This book covers biodevices, mainly implantable or quirurgical, for the diagnosis or treatment of different pathologies, which benefit from the use of active materials as sensors or actuators. Such active or "intelligent" materials are capable of responding in a controlled way to different external physical or chemical stimuli by changing some of their properties. These materials can be used to design and develop sensors, actuators, and multifunctional systems with a large number of applications for developing biodevices and medical appliances. Current work on these fields entails problems related to synthesis, characterization, modeling, simulation, processing, and prototyping technologies, as well as device testing and validation, all of which are treated in depth in this book, for the several types of active or intelligent materials covered. The research presented in this book helps further development of medical devices, based on the additional functionalities that the use of active or "intelligent" materials, both as sensors and actuators, supplies. The main results exposed may help with the industrial expansion of this kind of materials as part of more complex systems.

This book covers biodevices, mainly implantable or quirurgical, for the diagnosis or treatment of different pathologies, which benefit from the use of active materials as sensors or actuators. Such active or "intelligent" materials are capable of responding in a controlled way to different external physical or chemical stimuli by changing some of t

​The last decades have seen remarkable advances in computer‐aided design, engineering and manufacturing technologies, multi‐variable simulation tools, medical imaging, biomimetic design, rapid prototyping, micro and nanomanufacturing methods and information management resources, all of which provide new horizons for the Biomedical Engineering fields and the Medical Device Industry. Advanced Design and Manufacturing Technologies for Biomedical Devices covers such topics in depth, with an applied perspective and providing several case studies that help to analyze and understand the key factors of the different stages linked to the development of a novel biomedical device, from the conceptual and design steps, to the prototyping and industrialization phases. Main research challenges and future potentials are also discussed, taking into account relevant social demands and a growing market already exceeding billions of dollars. In time, advanced biomedical devices will decisively change methods and results in the medical world, dramatically improving diagnoses and therapies for all kinds of pathologies. But if these biodevices are to fulfill present expectations, today’s engineers need a thorough grounding in related simulation, design and manufacturing technologies, and collaboration between experts of different areas has to be promoted, as is also analyzed within this handbook.

Metallic Biomaterials Processing and Medical Device Manufacturing details the principles and practices of the technologies used in biomaterials processing and medical device manufacturing. The book reviews the main categories of metallic biomaterials and the essential considerations in design and manufacturing of medical devices. It bridges the gap between the designing of biomaterials and manufacturing of medical devices including requirements and standards. Main themes of the book include, manufacturing, coatings and surface modifications of medical devices, metallic biomaterials and their mechanical behaviour, degradation, testing and characterization, and quality controls, standards and FDA regulations of medical devices. The leading experts in the filed discuss the requirements, challenges, recent progresses and future research directions in the processing of materials and manufacturing of medical devices. Metallic Biomaterials Processing and Medical Device Manufacturing is ideal for those working in the disciplines of materials science, manufacturing, biomedical engineering, and mechanical engineering. - Reviews key topics of biomaterials processing for medical device applications including metallic biomaterials and their mechanical behavior, degradation, testing and characterization - Bridges the gap between biomaterials design and medical device manufacturing - Discusses the quality controls, standards, and FDA requirements for biomaterials and medical devices

This handbook focuses on the entire development process of biomedical microsystems that promote special interactions with cells. Fundamentals of cell biology and mechanobiology are described as necessary preparatory input for design tasks. Advanced design, simulation, and micro/nanomanufacturing resources, whose combined use enables the development of biomedical microsystems capable of interacting at a cellular level, are covered in depth. A detailed series of chapters is then devoted to applications based on microsystems that offer enhanced cellular control, including microfluidic devices for diagnosis and therapy, cell-based sensors and actuators (smart biodevices), microstructured prostheses for improvement of biocompatibility, microstructured and microtextured cell culture matrices for promotion of cell growth and differentiation, electrophoretic microsystems for study of cell mechanics, microstructured and microtextured biodevices for study of cell adhesion and dynamics, and biomimetic microsystems (including organs-on-chips), among others. Challenges relating to the development of reliable in vitro biomimetic microsystems, the design and manufacture of complex geometries, and biofabrication are also discussed.

This handbook covers medical device regulatory systems in different countries, ISO standards for medical devices, clinical trial and regulatory requirements, and documentation for application. It is the first to cover the medical device regulatory affairs in Asia. Experts from influential international regulatory bodies, including the US Food and Drug Administration (FDA), UK Medicines and Healthcare Products Regulatory Agency, Japan Pharmaceuticals and Medical Devices Agency, Saudi Food and Drug Authority, Korea Testing Laboratory, Taiwan FDA, World Health Organization, Asian Harmonization Working Party, Regulatory Affairs Professionals Society, and British Standards Institution, have contributed to the book. Government bodies, the medical device industry, academics, students, and general readers will find the book immensely useful for understanding the global regulatory environment and in their research and development projects.

Medical Devices and Regulations: Standards and Practices will shed light on the importance of regulations and standards among all stakeholders, bioengineering designers, biomaterial scientists and researchers to enable development of future medical devices. Based on the authors' practical experience, this book provides a concise, practical guide on key issues and processes in developing new medical devices to meet international regulatory requirements and standards. - Provides readers with a global perspective on medical device regulations - Concise and comprehensive information on how to design medical devices to ensure they meet regulations and standards - Includes a useful case study demonstrating the design and approval process

This chapter focuses on adhesives used in direct physiological contact in dental and medical procedures. Activity in both areas has been quite extensive outside the United States for decades. In contrast, adhesive use in medical devices, patches, and plasters has been ongoing in the United States for a long time. In the case of medical devices, adhesion is concerned with the joining of materials such as plastics, elastomers, textiles, metals, and ceramics, which are examined in other chapters of the present volume and are covered in various references [1–6], The coverage of this chapter is devoted to applications where to adhesives are in direct contact with tissues and other live organs.

Functional Nanocomposite Hydrogels: Synthesis, Characterization, and Biomedical Applications reviews how the unique properties of nanoscale composite materials make them ideal candidates for use in biomedical hydrogels. The book covers a range of key nanocomposite materials for use in biomedical hydrogels, including graphene quantum dot, cellulose and collagen nanocomposites. A wide selection of biomedical applications for functional nanocomposite hydrogels is explored, from drug delivery and cancer therapy, to wound healing and bioimaging. This is a key reference for those working in the fields of biomaterials, nanotechnology, pharmacology, biomedical engineering, and anyone with a particular interest in composites and hydrogels. To improve the properties of conventional hydrogels, nanoparticles or nanostructures are incorporated into the hydrogel networks, forming a composite hydrogel with specialized functional properties which are tailored to a specific biomedical application. - Reviews the benefits and challenges of nanocomposites as novel materials in biomedical hydrogels, providing the reader with a wider range of choice and improved options for hydrogel development - Describes the synthesis and characterization of nanocomposite hydrogels, offering end-to-end analysis of the process - Details the range of applications in biomedicine for nanocomposite hydrogels, including biosensing, antimicrobics and drug delivery

No book has been published that gives a detailed description of all the types of plastic materials used in medical devices, the unique requirements that the materials need to comply with and the ways standard plastics can be modified to meet such needs. This book will start with an introduction to medical devices, their classification and some of the regulations (both US and global) that affect their design, production and sale. A couple of chapters will focus on all the requirements that plastics need to meet for medical device applications. The subsequent chapters describe the various types of plastic materials, their properties profiles, the advantages and disadvantages for medical device applications, the techniques by which their properties can be enhanced, and real-world examples of their use. Comparative tables will allow readers to find the right classes of materials suitable for their applications or new product development needs.