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.

Autorentext

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.