u3001\u88fd\u54c1\u306e\u8981\u4ef6\u3092\u5b9a\u7fa9\u3059\u308b\u3053\u3068\u306b\u6642\u9593\u3092\u8cbb\u3084\u3059\u3053\u3068\u3067\u3059\u3002\u8a08\u753b\u6bb5\u968e\u3067\u306f\u3001\u533b\u7642\u6a5f\u5668\u30e1\u30fc\u30ab\u30fc\u306f\u3001\u898f\u5236\u9762\u3067\u306e\u88fd\u54c1\u6226\u7565\u306e\u7b56\u5b9a\u306b\u6642\u9593\u3092\u8cbb\u3084\u3057\u3001\u3055\u3089\u306b\u30b3\u30b9\u30c8\u3082\u8003\u616e\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002\u88fd\u54c1\u304c\u4f55\u3067\u3042\u308b\u304b\u3001\u305d\u3057\u3066\u305d\u308c\u3092\u5e02\u5834\u306b\u6295\u5165\u3059\u308b\u305f\u3081\u306e\u6226\u7565\u3092\u660e\u78ba\u306b\u3059\u308b\u3053\u3068\u3067\u3001\u958b\u767a\u6bb5\u968e\u306b\u5165\u308b\u3053\u3068\u304c\u3067\u304d\u3001\u52b9\u679c\u7684\u304b\u3064\u52b9\u7387\u7684\u306a\u30d7\u30ed\u30bb\u30b9\u304c\u53ef\u80fd\u306b\u306a\u308a\u307e\u3059\u3002\u4f01\u753b\u6bb5\u968e\u306b\u6642\u9593\u3068\u30ea\u30bd\u30fc\u30b9\u3092\u5272\u304f\u3053\u3068\u3067\u3001\u524d\u3082\u3063\u3066\u554f\u984c\u70b9\u3092\u89e3\u6c7a\u3057\u3088\u3046\u3068\u3059\u308b\u306e\u3067\u3001\u958b\u767a\u306e\u9053\u3092\u6f2b\u7136\u3068\u6b69\u3080\u3053\u3068\u306f\u3042\u308a\u307e\u305b\u3093\u3002\u3053\u308c\u306f\u3001\u975e\u5e38\u306b\u96c6\u4e2d\u3057\u305f\u52aa\u529b\u306b\u3088\u308b\u3001\u975e\u5e38\u306b\u96c6\u4e2d\u3057\u305f\u9053\u306a\u306e\u3067\u3059\u3002<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u30b9\u30b1\u30c3\u30c1\u306e\u6bb5\u968e\u3067\u306f\u3001ROI\u3092\u30de\u30c3\u30d4\u30f3\u30b0\u3059\u308b\u306e\u306f\u65e9\u3059\u304e\u307e\u3059\u304c\u3001\u533b\u7642\u6a5f\u5668\u3092\u30ca\u30d7\u30ad\u30f3\u304b\u3089\u958b\u767a\u6bb5\u968e\u306b\u6301\u3063\u3066\u3044\u304f\u969b\u306b\u306f\u3001\u6700\u521d\u306e\u6bb5\u968e\u3067\u30ea\u30bf\u30fc\u30f3\u3092\u691c\u8a0e\u3059\u308b\u306e\u304c\u826f\u3044\u3067\u3057\u3087\u3046\u3002ROI\u306b\u95a2\u3059\u308b\u6226\u7565\u3068\u3001\u3069\u306e\u3088\u3046\u306b\u30a2\u30d7\u30ed\u30fc\u30c1\u3059\u308b\u304b\u306e\u30b3\u30f3\u30bb\u30d7\u30c8\u3092\u6301\u3064\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002\u4f01\u753b\u6bb5\u968e\u3067\u306f\u3001\u30d7\u30ed\u30b8\u30a7\u30af\u30c8\u306e\u30ad\u30fc\u30d1\u30fc\u30bd\u30f3\u5168\u54e1\u304c\u96c6\u307e\u3063\u3066\u30011\u5e74\u76ee\u306e\u4e88\u6e2c\u30012\u5e74\u76ee\u30013\u5e74\u76ee\u30014\u5e74\u76ee\u30015\u5e74\u76ee\u306e\u4e88\u6e2c\u306b\u3064\u3044\u3066\u5bbf\u984c\u3092\u51fa\u3057\u307e\u3059\u3002\u3053\u306e\u3088\u3046\u306a\u5bbf\u984c\u306f\u3001\u7406\u306b\u304b\u306a\u3063\u305f\u6226\u7565\u3092\u7acb\u3066\u308b\u305f\u3081\u306b\u306f\u6975\u3081\u3066\u91cd\u8981\u3067\u3042\u308a\u3001\u305d\u308c\u304c\u6210\u529f\u306b\u3064\u306a\u304c\u308b\u306e\u3067\u3059\u3002\u533b\u7642\u6a5f\u5668\u30e1\u30fc\u30ab\u30fc\uff08\u3042\u308b\u3044\u306f\u4ed6\u306e\u4f01\u696d\uff09\u306b\u3068\u3063\u3066\u6700\u60aa\u306a\u306e\u306f\u3001\u88fd\u54c1\u3092\u767a\u58f2\u3057\u3066\u307f\u3093\u306a\u304c\u6c17\u306b\u5165\u3063\u3066\u304f\u308c\u305f\u306e\u306b\u3001\u751f\u7523\u80fd\u529b\u3084\u305d\u306e\u4ed6\u306e\u7406\u7531\u3067\u30d0\u30c3\u30af\u30aa\u30fc\u30c0\u30fc\u306b\u306a\u3063\u3066\u3057\u307e\u3044\u3001\u88fd\u54c1\u3092\u624b\u306b\u5165\u308c\u308b\u3053\u3068\u304c\u3067\u304d\u306a\u3044\u3053\u3068\u3067\u3059\u3002<\/span><\/p>\n<h3><span class=\"ez-toc-section\" id=\"2_Patent_Analysis\"><\/span>2. <b>\u7279\u8a31\u5206\u6790<\/b><span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p><span style=\"font-weight: 400;\">\u6700\u3082\u91cd\u8981\u306a\u30b9\u30c6\u30c3\u30d7\u306f\u3001\u77e5\u7684\u8ca1\u7523\uff08IP\uff09\u3092\u81ea\u793e\u306e\u7ba1\u7406\u4e0b\u306b\u7f6e\u304f\u3053\u3068\u3067\u3059\u3002IP\u306f\u3001\u533b\u7642\u6a5f\u5668\u30e1\u30fc\u30ab\u30fc\u304c\u88fd\u54c1\u3092\u5546\u54c1\u5316\u3057\u3066\u304a\u91d1\u3092\u7a3c\u3050\u305f\u3081\u306e\u624b\u6bb5\u3067\u3059\u3002\u6280\u8853\u3092\u7d39\u4ecb\u3055\u308c\u305f\u308a\u3001\u81ea\u5206\u3067\u6280\u8853\u3092\u767a\u660e\u3057\u305f\u308a\u3057\u305f\u5834\u5408\u3001\u307e\u305a\u6700\u521d\u306b\u3084\u308b\u3079\u304d\u3053\u3068\u306fIP\u3067\u3059\u3002IP\u304c\u30ab\u30d0\u30fc\u3055\u308c\u308b\u3068\u3001\u6b21\u306b\u5e02\u5834\u306b\u76ee\u3092\u5411\u3051\u307e\u3059\u3002\u533b\u7642\u6a5f\u5668\u30e1\u30fc\u30ab\u30fc\u306f\u3001\u305f\u3068\u3048\u8a2d\u8a08\u306e\u518d\u691c\u8a0e\u6bb5\u968e\u3092\u7d4c\u305f\u3068\u3057\u3066\u3082\u3001IP\u3092\u78ba\u5b9f\u306b\u7ba1\u7406\u3059\u308b\u3053\u3068\u3092\u304a\u52e7\u3081\u3057\u307e\u3059\u3002\u533b\u7642\u6a5f\u5668\u30e1\u30fc\u30ab\u30fc\u304c\u77e5\u7684\u8ca1\u7523\u6a29\u306e\u7d1b\u4e89\u306b\u76f4\u9762\u3057\u305f\u5834\u5408\u306e\u554f\u984c\u70b9\u3092\u3044\u304f\u3064\u304b\u6319\u3052\u308b\u3068\u3059\u308c\u3070\u3001\u8a34\u8a1f\u8cbb\u7528\u3001\u5e83\u5831\u6d3b\u52d5\u3084\u95a2\u4fc2\u69cb\u7bc9\u306e\u554f\u984c\u3001\u958b\u767a\u30fb\u751f\u7523\u30fb\u8ca9\u58f2\u3078\u306e\u5f71\u97ff\u3001\u305d\u3057\u3066\u6700\u5f8c\u306b\u3001\u7d4c\u55b6\u9663\u306e\u6c17\u82e6\u52b4\u3067\u3059\u3002<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u65b0\u3057\u3044\u533b\u7642\u6a5f\u5668\u306e\u77e5\u7684\u8ca1\u7523\u3092\u4f01\u753b\u30fb\u958b\u767a\u6bb5\u968e\u304b\u3089\u78ba\u5b9f\u306b\u4fdd\u8b77\u3059\u308b\u305f\u3081\u306b\u306f\u3001\u533b\u7642\u6a5f\u5668\u7279\u8a31\u3068\u533b\u7642\u88fd\u54c1\u5546\u6a19\u306e\u4e21\u65b9\u3092\u51fa\u9858\u3059\u308b\u3053\u3068\u3092\u691c\u8a0e\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002\u533b\u7642\u6a5f\u5668\u306e\u5834\u5408\u3001\u30ea\u30d0\u30fc\u30b9\u30a8\u30f3\u30b8\u30cb\u30a2\u30ea\u30f3\u30b0\u3092\u884c\u3044\u3001\u4ee3\u66ff\u30c7\u30b6\u30a4\u30f3\u3084\u6539\u826f\u306e\u305f\u3073\u306b\u4fdd\u8b77\u3092\u7533\u8acb\u3059\u308b\u3053\u3068\u3092\u304a\u52e7\u3081\u3057\u307e\u3059\u3002\u533b\u7642\u6a5f\u5668\u30e1\u30fc\u30ab\u30fc\u306f\u3001\u533b\u7642\u88fd\u54c1\u306e\u88fd\u9020\u3001\u8ca9\u58f2\u3001\u6d41\u901a\u3092\u884c\u3046\u5834\u6240\u3092\u78ba\u7acb\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002\u30b3\u30b9\u30c8\u3068\u30d9\u30cd\u30d5\u30a3\u30c3\u30c8\u306e\u30d0\u30e9\u30f3\u30b9\u304c\u3068\u308c\u305f\u56fd\u3067\u4fdd\u8b77\u3092\u7533\u8acb\u3059\u308b\u3053\u3068\u3092\u304a\u52e7\u3081\u3057\u307e\u3059\u3002\u30de\u30fc\u30ab\u30fc\u30b5\u30a4\u30ba\u306b\u3064\u3044\u3066\u306f\u3001\u56fd\u969b\u5e02\u5834\u304c\u7c73\u56fd\u5e02\u5834\u3068\u540c\u7a0b\u5ea6\u306e\u898f\u6a21\u3067\u3042\u308b\u3068\u4eee\u5b9a\u3059\u308b\u306e\u304c\u826f\u3044\u7d4c\u9a13\u5247\u3068\u306a\u308a\u307e\u3059\u3002\u533b\u7642\u6a5f\u5668\u306e\u8a2d\u8a08\u3067\u306f\u3001\u30d5\u30eb\u30bf\u30a4\u30e0\u3067\u96c7\u7528\u3059\u308b\u306e\u3067\u306f\u306a\u304f\u3001\u591a\u304f\u306e\u30d5\u30ea\u30fc\u30e9\u30f3\u30b5\u30fc\u3084\u5951\u7d04\u306e\u4e3b\u984c\u5c02\u9580\u5bb6\uff08SME\uff09\u3092\u6271\u3046\u3053\u3068\u304c\u3042\u308a\u307e\u3059\u3002\u3053\u306e\u5834\u5408\u3001\u3059\u3079\u3066\u306e\u6295\u8cc7\u30d1\u30fc\u30c8\u30ca\u30fc\u3001\u958b\u767a\u8005\u3001\u88fd\u9020\u8005\u3001\u30d5\u30ea\u30fc\u30e9\u30f3\u30b5\u30fc\u3001\u5951\u7d04\u8005\u3001\u8ca9\u58f2\u696d\u8005\u3001\u304a\u3088\u3073\u5c02\u6709\u60c5\u5831\u306b\u30a2\u30af\u30bb\u30b9\u3059\u308b\u3053\u3068\u306b\u306a\u308b\u305d\u306e\u4ed6\u306e\u500b\u4eba\u3068\u306e\u9593\u3067\u79d8\u5bc6\u4fdd\u6301\u5951\u7d04\uff08NDA\uff09\u3092\u7d50\u3093\u3067\u304a\u304f\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002\u6700\u8fd1\u3067\u306f\u3001IP\u4fdd\u967a\u306b\u52a0\u5165\u3059\u308b\u3053\u3068\u3067\u5f97\u3089\u308c\u308b\u4fdd\u8b77\u3068\u30b3\u30b9\u30c8\u306e\u30d0\u30e9\u30f3\u30b9\u3092\u8003\u616e\u3057\u3066\u3001IP\u4fdd\u967a\u3078\u306e\u52a0\u5165\u3092\u691c\u8a0e\u3059\u308b\u3053\u3068\u3082\u3067\u304d\u307e\u3059\u3002<\/span><\/p>\n<h3><span class=\"ez-toc-section\" id=\"3_Market_Relevance\"><\/span>3. <b>\u5e02\u5834\u3068\u306e\u95a2\u9023\u6027<\/b><span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p><span style=\"font-weight: 400;\">\u533b\u7642\u6a5f\u5668\u306e\u5546\u54c1\u5316\u3092\u691c\u8a0e\u3059\u308b\u969b\u3001\u5e02\u5834\u8abf\u67fb\u306f\u975e\u5e38\u306b\u91cd\u8981\u3067\u3059\u3002\u533b\u7642\u6a5f\u5668\u306e\u30b9\u30bf\u30fc\u30c8\u30a2\u30c3\u30d7\u3068\u3057\u3066\u306f\u3001\u81ea\u793e\u88fd\u54c1\u306e\u5e02\u5834\u304c\u3042\u308b\u304b\u3069\u3046\u304b\u3092\u78ba\u8a8d\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002\u6f5c\u5728\u7684\u306a\u7af6\u5408\u4ed6\u793e\u306b\u3064\u3044\u3066\u306f\u3001\u30c7\u30e5\u30fc\u30c7\u30ea\u30b8\u30a7\u30f3\u30b9\u3092\u884c\u3044\u3001\u65e2\u306b\u5e02\u5834\u306b\u51fa\u56de\u3063\u3066\u3044\u308b\u88fd\u54c1\u3068\u6bd4\u8f03\u3057\u3066\u3001\u81ea\u793e\u306e\u88fd\u54c1\u3092\u8a55\u4fa1\u3059\u308b\u3053\u3068\u3092\u5f37\u304f\u304a\u52e7\u3081\u3057\u307e\u3059\u3002\u5e02\u5834\u8abf\u67fb\u306e\u6bb5\u968e\u3067\u306f\u3001\u3044\u304f\u3064\u304b\u306e\u91cd\u8981\u306a\u8cea\u554f\u3092\u81ea\u5206\u305f\u3061\u306b\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002<\/span><\/p>\n<ul>\n<li><span style=\"font-weight: 400;\"> \u00a0 \u00a0 \u00a0 <\/span><span style=\"font-weight: 400;\">\u79c1\u306e\u533b\u7642\u6a5f\u5668\u306f\u3001\u5e02\u5834\u306b\u9069\u3057\u3066\u3044\u308b\u306e\u304b\uff1f<\/span><\/li>\n<li><span style=\"font-weight: 400;\"> \u00a0 \u00a0 \u00a0 <\/span><span style=\"font-weight: 400;\">\u79c1\u306e\u30c7\u30d0\u30a4\u30b9\u306f\u3001\u30a2\u30f3\u30e1\u30c3\u30c8\u30cb\u30fc\u30ba\u3092\u6e80\u305f\u3059\u3082\u306e\u304b\uff1f<\/span><\/li>\n<li><span style=\"font-weight: 400;\"> \u00a0 \u00a0 \u00a0 <\/span><span style=\"font-weight: 400;\">\u533b\u7642\u306e\u63d0\u4f9b\u65b9\u6cd5\u304c\u5909\u308f\u308b\u306e\u3067\u3057\u3087\u3046\u304b\uff1f<\/span><\/li>\n<li><span style=\"font-weight: 400;\"> \u00a0 \u00a0 \u00a0 <\/span><span style=\"font-weight: 400;\">\u81ea\u5206\u306e\u88fd\u54c1\u3092\u8cb7\u3063\u3066\u304f\u308c\u308b\u306e\u306f\u8ab0\u304b\u3001\u4e16\u754c\u306e\u3069\u3053\u3067\u58f2\u308b\u3053\u3068\u304c\u3067\u304d\u308b\u306e\u304b\u3002<\/span><\/li>\n<li><span style=\"font-weight: 400;\"> \u00a0 \u00a0 \u00a0 <\/span><span style=\"font-weight: 400;\">\u7269\u4e8b\u306e\u9032\u3081\u65b9\u304c\u6539\u5584\u3055\u308c\u308b\u306e\u304b\uff1f\u00a0<\/span><\/li>\n<li><span style=\"font-weight: 400;\"> \u00a0 \u00a0 \u00a0 <\/span><span style=\"font-weight: 400;\">\u305d\u308c\u306f\u751f\u6d3b\u306e\u8cea\u3092\u5411\u4e0a\u3055\u305b\u308b\u3082\u306e\u306a\u306e\u304b\uff1f<\/span><\/li>\n<li><span style=\"font-weight: 400;\"> \u00a0 \u00a0 \u00a0 <\/span><span style=\"font-weight: 400;\">\u81ea\u5206\u304c\u767a\u58f2\u3057\u3088\u3046\u3068\u3057\u3066\u3044\u308b\u88fd\u54c1\u3068\u540c\u3058\u3088\u3046\u306a\u6a5f\u80fd\u3092\u6301\u3064\u88fd\u54c1\u306f\u4ed6\u306b\u3042\u308b\u3060\u308d\u3046\u304b\uff1f<\/span><\/li>\n<li><span style=\"font-weight: 400;\"> \u00a0 \u00a0 \u00a0 <\/span><span style=\"font-weight: 400;\">\u73fe\u5728\u5165\u624b\u53ef\u80fd\u306a\u7af6\u5408\u88fd\u54c1\u3001\u6280\u8853\u3001\u30b5\u30fc\u30d3\u30b9\u306f\u4f55\u304b\uff1f<\/span><\/li>\n<li><span style=\"font-weight: 400;\"> \u00a0 \u00a0 \u00a0 <\/span><span style=\"font-weight: 400;\">\u81ea\u5206\u306e\u88fd\u54c1\u304c\u7af6\u5408\u4ed6\u793e\u306b\u6bd4\u3079\u3066\u3069\u306e\u3088\u3046\u306b\u512a\u308c\u3066\u3044\u308b\u306e\u304b\uff1f<\/span><\/li>\n<\/ul>\n<p><span style=\"font-weight: 400;\">\u533b\u7642\u6a5f\u5668\u30e1\u30fc\u30ab\u30fc\u3068\u3057\u3066\u306f\u3001\u4e0a\u8a18\u306e\u3088\u3046\u306a\u8cea\u554f\u304c\u304d\u3061\u3093\u3068\u8d77\u304d\u3066\u3044\u3066\u3001\u6700\u521d\u306e\u30d6\u30ec\u30fc\u30f3\u30b9\u30c8\u30fc\u30df\u30f3\u30b0\u3067\u53d6\u308a\u4e0a\u3052\u3089\u308c\u3066\u3044\u308b\u304b\u3001\u5c11\u306a\u304f\u3068\u3082\u30ad\u30c3\u30af\u30aa\u30d5\u3067\u8a71\u3057\u5408\u308f\u308c\u3066\u3044\u308b\u3053\u3068\u3092\u81ea\u5206\u305f\u3061\u3067\u8a3c\u660e\u3057\u306a\u3051\u308c\u3070\u306a\u308a\u307e\u305b\u3093\u3002\u3053\u308c\u304c\u884c\u308f\u308c\u3066\u3044\u306a\u3051\u308c\u3070\u3001\u524d\u306b\u9032\u3080\u3053\u3068\u306f\u3067\u304d\u307e\u305b\u3093\u3002\u79c1\u306e\u63a8\u5968\u3059\u308b\u3068\u3053\u308d\u3067\u306f\u3001\u6642\u9593\u3092\u304b\u3051\u3066\u88fd\u54c1\u306e\u8aac\u660e\u3092\uff08\u4f01\u753b\u6bb5\u968e\u3088\u308a\u3082\u5e83\u3044\u610f\u5473\u3067\uff09\u66f8\u304d\u51fa\u3057\u3001\u4e0a\u8a18\u306e\u8cea\u554f\u306b\u5bfe\u3059\u308b\u7b54\u3048\u306e\u30ea\u30b9\u30c8\u3092\u4f5c\u308b\u3079\u304d\u3067\u3059\u3002\u3053\u306e\u30ea\u30b9\u30c8\u306f\u7db2\u7f85\u7684\u3067\u3042\u308b\u5fc5\u8981\u306f\u3042\u308a\u307e\u305b\u3093\u304c\u3001\u3053\u306e\u3088\u3046\u306a\u30ea\u30b9\u30c8\u304c\u3042\u308c\u3070\u3001\u3042\u306a\u305f\u306e\u533b\u7642\u6a5f\u5668\u306b\u5bfe\u3059\u308b\u5e02\u5834\u306e\u9700\u8981\u3092\u5224\u65ad\u3059\u308b\u305f\u3081\u306e\u826f\u3044\u8cc7\u6599\u306b\u306a\u308a\u307e\u3059\u3002\u3055\u3089\u306b\u3001\u3053\u306e\u30ea\u30b9\u30c8\u306f\u3001\u3042\u306a\u305f\u304c\u533b\u7642\u6a5f\u5668\u306e\u30b9\u30bf\u30fc\u30c8\u30a2\u30c3\u30d7\u306e\u5275\u696d\u8005\u3067\u3042\u308a\u3001\u672c\u6c17\u3067\u305d\u308c\u3092\u6210\u529f\u3055\u305b\u305f\u3044\u3068\u601d\u3063\u3066\u3044\u308b\u5834\u5408\u3001\u8d77\u696d\u5bb6\u3068\u3057\u3066\u306e\u76ee\u7684\u3092\u601d\u3044\u51fa\u3059\u306e\u306b\u5f79\u7acb\u3064\u3068\u8a00\u3048\u308b\u3067\u3057\u3087\u3046\u3002\u6b8b\u5ff5\u306a\u3053\u3068\u306b\u3001\u79c1\u306f\u4eba\u985e\u3092\u52a9\u3051\u308b\u3053\u3068\u304c\u3067\u304d\u308b\u7d20\u6674\u3089\u3057\u3044\u88fd\u54c1\u3084\u30bd\u30ea\u30e5\u30fc\u30b7\u30e7\u30f3\u3092\u305f\u304f\u3055\u3093\u898b\u3066\u304d\u307e\u3057\u305f\u304c\u3001\u305d\u306e\u3088\u3046\u306a\u30bd\u30ea\u30e5\u30fc\u30b7\u30e7\u30f3\u306b\u304a\u91d1\u3092\u6255\u3046\u4f59\u88d5\u306e\u3042\u308b\u4eba\u306f\u3044\u307e\u305b\u3093\u3057\u3001\u30e1\u30fc\u30ab\u30fc\u306b\u305f\u3069\u308a\u7740\u304f\u307e\u3067\u306b\u4f55\u5104\u3082\u306e\u8cbb\u7528\u304c\u304b\u304b\u308a\u3001\u4eba\u3005\u306f\u305d\u306e\u88fd\u54c1\u306b\u6570\u30c9\u30eb\u3057\u304b\u6255\u308f\u306a\u3044\u3067\u3057\u3087\u3046\u3002\u8ca1\u52d9\u7684\u5b9f\u73fe\u6027\u30e2\u30c7\u30eb\u306f\u3001\u4e88\u7b97\u3084\u30d7\u30ed\u30d5\u30a9\u30fc\u30de\u306e\u8cb8\u501f\u5bfe\u7167\u8868\u3068\u306f\u7570\u306a\u308a\u3001\u5e02\u5834\u306e\u95a2\u9023\u6027\u3092\u8a55\u4fa1\u3059\u308b\u6bb5\u968e\u3067\u884c\u308f\u308c\u307e\u3059\u3002\u3053\u308c\u306f\u3001\u5e02\u5834\u304c\u8ca0\u62c5\u3059\u308b\u91d1\u984d\u306b\u5bfe\u3059\u308b\u6709\u52b9\u6027\u3092\u8a55\u4fa1\u3057\u3001\u533b\u7642\u6a5f\u5668\u30e1\u30fc\u30ab\u30fc\u304c\u59a5\u5f53\u306a\u4fa1\u683c\u3067\u88fd\u54c1\u3092\u88fd\u9020\u3067\u304d\u308b\u304b\u3069\u3046\u304b\u3092\u5224\u65ad\u3059\u308b\u305f\u3081\u306b\u884c\u308f\u308c\u308b\u3082\u306e\u3067\u3059\u3002\u3053\u308c\u304c\u91cd\u8981\u3067\u3001\u540c\u3058\u533b\u7642\u6a5f\u5668\u3067\u3082\u56fd\u3084\u5730\u57df\u306b\u3088\u3063\u3066\u4fa1\u683c\u304c\u7570\u306a\u308a\u307e\u3059\u3002\u4f8b\u3048\u3070\u3001\u79c1\u306e\u30af\u30e9\u30a4\u30a2\u30f3\u30c8\u306e\u4e00\u4eba\u306f\u3001\u3042\u308b\u6587\u5316\u570f\u3067\u306f\u305d\u306e\u30c7\u30d0\u30a4\u30b9\u304c\u4ed6\u306e\u6587\u5316\u570f\u3088\u308a\u3082\u504f\u3063\u3066\u3044\u308b\u304b\u3082\u3057\u308c\u306a\u3044\u3068\u3044\u3046\u5927\u304d\u306a\u8981\u56e0\u3092\u5ff5\u982d\u306b\u7f6e\u3044\u3066\u3001\u305d\u306e\u30c7\u30d0\u30a4\u30b9\u306e\u4fa1\u683c\u3092\u5927\u307e\u304b\u306b\u898b\u7a4d\u3082\u308b\u305f\u3081\u306e\u6587\u5316\u8abf\u67fb\u3092\u884c\u3063\u3066\u3044\u307e\u3057\u305f\u3002\u3053\u306e\u3088\u3046\u306b\u3057\u3066\u3001\u8cc7\u672c\u91d1\u306e\u984d\u3092\u6c7a\u3081\u308b\u3053\u3068\u304c\u3067\u304d\u305f\u306e\u3067\u3059\u3002\u3053\u306e\u3088\u3046\u306a\u8981\u7d20\u306f\u3001\u56fd\u969b\u7684\u306a\u5e02\u5834\u3092\u77e5\u3089\u306a\u3044\u3068\u306a\u304b\u306a\u304b\u6e2c\u308c\u307e\u305b\u3093\u3002<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u4e00\u8a00\u3067\u8a00\u3048\u3070\u3001\u533b\u7642\u6a5f\u5668\u3092\u5e02\u5834\u306b\u6295\u5165\u3059\u308b\u305f\u3081\u306b\u306f\u3001\u540c\u3058\u76ee\u7684\u3092\u6301\u3063\u305f\u4ed6\u306e\u88fd\u54c1\u306b\u5bfe\u3059\u308b\u7af6\u4e89\u529b\u304c\u5fc5\u8981\u3067\u3042\u308a\u3001\u65e9\u3044\u6bb5\u968e\u3067\u305d\u306e\u5dee\u5225\u5316\u8981\u7d20\u3092\u5f37\u8abf\u3059\u308b\u305f\u3081\u306e\u6982\u8981\u3068\u8a08\u753b\u304c\u5fc5\u8981\u306b\u306a\u308a\u307e\u3059\u3002<\/span><\/p>\n<h3><span class=\"ez-toc-section\" id=\"4_Regulatory_Compliance\"><\/span>4. <b>\u6cd5\u4ee4\u9075\u5b88<\/b><span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p><span style=\"font-weight: 400;\">\u30ec\u30ae\u30e5\u30e9\u30c8\u30ea\u30fc\u30fb\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u307e\u305f\u306f\u30ec\u30ae\u30e5\u30e9\u30c8\u30ea\u30fc\u30fb\u30b9\u30c8\u30e9\u30c6\u30b8\u30fc\u306f\u3001\u533b\u7642\u6a5f\u5668\u306e\u7acb\u3061\u4e0a\u3052\u306b\u304a\u3044\u3066\u6700\u3082\u56f0\u96e3\u306a\u5074\u9762\u306e\u4e00\u3064\u3067\u3059\u3002\u898f\u5236\u306e\u6ce2\u3092\u3046\u307e\u304f\u4e57\u308a\u8d8a\u3048\u308b\u305f\u3081\u306b\u306f\u3001\u958b\u767a\u306e\u65e9\u3044\u6bb5\u968e\u3067\u898f\u5236\u62c5\u5f53\u8005\u3092\u898b\u3064\u3051\u308b\u3053\u3068\u304c\u671b\u307e\u308c\u307e\u3059\u3002\u307e\u305f\u3001\u533b\u7642\u6a5f\u5668\u4f01\u696d\u3068\u3057\u3066\u3001\u30d4\u30c3\u30c1\u30c7\u30c3\u30ad\u3084\u30d3\u30b8\u30cd\u30b9\u30d7\u30e9\u30f3\u3092\u4f5c\u6210\u3059\u308b\u969b\u306b\u306f\u3001\u81ea\u793e\u306e\u6a5f\u5668\u304c\u3069\u306e\u3088\u3046\u306a\u85ac\u4e8b\u898f\u5236\u3092\u53d7\u3051\u308b\u53ef\u80fd\u6027\u304c\u3042\u308b\u304b\u3092\u8abf\u67fb\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002 <\/span><\/p>\n<blockquote><p><span style=\"font-weight: 400;\">\u79c1\u306f\u3044\u3064\u3082\u3001\u5177\u4f53\u7684\u3067\u8a73\u7d30\u306a\u898f\u5236\u306e\u8a08\u753b\u3092\u7acb\u3066\u308b\u306e\u306f\u3044\u3064\u304c\u3044\u3044\u306e\u304b\u3068\u805e\u304b\u308c\u307e\u3059\u3002\u3067\u304d\u308b\u3060\u3051\u65e9\u3044\u307b\u3046\u304c\u3044\u3044\u3067\u3059\u306d\u3002\u3059\u3079\u3066\u306e\u533b\u7642\u6a5f\u5668\u306f\u305d\u308c\u305e\u308c\u7570\u306a\u308a\u3001\u72ec\u81ea\u306e\u85ac\u4e8b\u6226\u7565\u3092\u6301\u3063\u3066\u3044\u308b\u3053\u3068\u3092\u899a\u3048\u3066\u304a\u304f\u3053\u3068\u306f\u975e\u5e38\u306b\u91cd\u8981\u3067\u3059\u3002<\/span><\/p><\/blockquote>\n<p><span style=\"font-weight: 400;\"> \u898f\u5b9a\u3055\u308c\u305f\u898f\u5236\u306e\u9053\u7b4b\u306f\u3042\u308a\u307e\u305b\u3093\u304c\u3001\u898f\u5236\u9075\u5b88\u306e\u305f\u3081\u306e\u6700\u826f\u306e\u6226\u7565\u306f\u3001\u30c7\u30d0\u30a4\u30b9\u958b\u767a\u306b\u5411\u3051\u305f\u3059\u3079\u3066\u306e\u30b9\u30c6\u30c3\u30d7\u3092\u660e\u78ba\u306b\u6587\u66f8\u5316\u3057\u3001\u305d\u306e\u6839\u62e0\u3092\u793a\u3057\u305f\u4e0a\u3067\u3001\u7a4d\u6975\u7684\u306a\u8a08\u753b\u3092\u7acb\u3066\u308b\u3053\u3068\u3067\u3059\u3002\u3059\u3079\u3066\u306e\u4e3b\u8981\u5e02\u5834\u306b\u306f\u3001\u7279\u5b9a\u306e\u898f\u5236\u306e\u67a0\u7d44\u307f\u304c\u3042\u308a\u307e\u3059\u3002\u533b\u7642\u6a5f\u5668\u4f01\u696d\u3068\u3057\u3066\u3001\u898f\u5236\u8981\u4ef6\u306e\u7d30\u304b\u306a\u9055\u3044\u3092\u7406\u89e3\u3059\u308b\u305f\u3081\u306b\u6642\u9593\u3092\u8cbb\u3084\u3059\u5fc5\u8981\u306f\u3042\u308a\u307e\u305b\u3093\u304c\u3001\u9069\u5207\u306a\u30d3\u30b8\u30cd\u30b9\u30d7\u30e9\u30f3\u306b\u5f93\u3046\u3053\u3068\u3067\u3001\u6295\u8cc7\u306b\u898b\u5408\u3063\u305f\u5229\u76ca\u3092\u5f97\u308b\u3053\u3068\u304c\u3067\u304d\u307e\u3059\u3002\u307e\u305f\u3001\u3042\u308b\u5e02\u5834\u3092\u8e0f\u307f\u53f0\u306b\u3057\u3066\u3001\u5225\u306e\u898f\u5236\u5e02\u5834\u306b\u53c2\u5165\u3059\u308b\u3053\u3068\u3082\u91cd\u8981\u3067\u3059\u3002\u533b\u7642\u6a5f\u5668\u306e\u5834\u5408\u3001\u610f\u56f3\u3055\u308c\u305f\u7528\u9014\u3092\u7406\u89e3\u3057\u3001\u5b9a\u7fa9\u3057\u3001\u6587\u66f8\u5316\u3059\u308b\u3053\u3068\u304c\u91cd\u8981\u3067\u3059\u3002\u3053\u308c\u306f\u3001\u6a5f\u5668\u306e\u7bc4\u56f2\u3092\u78ba\u7acb\u3059\u308b\u306e\u306b\u5f79\u7acb\u3061\u3001\u30e6\u30fc\u30b6\u30fc\u30cb\u30fc\u30ba\u3001\u8a2d\u8a08\u30a4\u30f3\u30d7\u30c3\u30c8\u3001\u305d\u306e\u4ed6\u306e\u8a2d\u8a08\u30fb\u958b\u767a\u6d3b\u52d5\u3092\u5b9a\u7fa9\u3059\u308b\u969b\u306b\u5f79\u7acb\u3061\u307e\u3059\u3002\u610f\u56f3\u7684\u306a\u4f7f\u7528\u306f\u3001\u6700\u7d42\u7684\u306b\u898f\u5236\u6a5f\u95a2\u304b\u3089\u306e\u8a8d\u53ef\u3092\u5f97\u308b\u305f\u3081\u306e\u7d4c\u8def\u3092\u6c7a\u5b9a\u3059\u308b\u3001\u898f\u5236\u4e0a\u306e\u88fd\u54c1\u5206\u985e\u3092\u30b5\u30dd\u30fc\u30c8\u3059\u308b\u305f\u3081\u306b\u3082\u91cd\u8981\u3067\u3059\u3002<\/span><\/p>\n<p><span style=\"font-weight: 400;\">FDA\u3092\u4f8b\u306b\u3068\u308b\u3068\u3001\u30ec\u30ae\u30e5\u30e9\u30c8\u30ea\u30fc\u30fb\u30c1\u30e3\u30f3\u30d4\u30aa\u30f3\u3084\u5f01\u8b77\u58eb\u306e\u5b58\u5728\u306f\u3001\u898f\u5236\u9075\u5b88\u306e\u305f\u3081\u306b\u975e\u5e38\u306b\u91cd\u8981\u3067\u3059\u3002FDA\u3067\u306e\u7d4c\u9a13\u3092\u6301\u3064\u898f\u5236\u306e\u5c02\u9580\u5bb6\u306f\u3001\u30d7\u30ed\u30b8\u30a7\u30af\u30c8\u306e\u30cb\u30fc\u30ba\u306b\u3064\u3044\u3066FDA\u3092\u6559\u80b2\u3059\u308b\u305f\u3081\u306e\u6642\u9593\u3092\u77ed\u7e2e\u3059\u308b\u306e\u306b\u5f79\u7acb\u3061\u307e\u3059\u3002  FDA\u3078\u306e\u6559\u80b2\u3084\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u306b\u8cbb\u3084\u3059\u6642\u9593\u306f\u3001\u5e02\u5834\u304b\u3089\u96e2\u308c\u308b\u6642\u9593\u3068\u306a\u308a\u307e\u3059\u3002  \u30ec\u30ae\u30e5\u30e9\u30c8\u30ea\u30fc\u5f01\u8b77\u58eb\u306f\u3001\u3053\u306e\u30d7\u30ed\u30bb\u30b9\u3092\u8fc5\u901f\u306b\u9032\u3081\u308b\u3053\u3068\u304c\u3067\u304d\u307e\u3059\u3002\u7d99\u7d9a\u7684\u306bFDA\u3068\u3084\u308a\u3068\u308a\u3059\u308b\u9069\u5207\u306a\u898f\u5236\u95a2\u9023\u5f01\u8b77\u58eb\u3092\u898b\u3064\u3051\u308b\u3053\u3068\u304c\u91cd\u8981\u3067\u3059\u3002FDA\u3068\u306e\u95a2\u4fc2\u3092\u6301\u3064\u3053\u3068\u306f\u975e\u5e38\u306b\u91cd\u8981\u3067\u3059\u3002FDA\u306e\u627f\u8a8d\u3092\u5f97\u3088\u3046\u3068\u3057\u3066\u3044\u308b\u533b\u7642\u6a5f\u5668\u30e1\u30fc\u30ab\u30fc\u306f\u3001\u65e9\u3044\u6bb5\u968e\u3067\u898f\u5236\u62c5\u5f53\u8005\u3068\u4f1a\u3046\u305f\u3081\u306e\u30aa\u30d7\u30b7\u30e7\u30f3\u3092\u6d3b\u7528\u3059\u308b\u3053\u3068\u304c\u91cd\u8981\u3067\u3059\u3002FDA\u3068\u306e\u30d7\u30ec\u30b5\u30d6\u30df\u30c3\u30b7\u30e7\u30f3\u30df\u30fc\u30c6\u30a3\u30f3\u30b0\u3092\u7533\u8acb\u3057\u3066\u304f\u3060\u3055\u3044\u3002\u3053\u306e\u3088\u3046\u306a\u30df\u30fc\u30c6\u30a3\u30f3\u30b0\u306f\u975e\u5e38\u306b\u4fa1\u5024\u304c\u3042\u308a\u307e\u3059\u3002\u63d0\u51fa\u524d\u30df\u30fc\u30c6\u30a3\u30f3\u30b0\u306f\u30d7\u30ed\u30bb\u30b9\u306e\u4e00\u90e8\u3067\u3042\u308b\u3079\u304d\u3067\u3001\u898f\u5236\u5f53\u5c40\u3068\u306e\u8b70\u8ad6\u306b\u5165\u308b\u306e\u3067\u306f\u306a\u304f\u3001\u304d\u3061\u3093\u3068\u4e0b\u8abf\u3079\u3092\u3057\u3066\u5f7c\u3089\u306e\u8996\u70b9\u3092\u7406\u89e3\u3059\u308b\u3053\u3068\u304c\u975e\u5e38\u306b\u91cd\u8981\u3067\u3059\u3002<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u30b9\u30bf\u30fc\u30c8\u30a2\u30c3\u30d7\u4f01\u696d\u306b\u3068\u3063\u3066\u3001\u898f\u5236\u95a2\u9023\u306e\u5f01\u8b77\u58eb\u3092\u96c7\u3063\u305f\u308a\u3001\u898f\u5236\u95a2\u9023\u306e\u5c02\u9580\u77e5\u8b58\u3092\u5f97\u308b\u305f\u3081\u306b\u591a\u984d\u306e\u8cbb\u7528\u3092\u304b\u3051\u305f\u308a\u3059\u308b\u3053\u3068\u306f\u30b3\u30b9\u30c8\u7684\u306b\u96e3\u3057\u3044\u3068\u601d\u308f\u308c\u308b\u3053\u3068\u304c\u3042\u308a\u307e\u3059\u304c\u3001\u8a2d\u8a08\u306e\u3084\u308a\u76f4\u3057\u3084\u53cd\u5fa9\u4f5c\u696d\u306b\u76f4\u9762\u3059\u308b\u3053\u3068\u306f\u907f\u3051\u305f\u3044\u3082\u306e\u3067\u3059\u3002\u958b\u767a\u30d7\u30ed\u30bb\u30b9\u3092\u9032\u3081\u3066\u3044\u304f\u3068\u3001\u305d\u306e\u3088\u3046\u306a\u8ab2\u984c\u306f\u3044\u304f\u3089\u3067\u3082\u3042\u308a\u307e\u3059\u3002\u6700\u7d42\u7684\u306b\u898f\u5236\u306b\u9069\u5408\u3057\u3066\u3044\u306a\u3044\u3053\u3068\u304c\u5224\u660e\u3059\u308b\u3068\u3001\u6700\u521d\u304b\u3089\u3084\u308a\u76f4\u3059\u3053\u3068\u306b\u306a\u308a\u307e\u3059\u3002\u305d\u3046\u306a\u308b\u3068\u3001\u975e\u5e38\u306b\u30b3\u30b9\u30c8\u304c\u304b\u304b\u308a\u307e\u3059\u3057\u3001\u5e02\u5834\u3078\u306e\u53c2\u5165\u304c\u9045\u308c\u3066\u3057\u307e\u3044\u307e\u3059\u3002<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u85ac\u4e8b\u898f\u5236\u306e\u30cf\u30fc\u30c9\u30eb\u3092\u8d8a\u3048\u305f\u5f8c\u306f\u3001\u5e02\u5834\u5c0e\u5165\u306e\u305f\u3081\u306e\u54c1\u8cea\u4fdd\u8a3c\u306b\u5165\u3089\u306a\u3051\u308c\u3070\u306a\u308a\u307e\u305b\u3093\u3002<\/span><\/p>\n<h3><span class=\"ez-toc-section\" id=\"5_Quality_Assurance\"><\/span>5. <b>\u54c1\u8cea\u4fdd\u8a3c<\/b><span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p><span style=\"font-weight: 400;\">\u533b\u7642\u6a5f\u5668\u30e1\u30fc\u30ab\u30fc\u3068\u3057\u3066\u3001\u54c1\u8cea\u30b7\u30b9\u30c6\u30e0\u3092\u69cb\u7bc9\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002\u88fd\u54c1\u306e\u767a\u58f2\u3092\u6210\u529f\u3055\u305b\u308b\u305f\u3081\u306b\u306f\u3001\u54c1\u8cea\u7ba1\u7406\u30b7\u30b9\u30c6\u30e0\uff08QMS\uff09\u304c\u4e0d\u53ef\u6b20\u3067\u3059\u3002\u88fd\u54c1\u3092\u5e02\u5834\u306b\u6295\u5165\u3059\u308b\u969b\u306b\u306f\u3001QMS\u306b\u57fa\u3065\u3044\u3066\u4f5c\u696d\u3092\u884c\u308f\u306a\u3051\u308c\u3070\u306a\u3089\u305a\u3001\u305d\u308c\u306b\u3088\u3063\u3066\u6642\u9593\u3001\u8cbb\u7528\u3001\u305d\u306e\u4ed6\u306e\u8cb4\u91cd\u306a\u30ea\u30bd\u30fc\u30b9\u3092\u7bc0\u7d04\u3059\u308b\u3053\u3068\u304c\u3067\u304d\u307e\u3059\u3002\u6700\u3082\u91cd\u8981\u306a\u3053\u3068\u306f\u3001\u7c73\u56fd\u5e02\u5834\u3067\u306f\u3001FDA\u306f\u7533\u8acb\u8005\u306b21 CFR\u30d1\u30fc\u30c8820\u306b\u8a18\u8f09\u3055\u308c\u305f\u898f\u5236\u306b\u5f93\u3046\u3053\u3068\u3092\u671f\u5f85\u3057\u3066\u3044\u307e\u3059\u304c\u3001\u7c73\u56fd\u5916\u3067\u306f\u3001ISO 13485\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u306b\u5f93\u3046\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002\u3053\u306e2\u3064\u306e\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u306b\u306f\u5927\u304d\u306a\u91cd\u8907\u304c\u3042\u308a\u3001\u307b\u3068\u3093\u3069\u306e\u5834\u5408\u3001\u7247\u65b9\u306e\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u306b\u6e96\u62e0\u3057\u3066\u3044\u308c\u3070\u3001\u91cd\u8907\u3057\u305f\u8a66\u9a13\u3092\u884c\u3046\u3053\u3068\u306a\u304f\u3001\u3082\u3046\u7247\u65b9\u306e\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u306b\u6e96\u62e0\u3059\u308b\u3053\u3068\u304c\u3067\u304d\u307e\u3059\u3002QMS\u306e\u826f\u3044\u3068\u3053\u308d\u306f\u3001QMS\u306b\u753b\u4e00\u7684\u306a\u6982\u5ff5\u306f\u306a\u304f\u3001\u81ea\u793e\u3068\u305d\u306e\u30cb\u30fc\u30ba\u306b\u5408\u3063\u305fQMS\u3092\u69cb\u7bc9\u3059\u308b\u3053\u3068\u304c\u3067\u304d\u308b\u3053\u3068\u3067\u3059\u3002CDMO\u3084\u533b\u7642\u6a5f\u5668\u30e1\u30fc\u30ab\u30fc\u306e\u4e2d\u306b\u306f\u3001\u54c1\u8cea\u3092\u91cd\u8996\u3059\u308b\u6587\u5316\u3092\u91b8\u6210\u3057\u3001\u6b63\u3057\u3044\u3053\u3068\u3092\u6700\u521d\u306b\u884c\u3046\u3053\u3068\u3067\u52b9\u7387\u3092\u9ad8\u3081\u3001\u526f\u7523\u7269\u3068\u3057\u3066\u5b89\u5168\u3067\u54c1\u8cea\u306b\u9069\u5408\u3057\u305f\u533b\u7642\u6a5f\u5668\u3092\u5e38\u306b\u63d0\u4f9b\u3067\u304d\u308b\u3088\u3046\u306b\u3059\u308b\u3053\u3068\u3067\u3001\u9a5a\u7570\u7684\u306a\u4ed5\u4e8b\u3092\u3057\u3066\u3044\u308b\u3068\u3053\u308d\u3082\u3042\u308a\u307e\u3059\u3002\u54c1\u8cea\u4fdd\u8a3c\uff08QMS\uff09\u306b\u306f\u3001\u6587\u66f8\u7ba1\u7406\u3068\u8a18\u9332\u7ba1\u7406\u3001\u8a2d\u8a08\u7ba1\u7406\u3001\u30ea\u30b9\u30af\u7ba1\u7406\u3001\u30b5\u30d7\u30e9\u30a4\u30e4\u30fc\u7ba1\u7406\u306a\u3069\u3001\u6700\u521d\u304b\u3089\u5b9f\u65bd\u3057\u306a\u3051\u308c\u3070\u306a\u3089\u306a\u3044\u57fa\u672c\u7684\u306a\u8981\u7d20\u304c\u3042\u308a\u307e\u3059\u3002\u30a8\u30f3\u30b8\u30cb\u30a2\u30ea\u30f3\u30b0\u3068\u5b9f\u88c5\u306e\u6bb5\u968e\u3067\u306f\u3001CAPA\u3001\u82e6\u60c5\u306e\u89e3\u6c7a\u3001\u9038\u8131\u8981\u6c42\u3001\u8abf\u67fb\u306a\u3069\u3001\u54c1\u8cea\u306e\u6b8b\u308a\u306e\u69cb\u6210\u8981\u7d20\u306b\u5bfe\u51e6\u3057\u307e\u3059\u3002<\/span><\/p>\n<h3><span class=\"ez-toc-section\" id=\"6_Implementation\"><\/span>6. <b>\u30a4\u30f3\u30d7\u30ea\u30e1\u30f3\u30c6\u30fc\u30b7\u30e7\u30f3<\/b><span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p><span style=\"font-weight: 400;\">\u5b9f\u88c5\u306e\u6bb5\u968e\u3067\u306f\u3001\u3059\u3067\u306b\u30d7\u30ed\u30c8\u30bf\u30a4\u30d7\u306e\u6bb5\u968e\u3092\u7d4c\u3066\u3044\u307e\u3059\u3002\u8a66\u4f5c\u6bb5\u968e\u3067\u306f\u3001\u4e00\u822c\u7684\u306a\u554f\u984c\u306b\u76f4\u9762\u3057\u3001\u533b\u7642\u6a5f\u5668\u306e\u7279\u5b9a\u306e\u6a5f\u80fd\u3092\u6539\u5584\u3059\u308b\u305f\u3081\u306e\u30c8\u30e9\u30d6\u30eb\u30b7\u30e5\u30fc\u30c6\u30a3\u30f3\u30b0\u6226\u7565\u3092\u3059\u3067\u306b\u6301\u3063\u3066\u3044\u308b\u306f\u305a\u3067\u3059\u3002\u6b21\u306f\u30013D\u30d7\u30ea\u30f3\u30c8\u3055\u308c\u305f\u30c7\u30d0\u30a4\u30b9\u3092\u5b9f\u969b\u306e\u6210\u5f62\u54c1\u306b\u30b9\u30b1\u30fc\u30eb\u30a2\u30c3\u30d7\u3059\u308b\u756a\u3067\u3059\u3002  \u57fa\u672c\u8a2d\u8a08\u306b\u6e80\u8db3\u3057\u305f\u3089\u3001\u88fd\u9020\u59d4\u8a17\u5148\u3068\u5354\u529b\u3057\u3066\u3001\u3088\u308a\u5f37\u56fa\u306a\u30d7\u30ed\u30c8\u30bf\u30a4\u30d7\u3092\u4f5c\u308b\u3053\u3068\u304c\u3067\u304d\u307e\u3059\u3002\u3053\u306e\u5b9f\u7528\u7684\u306a\u30d7\u30ed\u30c8\u30bf\u30a4\u30d7\u306f\u3001\u57fa\u672c\u7684\u306a\u30d5\u30a3\u30fc\u30b8\u30d3\u30ea\u30c6\u30a3\u30b9\u30bf\u30c7\u30a3\u306b\u4f7f\u7528\u3057\u307e\u3059\u3002\u5b9f\u73fe\u53ef\u80fd\u6027\u8abf\u67fb\u306e\u76ee\u7684\u306f\u3001\u672c\u683c\u7684\u306a\u30d7\u30ed\u30b8\u30a7\u30af\u30c8\u3092\u9032\u3081\u3066\u30a8\u30f3\u30b8\u30cb\u30a2\u30ea\u30f3\u30b0\u6bb5\u968e\u306b\u79fb\u884c\u3059\u3079\u304d\u304b\u3001\u3042\u308b\u3044\u306f\u30d7\u30ed\u30c8\u30bf\u30a4\u30d7\u3092\u518d\u691c\u8a0e\u3059\u3079\u304d\u304b\u3092\u5224\u65ad\u3059\u308b\u3053\u3068\u3067\u3059\u3002\u79c1\u306f\u3053\u306e\u6bb5\u968e\u3092\u4f55\u5ea6\u3082\u7d4c\u9a13\u3057\u3066\u3044\u307e\u3059\u304c\u3001\u30b9\u30bf\u30fc\u30c8\u30a2\u30c3\u30d7\u4f01\u696d\u3078\u306e\u30a2\u30c9\u30d0\u30a4\u30b9\u306e\u4e00\u3064\u306f\u3001\u30d5\u30a3\u30fc\u30b8\u30d3\u30ea\u30c6\u30a3\u30fb\u30c6\u30b9\u30c8\u306e\u305f\u3081\u306e\u8cc7\u91d1\u3092\u524d\u3082\u3063\u3066\u78ba\u4fdd\u3059\u308b\u3053\u3068\u3067\u3059\u3002\u30b9\u30bf\u30fc\u30c8\u30a2\u30c3\u30d7\u4f01\u696d\u304c\u30d9\u30fc\u30bf\u30c6\u30b9\u30c8\u306e\u305f\u3081\u306b\u8cc7\u91d1\u3092\u8abf\u9054\u3059\u308b\u969b\u3001\u5b9f\u9a13\u8a08\u753b\u6cd5\uff08DoE\uff09\u306e\u3088\u3046\u306a\u9069\u5207\u306a\u30a2\u30d7\u30ed\u30fc\u30c1\u3067\u306f\u306a\u304f\u3001\uff08\u53ef\u80fd\u3067\u3042\u308c\u3070\uff09\u5c11\u306a\u304f\u3068\u30822\u301c3\u7a2e\u985e\u306e\u30d7\u30ed\u30c8\u30bf\u30a4\u30d7\u3092\u7528\u610f\u3057\u3066\u30c6\u30b9\u30c8\u3092\u884c\u3046\u306e\u3067\u306f\u306a\u304f\u30011\u3064\u306e\u30d7\u30ed\u30c8\u30bf\u30a4\u30d7\u3060\u3051\u3092\u4f7f\u7528\u3057\u3088\u3046\u3068\u3059\u308b\u3053\u3068\u304c\u3042\u308a\u307e\u3059\u3002\u30a8\u30f3\u30b8\u30cb\u30a2\u30ea\u30f3\u30b0\u3068\u5b9f\u88c5\u306f\u975e\u5e38\u306b\u96e3\u3057\u3044\u306e\u3067\u3001\u3053\u306e\u30a2\u30d7\u30ed\u30fc\u30c1\u306f\u6642\u9593\u306e\u7bc0\u7d04\u306b\u306a\u308a\u307e\u3059\u3002\u3055\u3089\u306b\u3001\u30d5\u30a3\u30fc\u30b8\u30d3\u30ea\u30c6\u30a3\u30b9\u30bf\u30c7\u30a3\u3067\u6700\u7d42\u7684\u306a\u30d7\u30ed\u30c8\u30bf\u30a4\u30d7\u3092\u30c6\u30b9\u30c8\u3057\u3066\u3044\u308c\u3070\u3001\u305d\u306e\u7d50\u679c\u3092\u85ac\u4e8b\u7533\u8acb\u306b\u6d3b\u7528\u3059\u308b\u3053\u3068\u304c\u3067\u304d\u307e\u3059\u3002\u533b\u7642\u6a5f\u5668\u30e1\u30fc\u30ab\u30fc\u304c\u30d5\u30a3\u30fc\u30b8\u30d3\u30ea\u30c6\u30a3\u30b9\u30bf\u30c7\u30a3\u306e\u7d50\u679c\u3092\u6d3b\u7528\u3057\u305f\u3044\u5834\u5408\u306f\u3001\u3059\u3079\u3066\u306e\u30b9\u30bf\u30c7\u30a3\u304c\u30c7\u30b6\u30a4\u30f3\u30b3\u30f3\u30c8\u30ed\u30fc\u30eb\u4e0b\u3067\u884c\u308f\u308c\u3066\u3044\u308b\u3053\u3068\u3092\u78ba\u8a8d\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002\u5b9f\u88c5\u6bb5\u968e\u3067\u306f\u3001\u9069\u5207\u306a\u30d7\u30ed\u30b8\u30a7\u30af\u30c8\u7ba1\u7406\u3068\u30c7\u30d0\u30a4\u30b9\u8a2d\u8a08\u3078\u306e\u8a73\u7d30\u306a\u914d\u616e\u3001\u305d\u3057\u3066\u591a\u304f\u306e\u5275\u9020\u6027\u304c\u6c42\u3081\u3089\u308c\u307e\u3059\u3002\u3053\u306e\u6bb5\u968e\u3067\u5275\u9020\u6027\u3092\u767a\u63ee\u3059\u308b\u5fc5\u8981\u304c\u3042\u308b\u306e\u306f\u3001\u65e2\u6210\u6982\u5ff5\u306b\u3068\u3089\u308f\u308c\u305a\u306b\u554f\u984c\u3092\u89e3\u6c7a\u3057\u3066\u304f\u308c\u308b\u4eba\u304c\u5fc5\u8981\u306b\u306a\u308b\u5834\u5408\u304c\u3042\u308b\u304b\u3089\u3067\u3059\u3002\u3053\u306e\u6bb5\u968e\u3092\u901a\u904e\u3059\u308b\u305f\u3081\u306b\u306f\u591a\u304f\u306e\u52aa\u529b\u304c\u5fc5\u8981\u3067\u3042\u308a\u3001\u5b9f\u88c5\u6bb5\u968e\u3067\u306f\u9069\u5207\u306a\u4eba\u6750\u304c\u5fc5\u8981\u3067\u3059\u3002\u554f\u984c\u89e3\u6c7a\u306e\u305f\u3081\u306e\u30a8\u30f3\u30b8\u30cb\u30a2\u30ea\u30f3\u30b0\u30c1\u30fc\u30e0\u306e\u5275\u9020\u7684\u306a\u30c1\u30fc\u30e0\u30ef\u30fc\u30af\u306b\u3064\u3044\u3066\u306f\u3001\u3053\u308c\u4ee5\u4e0a\u5f37\u8abf\u3059\u308b\u3053\u3068\u306f\u3067\u304d\u307e\u305b\u3093\u3002<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u30d2\u30e5\u30fc\u30de\u30f3\u30d5\u30a1\u30af\u30bf\u30fc\u3068\u30e6\u30fc\u30b6\u30d3\u30ea\u30c6\u30a3\u306b\u3064\u3044\u3066\u306f\u3001\u4ee5\u4e0b\u306e\u30da\u30fc\u30b8\u3067\u8a73\u3057\u304f\u8aac\u660e\u3057\u3066\u3044\u307e\u3059\u3002 <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=MDComm3a\">\u8a18\u4e8b1<\/a> \u672c\u30b7\u30ea\u30fc\u30ba\u306e[6]\u3092\u3054\u89a7\u304f\u3060\u3055\u3044\u3002\u3082\u3057\u3042\u306a\u305f\u306e\u533b\u7642\u6a5f\u5668\u304c\u60a3\u8005\u3068\u63a5\u89e6\u3057\u305f\u308a\u3001\u8ab0\u304b\u304c\u3042\u306a\u305f\u306e\u533b\u7642\u6a5f\u5668\u3092\u64cd\u4f5c\u3059\u308b\u5fc5\u8981\u304c\u3042\u308b\u306a\u3089\u3070\u3001FDA\u306f\u975e\u5e38\u306b\u6ce8\u610f\u6df1\u304f\u76e3\u8996\u3059\u308b\u65b0\u3057\u3044\u57fa\u6e96\u3092\u5b9f\u65bd\u3057\u3066\u3044\u308b\u3053\u3068\u3092\u899a\u3048\u3066\u304a\u304f\u3053\u3068\u304c\u91cd\u8981\u3067\u3059\u3002\u30d2\u30e5\u30fc\u30de\u30f3\u30d5\u30a1\u30af\u30bf\u30fc\u30ba\u306e\u30e6\u30fc\u30b9\u30b1\u30fc\u30b9\u30b7\u30ca\u30ea\u30aa\u3092\u6587\u66f8\u5316\u3057\u3001\u533b\u7642\u6a5f\u5668\u3068\u3057\u3066\u306e\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u3092\u542b\u3081\u3066\u6a5f\u5668\u5185\u3067\u5b9f\u8a3c\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u533b\u7642\u6a5f\u5668\u306e\u5546\u696d\u5316\u306b\u4f34\u3046\u30d3\u30b8\u30cd\u30b9\u958b\u767a\u3068\u30de\u30fc\u30b1\u30c6\u30a3\u30f3\u30b0\u306e\u5074\u9762\u3092\u3001\u767a\u58f2\u3068\u3068\u3082\u306b\u8a73\u7d30\u306b\u30ab\u30d0\u30fc\u3057\u3066\u3044\u307e\u3059\u3002 <a href=\"https:\/\/infomeddnews.com\/medical-device-commercialization-challenges\/\">\u3053\u308c<\/a>.\u00a0<\/span><\/p>\n<p>\u533b\u7642\u6a5f\u5668\u306e\u5546\u54c1\u5316\u3067\u304a\u56f0\u308a\u3067\u3059\u304b\uff1fKolabtree\u306e\u30a8\u30ad\u30b9\u30d1\u30fc\u30c8\u306b\u3054\u76f8\u8ac7\u304f\u3060\u3055\u3044\u3002\u306e\u30ea\u30b9\u30c8\u3092\u898b\u308b <a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/medical-device\/?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=MDComm3a\">\u30d5\u30ea\u30fc\u30e9\u30f3\u30b9\u306e\u533b\u7642\u6a5f\u5668\u5c02\u9580\u5bb6<\/a> \u3092\u3054\u89a7\u304f\u3060\u3055\u3044\u3002<\/p>\n<p><strong>\u4f75\u305b\u3066\u304a\u8aad\u307f\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=MDComm3a\">\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<\/a><\/strong><\/p>\n<p><b>REFERENCES:<\/b><\/p>\n<ul>\n<li><span style=\"font-weight: 400;\">1)<\/span><span style=\"font-weight: 400;\"> \u00a0 \u00a0 <\/span><span style=\"font-weight: 400;\">Heineman, W.R.; Jensen, W.B. (2006).\"Leland C. Clark Jr. (1918-2005)\".Biosensors and Bioelectronics.21 (8): 1403-1404. doi:10.1016\/j.bios.2005.12.005<\/span><\/li>\n<li><span style=\"font-weight: 400;\">2)<\/span><span style=\"font-weight: 400;\"> \u00a0 \u00a0 <\/span><span style=\"font-weight: 400;\">Clarke, S.F.; Foster, J.R. (2012).\"\u8840\u7cd6\u5024\u6e2c\u5b9a\u5668\u306e\u6b74\u53f2\u3068\u305d\u306e\u5f79\u5272 <\/span><span style=\"font-weight: 400;\">in self-monitoring of diabetes mellitus'.British Journal of Biomedical Science.69 (2).<\/span><\/li>\n<li><span style=\"font-weight: 400;\">3)<\/span><span style=\"font-weight: 400;\"> \u00a0 \u00a0 <\/span><span style=\"font-weight: 400;\">NVCA\u306e\u7814\u7a76\u8cc7\u6e90\u3002Patient Capital, National Venture Capital Research Resources.\u30aa\u30f3\u30e9\u30a4\u30f3\u3067\u5229\u7528\u53ef\u80fd\u3067\u3059\u3002https:\/\/nvca.org\/redearch\/research-resources\/<\/span><\/li>\n<li><span style=\"font-weight: 400;\">4)<\/span><span style=\"font-weight: 400;\">\u00a0 \u00a0 <\/span><a href=\"https:\/\/www.mpo-mag.com\/issues\/2018-09-07\/view_columns\/the-impact-of-changing-healthcare-economics-on-device-design\/\"><span style=\"font-weight: 400;\">\u00a0<\/span><span style=\"font-weight: 400;\">https:\/\/www.mpo-mag.com\/issues\/2018-09-07\/view_columns\/the-impact-of-changing-healthcare-economics-on-device-design\/<\/span><\/a><\/li>\n<li><span style=\"font-weight: 400;\">5)<\/span><span style=\"font-weight: 400;\"> \u00a0 \u00a0 <\/span><span style=\"font-weight: 400;\">https:\/\/www.kolabtree.com\/blog\/medical-device-development-and-design-a-definitive-guide\/<\/span><\/li>\n<\/ul>\n<p><strong>\u3053\u306e\u30b7\u30ea\u30fc\u30ba\u306e\u5168\u8a18\u4e8b<\/strong><br \/>\n<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=MDComm3a\">\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=MDComm3a\">\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=MDComm3a\">\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=MDComm3a\">\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=MDComm3a\">\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=MDComm3a\">\u533b\u7642\u6a5f\u5668\u306e\u5e02\u8ca9\u5f8c\u8abf\u67fb\u3002\u5305\u62ec\u7684\u306a\u30ac\u30a4\u30c9<\/a><\/p>","protected":false},"excerpt":{"rendered":"<p>Shrinidh Joshi, medical device consultant on Kolabtree, provides a detailed guide to medical device commercialization in 9 steps from sketch to launch. Read to understand how to convert an idea to a commercially viable product.\u00a0 In this article, I would like to talk with you about what a medical device startup or an established company should know when they want to take an idea from the back of a napkin to the commercialization of a product. Technology from an individual idea, invention, research in a university or national lab, hospital, or from an entrepreneur becomes a tangible product when the idea, concept, or technology is translated into something commercially viable.<\/p>\n<div class=\"read-more\"><a href=\"https:\/\/www.kolabtree.com\/blog\/ja\/medical-device-commercialization-9-steps-from-sketch-to-launch\/\" title=\"\u7d9a\u304d\u3092\u8aad\u3080\">\u7d9a\u304d\u3092\u8aad\u3080<\/a><\/div>","protected":false},"author":12,"featured_media":8846,"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 Commercialization: 9 Steps from Sketch to Launch<\/title>\n<meta name=\"description\" content=\"From a rough sketch to product development and regulatory compliance, read this 9-step approach to medical device commercialization.\" \/>\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-commercialization-9-steps-from-sketch-to-launch\/\" \/>\n<meta property=\"og:locale\" content=\"ja_JP\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Medical Device Commercialization: 9 Steps from Sketch to Launch\" \/>\n<meta property=\"og:description\" content=\"From a rough sketch to product development and regulatory compliance, read this 9-step approach to medical device commercialization.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.kolabtree.com\/blog\/ja\/medical-device-commercialization-9-steps-from-sketch-to-launch\/\" \/>\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=\"2021-03-10T12:28:33+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2021-03-12T18:46:25+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/www.kolabtree.com\/blog\/wp-content\/uploads\/2021\/03\/medical-device-commercialization.jpg\" \/>\n\t<meta property=\"og:image:width\" content=\"626\" \/>\n\t<meta property=\"og:image:height\" content=\"417\" \/>\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=\"16\u5206\" \/>\n<!-- \/ Yoast SEO Premium plugin. -->","yoast_head_json":{"title":"Medical Device Commercialization: 9 Steps from Sketch to Launch","description":"From a rough sketch to product development and regulatory compliance, read this 9-step approach to medical device commercialization.","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/www.kolabtree.com\/blog\/ja\/medical-device-commercialization-9-steps-from-sketch-to-launch\/","og_locale":"ja_JP","og_type":"article","og_title":"Medical Device Commercialization: 9 Steps from Sketch to Launch","og_description":"From a rough sketch to product development and regulatory compliance, read this 9-step approach to medical device commercialization.","og_url":"https:\/\/www.kolabtree.com\/blog\/ja\/medical-device-commercialization-9-steps-from-sketch-to-launch\/","og_site_name":"The Kolabtree Blog","article_publisher":"https:\/\/www.facebook.com\/kolabtree","article_published_time":"2021-03-10T12:28:33+00:00","article_modified_time":"2021-03-12T18:46:25+00:00","og_image":[{"width":626,"height":417,"url":"https:\/\/www.kolabtree.com\/blog\/wp-content\/uploads\/2021\/03\/medical-device-commercialization.jpg","type":"image\/jpeg"}],"author":"Ramya Sriram","twitter_card":"summary_large_image","twitter_creator":"@kolabtree","twitter_site":"@kolabtree","twitter_misc":{"\u57f7\u7b46\u8005":"Ramya Sriram","\u63a8\u5b9a\u8aad\u307f\u53d6\u308a\u6642\u9593":"16\u5206"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/www.kolabtree.com\/blog\/fr\/medical-device-commercialization-9-steps-from-sketch-to-launch\/#article","isPartOf":{"@id":"https:\/\/www.kolabtree.com\/blog\/fr\/medical-device-commercialization-9-steps-from-sketch-to-launch\/"},"author":{"name":"Ramya Sriram","@id":"https:\/\/www.kolabtree.com\/blog\/#\/schema\/person\/81992f5863a1b06d132a47822e7b4400"},"headline":"Medical Device Commercialization: 9 Steps from Sketch to Launch","datePublished":"2021-03-10T12:28:33+00:00","dateModified":"2021-03-12T18:46:25+00:00","mainEntityOfPage":{"@id":"https:\/\/www.kolabtree.com\/blog\/fr\/medical-device-commercialization-9-steps-from-sketch-to-launch\/"},"wordCount":3636,"commentCount":0,"publisher":{"@id":"https:\/\/www.kolabtree.com\/blog\/#organization"},"articleSection":["Medical Devices"],"inLanguage":"ja","potentialAction":[{"@type":"CommentAction","name":"Comment","target":["https:\/\/www.kolabtree.com\/blog\/fr\/medical-device-commercialization-9-steps-from-sketch-to-launch\/#respond"]}]},{"@type":"WebPage","@id":"https:\/\/www.kolabtree.com\/blog\/fr\/medical-device-commercialization-9-steps-from-sketch-to-launch\/","url":"https:\/\/www.kolabtree.com\/blog\/fr\/medical-device-commercialization-9-steps-from-sketch-to-launch\/","name":"Medical Device Commercialization: 9 Steps from Sketch to Launch","isPartOf":{"@id":"https:\/\/www.kolabtree.com\/blog\/#website"},"datePublished":"2021-03-10T12:28:33+00:00","dateModified":"2021-03-12T18:46:25+00:00","description":"From a rough sketch to product development and regulatory compliance, read this 9-step approach to medical device commercialization.","breadcrumb":{"@id":"https:\/\/www.kolabtree.com\/blog\/fr\/medical-device-commercialization-9-steps-from-sketch-to-launch\/#breadcrumb"},"inLanguage":"ja","potentialAction":[{"@type":"ReadAction","target":["https:\/\/www.kolabtree.com\/blog\/fr\/medical-device-commercialization-9-steps-from-sketch-to-launch\/"]}]},{"@type":"BreadcrumbList","@id":"https:\/\/www.kolabtree.com\/blog\/fr\/medical-device-commercialization-9-steps-from-sketch-to-launch\/#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Home","item":"https:\/\/www.kolabtree.com\/blog\/"},{"@type":"ListItem","position":2,"name":"Medical Device Commercialization: 9 Steps from Sketch to Launch"}]},{"@type":"WebSite","@id":"https:\/\/www.kolabtree.com\/blog\/#website","url":"https:\/\/www.kolabtree.com\/blog\/","name":"The Kolabtree Blog","description":"Expert Views on Science, Innovation and Product Development","publisher":{"@id":"https:\/\/www.kolabtree.com\/blog\/#organization"},"potentialAction":[{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"https:\/\/www.kolabtree.com\/blog\/?s={search_term_string}"},"query-input":"required name=search_term_string"}],"inLanguage":"ja"},{"@type":"Organization","@id":"https:\/\/www.kolabtree.com\/blog\/#organization","name":"Kolabtree","url":"https:\/\/www.kolabtree.com\/blog\/","logo":{"@type":"ImageObject","inLanguage":"ja","@id":"https:\/\/www.kolabtree.com\/blog\/#\/schema\/logo\/image\/","url":"","contentUrl":"","caption":"Kolabtree"},"image":{"@id":"https:\/\/www.kolabtree.com\/blog\/#\/schema\/logo\/image\/"},"sameAs":["https:\/\/www.facebook.com\/kolabtree","https:\/\/twitter.com\/kolabtree","https:\/\/instagram.com\/kolabtree","https:\/\/www.linkedin.com\/company\/kolabtree","https:\/\/en.m.wikipedia.org\/wiki\/Kolabtree"]},{"@type":"Person","@id":"https:\/\/www.kolabtree.com\/blog\/#\/schema\/person\/81992f5863a1b06d132a47822e7b4400","name":"Ramya Sriram","image":{"@type":"ImageObject","inLanguage":"ja","@id":"https:\/\/www.kolabtree.com\/blog\/#\/schema\/person\/image\/","url":"https:\/\/secure.gravatar.com\/avatar\/8100b45c960ebbbbe420e8b3f250515f?s=96&d=mm&r=g","contentUrl":"https:\/\/secure.gravatar.com\/avatar\/8100b45c960ebbbbe420e8b3f250515f?s=96&d=mm&r=g","caption":"Ramya Sriram"},"description":"Ramya Sriram manages digital content and communications at Kolabtree (kolabtree.com), the world's largest freelancing platform for scientists. She has over a decade of experience in publishing, advertising and digital content creation.","url":"https:\/\/www.kolabtree.com\/blog\/ja\/author\/ramyas\/"}]}},"amp_enabled":true,"_links":{"self":[{"href":"https:\/\/www.kolabtree.com\/blog\/ja\/wp-json\/wp\/v2\/posts\/8840"}],"collection":[{"href":"https:\/\/www.kolabtree.com\/blog\/ja\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.kolabtree.com\/blog\/ja\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.kolabtree.com\/blog\/ja\/wp-json\/wp\/v2\/users\/12"}],"replies":[{"embeddable":true,"href":"https:\/\/www.kolabtree.com\/blog\/ja\/wp-json\/wp\/v2\/comments?post=8840"}],"version-history":[{"count":8,"href":"https:\/\/www.kolabtree.com\/blog\/ja\/wp-json\/wp\/v2\/posts\/8840\/revisions"}],"predecessor-version":[{"id":8907,"href":"https:\/\/www.kolabtree.com\/blog\/ja\/wp-json\/wp\/v2\/posts\/8840\/revisions\/8907"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.kolabtree.com\/blog\/ja\/wp-json\/wp\/v2\/media\/8846"}],"wp:attachment":[{"href":"https:\/\/www.kolabtree.com\/blog\/ja\/wp-json\/wp\/v2\/media?parent=8840"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.kolabtree.com\/blog\/ja\/wp-json\/wp\/v2\/categories?post=8840"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.kolabtree.com\/blog\/ja\/wp-json\/wp\/v2\/tags?post=8840"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}