FDA and Intellectual Property Strategies for Medical Device Technologies : Including Artificial Intelligence, Software and Applications / by Gerald B. Halt, Jr., John C. Donch, Jr., Amber R. Stiles, Brandon R. Theiss, Michelle Byrne, William F. Hodnick, Joshua Eldridge, Randy Goodman, Lisa Jenkins VanLuvanee, Dana L. Blue.

Format:

Book

Author/Creator:

Halt, Jr., Gerald B.

Series:

Engineering Series

Language:

English

Subjects (All):

Biomedical engineering.

Electronics.

Microtechnology.

Microelectromechanical systems.

Biomedical Engineering and Bioengineering.

Electronics and Microelectronics, Instrumentation.

Microsystems and MEMS.

Local Subjects:

Biomedical Engineering and Bioengineering.

Electronics and Microelectronics, Instrumentation.

Microsystems and MEMS.

Physical Description:

1 online resource (472 pages)

Edition:

2nd ed. 2026.

Place of Publication:

Cham : Springer Nature Switzerland : Imprint: Springer, 2026.

Summary:

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. Investigates the US FDA medical device approval/grant/clearance process and commercialization of these products in the US market; Addresses some of the major FDA hurdles that medical device innovators often face while seeking approval/grant/clearance; Discusses the interplay between FDA regulatory review of medical device technology and intellectual property strategy.

Contents:

Introduction

Development of A New Medical Device

Determining If A Medical Device Technology Is FDA Regulated

Basic FDA Regulatory Requirements For Medical Devices

Other Regulatory Consideration For Medical Devices

Benefits of Having FDA Approval

Patents

Trademarks and Trade Dress

Trade Secrets

Copyrights In Medical Device Technology

Design Protection For Medical Devices

Intellectual Property Issues in Medical Device Labeling and Marketing

Enforcement, Infringement and Monetization of Intellectual Property Rights

Successful Implementation of a Medical Device Company’s IP Strategy

Tips for Avoiding and Preventing Intellectual Property Problems

Successful Implementation of a Medical Device Company’s Regulatory Strategy

Tips for Avoiding and Preventing Regulatory Problems

Potential Combined IP and Regulatory Pitfalls.

Notes:

Description based on publisher supplied metadata and other sources.

ISBN:

3-032-12649-5

9783032126498

OCLC:

1574121032