由世博林家聖執行長、林志忠經理與李紹宸工程師共同撰寫，發表於成大前瞻醫療器材科技中心(MDIC)與成大醫院臨床創新研發中心(CIC)創刊之醫療器材與技術創新通訊 2026年2月 第二十二期，聚焦 AI 醫療器材（AI SaMD）在美國法規架構下的上市策略與戰略思維。
傳統上，FDA 510(k) 的「實質等同（substantial equivalence）」往往被視為快速上市的捷徑；然而，作者提醒業界，若缺乏整體商業與產品策略，僅取得實質等同認定可能只能換來入場券，而難以創造持久的市場競爭力。
透過解析 FDA 法規 21 CFR 870.2380 相關產品代碼的演進案例（例如 Viz.ai、Apple 等），文章指出，唯有採取 法規、智財（IP）與給付支付策略同步佈局，並有意識地主動定義與拓展產品代碼邊界，才能建立具備高商業含金量 的競爭護城河。
此外，作者也提出實務性策略，包括逆向策略性觸發新產品代碼、納入持續學習的變更控制計畫（PCCP）、營運自由分析（FTO）與給付路徑同步規劃，幫助醫材創新者將法規合規性轉化為真正的商業價值。
👉 詳細內容請見原文連結：
🔗 https://mdnews.web2.ncku.edu.tw/p/404-1174-217845.php?Lang=zh-tw
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