Author: Paul H. King,Richard C. Fries,Arthur T. Johnson
Publisher: CRC Press
Apply a Wide Variety of Design Processes to a Wide Category of Design Problems Design of Biomedical Devices and Systems, Third Edition continues to provide a real-world approach to the design of biomedical engineering devices and/or systems. Bringing together information on the design and initiation of design projects from several sources, this edition strongly emphasizes and further clarifies the standards of design procedure. Following the best practices for conducting and completing a design project, it outlines the various steps in the design process in a basic, flexible, and logical order. What’s New in the Third Edition: This latest edition contains a new chapter on biological engineering design, a new chapter on the FDA regulations for items other than devices such as drugs, new end-of-chapter problems, new case studies, and a chapter on product development. It adds mathematical modeling tools, and provides new information on FDA regulations and standards, as well as clinical trials and sterilization methods. Familiarizes the reader with medical devices, and their design, regulation, and use Considers safety aspects of the devices Contains an enhanced pedagogy Provides an overview of basic design issues Design of Biomedical Devices and Systems, Third Edition covers the design of biomedical engineering devices and/or systems, and is designed to support bioengineering and biomedical engineering students and novice engineers entering the medical device market.
Over the last century, medicine has come out of the "black bag" and emerged as one of the most dynamic and advanced fields of development in science and technology. Today, biomedical engineering plays a critical role in patient diagnosis, care, and rehabilitation. More than ever, biomedical engineers face the challenge of making sure that medical devices and systems are safe, effective, and cost-efficient. Reflecting the enormous growth and change in biomedical engineering during the infancy of the 21st century, The Biomedical Engineering Handbook enters its third edition as a set of three carefully focused and conveniently organized books. Offering an overview of the tools of the biomedical engineering trade, Medical Devices and Systems reviews the currently available technologies and lays a foundation for the next generation of medical devices. Beginning with biomedical signal analysis, renowned experts from around the world share their experience in imaging, sensing technologies, medical instruments and devices, clinical engineering, and ethics. In addition to new and updated chapters throughout, the book also contains new sections on infrared imaging and medical informatics. Engineers must be prepared to develop technologies that are more than incremental improvements over existing devices and systems. Medical Devices and Systems illuminates a path to achieving remarkable breakthroughs.
The design and functional complexity of medical devices and systems has increased during the past half century, evolving from the level of cardiac pacemakers to magnetic resonance imaging devices. Such life-saving advancements are monumentally advantageous, but with so much at stake, a step-by-step manual for biomedical engineers is essential. This edition of a bestselling textbook utilizes a strong design perspective to provide designers with a thorough overview of the field, including topics related to databases, process analysis, and device improvement. Covers All Necessary Design Aspects for Advanced Biomedical Projects Designed primarily for senior bioengineering students in the formative stages of planning their design project, Design of Biomedical Devices and Systems is also beneficial to graduate students in the field and practitioners working with medical devices. This standard-setting resource includes: A variety of open-ended design problems and examples An overview of device definitions and reliability A discussion of testing and hardware verification and validation principles Detailed photographs and illustrations within each chapter Systematic approaches to device development and maintenance are mandated to ensure safe and effective devices for the patient, an economical and competitive success for the manufacturer, and a reliable, cost-effective investment for the user. This authoritative textbook answers the call. A solutions manual is available for instructors wishing to convert this reference to classroom use.
Author: John A. Rogers,Roozbeh Ghaffari,Dae-Hyeong Kim
Category: Technology & Engineering
This book highlights recent advances in soft and stretchable biointegrated electronics. A renowned group of authors address key ideas in the materials, processes, mechanics, and devices of soft and stretchable electronics; the wearable electronics systems; and bioinspired and implantable biomedical electronics. Among the topics discussed are liquid metals, stretchable and flexible energy sources, skin-like devices, in vitro neural recording, and more. Special focus is given to recent advances in extremely soft and stretchable bio-inspired electronics with real-world clinical studies that validate the technology. Foundational theoretical and experimental aspects are also covered in relation to the design and application of these biointegrated electronics systems. This is an ideal book for researchers, engineers, and industry professionals involved in developing healthcare devices, medical tools and related instruments relevant to various clinical practices.
The first handbook ever written for the biomedical engineering field, this text contains comprehensive information on every aspect of biomedical engineering. It reflects the current perception of the field as one that encompasses emerging and expanding disciplines of investigation and application. It includes a complete review of the major physiological systems and accepted practices.
Author: Paul H. King,Richard C. Fries,Arthur T. Johnson
Publisher: CRC Press
This will be a substantial revision of a highly regarded text, intended for senior design capstone courses within departments of biomedical engineering, bioengineering, biological engineering and medical engineering, worldwide. Each chapter will be thoroughly updated and revised to reflect the latest developments. New material will be added on entrepreneurship, bioengineering statistics, clinical trials and CRISPR. New examples, applications and problems will be added in each chapter.There will be strong efforts made to increase the number of clinical applications to enhance the overall relevance of the material that's presented. Significant new material added on FDA regulations.
Analyzing product conception through to delivery in actual industry examples, Design of Biomedical Devices and Systems considers issues in the industrial design process exactly as they would arise in real-world applications, divulging valuable trade secrets within topics like materials selection, safety, prototyping, premarket testing and validation, liability, and learning from failure. The authors discuss product definition, development, marketing, verification, and validation; elucidate the QFD process, and address engineering licensure and codes of ethics. They also introduce new concepts in hardware and software design, including the use of computer tools to predict and document safety-related design issues.
A Systems Based Overview Using Engineering Standards
Author: Gail Baura
Publisher: Academic Press
Medical Device Technologies introduces undergraduate engineering students to commonly manufactured medical devices. It is the first textbook that discusses both electrical and mechanical medical devices. The first 20 chapters are medical device technology chapters; the remaining eight chapters focus on medical device laboratory experiments. Each medical device chapter begins with an exposition of appropriate physiology, mathematical modeling or biocompatibility issues, and clinical need. A device system description and system diagram provide details on technology function and administration of diagnosis and/or therapy. The systems approach lets students quickly identify the relationships between devices. Device key features are based on five applicable consensus standard requirements from organizations such as ISO and the Association for the Advancement of Medical Instrumentation (AAMI). The medical devices discussed are Nobel Prize or Lasker Clinical Prize winners, vital signs devices, and devices in high industry growth areas Three significant Food and Drug Administration (FDA) recall case studies which have impacted FDA medical device regulation are included in appropriate device chapters Exercises at the end of each chapter include traditional homework problems, analysis exercises, and four questions from assigned primary literature Eight laboratory experiments are detailed that provide hands-on reinforcement of device concepts
This book is dedicated to wearable and autonomous systems, including devices, offers to variety of users, namely, master degree students, researchers and practitioners, An opportunity of a dedicated and a deep approach in order to improve their knowledge in this specific field. The book draws the attention about interesting aspects, as for instance, advanced wearable sensors for enabling applications, solutions for arthritic patients in their limited and conditioned movements, wearable gate analysis, energy harvesting, physiological parameter monitoring, communication, pathology detection , etc..
Nanomedical Device and Systems Design: Challenges, Possibilities, Visions serves as a preliminary guide toward the inspiration of specific investigative pathways that may lead to meaningful discourse and significant advances in nanomedicine/nanotechnology. This volume considers the potential of future innovations that will involve nanomedical devices and systems. It endeavors to explore remarkable possibilities spanning medical diagnostics, therapeutics, and other advancements that may be enabled within this discipline. In particular, this book investigates just how nanomedical diagnostic and therapeutic devices and systems might ultimately be designed and engineered to accurately diagnose and eradicate pathogens, toxins, and myriad disease states. This text utilizes an author conceptualized exemplar nanodevice and system, the Vascular Cartographic Scanning Nanodevice (VCSN), to explore various prospective design considerations that might facilitate and enable selected functionalities of advanced autonomous nanomedical devices. It showcases a diverse group of expert contributing authors, who describe actual laboratory-based research aimed at the advancement of nanomedical capabilities. It also articulates more highly conceptual nanomedical possibilities and visions relating to the implementation of nanomedical technologies in remote regions and the developing world, as well as nanomedicine in space applications, human augmentation, and longevity. Investigates nanomedical diagnostic and therapeutic strategies that might be applied in remote regions and the developing world Discusses how nanomedicine might be utilized in space applications, inclusive of spacesuits, spacecraft, future human habitats on the Moon and Mars, and deep space Covers how nanomedicine may be implemented in selected forms of human augmentation and toward the potentially radical extension of the human life span This book benefits undergraduate and graduate students who are studying nanotechnology/nanomedicine, as well as medical administrative, scientific research, and manufacturing professionals in this industry.
A short decade ago, The Biomedical Engineering Handbook debuted and was quickly embraced as the biomedical engineer’s “Bible.” Four years later, the field had grown so dramatically that the handbook was offered in two volumes. Now, the early years of the new millennium have seen so much growth and change in the biomedical field that a new, larger, and broader resource is necessary. In its most versatile incarnation yet, this Third Edition is available as a set of three carefully organized and focused volumes that, when combined, maintain the handbook’s standing as the most comprehensive, interdisciplinary, and timely biomedical reference available. What’s included in the Third Edition? Biomedical Engineering Fundamentals This first volume surveys physiology, bioelectric phenomena, biomaterials, biomechanics, and the other broad disciplines that constitute the modern biomedical engineering landscape. It includes an entirely new section on neuroengineering in addition to many new and revised chapters and a 14-page full-color insert. Medical Devices and Systems Offering an overview of the tools of the biomedical engineering trade, this book focuses on signal analysis, imaging, sensors, devices, systems, instruments, and clinical engineering. It includes two new sections on infrared imaging and medical informatics, numerous other additions and updates, and a 32-page full-color insert. Tissue Engineering and Artificial Organs The third installment examines state-of-the-art applications of biomedical engineering. Integrating life sciences as another facet of the field, it includes a new section on molecular biology. The book also features a new section on bionanotechnology, 90 percent new material in the tissue engineering section, many new and updated chapters, and a 24-page full-color insert. Incorporating new developments, technologies, and disciplines, The Biomedical Engineering Handbook, Third Edition remains the most comprehensive central core of knowledge available to the field.
This reference provides real-world examples, strategies, and templates for the implementation of effective design control programs that meet current ISO 9000 and FDA QSR standards and regulations-offering product development models for the production of safe, durable, and cost-efficient medical devices and systems. Details procedures utilized by leading companies to successfully meet FDA and end-user requirements, manufacture high-quality products, and improve and generate profit. Design Controls for the Medical Device Industry contains valuable guidelines that enable readers to prepare for an FDA audit identify consumer needs, resolve project objectives, and process inconsistencies and discrepancies determine the compatibility of design specifications and manufacturing, installation, and servicing demands ensure that proper design, function, and performance stipulations are understood and met verify and validate design criteria and production schemes eliminate confusion and prevent communication breakdowns allocate and conserve resources perform risk assessment analyses predict potential hazards under normal and fault conditions Presenting blueprints for the application, evaluation, and refinement of quality assurance and performance practices-from product launch through engineering and assembly-Design Controls for the Medical Device Industry is a clear and indispensable source for biomedical, quality assurance, reliability, software, product design, manufacturing, research and development, and industrial engineers; project directors and managers; biomedical technicians; and upper-level undergraduate and graduate students in these disciplines.
Biomedical devices that contact with blood or tissue represent a wide range of products. Depending on their potential harm to a body, medical devices are categorized according to the degree, so their safety can be assured. All biomaterials are by definition designed to contact with a body for a certain period of time. The nature of the body contact, as well as the duration a material contacts with the body may initiate unwanted biological In comparison with invasive devices Oike catheters and medical responses. implants contact directly with tissue or with the circulating blood) non invasive devices (like wound-dressings and contact lenses contact with the skin, the sclera, and the mucosa or with open wounds) have a lesser risk of hurting a patient. When blood contacts with a foreign material, plasma proteins become absorpted to the surface within a few seconds. The reactions that follow, the so-called intrinsic pathway lead to the formation of fibrin and activation of platelets and white blood cells, result in blood clot formation.
As medical devices become even more intricate, concerns about efficacy, safety, and reliability continue to be raised. Users and patients both want the device to operate as specified, perform in a safe manner, and continue to perform over a long period of time without failure. Following in the footsteps of the bestselling second edition, Reliable Design of Medical Devices, Third Edition shows you how to improve reliability in the design of advanced medical devices. Reliability engineering is an integral part of the product development process and of problem-solving activities related to manufacturing and field failures. Mirroring the typical product development process, the book is organized into seven parts. After an introduction to the basics of reliability engineering and failures, it takes you through the concept, feasibility, design, verification and validation, design transfer and manufacturing, and field activity phases. Topics covered include Six Sigma for design, human factors, safety and risk analysis, and new techniques such as accelerated life testing (ALT) and highly accelerated life testing (HALT). What’s New in This Edition Updates throughout, reflecting changes in the field An updated software development process Updated hardware test procedures A new layout that follows the product development process A list of deliverables needed at the end of each development phase Incorporating reliability engineering as a fundamental design philosophy, this book shares valuable insight from the author’s more than 35 years of experience. A practical guide, it helps you develop a more effective reliability engineering program—contributing to increased profitability, more satisfied customers, and less risk of liability.
How have recent changes in domestic and international regulations affected quality management in the development and marketing of medical devices in the US and abroad? Consultants Daniel and Kimmelman take a close look at the Quality System Regulation (QsReg), the ISO 13485: 2003 standard and the ISO/TR 14969: 2004 guidance document as well as a number of US Food and Drug Administration (FDA) and Global Harmonization Task Force (GHTF) guidance documents. The authors provide extensive commentary and notes an update their material to include such topics as the incorporation of principles of risk management into the medical device organizations' quality management systems (QMSs) and considerations of combination products. Daniel and Kimmelman include full coverage of the QSReg requirements, descriptions of comparable requirements in the ISO documents, excerpts of the FDA's responses to the QSReg preamble and excerpts from FDA guidance documents related to QMSs.
"Biomedical Devices and Technology is a textbook for an introductory seminar course on biomedical devices and technology. The book covers devices and systems in diagnostic, surgical, and implant procedures, prepared by the much-respected faculty members at the UCLA School of Medicine"--
Proceedings of the AHFE 2017 International Conferences on Human Factors and Ergonomics in Healthcare and Medical Devices, July 17–21, 2017, The Westin Bonaventure Hotel, Los Angeles, California, USA
Author: Vincent Duffy,Nancy Lightner
This book discusses the latest advances in human factors and ergonomics, focusing on methods for improving quality, safety, efficiency, and effectiveness in patient care. By emphasizing the physical, cognitive, and organizational aspects of human factors and ergonomics applications, it presents various perspectives, including those of clinicians, patients, health organizations, and insurance providers. The book describes cutting-edge applications, highlighting best practices for staff interactions with patients, as well as interactions with computers and medical devices. It also presents new findings related to improved organizational outcomes in healthcare settings, and approaches to modeling and analysis specifically targeting those work aspects unique to healthcare. Based on the AHFE 2017 International Conference on Human Factors and Ergonomics in Healthcare and Medical Devices, held on July 17–21, 2017, in Los Angeles, California, USA, the book is intended as a timely reference guide for both researchers involved in the design of healthcare systems and devices and for healthcare professionals working to deliver safe and effective health service. Moreover, by providing a useful survey of cutting-edge methods for improving organizational outcomes in healthcare settings, the book also represents a source of inspiration for healthcare counselors and international health organizations.
Validation of computer systems is the process that assures the formal assessment and report of quality and performance measures for all the life-cycle stages of software and system development, its implementation, qualification and acceptance, operation, modification, requalification, maintenance and retirement (PICS CSV PI 011-3). It is a process that demonstrates the compliance of computer systems functional and non-functional requirements, data integrity, regulated company procedures and safety requirements, industry standards, and applicable regulatory authority’s requirements. Compliance is a state of being in adherence to application-related standards or conventions or regulations in laws and similar prescriptions. This book, which is relevant to the pharmaceutical and medical devices regulated operations, provides practical information to assist in the computer validation to production systems, while highlighting and efficiently integrating worldwide regulation into the subject. A practical approach is presented to increase efficiency and to ensure that the validation of computer systems is correctly achieved.
Known as the bible of biomedical engineering, The Biomedical Engineering Handbook, Fourth Edition, sets the standard against which all other references of this nature are measured. As such, it has served as a major resource for both skilled professionals and novices to biomedical engineering. Medical Devices and Human Engineering, the second volume of the handbook, presents material from respected scientists with diverse backgrounds in biomedical sensors, medical instrumentation and devices, human performance engineering, rehabilitation engineering, and clinical engineering. More than three dozen specific topics are examined, including optical sensors, implantable cardiac pacemakers, electrosurgical devices, blood glucose monitoring, human–computer interaction design, orthopedic prosthetics, clinical engineering program indicators, and virtual instruments in health care. The material is presented in a systematic manner and has been updated to reflect the latest applications and research findings.