This book offers comprehensive, easy to understand guidance for medical device technology innovators on how to work through the United States FDA regulatory review 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 process. Specifically, the first portion discusses the expansive range of medical devices and then walks through the most common routes to market: the PMA and 510(k) application processes. 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.

This book offers a comprehensive, easy to understand guide for startup entities and developing companies, providing insight on the various sources of funding that are available, how these funding sources are useful at each stage of a company's development, and offers a comprehensive intellectual property strategy that parallels each stage of development. The IP strategies offered in this book take into consideration the goals that most startups and companies have at each stage of development, as well as the limitations that exist at each stage (i.e., limited available resources earmarked for intellectual property asset development), and provides solutions that startups and companies can implement to maximize their return on intellectual property investments. This book also includes a number of descriptive examples, case studies and scenarios to illustrate the topics discussed, and is intended for use by startups and companies across all industries. Readers will garner an appreciation for the value that intellectual property rights provide to a startup entity or company and will gain an understanding of the types of intellectual property rights that are available to companies and how to procure, utilize and monetize those intellectual property rights to help their company grow.

This book provides a comprehensive guide to procuring, utilizing and monetizing intellectual property rights, tailored for readers in the high-tech consumer electronics and software industries, as well as technology startups. Numerous, real examples, case studies and scenarios are incorporated throughout the book to illustrate the topics discussed. Readers will learn what to consider throughout the various creative phases of a product's lifespan from initial research and development initiatives through post-production. Readers will gain an understanding of the intellectual property protections afforded to U.S. corporations, methods to pro-actively reduce potential problems, and guidelines for future considerations to reduce legal spending, prevent IP theft, and allow for greater profitability from corporate innovation and inventiveness.

Engineering Innovation is an overview of the interconnected business and product development techniques needed to nurture the development of raw, emerging technologies into commercially viable products. This book relates Funding Strategies, Business Development, and Product Development to one another as an idea is refined to a validated concept, iteratively developed into a product, then produced for commercialization. Engineering Innovation also provides an introduction to business strategies and manufacturing techniques on a technical level designed to encourage passionate clinicians, academics, engineers and savvy entrepreneurs. Offers a comprehensive overview of the process of bringing new technology to market. Identifies a variety of technology management skill sets and management tools. Explores concept generation in conjunction with intellectual property development for early-stage companies. Explores Quality and Transfer-to-Manufacturing.

This book provides a comprehensive guide to procuring, utilizing and monetizing intellectual property rights, tailored for readers in the high-tech consumer electronics and software industries, as well as technology startups. Numerous, real examples, case studies and scenarios are incorporated throughout the book to illustrate the topics discussed. Readers will learn what to consider throughout the various creative phases of a product's lifespan from initial research and development initiatives through post-production. Readers will gain an understanding of the intellectual property protections afforded to U.S. corporations, methods to pro-actively reduce potential problems, and guidelines for future considerations to reduce legal spending, prevent IP theft, and allow for greater profitability from corporate innovation and inventiveness.