Biocompatibility Protocols for Medical Devices and Materials provides comprehensive coverage of the basic science and toxicological testing protocols necessary for the risk assessment and safety analysis of medical devices and materials which are based on the ISO guidelines for body contact and duration of contact. The book begins with device/component selection for toxicological experiments and provides an introduction to topics such as sensitization, irritation tests, material-mediated pyrogenicity, and bacterial-mediated pyrogenicity. Toxicology-related chapters explain the protocols for cytotoxicity, acute systemic toxicity, repeated-exposure systemic toxicity, genotoxicity, carcinogenicity, and reproductive toxicity testing. Biocompatibility Protocols for Medical Devices and Materials is a practical guide that provides step-by-step toxicological protocols ranging from materials selection to data interpretation for toxicologists, biomedical researchers, healthcare professionals, product developers, and others working in risk assessment and safety analysis of medical devices. Explains the biocompatibility test protocols for medical devices Provides an overview about chemical characterization Describes toxicokinetic, carcinogenicity, and reproductive toxicity studies Discusses the basic points needed to leverage the data from another device

Principles of Biomedical Sciences and Industry Improve your product development skills to bring new ideas to biomedicine The development of innovative healthcare products, such as biodegradable implants, biopharmaceuticals, or companion diagnostics, requires a multi-disciplinary approach that incorporates scientific evidence with novel and innovative ideas to create new and improved products and treatments. Indeed, product development and the integration of science with commercial aspects have become key challenges for scientists working in the pharmaceutical, biotech, and medtech industries. Using a multi-pronged approach to development, Principles of Biomedical Sciences and Industry combines ideas and methodologies from four of the central areas of focus in the biomedical arena: pharmaceuticals, diagnostics, biomaterials, and medical devices. In doing so, the book covers the entire product lifecycle, from translating a scientific idea into a prototype to product development, launch, and management. Principles of Biomedical Sciences and Industry readers will also find: Several case studies from the most important product categories (pharmaceuticals, diagnostics, medical devices, combination products) Chapters dealing with toxicology and safety risks in development, as well as regulatory approval Key business aspects including how to secure funding, managing intellectual property, and price regulation in the market An ideal resource for teachers and students that conveys the information in an easily-digestible format Ideal for advanced students and young professionals pursuing a career in the biomedical and healthcare industries, Principles of Biomedical Sciences and Industry is an essential reference for those in pharmaceutical industry, biotechnologists, medicinal chemists, bio-engineers, pharma engineers, and management consultants.

​This handbook provides comprehensive and up-to-date information on the topic of scientific, industrial and legal metrology. It discusses the state-of-art review of various metrological aspects pertaining to redefinition of SI Units and their implications, applications of time and frequency metrology, certified reference materials, industrial metrology, industry 4.0, metrology in additive manufacturing, digital transformations in metrology, soft metrology and cyber security, optics in metrology, nano-metrology, metrology for advanced communication, environmental metrology, metrology in biomedical engineering, legal metrology and global trade, ionizing radiation metrology, advanced techniques in evaluation of measurement uncertainty, etc. The book has contributed chapters from world’s leading metrologists and experts on the diversified metrological theme. The internationally recognized team of editors adopt a consistent and systematic approach and writing style, including ample cross reference among topics, offering readers a user-friendly knowledgebase greater than the sum of its parts, perfect for frequent consultation. Moreover, the content of this volume is highly interdisciplinary in nature, with insights from not only metrology but also mechanical/material science, optics, physics, chemistry, biomedical and more. This handbook is ideal for academic and professional readers in the traditional and emerging areas of metrology and related fields.

A Practical Guide to Planning, Writing, and Reviewing Medical Device Clinical Evaluation Reports guides readers through clinical data evaluation of medical devices, in compliance with the EU MDR requirements and other similar regulatory requirements throughout the world. This book brings together knowledge learned as the author constructed hundreds of CERs and taught thousands of learners on how to conduct clinical data evaluations. This book will support training for clinical engineers, clinical evaluation scientists, and experts reviewing medical device CERs, and will help individual writers, teams and companies to develop stronger, more robust CERs. Identifies and explains data analysis for clinical evaluation of medical devices Teaches readers how to understand and evaluate medical device performance and safety in the context of new regulations Provides analysis of new clinical evaluation criteria in the context of medical device design as well as in-hospital deployment and servicing

3D Printing in Radiation Oncology: Personalization of Patient Treatment Through Digital Fabrication presents a comprehensive and practical view of the many forms in which 3D printing is being integrated into radiation oncology practice. Radiation oncology employs among the most sophisticated digital technologies in medicine. Until recently, however, the “last mile” of treatment has required manually produced or generic devices for patient set up, positioning, control of surface dose, and delivery of brachytherapy treatment. 3D printing is already offering enhancements in both precision and efficiency through the digital design and fabrication of patient photon and electron bolus, customized surface and gynecological brachytherapy applicators, proton beam compensators and range shifters, patient immobilization, novel radiation detectors, and phantoms. Various innovations are disrupting decades-old practices in radiation therapy (RT) facilities, resulting in vital improvements in personalization of treatment and patient experience. An essential read for radiation oncologists, medical physicists, radiation therapists, oncology nurses, hospital administrators, engineers, and medical educators, this book is an indispensable resource for those bringing 3D printing to the RT clinic, looking to expand the role of 3D printing in their practice, or embarking upon related research and development.

Silk-based Biomaterials for Tissue Engineering, Regenerative and Precision Medicine, Second Edition is a must-have reference, providing comprehensive coverage of silk-based biomaterials and their importance in translational uses and biomedicine. This new edition considers the progress made in the past eight years, featuring many new chapters, including a discussion of cutting-edge fabrication methods and techniques, new and improved blends/composites, and an expanded range of applications in tissue engineering, regenerative and precision medicine. The book holistically reviews the types, structure and properties, processing methods, and specific biomedical applications for silk-based biomaterials. This will be a vital resource for materials and tissue engineering scientists, R&D departments in industry and academia, and academics interested in biomaterials, regenerative, and precision medicine. - Covers all key silk biomaterial types, including mulberry, Bombyx mori and nonmulberry/wild silk protein fibroins, sericins and spider silk, as well as their composite blends and various structures and scaffold platforms - Describes the cutting-edge processing techniques for each silk type, from traditional to nonconventional methods, such as using ionic liquids and engineering nanofibers and other biomedical matrices - Explores a range of applications in tissue engineering and regenerative and precision medicine, including bioprinting, bioelectronics and medical devices

Discover the future of cybersecurity through the eyes of the world's first augmented ethical hacker In Human Hacked: My Life and Lessons as the World's First Augmented Ethical Hacker by Len Noe, a pioneering cyborg with ten microchips implanted in his body, you'll find a startlingly insightful take on the fusion of biology and technology. The author provides a groundbreaking discussion of bio-implants, cybersecurity threats, and defenses. Human Hacked offers a comprehensive guide to understanding an existing threat that is virtually unknown. How to implement personal and enterprise cybersecurity measures in an age where technology transcends human limits and any person you meet might be augmented. The book provides: Exposure of a subculture of augmented humans hiding in plain sight Explorations of the frontier of bio-Implants, showing you the latest advancements in the tech and how it paves the way for access to highly restricted technology areas Discussions of cybersecurity tactics, allowing you to gain in-depth knowledge of phishing, social engineering, MDM restrictions, endpoint management, and more to shield yourself and your organization from unseen threats A deep understanding of the legal and ethical landscape of bio-implants as it dives into the complexities of protections for augmented humans and the ethics of employing such technologies in the corporate and government sectors Whether you're a security professional in the private or government sector, or simply fascinated by the intertwining of biology and technology, Human Hacked is an indispensable resource. This book stands alone in its category, providing not just a glimpse into the life of the world's first augmented ethical hacker, but also offering actionable insights and lessons on navigating the evolving landscape of cybersecurity. Don't miss this essential read on the cutting edge of technology and security.