《醫材沛方：醫療器材產業秘辛大聲說》
你對醫療器材的世界感到好奇嗎？本節目由主持人阿沛，深入訪談來自醫材圈的專家與實戰玩家，從行銷策略、國際法規到市場實務，揭開產業的神祕面紗。無論你是醫材新鮮人、創業者，還是想了解產業趨勢的投資人，這裡都有你想知道的第一手觀點！
本節目由騏峰公司贊助播出，帶你用最貼近實務的方式，聽懂醫療器材的大小事。
Medical Secrets Exposed: Pei’s Inside Look into the Medical Device Industry
Are you curious about what really happens behind the scenes in the medical device world? Host Pei dives into real conversations with experts in marketing, regulations, and global markets. This podcast makes complex industry topics easy to understand, from product development to go-to-market strategies.
Whether you're new to the field, a healthcare entrepreneur, or an investor seeking insights, this show is your gateway to the inner workings of the medtech world.
Sponsored by Chi Feng Co., Ltd., helping you uncover the real stories behind medical innovation.
Powered by Firstory Hosting
《醫材沛方：醫療器材產業秘辛大聲說》
你對醫療器材的世界感到好奇嗎？本節目由主持人阿沛，深入訪談來自醫材圈的專家與實戰玩家，從行銷策略、國際法規到市場實務，揭開產業的神祕面紗。無論你是醫材新鮮人、創業者，還是想了解產業趨勢的投資人，這裡都有你想知道的第一手觀點！
本節目由騏峰公司贊助播出，帶你用最貼近實務的方式，聽懂醫療器材的大小事。
Medical Secrets Exposed: Pei’s Inside Look into the Medical Device Industry
Are you curious about what really happens behind the scenes in the medical device world? Host Pei dives into real conversations with experts in marketing, regulations, and global markets. This podcast makes complex industry topics easy to understand, from product development to go-to-market strategies.
Whether you're new to the field, a healthcare entrepreneur, or an investor seeking insights, this show is your gateway to the inner workings of the medtech world.
Sponsored by Chi Feng Co., Ltd., helping you uncover the real stories behind medical innovation.
Powered by Firstory Hosting
❝你以為醫材法規只是送件和報告？
其實，懂法規＝看得懂市場邏輯＋臨床風險＋設計思維。❞
在這一集《醫材沛方》中，我們邀請到亮宇生物科技總經理 高志豪 Howard Kao，他從外商主管轉戰創業，陪伴許多醫材製造商一路從無到有，取得CE、FDA 510(k)、TFDA等上市許可。
他深知每一家廠商面對法規的痛——不只在報告本身，而是整個設計、溝通、驗證、邏輯與風險管理的整合。這集你將聽到：
🔹 為什麼台灣醫材驗證常常卡關？
🔹 ISO10993 生物相容性，為何不只是送測而已？
🔹 測試與法規如何跨部門整合，打造真正「可用且能過審」的產品？
🔹 中小企業如何用有限資源，打國際市場的法規戰？
🔹 全球法規趨勢：區域化、強監控、後市場追蹤，準備好了嗎？
他不只是做驗證，更幫你想「這樣驗，有沒有意義？能不能解釋得通？審查人會不會買單？」
👉 如果你想從市場觀點重新理解醫材法規、或正在為產品卡在申請階段苦惱，這一集千萬別錯過！
歡迎追蹤主持人阿沛Facebook、醫材沛方Yotube頻道！
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