{"id":7443,"date":"2020-04-27T13:13:06","date_gmt":"2020-04-27T13:13:06","guid":{"rendered":"https:\/\/www.kolabtree.com\/blog\/?p=7443"},"modified":"2020-10-12T10:33:28","modified_gmt":"2020-10-12T10:33:28","slug":"13-proven-ways-to-reduce-medical-device-time-to-market-cheat-sheet","status":"publish","type":"post","link":"https:\/\/www.kolabtree.com\/blog\/ja\/13-proven-ways-to-reduce-medical-device-time-to-market-cheat-sheet\/","title":{"rendered":"\u533b\u7642\u6a5f\u5668\u306e\u5e02\u5834\u6295\u5165\u307e\u3067\u306e\u6642\u9593\u3092\u77ed\u7e2e\u3059\u308b13\u306e\u5b9f\u8a3c\u6e08\u307f\u65b9\u6cd5\uff08\u30c1\u30fc\u30c8\u30b7\u30fc\u30c8\uff09"},"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-69f378cda51d2\" 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-69f378cda51d2\"><\/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\/13-proven-ways-to-reduce-medical-device-time-to-market-cheat-sheet\/#Tip_1_Understand_Design_Controls\" title=\"\u30d2\u30f3\u30c8 #1:\u30c7\u30b6\u30a4\u30f3\u30b3\u30f3\u30c8\u30ed\u30fc\u30eb\u3092\u7406\u89e3\u3059\u308b\">\u30d2\u30f3\u30c8 #1:\u30c7\u30b6\u30a4\u30f3\u30b3\u30f3\u30c8\u30ed\u30fc\u30eb\u3092\u7406\u89e3\u3059\u308b<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-2\" href=\"https:\/\/www.kolabtree.com\/blog\/ja\/13-proven-ways-to-reduce-medical-device-time-to-market-cheat-sheet\/#Tip_2_Emphasize_upfront_research_and_planning\" title=\"\u30d2\u30f3\u30c8 #2: \u524d\u3082\u3063\u3066\u306e\u8abf\u67fb\u3068\u8a08\u753b\u3092\u91cd\u8996\u3059\u308b\u00a0\">\u30d2\u30f3\u30c8 #2: \u524d\u3082\u3063\u3066\u306e\u8abf\u67fb\u3068\u8a08\u753b\u3092\u91cd\u8996\u3059\u308b\u00a0<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-3\" href=\"https:\/\/www.kolabtree.com\/blog\/ja\/13-proven-ways-to-reduce-medical-device-time-to-market-cheat-sheet\/#Tip_3_Develop_a_clear_Product_Requirements_Document\" title=\"\u30d2\u30f3\u30c8 #3:\u660e\u78ba\u306a\u88fd\u54c1\u8981\u6c42\u66f8\u3092\u4f5c\u6210\u3059\u308b\">\u30d2\u30f3\u30c8 #3:\u660e\u78ba\u306a\u88fd\u54c1\u8981\u6c42\u66f8\u3092\u4f5c\u6210\u3059\u308b<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-4\" href=\"https:\/\/www.kolabtree.com\/blog\/ja\/13-proven-ways-to-reduce-medical-device-time-to-market-cheat-sheet\/#Tip_4_Understand_the_customer\" title=\"\u30d2\u30f3\u30c8 #4:\u304a\u5ba2\u69d8\u3092\u7406\u89e3\u3059\u308b\">\u30d2\u30f3\u30c8 #4:\u304a\u5ba2\u69d8\u3092\u7406\u89e3\u3059\u308b<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-5\" href=\"https:\/\/www.kolabtree.com\/blog\/ja\/13-proven-ways-to-reduce-medical-device-time-to-market-cheat-sheet\/#Tip_5_Identify_customers_Needs_Wants\" title=\"\u30d2\u30f3\u30c8 #5: \u9867\u5ba2\u306e\u30cb\u30fc\u30ba\u3068\u30a6\u30a9\u30f3\u30c4\u3092\u7279\u5b9a\u3059\u308b&quot;\">\u30d2\u30f3\u30c8 #5: \u9867\u5ba2\u306e\u30cb\u30fc\u30ba\u3068\u30a6\u30a9\u30f3\u30c4\u3092\u7279\u5b9a\u3059\u308b\"<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-6\" href=\"https:\/\/www.kolabtree.com\/blog\/ja\/13-proven-ways-to-reduce-medical-device-time-to-market-cheat-sheet\/#Tip_6_Arrive_at_a_regulatory_consensus\" title=\"\u30d2\u30f3\u30c8#6\uff1a\u30ec\u30ae\u30e5\u30ec\u30fc\u30b7\u30e7\u30f3\u306e\u30b3\u30f3\u30bb\u30f3\u30b5\u30b9\u3092\u5f97\u308b\u305f\u3081\u306b\">\u30d2\u30f3\u30c8#6\uff1a\u30ec\u30ae\u30e5\u30ec\u30fc\u30b7\u30e7\u30f3\u306e\u30b3\u30f3\u30bb\u30f3\u30b5\u30b9\u3092\u5f97\u308b\u305f\u3081\u306b<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-7\" href=\"https:\/\/www.kolabtree.com\/blog\/ja\/13-proven-ways-to-reduce-medical-device-time-to-market-cheat-sheet\/#Tip_7_Know_your_target_market_geography\" title=\"\u30d2\u30f3\u30c8#7\uff1a\u30bf\u30fc\u30b2\u30c3\u30c8\u5e02\u5834\u306e\u5730\u7406\u3092\u77e5\u308b\">\u30d2\u30f3\u30c8#7\uff1a\u30bf\u30fc\u30b2\u30c3\u30c8\u5e02\u5834\u306e\u5730\u7406\u3092\u77e5\u308b<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-8\" href=\"https:\/\/www.kolabtree.com\/blog\/ja\/13-proven-ways-to-reduce-medical-device-time-to-market-cheat-sheet\/#Tip_8_Understand_the_Purchasing_Decision\" title=\"\u30d2\u30f3\u30c8#8\uff1a\u8cfc\u8cb7\u6c7a\u5b9a\u306e\u7406\u89e3\">\u30d2\u30f3\u30c8#8\uff1a\u8cfc\u8cb7\u6c7a\u5b9a\u306e\u7406\u89e3<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-9\" href=\"https:\/\/www.kolabtree.com\/blog\/ja\/13-proven-ways-to-reduce-medical-device-time-to-market-cheat-sheet\/#Tip_9_Conduct_an_intellectual_property_investigation\" title=\"\u30d2\u30f3\u30c8#9\uff1a\u77e5\u7684\u8ca1\u7523\u6a29\u306e\u8abf\u67fb\u3092\u884c\u3046\u00a0\">\u30d2\u30f3\u30c8#9\uff1a\u77e5\u7684\u8ca1\u7523\u6a29\u306e\u8abf\u67fb\u3092\u884c\u3046\u00a0<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-10\" href=\"https:\/\/www.kolabtree.com\/blog\/ja\/13-proven-ways-to-reduce-medical-device-time-to-market-cheat-sheet\/#Tip_10_Carefully_plan_time_money_and_resource\" title=\"\u30d2\u30f3\u30c8#10\uff1a\u6642\u9593\u3001\u304a\u91d1\u3001\u30ea\u30bd\u30fc\u30b9\u3092\u614e\u91cd\u306b\u8a08\u753b\u3059\u308b\u00a0\">\u30d2\u30f3\u30c8#10\uff1a\u6642\u9593\u3001\u304a\u91d1\u3001\u30ea\u30bd\u30fc\u30b9\u3092\u614e\u91cd\u306b\u8a08\u753b\u3059\u308b\u00a0<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-11\" href=\"https:\/\/www.kolabtree.com\/blog\/ja\/13-proven-ways-to-reduce-medical-device-time-to-market-cheat-sheet\/#Tip_11_Use_a_cross-functional_team_approach\" title=\"\u30d2\u30f3\u30c8 #11: \u30af\u30ed\u30b9\u30d5\u30a1\u30f3\u30af\u30b7\u30e7\u30ca\u30eb\u306a\u30c1\u30fc\u30e0\u30a2\u30d7\u30ed\u30fc\u30c1\u3092\u4f7f\u3046\u00a0\">\u30d2\u30f3\u30c8 #11: \u30af\u30ed\u30b9\u30d5\u30a1\u30f3\u30af\u30b7\u30e7\u30ca\u30eb\u306a\u30c1\u30fc\u30e0\u30a2\u30d7\u30ed\u30fc\u30c1\u3092\u4f7f\u3046\u00a0<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-12\" href=\"https:\/\/www.kolabtree.com\/blog\/ja\/13-proven-ways-to-reduce-medical-device-time-to-market-cheat-sheet\/#Tip_12_Get_expert_help_when_you_need_it\" title=\"\u30d2\u30f3\u30c8#12\uff1a\u5fc5\u8981\u306a\u3068\u304d\u306b\u5c02\u9580\u5bb6\u306e\u52a9\u3051\u3092\u5f97\u308b\">\u30d2\u30f3\u30c8#12\uff1a\u5fc5\u8981\u306a\u3068\u304d\u306b\u5c02\u9580\u5bb6\u306e\u52a9\u3051\u3092\u5f97\u308b<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-13\" href=\"https:\/\/www.kolabtree.com\/blog\/ja\/13-proven-ways-to-reduce-medical-device-time-to-market-cheat-sheet\/#Tip_13_Avoid_dismantling_successful_Project_Teams\" title=\"\u30d2\u30f3\u30c8#13\uff1a\u6210\u529f\u3057\u305f\u30d7\u30ed\u30b8\u30a7\u30af\u30c8\u30c1\u30fc\u30e0\u3092\u89e3\u4f53\u3057\u306a\u3044\u3088\u3046\u306b\u3059\u308b\">\u30d2\u30f3\u30c8#13\uff1a\u6210\u529f\u3057\u305f\u30d7\u30ed\u30b8\u30a7\u30af\u30c8\u30c1\u30fc\u30e0\u3092\u89e3\u4f53\u3057\u306a\u3044\u3088\u3046\u306b\u3059\u308b<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-14\" href=\"https:\/\/www.kolabtree.com\/blog\/ja\/13-proven-ways-to-reduce-medical-device-time-to-market-cheat-sheet\/#Reduce_Medical_Device_Time_to_Market_Free_Reference_Cheat_Sheet\" title=\"\u533b\u7642\u6a5f\u5668\u306eTime to Market\u3092\u77ed\u7e2e\u3059\u308b\u3002\u7121\u6599\u53c2\u7167\u30c1\u30fc\u30c8\u30b7\u30fc\u30c8\">\u533b\u7642\u6a5f\u5668\u306eTime to Market\u3092\u77ed\u7e2e\u3059\u308b\u3002\u7121\u6599\u53c2\u7167\u30c1\u30fc\u30c8\u30b7\u30fc\u30c8<\/a><\/li><\/ul><\/nav><\/div>\n<p><em><a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/thomas-williams?utm_source=Blog&amp;utm_medium=Source&amp;utm_campaign=MDTimetoMarket\"><b>\u00a0<\/b>\u30c8\u30fc\u30de\u30b9\u30fb\u30a6\u30a3\u30ea\u30a2\u30e0\u30ba<\/a>, <a href=\"https:\/\/www.kolabtree.com\/industry\/medical-device\/?utm_source=Blog&amp;utm_medium=Source&amp;utm_campaign=MDTimetoMarket\">\u533b\u7642\u6a5f\u5668\u30a4\u30ce\u30d9\u30fc\u30b7\u30e7\u30f3\u30b3\u30f3\u30b5\u30eb\u30bf\u30f3\u30c8<\/a> \u306eKolabtree\u3067\u306f\u3001\u5e02\u5834\u6295\u5165\u307e\u3067\u306e\u6642\u9593\u3092\u77ed\u7e2e\u3059\u308b\u305f\u3081\u306e13\u306e\u30d2\u30f3\u30c8\u3092\u7d39\u4ecb\u3057\u3066\u3044\u307e\u3059\u3002\u6700\u5f8c\u307e\u3067\u30b9\u30af\u30ed\u30fc\u30eb\u3059\u308b\u3068\u3001\u7121\u6599\u306e\u30ea\u30d5\u30a1\u30ec\u30f3\u30b9\u30fb\u30c1\u30fc\u30c8\u30b7\u30fc\u30c8\u304c\u8868\u793a\u3055\u308c\u307e\u3059\u3002\u00a0<\/em><\/p>\n<p><span style=\"font-weight: 400;\">\u5e02\u5834\u6295\u5165\u307e\u3067\u306e\u6642\u9593\u3092\u77ed\u7e2e <a href=\"https:\/\/www.kolabtree.com\/industry\/medical-device\/?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=MDTimetoMarket\">\u533b\u7642\u6a5f\u5668<\/a> \u306f\u3001\u5927\u4f01\u696d\u3001\u4e2d\u5c0f\u4f01\u696d\u3092\u554f\u308f\u305a\u3001\u5927\u304d\u306a\u8ab2\u984c\u3068\u306a\u3063\u3066\u3044\u307e\u3059\u3002\u88fd\u54c1\u306e\u5e02\u5834\u6295\u5165\u307e\u3067\u306e\u6642\u9593\u3092\u5b89\u5168\u306b\u77ed\u7e2e\u3059\u308b\u65b9\u6cd5\u306f\u6570\u591a\u304f\u3042\u308a\u307e\u3059\u304c\u3001\u305d\u306e\u3069\u308c\u3082\u304c\u8fd1\u9053\u3067\u306f\u3042\u308a\u307e\u305b\u3093\u3002\u3053\u306e\u8a18\u4e8b\u306f\u3001\u30ea\u30b9\u30af\u3092\u6392\u9664\u3059\u308b\u3053\u3068\u3092\u76ee\u7684\u3068\u3057\u305f\u898f\u5f8b\u3042\u308b\u30a2\u30d7\u30ed\u30fc\u30c1\u3092\u7528\u3044\u3066\u3001\u88fd\u54c1\u958b\u767a\u30b5\u30a4\u30af\u30eb\u3092\u52a0\u901f\u3055\u305b\u305f\u3044\u3068\u8003\u3048\u3066\u3044\u308b\u533b\u7642\u6a5f\u5668\u306e\u30a8\u30b0\u30bc\u30af\u30c6\u30a3\u30d6\u3084\u30de\u30cd\u30fc\u30b8\u30e3\u30fc\u3092\u652f\u63f4\u3059\u308b\u3053\u3068\u3092\u76ee\u7684\u3068\u3057\u3066\u3044\u307e\u3059\u3002\u30d7\u30ed\u30b8\u30a7\u30af\u30c8\u306e\u521d\u671f\u6bb5\u968e\u3067\u306f\u3001\u77e5\u3089\u305a\u77e5\u3089\u305a\u306e\u3046\u3061\u306b\u30ea\u30b9\u30af\u304c\u7d44\u307f\u8fbc\u307e\u308c\u3001\u5f8c\u306b\u306a\u3063\u3066\u60b2\u60e8\u306a\u7d50\u679c\u3092\u62db\u304f\u3053\u3068\u304c\u3088\u304f\u3042\u308a\u307e\u3059\u3002\u30d7\u30ed\u30bb\u30b9\u3092\u91cd\u8996\u3057\u305f\u898f\u5f8b\u3042\u308b\u30a2\u30d7\u30ed\u30fc\u30c1\u3092\u3068\u308b\u3053\u3068\u3067 <\/span><i><span style=\"font-weight: 400;\">\u8fc5\u901f\u306a\u5e02\u5834\u6295\u5165<\/span><\/i><span style=\"font-weight: 400;\"> \u30a2\u30d7\u30ed\u30fc\u30c1\u306f\u3001\u3088\u308a\u591a\u304f\u306e\u5834\u5408\u3001\u5e02\u5834\u3078\u306e\u7af6\u4e89\u306b\u52dd\u3064\u3002\u4ee5\u4e0b\u306b\u3001\u79c1\u306e\u30c8\u30c3\u30d713\u306e\u30d2\u30f3\u30c8\u3092\u793a\u3057\u307e\u3059\u3002<\/span><\/p>\n<h2><span class=\"ez-toc-section\" id=\"Tip_1_Understand_Design_Controls\"><\/span><b>\u30d2\u30f3\u30c8 #1:\u30c7\u30b6\u30a4\u30f3\u30b3\u30f3\u30c8\u30ed\u30fc\u30eb\u3092\u7406\u89e3\u3059\u308b<\/b><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><span style=\"font-weight: 400;\">\u7c73\u56fd\u3067\u306f\u3001\u65b0\u88fd\u54c1\u306e\u958b\u767a\u30d7\u30ed\u30bb\u30b9\u306f\u3001\u4e3b\u306b\u6b21\u306e\u3088\u3046\u306b\u5b9a\u7fa9\u3055\u308c\u3066\u3044\u307e\u3059\u3002<\/span><a href=\"https:\/\/www.fda.gov\/media\/116762\/download\"> <span style=\"font-weight: 400;\">FDA\u306e\u30c7\u30b6\u30a4\u30f3\u30b3\u30f3\u30c8\u30ed\u30fc\u30eb<\/span><\/a><span style=\"font-weight: 400;\"> \u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u3092\u53c2\u7167\u3057\u3066\u304f\u3060\u3055\u3044\u3002\u30c7\u30b6\u30a4\u30f3\u30b3\u30f3\u30c8\u30ed\u30fc\u30eb\u3092\u7406\u89e3\u3059\u308b\u305f\u3081\u306b\u6642\u9593\u3092\u304b\u3051\u3066\u3001\u88fd\u54c1\u3092\u958b\u767a\u3059\u308b\u305f\u3081\u306b\u884c\u3046\u3059\u3079\u3066\u306e\u3053\u3068\u304c\u3001\u88fd\u54c1\u306e<\/span><a href=\"https:\/\/www.fda.gov\/emc-mdqs-page-21\"> <span style=\"font-weight: 400;\">\u30c7\u30d0\u30a4\u30b9\u30de\u30b9\u30bf\u30fc\u30ec\u30b3\u30fc\u30c9<\/span><\/a><span style=\"font-weight: 400;\"> (DMR)\u3068\u547c\u3070\u308c\u3066\u3044\u307e\u3059\u3002  \u8a2d\u8a08\u7ba1\u7406\u306e\u67a0\u7d44\u307f\u3092\u53cd\u6620\u3057\u3066\u88fd\u54c1\u958b\u767a\u3092\u6587\u66f8\u5316\u3059\u308b\u3053\u3068\u3067\u3001\u88fd\u54c1\u306e\u8a2d\u8a08\u3092\u9032\u5316\u3055\u305b\u308b\u305f\u3081\u306e\u30ed\u30fc\u30c9\u30de\u30c3\u30d7\u3092\u4f5c\u6210\u3057\u307e\u3059\u3002  \u3053\u306e\u3088\u3046\u306a\u30a2\u30d7\u30ed\u30fc\u30c1\u3092\u3068\u308b\u3053\u3068\u306f\u3001\u6700\u521d\u306f\u5927\u5909\u306a\u3053\u3068\u306e\u3088\u3046\u306b\u601d\u3048\u307e\u3059\u304c\u3001\u6700\u7d42\u7684\u306b\u306f\u3001\u88fd\u54c1\u306e\u8ca9\u58f2\u3092\u958b\u59cb\u3059\u308b\u305f\u3081\u306bFDA\u306e\u8a31\u53ef\u3092\u6c42\u3081\u308b\u969b\u306b\u3001\u6642\u9593\u3068\u8cbb\u7528\u306e\u914d\u5f53\u3092\u5f97\u308b\u3053\u3068\u304c\u3067\u304d\u307e\u3059\u3002<\/span><\/p>\n<p>\u3057\u304b\u3057\u3001FDA\u306e\u30c7\u30b6\u30a4\u30f3\u30b3\u30f3\u30c8\u30ed\u30fc\u30eb\u306f\u3001\u88fd\u54c1\u306e\u5e02\u5834\u6295\u5165\u3092\u65e9\u3081\u308b\u305f\u3081\u306e\u552f\u4e00\u306e\u8003\u616e\u4e8b\u9805\u3067\u306f\u3042\u308a\u307e\u305b\u3093\u3002\u540c\u3058\u3088\u3046\u306b\u96e3\u3057\u3044\u306e\u306f\u3001\u30a8\u30f3\u30b8\u30cb\u30a2\u30ea\u30f3\u30b0\u304c\u8a2d\u8a08\u30fb\u958b\u767a\u6d3b\u52d5\u3092\u958b\u59cb\u3059\u308b\u524d\u306b\u5fc5\u8981\u306a\u5148\u884c\u4f5c\u696d\u3092\u884c\u3046\u305f\u3081\u306e\u898f\u5f8b\u3067\u3059\u3002<\/p>\n<h2><span class=\"ez-toc-section\" id=\"Tip_2_Emphasize_upfront_research_and_planning\"><\/span><b>\u30d2\u30f3\u30c8 #2: \u524d\u3082\u3063\u3066\u306e\u8abf\u67fb\u3068\u8a08\u753b\u3092\u91cd\u8996\u3059\u308b\u00a0<\/b><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>\u3068\u547c\u3070\u308c\u308b\u3053\u3068\u3082\u3042\u308a\u307e\u3059\u3002 <a href=\"https:\/\/sapioresearch.com\/tutorials\/what-is-market-opportinity-assessement\">\u5e02\u5834\u6a5f\u4f1a\u306e\u8a55\u4fa1<\/a> this early <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> and planning is all too often overlooked in the rush to begin building out your DMR.\u00a0 The extra time you spend doing the upfront work to focus the scope of your project will serve to prevent it from straying off course and off budget later. Within the Market Opportunity Assessment process there are several tips that stand out as time savers.<\/p>\n<h2><span class=\"ez-toc-section\" id=\"Tip_3_Develop_a_clear_Product_Requirements_Document\"><\/span><b>\u30d2\u30f3\u30c8 #3:\u660e\u78ba\u306a\u88fd\u54c1\u8981\u6c42\u66f8\u3092\u4f5c\u6210\u3059\u308b<\/b><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>DMR\u306e\u4e2d\u3067\u6700\u3082\u91cd\u8981\u306a\u66f8\u985e\u306e\u4e00\u3064\u304c <a href=\"https:\/\/www.productplan.com\/glossary\/product-requirements-document\/\">\u88fd\u54c1\u8981\u6c42\u66f8<\/a> (PRD\uff09\u3092\u4f5c\u6210\u3057\u307e\u3057\u305f\u3002  \u3053\u306e\u30c9\u30ad\u30e5\u30e1\u30f3\u30c8\u306f\u3001\u958b\u767a\u3057\u3088\u3046\u3068\u3057\u3066\u3044\u308b\u88fd\u54c1\u304c\u4f55\u3067\u3042\u308b\u304b\u3092\u660e\u78ba\u306b\u5b9a\u7fa9\u3059\u308b\u305f\u3081\u306b\u5fc5\u8981\u306a\u3001\u3044\u304f\u3064\u304b\u306e\u91cd\u8981\u306a\u30ea\u30b5\u30fc\u30c1\u30bf\u30b9\u30af\u3092\u307e\u3068\u3081\u305f\u3082\u306e\u3067\u3059\u3002PRD\u306f\u3001\u30d7\u30ed\u30b8\u30a7\u30af\u30c8\u30c1\u30fc\u30e0\u306e\u69d8\u3005\u306a\u5206\u91ce\u306e\u9593\u3067\u300c\u63e1\u624b\u300d\u3092\u3059\u308b\u305f\u3081\u306e\u30c9\u30ad\u30e5\u30e1\u30f3\u30c8\u306b\u306a\u308b\u306f\u305a\u3067\u3059\u3002<\/p>\n<h2><span class=\"ez-toc-section\" id=\"Tip_4_Understand_the_customer\"><\/span><b>\u30d2\u30f3\u30c8 #4:\u304a\u5ba2\u69d8\u3092\u7406\u89e3\u3059\u308b<\/b><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><span style=\"font-weight: 400;\">\u3053\u306e\u65b0\u88fd\u54c1\u306e\u9867\u5ba2\u306f\u8ab0\u306b\u306a\u308b\u306e\u304b\u3001\u5e02\u5834\u8abf\u67fb\u3092\u884c\u3046\u3002\u533b\u7642\u6a5f\u5668\u306e\u4e16\u754c\u3067\u306f\u3001\u533b\u5e2b\u3001\u770b\u8b77\u5e2b\u3001\u305d\u3057\u3066\u6700\u7d42\u7684\u306b\u306f\u60a3\u8005\u3055\u3093\u306a\u3069\u3001\u8907\u6570\u306e\u304a\u5ba2\u69d8\u304c\u3044\u3089\u3063\u3057\u3083\u3044\u307e\u3059\u3002\u3053\u308c\u3089\u306e\u304a\u5ba2\u69d8\u306f\u3001\u305d\u308c\u305e\u308c\u7570\u306a\u308b\u8996\u70b9\u3067\u88fd\u54c1\u3092\u898b\u3066\u3044\u307e\u3059\u3002\u4f8b\u3048\u3070\u3001\u770b\u8b77\u5e2b\u306f\u81ea\u5206\u306e\u6642\u9593\u3092\u7bc0\u7d04\u3067\u304d\u308b\u88fd\u54c1\u3092\u6c42\u3081\u3066\u3044\u308b\u304b\u3082\u3057\u308c\u306a\u3044\u3057\u3001\u60a3\u8005\u3055\u3093\u306f\u88fd\u54c1\u304c\u3082\u305f\u3089\u3059\u5feb\u9069\u3055\u306b\u95a2\u5fc3\u304c\u3042\u308b\u304b\u3082\u3057\u308c\u306a\u3044\u3002\u4e00\u65b9\u3001\u533b\u5e2b\u306f\u81e8\u5e8a\u7d50\u679c\u306e\u6539\u5584\u3092\u91cd\u8996\u3059\u308b\u3067\u3057\u3087\u3046\u3002\u305d\u308c\u305e\u308c\u306e\u304a\u5ba2\u69d8\u306e\u5177\u4f53\u7684\u306a\u8981\u6c42\u3092\u628a\u63e1\u3059\u308b\u305f\u3081\u306b\u3001\u30da\u30eb\u30bd\u30ca\u306e\u30d7\u30ed\u30d5\u30a3\u30fc\u30eb\u3092\u4f5c\u6210\u3057\u307e\u3059\u3002 <\/span><\/p>\n<h2><span class=\"ez-toc-section\" id=\"Tip_5_Identify_customers_Needs_Wants\"><\/span><b>\u30d2\u30f3\u30c8 #5: \u9867\u5ba2\u306e\u30cb\u30fc\u30ba\u3068\u30a6\u30a9\u30f3\u30c4\u3092\u7279\u5b9a\u3059\u308b\"<\/b><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>\u5305\u62ec\u7684\u306a\u88fd\u54c1\u8981\u6c42\u6587\u66f8\u3092\u4f5c\u6210\u3059\u308b\u305f\u3081\u306e\u30d2\u30f3\u30c8#5\u306f\u3001\u304a\u5ba2\u69d8\u306e\u300c\u30cb\u30fc\u30ba\uff06\u30a6\u30a9\u30f3\u30c4\u300d\u3092\u8a73\u7d30\u306b\u7279\u5b9a\u3059\u308b\u3053\u3068\u3067\u3059\u3002\u3053\u308c\u306f\u3001\u304a\u5ba2\u69d8\u306e\u671f\u5f85\u306b\u5fdc\u3048\u3001\u3067\u304d\u308c\u3070\u671f\u5f85\u4ee5\u4e0a\u306e\u3082\u306e\u3092\u63d0\u4f9b\u3057\u305f\u3068\u304a\u5ba2\u69d8\u306b\u7d0d\u5f97\u3057\u3066\u3044\u305f\u3060\u304f\u305f\u3081\u306b\u3001\u65b0\u88fd\u54c1\u304c\u63d0\u4f9b\u3057\u306a\u3051\u308c\u3070\u306a\u3089\u306a\u3044\u88fd\u54c1\u6a5f\u80fd\u306e\u3053\u3068\u3067\u3059\u3002  \u304a\u5ba2\u69d8\u304c\u65b0\u88fd\u54c1\u306b\u4f55\u3092\u6c42\u3081\u3066\u3044\u308b\u306e\u304b\u3092\u767a\u898b\u3059\u308b\u305f\u3081\u306b\u306f\u3001\u30a2\u30c9\u30d0\u30a4\u30b6\u30ea\u30fc\u30dc\u30fc\u30c9\u3092\u4f7f\u3063\u305f\u30a2\u30d7\u30ed\u30fc\u30c1\u304c\u4e00\u822c\u7684\u3067\u3059\u3002  \u307e\u305f\u3001\u30d5\u30a9\u30fc\u30ab\u30b9\u30d1\u30cd\u30eb\u3082\u3001\u3053\u306e\u60c5\u5831\u3092\u5f97\u308b\u305f\u3081\u306b\u3088\u304f\u4f7f\u308f\u308c\u308b\u624b\u6cd5\u3067\u3059\u3002<\/p>\n<p>\u3057\u304b\u3057\u3001\u3053\u308c\u3089\u306e\u300c\u30cb\u30fc\u30ba\uff06\u30a6\u30a9\u30f3\u30c4\u300d\u3092\u5de5\u5b66\u7684\u306a\u8a2d\u8a08\u57fa\u6e96\u306b\u5909\u63db\u3059\u308b\u3068\u3044\u3046\u91cd\u8981\u306a\u30b9\u30c6\u30c3\u30d7\u304c\u5b8c\u4e86\u3057\u306a\u3051\u308c\u3070\u3001\u88fd\u54c1\u8981\u6c42\u66f8\u306f\u5b8c\u6210\u3057\u307e\u305b\u3093\u3002  \u4f8b\u3048\u3070\u3001\u304a\u5ba2\u69d8\u306f\u65b0\u3057\u3044\u30c7\u30d0\u30a4\u30b9\u306e\u30cf\u30f3\u30c9\u30eb\u3092\u3001\u6ed1\u3089\u305a\u306b\u63e1\u308a\u3084\u3059\u3044\u3082\u306e\u306b\u3057\u305f\u3044\u3068\u601d\u3063\u3066\u3044\u308b\u304b\u3082\u3057\u308c\u307e\u305b\u3093\u3002  \u305d\u306e\u305f\u3081\u306b\u306f\u3001\u30cf\u30f3\u30c9\u30eb\u306e\u8868\u9762\u306b\u30c6\u30af\u30b9\u30c1\u30e3\u30fc\u3092\u65bd\u3057\u305f\u308a\u3001\u6ed1\u308a\u306b\u304f\u3044\u7d20\u6750\u3092\u4f7f\u3046\u306a\u3069\u306e\u5de5\u592b\u304c\u5fc5\u8981\u306b\u306a\u308a\u307e\u3059\u3002  \u3053\u306e\u3088\u3046\u306b\u3057\u3066\u3001\u30cb\u30fc\u30ba\u3068\u30a6\u30a9\u30f3\u30c4\u3092\u4e00\u3064\u305a\u3064\u30c7\u30b6\u30a4\u30f3\u306e\u57fa\u6e96\u306b\u7167\u3089\u3057\u5408\u308f\u305b\u3066\u3044\u304f\u3068\u3001\u7dcf\u5408\u7684\u306a\u88fd\u54c1\u30c7\u30b6\u30a4\u30f3\u304c\u7d19\u306e\u4e0a\u306b\u6d6e\u304b\u3073\u4e0a\u304c\u3063\u3066\u304f\u308b\u306e\u3067\u3059\u3002<\/p>\n<h2><span class=\"ez-toc-section\" id=\"Tip_6_Arrive_at_a_regulatory_consensus\"><\/span><b>\u30d2\u30f3\u30c8#6\uff1a\u30ec\u30ae\u30e5\u30ec\u30fc\u30b7\u30e7\u30f3\u306e\u30b3\u30f3\u30bb\u30f3\u30b5\u30b9\u3092\u5f97\u308b\u305f\u3081\u306b<\/b><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><span style=\"font-weight: 400;\">\u7c73\u56fd\u3067\u306f\u3001Food and Drug Administration (FDA)\u3068Regulatory Affairs Department\u306e\u9593\u3067\u65e9\u671f\u306b\u30b3\u30f3\u30bb\u30f3\u30b5\u30b9\u3092\u5f97\u308b\u3053\u3068\u3067\u3001\u5e02\u5834\u6295\u5165\u307e\u3067\u306e\u6642\u9593\u3092\u77ed\u7e2e\u3059\u308b\u3053\u3068\u304c\u3067\u304d\u307e\u3059\u3002\u4f8b\u3048\u3070\u3001\u88fd\u54c1\u304cFDA\u306e\u8a31\u53ef\u3092\u5f97\u308b\u305f\u3081\u306e\u300cletter to file\u300d\u30a2\u30d7\u30ed\u30fc\u30c1\u3092\u6b63\u5f53\u5316\u3059\u308b\u3053\u3068\u304c\u3067\u304d\u308c\u3070\u3001510k\u30a2\u30d7\u30ed\u30fc\u30c1\u3092\u53d6\u308b\u3088\u308a\u3082\u5927\u5e45\u306b\u6642\u9593\u3092\u7bc0\u7d04\u3059\u308b\u3053\u3068\u304c\u3067\u304d\u307e\u3059\u3002\u307e\u305f\u3001\u300c\u30ec\u30bf\u30fc\u30fb\u30c4\u30fc\u30fb\u30d5\u30a1\u30a4\u30eb\u300d\u3092\u56de\u907f\u3059\u308b\u3053\u3068\u304c\u3067\u304d\u308c\u3070<\/span><a href=\"https:\/\/www.fda.gov\/vaccines-blood-biologics\/development-approval-process-cber\/premarket-approval-pma-process-cber\"> <span style=\"font-weight: 400;\">FDA\u306e\u5e02\u8ca9\u524d\u627f\u8a8d\uff08PMA\uff09\u306b\u3064\u3044\u3066<\/span><\/a><span style=\"font-weight: 400;\"> \u3053\u306e\u3088\u3046\u306b\u3001501k\u306e\u30a2\u30d7\u30ed\u30fc\u30c1\u3092\u3068\u308b\u3053\u3068\u3067\u3001\u5e02\u5834\u6295\u5165\u307e\u3067\u306e\u6642\u9593\u304c\u3055\u3089\u306b\u5927\u5e45\u306b\u77ed\u7e2e\u3055\u308c\u307e\u3059\u3002<\/span><\/p>\n<p><strong>\u3082\u8aad\u3093\u3067\u304f\u3060\u3055\u3044\u3002 <a href=\"https:\/\/www.kolabtree.com\/blog\/13-mistakes-to-avoid-in-a-510k-submission-for-quick-fda-clearance\/?utm_source=Blog&amp;utm_medium=Source&amp;utm_campaign=MDTimetoMarket\">\u8fc5\u901f\u306aFDA\u30af\u30ea\u30a2\u30e9\u30f3\u30b9\u306e\u305f\u3081\u306b510(k)\u7533\u8acb\u3067\u907f\u3051\u308b\u3079\u304d13\u306e\u9593\u9055\u3044<\/a><\/strong><\/p>\n<h2><span class=\"ez-toc-section\" id=\"Tip_7_Know_your_target_market_geography\"><\/span><b>\u30d2\u30f3\u30c8#7\uff1a\u30bf\u30fc\u30b2\u30c3\u30c8\u5e02\u5834\u306e\u5730\u7406\u3092\u77e5\u308b<\/b><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><span style=\"font-weight: 400;\">FDA\u4ee5\u5916\u306e\u4e16\u754c\u4e2d\u306e\u69d8\u3005\u306a\u898f\u5236\u6a5f\u95a2\u304b\u3089\u627f\u8a8d\u3092\u5f97\u308b\u305f\u3081\u306b\u3001\u88fd\u54c1\u304c\u3069\u306e\u3088\u3046\u306a\u898f\u5236\u8981\u4ef6\u3092\u6e80\u305f\u3055\u306a\u3051\u308c\u3070\u306a\u3089\u306a\u3044\u304b\u3092\u4e8b\u524d\u306b\u77e5\u3063\u3066\u304a\u304f\u3053\u3068\u306f\u3001\u30d2\u30f3\u30c8#10\u3067\u3059\u3002\u88fd\u54c1\u304c\u3069\u306e\u56fd\u3067\u8ca9\u58f2\u3055\u308c\u308b\u304b\u3092\u4e8b\u524d\u306b\u628a\u63e1\u3057\u3066\u304a\u3051\u3070\u3001EU\u306eMDR\/EMA\u3001\u65e5\u672c\u306ePMDA\u3001\u4e2d\u56fd\u306eNMPA\u306a\u3069\u3001\u4ed6\u306e\u5730\u57df\u306b\u7279\u6709\u306e\u627f\u8a8d\u8981\u4ef6\u3092\u6e80\u305f\u3059\u305f\u3081\u306b\u3001\u3059\u3067\u306b\u5b8c\u4e86\u3057\u305f\u958b\u767a\u4f5c\u696d\u3092\u3084\u308a\u76f4\u3059\u5fc5\u8981\u304c\u306a\u304f\u306a\u308a\u3001\u81a8\u5927\u306a\u6642\u9593\u3092\u7bc0\u7d04\u3059\u308b\u3053\u3068\u304c\u3067\u304d\u307e\u3059\u3002<\/span><\/p>\n<p><strong>\u3082\u8aad\u3093\u3067\u304f\u3060\u3055\u3044\u3002 <a href=\"https:\/\/www.kolabtree.com\/blog\/how-to-get-a-ce-mark-for-your-medical-device-eu-mdr\/?utm_source=Blog&amp;utm_medium=Source&amp;utm_campaign=MDTimetoMarket\">\u533b\u7642\u6a5f\u5668\u306eCE\u30de\u30fc\u30af\u3092\u53d6\u5f97\u3059\u308b\u306b\u306f<\/a>\u00a0<\/strong><\/p>\n<h2><span class=\"ez-toc-section\" id=\"Tip_8_Understand_the_Purchasing_Decision\"><\/span><b>\u30d2\u30f3\u30c8#8\uff1a\u8cfc\u8cb7\u6c7a\u5b9a\u306e\u7406\u89e3<\/b><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><span style=\"font-weight: 400;\">\u88fd\u54c1\u306e\u6210\u529f\u306e\u9375\u3068\u306a\u308b\u306e\u306f\u3001\u8ab0\u304c\u3001\u3069\u306e\u3088\u3046\u306b\u8cfc\u5165\u3092\u6c7a\u5b9a\u3059\u308b\u306e\u304b\u3092\u7406\u89e3\u3059\u308b\u3053\u3068\u3067\u3059\u3002\u5927\u898f\u6a21\u306a\u533b\u7642\u6a5f\u95a2\u3067\u306f\u3001\u533b\u5e2b\u3001\u770b\u8b77\u5e2b\u3001\u60a3\u8005\u3060\u3051\u3067\u306a\u304f\u3001\u65e5\u5e38\u7684\u306b\u8cfc\u8cb7\u6c7a\u5b9a\u304c\u884c\u308f\u308c\u3066\u3044\u307e\u3059\u3002\u4f8b\u3048\u3070\u3001\u65b0\u88fd\u54c1\u306e\u8cfc\u5165\u6c7a\u5b9a\u306b\u306f\u3001\u8ca1\u52d9\u3001\u8cfc\u8cb7\u3001\u611f\u67d3\u7ba1\u7406\u3001\u54c1\u8cea\u7ba1\u7406\u306a\u3069\u306e\u8907\u6570\u306e\u90e8\u9580\u3067\u69cb\u6210\u3055\u308c\u308bClinical Review Board\u306e\u627f\u8a8d\u304c\u5fc5\u8981\u306b\u306a\u308b\u3053\u3068\u304c\u3088\u304f\u3042\u308a\u307e\u3059\u3002<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u3057\u304b\u3057\u3001\u6700\u7d42\u7684\u306b\u306f\u3001\u8cfc\u5165\u306e\u610f\u601d\u6c7a\u5b9a\u306f\u7279\u306b\u91cd\u8981\u306a\u8981\u7d20\u306b\u5de6\u53f3\u3055\u308c\u308b\u3053\u3068\u304c\u591a\u3044\u3002REIMBURSEMENT\u3067\u3059\u3002\u4eca\u65e5\u306e\u30de\u30cd\u30fc\u30b8\u30c9\u30b1\u30a2\u306e\u533b\u7642\u30b7\u30b9\u30c6\u30e0\u3067\u306f\u3001\u9ad8\u9a30\u3059\u308b\u533b\u7642\u8cbb\u306e\u7ba1\u7406\u304c\u4e2d\u5fc3\u3068\u306a\u308a\u307e\u3059\u304c\u3001\u8cb4\u793e\u306e\u88fd\u54c1\u304c\u7c73\u56fd\u3067\u6210\u529f\u3059\u308b\u304b\u3069\u3046\u304b\u306f\u3001\u4ee5\u4e0b\u306e\u70b9\u306b\u304b\u304b\u3063\u3066\u3044\u307e\u3059\u3002 <\/span><a href=\"https:\/\/www.cms.gov\/\"><span style=\"font-weight: 400;\">Centers for Medicare and Medicaid\uff08CMS\uff09\u3002 <\/span><\/a><span style=\"font-weight: 400;\">\u8cb4\u793e\u306e\u88fd\u54c1\u306b\u5fc5\u8981\u306aHCPCS\u30b3\u30fc\u30c9\u3092CMS\u304b\u3089\u53d6\u5f97\u3059\u308b\u3053\u3068\u3067\u3001\u5e02\u5834\u5168\u4f53\u306e\u4fdd\u967a\u4f1a\u793e\u304c\u8cb4\u793e\u88fd\u54c1\u306e\u4f7f\u7528\u306b\u5bfe\u3057\u3066\u9069\u5207\u306a\u652f\u6255\u3044\u3092\u53d7\u3051\u308b\u3053\u3068\u304c\u3067\u304d\u307e\u3059\u3002  \u4fdd\u967a\u91d1\u304c\u652f\u6255\u308f\u308c\u306a\u3051\u308c\u3070\u3001CMS\u306e\u627f\u8a8d\u3092\u5f97\u308b\u307e\u3067\u3001\u65b0\u88fd\u54c1\u304c\u5e02\u5834\u306b\u53d7\u3051\u5165\u308c\u3089\u308c\u308b\u5272\u5408\u306f\u5927\u5e45\u306b\u6e1b\u5c11\u3057\u307e\u3059\u3002<\/span><\/p>\n<h2><span class=\"ez-toc-section\" id=\"Tip_9_Conduct_an_intellectual_property_investigation\"><\/span><b>\u30d2\u30f3\u30c8#9\uff1a\u77e5\u7684\u8ca1\u7523\u6a29\u306e\u8abf\u67fb\u3092\u884c\u3046\u00a0<\/b><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><span style=\"font-weight: 400;\">\u88fd\u54c1\u8981\u6c42\u66f8\u306b\u52a0\u3048\u3066\u3001\u8a08\u753b\u306e\u521d\u671f\u6bb5\u968e\u3067\u53d6\u308a\u7d44\u3080\u5fc5\u8981\u306e\u3042\u308b\u91cd\u8981\u306a\u691c\u8a0e\u4e8b\u9805\u304c\u3042\u308a\u307e\u3059\u3002  \u30d2\u30f3\u30c8#7\u306f\u3001\u77e5\u7684\u8ca1\u7523\u306e\u8abf\u67fb\u3092\u884c\u3046\u3068\u3044\u3046\u5fc5\u8981\u306a\u30c7\u30e5\u30fc\u30c7\u30ea\u30b8\u30a7\u30f3\u30b9\u3092\u884c\u3046\u3053\u3068\u3067\u3059\u3002\u88fd\u54c1\u8a2d\u8a08\u304c\u65e2\u5b58\u306e\u7279\u8a31\u3092\u4fb5\u5bb3\u3057\u3066\u3044\u308b\u3053\u3068\u306b\u6c17\u3065\u304f\u306e\u304c\u9045\u308c\u308b\u3053\u3068\u307b\u3069\u3001\u5e02\u5834\u6295\u5165\u307e\u3067\u306e\u6642\u9593\u3092\u9045\u3089\u305b\u308b\u3082\u306e\u306f\u3042\u308a\u307e\u305b\u3093\u3002<\/span><\/p>\n<blockquote><p><span style=\"font-weight: 400;\">\u307e\u305f\u3001\u65b0\u88fd\u54c1\u306b\u72ec\u81ea\u306e\u7279\u8a31\u6027\u306e\u3042\u308b\u77e5\u7684\u8ca1\u7523\u304c\u542b\u307e\u308c\u3066\u3044\u308b\u304b\u3069\u3046\u304b\u3092\u5224\u65ad\u3059\u308b\u306e\u3082\u4eca\u306e\u3046\u3061\u3067\u3059\u3002\u591a\u304f\u306e\u5834\u5408\u3001\u65b0\u3057\u3044\u7279\u8a31\u51fa\u9858\u3092\u65e9\u304f\u3001\u5e83\u304f\u884c\u3048\u3070\u884c\u3046\u307b\u3069\u3001\u30c7\u30b6\u30a4\u30f3\u306e\u4fdd\u8b77\u304c\u5f37\u5316\u3055\u308c\u307e\u3059\u3002<\/span><\/p><\/blockquote>\n<h2><span class=\"ez-toc-section\" id=\"Tip_10_Carefully_plan_time_money_and_resource\"><\/span><b>\u30d2\u30f3\u30c8#10\uff1a\u6642\u9593\u3001\u304a\u91d1\u3001\u30ea\u30bd\u30fc\u30b9\u3092\u614e\u91cd\u306b\u8a08\u753b\u3059\u308b\u00a0<\/b><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><span style=\"font-weight: 400;\">\u4f1a\u793e\u306e\u7d4c\u55b6\u9663\u306e\u627f\u8a8d\u3092\u5fc5\u8981\u3068\u3059\u308b\u30d7\u30ed\u30b8\u30a7\u30af\u30c8\u306f\u3001\u88fd\u54c1\u63d0\u6848\u3060\u3051\u3067\u306f\u306a\u3044\u3067\u3057\u3087\u3046\u3002\u88fd\u54c1\u3092\u5e02\u5834\u306b\u6295\u5165\u3059\u308b\u305f\u3081\u306b\u5fc5\u8981\u306a\u6642\u9593\u3001\u8cc7\u91d1\u3001\u30ea\u30bd\u30fc\u30b9\u3001\u304a\u3088\u3073\u305d\u306e\u4e88\u6e2c\u3092\u793a\u3059\u6e96\u5099\u3092\u3057\u3066\u304f\u3060\u3055\u3044\u3002<\/span><a href=\"https:\/\/corporatefinanceinstitute.com\/resources\/knowledge\/finance\/return-on-investment-roi-formula\/\"> <span style=\"font-weight: 400;\">\u6295\u8cc7\u53ce\u76ca\u7387\uff08ROI\uff09<\/span><\/a><span style=\"font-weight: 400;\"> \u304c\u3001\u6700\u7d42\u7684\u306b\u591a\u304f\u306e\u7d4c\u55b6\u5224\u65ad\u3092\u9032\u3081\u3066\u3044\u304f\u3053\u3068\u306b\u306a\u308a\u307e\u3059\u3002<\/span><\/p>\n<h2><span class=\"ez-toc-section\" id=\"Tip_11_Use_a_cross-functional_team_approach\"><\/span><b>\u30d2\u30f3\u30c8 #11: \u30af\u30ed\u30b9\u30d5\u30a1\u30f3\u30af\u30b7\u30e7\u30ca\u30eb\u306a\u30c1\u30fc\u30e0\u30a2\u30d7\u30ed\u30fc\u30c1\u3092\u4f7f\u3046\u00a0<\/b><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>\u305d\u306e11<sup>th<\/sup> \u88fd\u54c1\u958b\u767a\u30d7\u30ed\u30b8\u30a7\u30af\u30c8\u304c\u6025\u505c\u6b62\u3057\u306a\u3044\u305f\u3081\u306e\u30d2\u30f3\u30c8\u306f\u3001\u30d7\u30ed\u30b8\u30a7\u30af\u30c8\u306e\u521d\u671f\u6bb5\u968e\u3067\u300c\u4e00\u4eba\u3067\u306f\u3067\u304d\u306a\u3044\u300d\u3068\u8a8d\u8b58\u3059\u308b\u3053\u3068\u3067\u3059\u3002\u4eca\u65e5\u306e\u53b3\u3057\u3044\u898f\u5236\u74b0\u5883\u306e\u4e2d\u3067\u65b0\u3057\u3044\u533b\u7642\u6a5f\u5668\u3092\u5e02\u5834\u306b\u6295\u5165\u3059\u308b\u305f\u3081\u306b\u306f\u3001\u4f01\u696d\u306f\u4ee5\u4e0b\u306e\u3053\u3068\u3092\u8a8d\u8b58\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002 <a href=\"https:\/\/www.inc.com\/encyclopedia\/cross-functional-teams.html\">\u30af\u30ed\u30b9\u30d5\u30a1\u30f3\u30af\u30b7\u30e7\u30ca\u30eb\u30fb\u30c1\u30fc\u30e0<\/a> \u30d7\u30ed\u30b8\u30a7\u30af\u30c8\u3092\u30bf\u30a4\u30e0\u30ea\u30fc\u306b\u9042\u884c\u3059\u308b\u305f\u3081\u306b\u306f\u3001\u3053\u306e\u3088\u3046\u306a\u30a2\u30d7\u30ed\u30fc\u30c1\u304c\u4e0d\u53ef\u6b20\u3067\u3059\u3002  \u5f80\u3005\u306b\u3057\u3066\u3001\u4f01\u696d\u306f\u91cd\u8981\u306a\u6a5f\u80fd\u90e8\u9580\u306e\u4eba\u3005\u306e\u30a2\u30b5\u30a4\u30f3\u3092\u6020\u308a\u304c\u3061\u3067\u3059\u3002<\/p>\n<blockquote><p>\u6700\u3082\u3088\u304f\u3042\u308b\u9593\u9055\u3044\u306f\u3001\u30c1\u30fc\u30e0\u5185\u306b\u88fd\u9020\u62c5\u5f53\u8005\u304c\u3044\u306a\u3044\u3053\u3068\u3067\u3059\u3002\u30d7\u30ed\u30b8\u30a7\u30af\u30c8\u30c1\u30fc\u30e0\u304c\u300c\u30d5\u30ea\u30fc\u30ba\u3057\u305f\u30c7\u30b6\u30a4\u30f3\u300d\u3068\u601d\u3063\u3066\u3044\u305f\u306e\u306b\u3001\u88fd\u9020\u4f1a\u793e\u304c\u305d\u306e\u88fd\u54c1\u3092\u4f5c\u308b\u3053\u3068\u304c\u3067\u304d\u306a\u3044\u3068\u308f\u304b\u3063\u305f\u3089\u3001\u3053\u308c\u307b\u3069\u3072\u3069\u3044\u3053\u3068\u306f\u3042\u308a\u307e\u305b\u3093\u3002<\/p><\/blockquote>\n<p>\u3053\u308c\u306f\u3001\u5fd8\u308c\u53bb\u3089\u308c\u305f\u4ed6\u306e\u6a5f\u80fd\u5206\u91ce\u306b\u3082\u5f53\u3066\u306f\u307e\u308a\u307e\u3059\u3002\"\u30c6\u30fc\u30d6\u30eb\u306b\u7740\u304f\u5834\u6240 \"\u3092\u6301\u3064\u3079\u304d\u3067\u3059\u3002  \u4f8b\u3048\u3070\u3001\u7279\u6b8a\u306a\u6750\u6599\u3084\u90e8\u54c1\u3092\u5fc5\u8981\u3068\u3059\u308b\u65b0\u88fd\u54c1\u306b\u306f\u3001\u751f\u7523\u9700\u8981\u3092\u6e80\u305f\u3059\u305f\u3081\u306b\u3001\u54c1\u8cea\u7ba1\u7406\u30b0\u30eb\u30fc\u30d7\u3084\u8cfc\u8cb7\u30b0\u30eb\u30fc\u30d7\u306e\u4eba\u9593\u304c\u53c2\u52a0\u3059\u3079\u304d\u3067\u3059\u3002  \u30d7\u30ed\u30b8\u30a7\u30af\u30c8\u306e\u7d42\u76e4\u306b\u306a\u3063\u3066\u3053\u308c\u3089\u306e\u6a5f\u80fd\u5206\u91ce\u306b\u76f8\u8ac7\u3059\u308b\u3068\u3001\u5fc5\u305a\u5e02\u5834\u6295\u5165\u306e\u9045\u308c\u306b\u3064\u306a\u304c\u308b\u3053\u3068\u304c\u591a\u3044\u3002<\/p>\n<p>\u5730\u57df\u3084\u6642\u5dee\u3092\u8d85\u3048\u305f\u30af\u30ed\u30b9\u30d5\u30a1\u30f3\u30af\u30b7\u30e7\u30ca\u30eb\u306a\u30c1\u30fc\u30e0\u3092\u7ba1\u7406\u3059\u308b\u3053\u3068\u306f\u3001\u30d7\u30ed\u30b8\u30a7\u30af\u30c8\u306e\u8ab2\u984c\u3068\u306a\u308a\u307e\u3059\u3002\u30bf\u30b9\u30af\u306e\u7d99\u7d9a\u6027\u3092\u7dad\u6301\u3059\u308b\u305f\u3081\u306b\u306f\u3001\u69d8\u3005\u306a\u30c1\u30fc\u30e0\u30e1\u30f3\u30d0\u30fc\u306e\u6d3b\u52d5\u3092\u8abf\u6574\u3059\u308b\u5fc5\u8981\u6027\u3092\u8a8d\u8b58\u3059\u308b\u3053\u3068\u304c\u91cd\u8981\u3067\u3059\u3002<\/p>\n<blockquote><p>\u5404\u6a5f\u80fd\u9818\u57df\u306e\u6d3b\u52d5\u3092\u542b\u3080\u30bf\u30a4\u30e0\u30e9\u30a4\u30f3\u3092\u69cb\u7bc9\u30fb\u7ba1\u7406\u3059\u308b\u3053\u3068\u3067\u3001\u30d7\u30ed\u30b8\u30a7\u30af\u30c8\u304c\u3069\u306e\u6642\u70b9\u3067\u3069\u306e\u30d7\u30ed\u30bb\u30b9\u306b\u3042\u308b\u306e\u304b\u3092\u30b0\u30eb\u30fc\u30d7\u3067\u8a8d\u8b58\u3059\u308b\u3053\u3068\u304c\u3067\u304d\u307e\u3059\u3002\u307e\u305f\u3001\u30d7\u30ed\u30b8\u30a7\u30af\u30c8\u306e\u30bf\u30a4\u30e0\u30e9\u30a4\u30f3\u3092\u7ba1\u7406\u3059\u308b\u3053\u3068\u3067\u3001\u7d4c\u55b6\u9663\u306b\u60c5\u5831\u3092\u63d0\u4f9b\u3057\u3001\u5fc5\u8981\u306b\u5fdc\u3058\u3066\u6642\u9593\u77ed\u7e2e\u306e\u305f\u3081\u306b\u30ea\u30bd\u30fc\u30b9\u3092\u518d\u914d\u5206\u3059\u308b\u306a\u3069\u3001\u4ecb\u5165\u3059\u308b\u6a5f\u4f1a\u3092\u4e0e\u3048\u308b\u3053\u3068\u304c\u3067\u304d\u307e\u3059\u3002<\/p><\/blockquote>\n<h2><span class=\"ez-toc-section\" id=\"Tip_12_Get_expert_help_when_you_need_it\"><\/span><b>\u30d2\u30f3\u30c8#12\uff1a\u5fc5\u8981\u306a\u3068\u304d\u306b\u5c02\u9580\u5bb6\u306e\u52a9\u3051\u3092\u5f97\u308b<\/b><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>\u3059\u3079\u3066\u306e\u4f01\u696d\u3001\u7279\u306b\u5c0f\u898f\u6a21\u306a\u8d77\u696d\u5bb6\u306f\u3001\u65b0\u88fd\u54c1\u3092\u958b\u767a\u3057\u3066\u5e02\u5834\u306b\u6295\u5165\u3059\u308b\u305f\u3081\u306e\u3042\u3089\u3086\u308b\u5074\u9762\u3092\u30ca\u30d3\u30b2\u30fc\u30c8\u3059\u308b\u305f\u3081\u306b\u5fc5\u8981\u306a\u5c02\u9580\u77e5\u8b58\u3092\u793e\u5185\u306b\u5099\u3048\u3066\u3044\u308b\u308f\u3051\u3067\u306f\u3042\u308a\u307e\u305b\u3093\u3002\u5fc5\u8981\u306a\u6a5f\u80fd\u304c\u3059\u3079\u3066\u5782\u76f4\u7d71\u5408\u3055\u308c\u3066\u3044\u308b\u3088\u3046\u306b\u898b\u3048\u308b\u5927\u4f01\u696d\u3067\u3082\u3001\u65b0\u3057\u3044\u5206\u91ce\u3067\u306e\u7279\u5b9a\u306e\u7d4c\u9a13\u304c\u4e0d\u8db3\u3057\u3066\u3044\u308b\u3053\u3068\u304c\u3042\u308a\u307e\u3059\u3002\u3053\u306e\u3088\u3046\u306a\u5834\u5408\u3001\u52a9\u3051\u304c\u5fc5\u8981\u306a\u6642\u3092\u77e5\u3063\u3066\u3044\u308b\u304b\u3069\u3046\u304b\u304c\u3001\u88fd\u54c1\u3092\u4e88\u5b9a\u901a\u308a\u306b\u5e02\u5834\u306b\u6295\u5165\u3067\u304d\u308b\u304b\u3001\u7af6\u5408\u4ed6\u793e\u306b\u5148\u3092\u8d8a\u3055\u308c\u3066\u3057\u307e\u3046\u304b\u306e\u5206\u304b\u308c\u76ee\u3068\u306a\u308a\u307e\u3059\u3002<\/p>\n<p><span style=\"font-weight: 400;\">\u6025\u901f\u306b\u5909\u5316\u3059\u308b\u4eca\u65e5\u306e\u52b4\u50cd\u74b0\u5883\u3067\u306f\u3001\u4f01\u696d\u306e\u30d5\u30eb\u30bf\u30a4\u30e0W2\u306e\u52b4\u50cd\u529b\u306f\u3001\u5951\u7d04\u793e\u54e1\u3084\u30d5\u30ea\u30fc\u30e9\u30f3\u30b5\u30fc\u306a\u3069\u306e\u5916\u90e8\u30ea\u30bd\u30fc\u30b9\u3067\u7c21\u5358\u306b\u88dc\u3046\u3053\u3068\u304c\u3067\u304d\u307e\u3059\u3002<\/span> \u30ae\u30b0\u30fb\u30a8\u30b3\u30ce\u30df\u30fc<a href=\"https:\/\/www.naco.org\/featured-resources\/future-work-rise-gig-economy\"><span style=\"font-weight: 400;\">\u00a0<\/span><\/a><span style=\"font-weight: 400;\">\u306f\u3001\u5e02\u5834\u6295\u5165\u307e\u3067\u306e\u6642\u9593\u3092\u77ed\u7e2e\u3059\u308b\u3060\u3051\u3067\u306a\u304f\u3001\u958b\u767a\u30b3\u30b9\u30c8\u3092\u524a\u6e1b\u3059\u308b\u3053\u3068\u304c\u3067\u304d\u308b\u305f\u3081\u3001\u4f01\u696d\u306e\u898f\u6a21\u3092\u554f\u308f\u305a\u30e1\u30ea\u30c3\u30c8\u304c\u3042\u308a\u307e\u3059\u3002\u00a0 <\/span><\/p>\n<blockquote><p><span style=\"font-weight: 400;\">\u4f8b\u3048\u3070\u3001\u30a8\u30ad\u30b9\u30d1\u30fc\u30c8 <a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/regulatory-writing?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=MDTimetoMarket\">\u85ac\u4e8b\u95a2\u9023\u306e\u30d5\u30ea\u30fc\u30e9\u30f3\u30b5\u30fc<\/a> FDA\u3068\u306e\u9577\u5e74\u306e\u5177\u4f53\u7684\u306a\u4ed5\u4e8b\u306e\u7d4c\u9a13\u3092\u6301\u3064\u30b9\u30bf\u30c3\u30d5\u304c\u3001\u305f\u3063\u305f\u4e00\u5ea6\u306e\u6709\u5229\u306a\u5224\u65ad\u306b\u5927\u304d\u304f\u8ca2\u732e\u3057\u307e\u3059\u3002 <a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/technical-writing\/?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=MDTimetoMarket\">\u30c6\u30af\u30cb\u30ab\u30eb\u30e9\u30a4\u30bf\u30fc<\/a> \u660e\u77ad\u3067\u7c21\u6f54\u306a\u4f7f\u7528\u8aac\u660e\u66f8\u3092\u66f8\u304f\u6280\u8853\u3082\u3001\u30e6\u30fc\u30b6\u30fc\u306e\u30df\u30b9\u3092\u306a\u304f\u3059\u305f\u3081\u306b\u306f\u3001\u306a\u304b\u306a\u304b\u624b\u306b\u5165\u3089\u306a\u3044\u30ce\u30a6\u30cf\u30a6\u3067\u3059\u3002\u3069\u306e\u3088\u3046\u306a\u30cb\u30fc\u30ba\u3067\u3042\u3063\u3066\u3082\u3001\u81ea\u5206\u3067\u4f5c\u696d\u3092\u3057\u3066\u521d\u5fc3\u8005\u306e\u30df\u30b9\u3092\u72af\u3059\u3088\u308a\u3082\u3001\u5916\u90e8\u306e\u5c02\u9580\u5bb6\u306e\u52a9\u3051\u3092\u501f\u308a\u305f\u65b9\u304c\u65e9\u3044\u5834\u5408\u304c\u3042\u308a\u307e\u3059\u3002<\/span><\/p><\/blockquote>\n<p><span style=\"font-weight: 400;\">\u7d50\u8ad6\u304b\u3089\u8a00\u3046\u3068\u3001\u88fd\u54c1\u3092\u3067\u304d\u308b\u3060\u3051\u65e9\u304f\u5e02\u5834\u306b\u6295\u5165\u3059\u308b\u305f\u3081\u306e\u30dd\u30a4\u30f3\u30c8\u306f\u660e\u78ba\u306a\u306f\u305a\u3067\u3059\u3002\u7269\u7406\u7684\u306a\u8a2d\u8a08\u3001\u30c6\u30b9\u30c8\u3001\u691c\u8a3c\u306a\u3069\u3092\u884c\u3046\u524d\u306b\u3001\u3067\u304d\u308b\u3060\u3051\u591a\u304f\u306e\u4e8b\u524d\u8abf\u67fb\u3068\u8a08\u753b\u3092\u884c\u3046\u3053\u3068\u304c\u3001\u3088\u308a\u8fc5\u901f\u306a\u5e02\u5834\u6295\u5165\u306b\u3064\u306a\u304c\u308a\u307e\u3059\u3002  \u76f4\u611f\u7684\u306b\u306f\u7406\u89e3\u3067\u304d\u306a\u3044\u304b\u3082\u3057\u308c\u307e\u305b\u3093\u304c\u3001\u5e02\u5834\u6295\u5165\u307e\u3067\u306e\u6642\u9593\u3092\u77ed\u7e2e\u3059\u308b\u6226\u7565\u3068\u306f\u3001\u57fa\u672c\u7684\u306b\u3001\u969c\u5bb3\u3001\u632b\u6298\u3001\u30df\u30b9\u3092\u524d\u3082\u3063\u3066\u6392\u9664\u3057\u3088\u3046\u3068\u3059\u308b\u3082\u306e\u3067\u3059\u3002  \u6210\u529f\u3057\u3066\u3044\u308b\u533b\u7642\u6a5f\u5668\u30e1\u30fc\u30ab\u30fc\u306f\u3001\u9577\u5e74\u306b\u308f\u305f\u308a\u3001\u3053\u306e\u3088\u3046\u306a\u771f\u5b9f\u3092\u5b66\u3093\u3067\u304d\u307e\u3057\u305f\u3002 <\/span><i><span style=\"font-weight: 400;\">\u8fc5\u901f\u306a\u5e02\u5834\u6295\u5165<\/span><\/i><span style=\"font-weight: 400;\"> \u306e\u51e6\u7406\u3092\u884c\u3044\u307e\u3059\u3002<\/span><\/p>\n<h2><span class=\"ez-toc-section\" id=\"Tip_13_Avoid_dismantling_successful_Project_Teams\"><\/span><strong>\u30d2\u30f3\u30c8#13\uff1a\u6210\u529f\u3057\u305f\u30d7\u30ed\u30b8\u30a7\u30af\u30c8\u30c1\u30fc\u30e0\u3092\u89e3\u4f53\u3057\u306a\u3044\u3088\u3046\u306b\u3059\u308b<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>\u65b0\u8208\u4f01\u696d\u306e\u3088\u3046\u306a\u5c0f\u898f\u6a21\u306a\u533b\u7642\u6a5f\u5668\u30e1\u30fc\u30ab\u30fc\u306f\u3001\u4e00\u822c\u7684\u306b\u3053\u306e\u3088\u3046\u306a\u6b74\u53f2\u7684\u5c55\u671b\u3092\u6301\u3063\u3066\u3044\u307e\u305b\u3093\u3002\u30c1\u30fc\u30e0\u306e\u5c02\u9580\u77e5\u8b58\u3068\u7d4c\u9a13\u306b\u983c\u3089\u3056\u308b\u3092\u5f97\u306a\u3044\u306e\u3067\u3059\u3002  \u65b0\u88fd\u54c1\u306e\u5e02\u5834\u6295\u5165\u3092\u52a0\u901f\u3059\u308b\u305f\u3081\u306e\u6700\u5f8c\u306e\u30a2\u30c9\u30d0\u30a4\u30b9\u306f\u3001\u6210\u529f\u3057\u305f\u30d7\u30ed\u30b8\u30a7\u30af\u30c8\u30c1\u30fc\u30e0\u3092\u3059\u3050\u306b\u89e3\u4f53\u3057\u306a\u3044\u3053\u3068\u3067\u3059\u3002  \u6210\u529f\u3057\u305f\u30d7\u30ed\u30b8\u30a7\u30af\u30c8\u30c1\u30fc\u30e0\u3092\u305d\u306e\u307e\u307e\u5b58\u7d9a\u3055\u305b\u3001\u4ee5\u524d\u306e\u6210\u529f\u4f53\u9a13\u3092\u7a4d\u307f\u91cd\u306d\u308b\u3053\u3068\u3067\u3001\u958b\u767a\u30d7\u30ed\u30bb\u30b9\u306b\u95a2\u3059\u308b\u5f37\u529b\u306a\u30a4\u30f3\u30b5\u30a4\u30c8\u3092\u5f97\u308b\u3053\u3068\u304c\u3067\u304d\u3001\u5e02\u5834\u6295\u5165\u307e\u3067\u306e\u6642\u9593\u3092\u77ed\u7e2e\u3059\u308b\u3053\u3068\u304c\u3067\u304d\u307e\u3059\u3002<\/p>\n<p>\u3057\u304b\u3057\u3001\u4eca\u65e5\u306e\u4e16\u754c\u3067\u306f\u3001\u6210\u529f\u3057\u305f\u30c1\u30fc\u30e0\u30922\u30013\u5e74\u4ee5\u4e0a\u7dad\u6301\u3059\u308b\u3053\u3068\u306f\u96e3\u3057\u304f\u3001\u5c0f\u3055\u306a\u8d77\u696d\u5bb6\u4f01\u696d\u3067\u3042\u3063\u3066\u3082\u3001\u904e\u53bb\u306e\u30d7\u30ed\u30b8\u30a7\u30af\u30c8\u304b\u3089\u5f97\u3089\u308c\u305f\u7d44\u7e54\u7684\u306a\u5b66\u3073\u3092\u4fdd\u5b58\u3059\u308b\u65b9\u6cd5\u3092\u5de5\u592b\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002\u305d\u306e\u305f\u3081\u306b\u306f\u3001\u904e\u53bb\u306e\u30d7\u30ed\u30b8\u30a7\u30af\u30c8\u3092\u8a18\u9332\u3057\u3001\u6587\u66f8\u5316\u3059\u308b\u3053\u3068\u304c\u65e9\u6025\u306b\u5fc5\u8981\u3067\u3059\u3002 <em>\u30d9\u30b9\u30c8\u30d7\u30e9\u30af\u30c6\u30a3\u30b9<\/em> \u3068\u3059\u308c\u3070\u3001\u500b\u4eba\u306e\u982d\u306e\u4e2d\u3060\u3051\u3067\u306f\u306a\u304f\u3001\u7d44\u7e54\u306e\u4e2d\u306b\u6210\u529f\u306e\u305f\u3081\u306e\u77e5\u8b58\u30d9\u30fc\u30b9\u3092\u65e9\u304f\u69cb\u7bc9\u3059\u308b\u3053\u3068\u304c\u3067\u304d\u307e\u3059\u3002<\/p>\n<p>\u6700\u5f8c\u306b\u3001\u6700\u9ad8\u306e\u30d1\u30d5\u30a9\u30fc\u30de\u30f3\u30b9\u3092\u767a\u63ee\u3057\u3066\u3044\u305f\u30c1\u30fc\u30e0\u304c\u89e3\u6563\u3057\u305f\u5f8c\u3082\u3001\u82e5\u3044\u30d7\u30ed\u30b8\u30a7\u30af\u30c8\u30c1\u30fc\u30e0\u306e\u80b2\u6210\u306e\u305f\u3081\u306b\u3001\u7d4c\u55b6\u9663\u304c\u7d4c\u9a13\u306b\u57fa\u3065\u304f\u6307\u5c0e\u3092\u7a4d\u6975\u7684\u306b\u884c\u3046\u3053\u3068\u304c\u3067\u304d\u308b\u3088\u3046\u306b\u306a\u308a\u307e\u3057\u305f\u3002  \u30d7\u30ed\u30b8\u30a7\u30af\u30c8\u306e\u9032\u6357\u72b6\u6cc1\u3092\u7d4c\u55b6\u9663\u306b\u5831\u544a\u3059\u308b\u969b\u306b\u306f\u3001\u5358\u306b\u30b9\u30b1\u30b8\u30e5\u30fc\u30eb\u3092\u78ba\u8a8d\u3059\u308b\u3060\u3051\u3067\u306f\u306a\u304f\u3001\u7d44\u7e54\u3068\u3057\u3066\u306e\u8a18\u61b6\u304c\u6b8b\u3063\u3066\u3044\u308b\u3002  \u4eca\u3067\u306f\u3001\u7d4c\u55b6\u9663\u304c\u30c1\u30fc\u30e0\u3068\u3088\u308a\u6307\u5c0e\u7684\u306a\u3084\u308a\u53d6\u308a\u3092\u3059\u308b\u305f\u3081\u306b\u9069\u7528\u3067\u304d\u308b\u5236\u5ea6\u7684\u306a\u8a18\u61b6\u304c\u3042\u308b\u3002\u305f\u3063\u305f1\u3064\u306e\u30df\u30b9\u3092\u306a\u304f\u3059\u3060\u3051\u3067\u3001\u30d7\u30ed\u30b8\u30a7\u30af\u30c8\u5168\u4f53\u306e\u6d41\u308c\u304c\u5909\u308f\u308a\u307e\u3059\u3002\u305f\u3063\u305f\u4e00\u3064\u306e\u6210\u529f\u3092\u518d\u73fe\u3059\u308b\u3053\u3068\u3067\u3001\u65b0\u88fd\u54c1\u3092\u5e02\u5834\u306b\u9001\u308a\u51fa\u3059\u30b9\u30d4\u30fc\u30c9\u3092\u3055\u3089\u306b\u4e0a\u3052\u308b\u3053\u3068\u304c\u3067\u304d\u308b\u306e\u3067\u3059\u3002<\/p>\n<p><strong>\u3053\u306e\u8a18\u4e8b\u306f\u3001Kolabtree\u306e\u30d5\u30ea\u30fc\u30e9\u30f3\u30b9\u306e\u533b\u7642\u6a5f\u5668\u30a8\u30ad\u30b9\u30d1\u30fc\u30c8\u3067\u3042\u308bThomas Williams\u304c\u57f7\u7b46\u3057\u307e\u3057\u305f\u3002\u5f7c\u306b\u76f4\u63a5\u9023\u7d61\u3059\u308b <a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/thomas-williams?utm_source=Blog&amp;utm_medium=Source&amp;utm_campaign=MDTimetoMarket\">\u3053\u308c<\/a> \u307e\u305f\u306f <a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/medical-device?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=MDTimetoMarket\">\u5f7c\u306e\u3088\u3046\u306a\u30d7\u30ed\u30d5\u30a3\u30fc\u30eb\u3092\u3082\u3063\u3068\u898b\u308b<\/a>.\u00a0<\/strong><\/p>\n<h2><span class=\"ez-toc-section\" id=\"Reduce_Medical_Device_Time_to_Market_Free_Reference_Cheat_Sheet\"><\/span><strong>\u533b\u7642\u6a5f\u5668\u306eTime to Market\u3092\u77ed\u7e2e\u3059\u308b\u3002\u7121\u6599\u53c2\u7167\u30c1\u30fc\u30c8\u30b7\u30fc\u30c8<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><img decoding=\"async\" loading=\"lazy\" class=\"alignnone wp-image-7467 size-full\" src=\"https:\/\/www.kolabtree.com\/blog\/wp-content\/uploads\/2020\/04\/Reduce-Medical-Device-Time-To-Market.png\" alt=\"\" width=\"800\" height=\"2000\" srcset=\"https:\/\/www.kolabtree.com\/blog\/wp-content\/uploads\/2020\/04\/Reduce-Medical-Device-Time-To-Market.png 800w, https:\/\/www.kolabtree.com\/blog\/wp-content\/uploads\/2020\/04\/Reduce-Medical-Device-Time-To-Market-120x300.png 120w, https:\/\/www.kolabtree.com\/blog\/wp-content\/uploads\/2020\/04\/Reduce-Medical-Device-Time-To-Market-410x1024.png 410w, https:\/\/www.kolabtree.com\/blog\/wp-content\/uploads\/2020\/04\/Reduce-Medical-Device-Time-To-Market-768x1920.png 768w, https:\/\/www.kolabtree.com\/blog\/wp-content\/uploads\/2020\/04\/Reduce-Medical-Device-Time-To-Market-614x1536.png 614w, https:\/\/www.kolabtree.com\/blog\/wp-content\/uploads\/2020\/04\/Reduce-Medical-Device-Time-To-Market-120x300@2x.png 240w\" sizes=\"(max-width: 800px) 100vw, 800px\" \/><\/p>\n<p><strong>\u533b\u7642\u6a5f\u5668\u306e\u5e02\u5834\u6295\u5165\u307e\u3067\u306e\u6642\u9593\u3092\u77ed\u7e2e\u3059\u308b\u6e96\u5099\u306f\u3067\u304d\u3066\u3044\u307e\u3059\u304b\uff1fKolabtree\u3067\u306f\u3001\u4fe1\u983c\u3067\u304d\u308b\u533b\u7642\u6a5f\u5668\u30b3\u30f3\u30b5\u30eb\u30bf\u30f3\u30c8\u3084\u30d5\u30ea\u30fc\u30e9\u30f3\u30b9\u306e\u30ec\u30ae\u30e5\u30e9\u30c8\u30ea\u30fc\u30fb\u30e9\u30a4\u30bf\u30fc\u304c\u30b5\u30dd\u30fc\u30c8\u3057\u307e\u3059\u3002 <a href=\"https:\/\/www.kolabtree.com\/?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=MDTimetoMarket\">\u3042\u306a\u305f\u306e\u30d7\u30ed\u30b8\u30a7\u30af\u30c8\u3092\u4eca\u3059\u3050\u6295\u7a3f<\/a><\/strong><\/p>","protected":false},"excerpt":{"rendered":"<p>\u00a0Thomas Williams, medical device innovation consultant on Kolabtree, provides 13 tips to help you reduce time to market. Scroll to the end to see the free reference cheat sheet.\u00a0 Reducing the time to market in today\u2019s medical device industry is a major challenge for both large and small companies. There are many ways to safely accelerate your product\u2019s time to market, and none of them involve taking shortcuts. This article is intended to help Medical Device Executives and Managers who want to speed up their product development cycle using a disciplined approach aimed at eliminating risk. Often risks are unknowingly built into projects in the early stages with disastrous consequences<\/p>\n<div class=\"read-more\"><a href=\"https:\/\/www.kolabtree.com\/blog\/ja\/13-proven-ways-to-reduce-medical-device-time-to-market-cheat-sheet\/\" title=\"\u7d9a\u304d\u3092\u8aad\u3080\">\u7d9a\u304d\u3092\u8aad\u3080<\/a><\/div>","protected":false},"author":12,"featured_media":7466,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":[],"categories":[443,540],"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>13 Proven Ways to Reduce Medical Device Time to Market (Cheat Sheet)<\/title>\n<meta name=\"description\" content=\"Experienced consultant Thomas Williams provides 13 expert tips on how to reduce medical device time to market. Also includes a reference cheat sheet.\" \/>\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\/13-formas-probadas-de-reducir-el-tiempo-de-comercializacion-de-los-dispositivos-medicos\/\" \/>\n<meta property=\"og:locale\" content=\"ja_JP\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"13 Proven Ways to Reduce Medical Device Time to Market (Cheat Sheet)\" \/>\n<meta property=\"og:description\" content=\"Experienced consultant Thomas Williams provides 13 expert tips on how to reduce medical device time to market. Also includes a reference cheat sheet.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.kolabtree.com\/blog\/ja\/13-formas-probadas-de-reducir-el-tiempo-de-comercializacion-de-los-dispositivos-medicos\/\" \/>\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=\"2020-04-27T13:13:06+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2020-10-12T10:33:28+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/www.kolabtree.com\/blog\/wp-content\/uploads\/2020\/04\/Medical-Device-Time-To-Market.jpg\" \/>\n\t<meta property=\"og:image:width\" content=\"1280\" \/>\n\t<meta property=\"og:image:height\" content=\"853\" \/>\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=\"11\u5206\" \/>\n<!-- \/ Yoast SEO Premium plugin. -->","yoast_head_json":{"title":"13 Proven Ways to Reduce Medical Device Time to Market (Cheat Sheet)","description":"Experienced consultant Thomas Williams provides 13 expert tips on how to reduce medical device time to market. 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