Methods In Research And Development Of Biomedical Devices

This book presents a road map for applying the stages in conceptualization, evaluation, and testing of biomedical devices in a systematic order of approach, leading to solutions for medical problems within a well-deserved safety limit. The issues discussed will pave the way for understanding the preliminary concepts used in modern biomedical device engineering, which include medical imaging, computational fluid dynamics, finite element analysis, particle image velocimetry, and rapid prototyping. This book would undoubtedly be of use to biomedical engineers, medical doctors, radiologists, and any other professionals related to the research and development of devices for health care.

The Medical Device R&D Handbook presents a wealth of information for the hands-on design and building of medical devices. Detailed information on such diverse topics as catheter building, prototyping, materials, processes, regulatory issues, and much more are available in this convenient handbook for the first time. The Medical Device R&D Ha

Rare diseases collectively affect millions of Americans of all ages, but developing drugs and medical devices to prevent, diagnose, and treat these conditions is challenging. The Institute of Medicine (IOM) recommends implementing an integrated national strategy to promote rare diseases research and product development.

The very rapid pace of advances in biomedical research promises us a wide range of new drugs, medical devices, and clinical procedures. The extent to which these discoveries will benefit the public, however, depends in large part on the methods we choose for developing and testing them. Modern Methods of Clinical Investigation focuses on strategies for clinical evaluation and their role in uncovering the actual benefits and risks of medical innovation. Essays explore differences in our current systems for evaluating drugs, medical devices, and clinical procedures; health insurance databases as a tool for assessing treatment outcomes; the role of the medical profession, the Food and Drug Administration, and industry in stimulating the use of evaluative methods; and more. This book will be of special interest to policymakers, regulators, executives in the medical industry, clinical researchers, and physicians.

This textbook provides essential knowledge for biomedical product development, including material properties, fabrication processes and design techniques for different applications, as well as process design and optimization. This book is multidisciplinary and readers can learn techniques to apply acquired knowledge for various applications of biomedical design. Further, this book encourages readers to discover and convert newly reported technologies into products and services for the future development of biomedical applications. This is an ideal book for upper-level undergraduate and graduate students, engineers, technologists, and researchers working in the area of biomedical engineering and manufacturing. This book also: Provides a comprehensive set of fundamental knowledge for engineering students and entry level engineers to design biomedical devices Offers a unique approach to manufacturing of biomedical devices by integrating and formulating different considerations in process design tasks into optimization problems Provides a broad range of application examples to guide readers through the thinking process of designing and manufacturing biomedical devices, from basic understanding about the requirements and regulations to a set of manufacturing parameters

Exploring the practical, entrepreneurial, and historical aspects of medical device development, this second edition of The Medical Device R&D Handbook provides a how-to guide for medical device product development. The book offers knowledge of practical skills such as prototyping, plastics selection, and catheter construction, allowing designers to apply these specialized techniques for greater innovation and time saving. The author discusses the historical background of various technologies, helping readers understand how and why certain devices were developed. The text also contains interviews with leaders in the industry who offer their vast experience and insights on how to start and grow successful companies—both what works and what doesn’t work. This updated and expanded edition adds new information to help meet the challenges of the medical device industry, including strategic intellectual property management, operating room observation protocol, and the use of new technologies and new materials in device development.

​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.