Assurance of Sterility for Sensitive Combination Products and Materials: New Paradigms for the Next Generation of Medical Devices and Pharmaceuticals discusses the medical device industry and the difficult challenge it faces with regard to developments in the exciting new world of sensitive combination products (SCPs) and the terminal sterilization of these devices. Traditional sterilization technologies, validation methodologies, and regulatory frameworks that have worked well for more than three decades do not meet the current challenges for these new classes of products.