How do you read a patent and what subject matter is patentable? What is the purpose of a patent? Who is an inventor on the patent if work is done by many people on the project? What is the process of obtaining a patent in my country and globally? Read this chapter to see how you could lose commercialization rights to your own invention. When exactly does an invention or idea become patentable? Once you own a patent, how can you make money from it? What is the process of licensing and the key terms that should be negotiated in such a license agreement? What is the use of a copyright or a trade secret in biotech? What exactly constitutes patent infringement ? These questions and many others are addressed in this chapter on intellectual property.

The vast world of biotechnology applications to human health is reviewed and the terminology used in the rest of the book is defined here. An overview of the industry, the value chains, the specific types of human health products covered in this text are presented in this chapter. A time-tested way to analyze an industry’s attractiveness for new entrants is presented here using Porter’s five forces model. Technology trends such as mobile health, artificial intelligence, 3D printing, cell and gene therapy, and robotics are presented to the reader in the context of the mission of improving human health. The overall process of development of new products in these various segments of drugs, devices and diagnostics sectors is reviewed here. The reader will leave this chapter with a 30,000-foot view of the industry dynamics and understand the context within which product commercialization is to be done.

From the long path through preclinical development, entering the regulatory field of interactions for human clinical trials can sometimes feel like you are walking into the lion’s den. This chapter guides you through an understanding of how to interact and how to prepare for FDA meetings so that they are on your side rather than fighting you. The common goals of companies and the FDA are highlighted here. Specific issues with identifying the appropriate regulatory approval pathway are discussed here with cautionary case studies. Complex new technologies which combine diagnostics and drugs, or devices and software, or AI-based dynamic software are reviewed here. The best approach to the appropriate regulatory pathway will be clear after reading this chapter. Case studies are used to show successful pathways taken by cutting-edge developments, such as cell-based therapy.

In this chapter, we focus on the role that innovation plays in the medtech ecosystem, including how innovation is financed by early-stage venture capital investors and valued by other stakeholders in the ecosystem. Using specific case studies and empirical data, we review the impact that innovation has on medical device companies’ revenue growth through market expansion and derivative product sales, and the ways in which medical device companies are valued by early-stage venture capital investors, public market investors, and strategic acquirers. In addition, there is a focus on the types of medtech product and service innovations that have driven the greatest value in the market, and the process of developing new technologies from ideation and invention to clinical evidence generation and regulatory approval, and then all of the way to widespread market adoption.