When it comes to inventing, developing, and commercializing medical devices, companies will invariably come to an intersection between business, regulatory compliance, intellectual property, and the law. These areas are diverse, but an understanding of each is absolutely critical to the successful development of a new medical device product. With years of experience as consultants to entrepreneurs, doctors, and medical device companies, the authors of this book have recognized the guidance that is needed and have sought to furnish a guide to issues that are important to medical device companies as they work to bring new medical device technologies to market. Specifically, this book identifies and explains FDA regulatory pathways that are available to medical companies, provides a primer on intellectual property rights, and explores implementation strategies for medical device innovators.