商品描述
This book offers comprehensive, easy to understand guidance for medical device technology innovators on how to work through the United States Food and Drug Administration (US FDA) regulatory review and approval/grant/clearance process, while also providing insight on the various intellectual property concerns that many medical device innovators face. In the first portion of this book, readers are introduced to important concepts concerning FDA compliance for medical devices, as well as strategies for successfully navigating the FDA regulatory review and approval/grant/clearance process. Specifically, the first portion discusses the expansive range of medical devices and then walks through the most common routes to market: the PMA, 510(k), and De Novo application processes. The complexities of medical device commercialization in the US market are also discussed. Additionally, this book explores how Artificial Intelligence (AI) and new software innovations are impacting the medical regulatory space. In the second portion of this book, readers are introduced to the various types of intellectual property rights that are available for medical device technology inventions and innovations and can explore ways to overcome unique intellectual property challenges faced by many medical device technology innovators. In the third portion of the book, specific strategies are discussed to navigate the interface between the FDA regulatory process and the process of obtaining intellectual property protection. This book also includes a number of descriptive examples, case studies, and scenarios to illustrate the topics discussed and is intended for use by medical device designers, developers, and innovators.
商品描述(中文翻譯)
本書為醫療器材技術創新者提供全面且易於理解的指導，幫助他們了解美國食品藥品監督管理局（US FDA）的法規審查及批准/授權/清關過程，同時提供對許多醫療器材創新者所面臨的各種智慧財產權問題的見解。在本書的第一部分，讀者將了解有關醫療器材FDA合規性的重要概念，以及成功導航FDA法規審查和批准/授權/清關過程的策略。具體而言，第一部分討論了醫療器材的廣泛範疇，並逐步介紹最常見的市場進入途徑：PMA、510(k)和De Novo申請過程。還討論了在美國市場上醫療器材商業化的複雜性。此外，本書探討了人工智慧（AI）和新軟體創新如何影響醫療法規領域。在本書的第二部分，讀者將了解可用於醫療器材技術發明和創新的各種智慧財產權類型，並探索克服許多醫療器材技術創新者所面臨的獨特智慧財產權挑戰的方法。在本書的第三部分，將討論具體策略，以導航FDA法規過程與獲取智慧財產保護過程之間的接口。
本書還包含多個描述性範例、案例研究和情境，以說明所討論的主題，並旨在供醫療器材設計師、開發者和創新者使用。
作者簡介
Gerald B. Halt Jr., JD is president of Volpe and Koenig, P.C., where he counsels a global roster of clients ranging from individual inventors to Fortune 500 companies. With more than 25 years of experience, he focuses his practice on securing, enforcing, and licensing intellectual property rights in a wide array of technologies, including significant work with medical devices. John C. Donch Jr, JD is a shareholder at Volpe and Koenig, P.C., with more than 18 years of experience. He regularly counsels domestic and multinational clients on strategies for securing, realizing, and defending the value of their intellectual property. He has extensive experience with a wide variety of IP issues, including portfolio development and strategy, acquisitions, licensing, domestic and foreign patent prosecution, and infringement/validity analysis. Amber R. Stiles, JD, MBA is a registered patent attorney with a background in biomedical engineering. Ms. Stiles is a published book author and is currently employed as a medical device patent examiner at the United States Patent and Trademark Office. Brandon R. Theiss, JD is a licensed professional engineer and a registered patent attorney. An inventor himself, Mr. Theiss previously worked for a leading medical device manufacturer designing FDA-compliant manufacturing systems. Mr. Theiss is currently an associate at Volpe and Koenig. Michelle L. Byrne, BME, RAC, is an accomplished regulatory strategist with Facet Life Sciences, LLC with over 23 years professional experience in the FDA-regulated medical device and pharmaceutical industries. Ms. Byrne is a biomedical engineer with extensive experience in clinical and regulatory affairs in many different therapeutic areas. Notably, Ms. Byrne was formerly a lead reviewer at the United States Food and Drug Administration (Center for Devices and Radiological Health). William F. Hodnick, Ph.D., DABT is a pharmaceutical scientist with 25 years of pharmaceutical experience in the areas of analytical method development and validation, drug stability, and lot release testing, drug target identification, pharmacological activity screening, mechanism of action studies, drug metabolism and pharmacokinetics, toxicology, and regulatory affairs. Dr. Hodnick is currently employed as a Strategic Regulatory Innovator at Facet Life Sciences, LLC. Joshua A. Eldridge, Ph.D., is a pharmaceutical scientist with over 13 years of pharmaceutical industry experience covering drug from design, pharmaceutics, scaleup, GMP manufacturing, regulatory CMC consulting, and quality assurance. Dr. Eldridge has been named as an inventor on two transdermal patch (medical device) patents as well as patent applications in the areas of buccal peptide delivery and non-crystallizing forms of cannabidiolic acid. Dr. Eldridge is currently employed as a regulatory strategist with Facet Life Sciences, LLC. Randy Goodman, Ph.D. is a health economist with a background in clinical outcomes research, economic model development and asset valuation with over 25 years of experience in pharmaceutical and medical device product commercialization. Dr. Goodman is currently employed as a commercial and HEOR strategy consultant at Facet Life Sciences, LLC. Lisa Jenkins VanLuvanee, PhD is a neuroscientist with a background in cognition and neuroimaging and 25 years of experience working in FDA-regulated development. Dr. VanLuvanee is currently employed as the Chief Operating Officer and Vice President of Research and Development at Facet Life Sciences, LLC, a regulatory and development services organization devoted to helping small companies get their products to and through the FDA and to patients in need. Dana L. Blue, M.Sc., is an organic chemist with a background in method and analytical development, quality control, and clinical development with over 25 years of experience working in the FDA-regulated pharmaceutical industry. Ms. Blue is currently employed as a Strategic Program Champion and Team Manager at Facet Life Sciences, LLC, a regulatory and development services organization developing to helping small companies get their products to and through the FDA and to patients in need.
作者簡介(中文翻譯)
杰拉德·B·霍特（Gerald B. Halt Jr.），法學博士，是Volpe and Koenig, P.C.的總裁，為從個別發明家到《財富》500強公司等全球客戶提供諮詢。擁有超過25年的經驗，他專注於在各種技術領域中確保、執行和授權知識產權，包括在醫療設備方面的重大工作。
約翰·C·唐奇（John C. Donch Jr.），法學博士，是Volpe and Koenig, P.C.的股東，擁有超過18年的經驗。他定期為國內和跨國客戶提供有關確保、實現和捍衛其知識產權價值的策略建議。他在各種知識產權問題上擁有豐富的經驗，包括投資組合開發和策略、收購、授權、國內和國外專利申請以及侵權/有效性分析。
安柏·R·斯泰爾斯（Amber R. Stiles），法學博士，工商管理碩士，是一名註冊專利律師，擁有生物醫學工程背景。斯泰爾斯女士是一位出版書籍的作者，目前在美國專利商標局擔任醫療設備專利審查員。
布蘭登·R·泰斯（Brandon R. Theiss），法學博士，是一名持牌專業工程師和註冊專利律師。作為一名發明者，泰斯先生曾在一家領先的醫療設備製造商工作，設計符合FDA標準的製造系統。泰斯先生目前是Volpe and Koenig的助理律師。
米歇爾·L·伯恩（Michelle L. Byrne），生物醫學工程學士，RAC，是Facet Life Sciences, LLC的成功法規策略師，擁有超過23年的FDA監管醫療設備和製藥行業的專業經驗。伯恩女士是一名生物醫學工程師，在多個治療領域的臨床和法規事務方面擁有豐富的經驗。值得注意的是，伯恩女士曾擔任美國食品藥品監督管理局（FDA）設備和放射健康中心的首席審查員。
威廉·F·霍德尼克（William F. Hodnick），博士，DABT，是一名藥物科學家，擁有25年的藥物經驗，專注於分析方法開發和驗證、藥物穩定性、批次釋放測試、藥物靶點識別、藥理活性篩選、作用機制研究、藥物代謝和藥物動力學、毒理學以及法規事務。霍德尼克博士目前在Facet Life Sciences, LLC擔任戰略法規創新者。
約書亞·A·埃爾德里奇（Joshua A. Eldridge），博士，是一名藥物科學家，擁有超過13年的製藥行業經驗，涵蓋藥物設計、製劑、放大、生產良好實踐（GMP）製造、法規CMC諮詢和質量保證。埃爾德里奇博士在兩項透皮貼片（醫療設備）專利以及在口腔肽遞送和非結晶形式的大麻二酚酸的專利申請中被列為發明人。埃爾德里奇博士目前在Facet Life Sciences, LLC擔任法規策略師。
蘭迪·古德曼（Randy Goodman），博士，是一名健康經濟學家，擁有臨床結果研究、經濟模型開發和資產評估的背景，擁有超過25年的製藥和醫療設備產品商業化經驗。古德曼博士目前在Facet Life Sciences, LLC擔任商業和HEOR策略顧問。
莉莎·詹金斯·范盧瓦尼（Lisa Jenkins VanLuvanee），博士，是一名神經科學家，擁有認知和神經影像學的背景，並在FDA監管的開發領域工作了25年。范盧瓦尼博士目前在Facet Life Sciences, LLC擔任首席運營官和研究與開發副總裁，該公司是一家專注於幫助小型公司將其產品推向FDA並提供給有需要的患者的法規和開發服務組織。
達娜·L·藍（Dana L. Blue），碩士，是一名有機化學家，擁有方法和分析開發、質量控制和臨床開發的背景，在FDA監管的製藥行業工作了超過25年。藍女士目前在Facet Life Sciences, LLC擔任戰略計劃負責人和團隊經理，該公司是一家專注於幫助小型公司將其產品推向FDA並提供給有需要的患者的法規和開發服務組織。
