Developed to promote the design of safe, effective, and usable medical devices, Handbook of Human Factors in Medical Device Design provides a single convenient source of authoritative information to support evidence-based design and evaluation of medical device user interfaces using rigorous human factors engineering principles. It offers guidance on user-centric design supported by discussions of design issues, case studies, and examples. The book sets the foundation with coverage of fundamental topics such as aligning the interactive nature of medical devices to the expected use environments ranging from hospitals and ambulances to patients’ homes, drawing on anthropometric and biomechanical data to ensure that designs match the intended users’ bodies and physical abilities, and conducting usability tests and other evaluations to ensure that devices perform as intended. It then focuses on applied design issues, offering guidance on the design of specific types of devices and designing devices for particular use environments. Adapted in part from established design standards and conventions, the design guidance presented in this work distills professional judgment extracted from the contributing authors’ years of experience in applied analysis and design. Written in true handbook style, each chapter stands alone and includes tables, illustrations, and cross references, allowing you to quickly find the exact information you need. Most chapters begin with a general introduction to the selected topic, followed by the presentation of general and special design considerations and then specific, numbered design guidelines. The book also presents a listing of resources, literature, and website references. It not only focuses on the human factors issues that arise when developing medical devices, it supplies the necessary guidance to resolve them. Read more

Biosecurity in the Age of Synthetic Biology is a comprehensive review of the biosecurity issues faced by the innovative and rapidly evolving field of synthetic biology. This is a meticulous review of the groundbreaking biotechnological advancements and the critical need for robust biosecurity measures. The book provides an in-depth examination of the ethical, legal, and societal dimensions shaping the future of synthetic biology research, in addition to a practical protocol for biosecurity risk assessment. This is the first book to offer a structured guideline for biosecurity risk assessment in synthetic biology. The author’s balanced view of the opportunities of synthetic biology and the inherent security risks reveals foundational concepts, cutting-edge applications, and international perspectives on biosecurity. This essential guide illuminates scientific and technological frontiers and advocates for a proactive approach ensuring the responsible development and use of synthetic biology. It is an indispensable resource for scientists, policymakers, and anyone interested in the intersection of biotechnology and biosecurity.Key Features: Provides instructions and examples for a biosecurity risk assessment. Includes detailed proposed outline for creating a Biosecurity Manual for broad adoption. Emphasizes the future challenges and opportunities. Offers insights on the role of artificial intelligence in synthetic biology and biosecurity. Read more

"This extensively revised third edition provides a comprehensive approach to studying biomedical devices and their applications. It is written for engineers and technologists who are interested in understanding the principles, design, and use of medical device technology. Many chapters have gone through revisions to keep up with new applications and advancements in medical technology. The book focuses on the applications, functions and principles of medical devices and uses specific designs and constructions to illustrate the concepts where appropriate. The first part of the book discusses the fundamental building blocks of biomedical instrumentations. Starting from an introduction of the origins of biological signals, the essential functional building blocks of a typical medical device are studied. These functional blocks include electrodes and transducers, biopotential amplifiers, signal conditioners and processors, electrical safety and isolation, and output devices. The next section of the book covers a selection of biomedical devices. Their principles of operations, functional building blocks, special features, and performance specifications are discussed. Architectural and schematic diagrams are used where appropriate to illustrate how specific device functions are being implemented. In addition, indications of use and clinical applications of each device are included. Common problems and hazards, and risk mitigation of each device are discussed. Four appendices are included at the end of the book to enhance the comprehension of the subject matters in the book. These are A Primer on Fourier Analysis, Overview of Medical Telemetry Development, Medical Gas Supply Systems, and the newest addition, Concepts of Infection Control in Biomedical Device Technology. Review questions are added for each chapter to help readers assess their comprehension of the content material"-- Read more

A good understanding of medical statistics is essential to evaluate medical research and to choose appropriate ways of implementing findings in clinical practice. The Oxford Handbook of Medical Statistics has been written to provide doctors and medical students with a comprehensive yet concise account of this often difficult subject. Described by readers as a 'statistical Bible', this new edition maintains the accessibility and thoroughness of the original, and includes comprehensive updates including new sections on transitional medicine, cluster designs, and modern statistical packages. The Handbook promotes understanding and interpretation of statistical methods across a wide range of topics, from study design and sample size considerations, through t- and chi-squared tests, to complex multifactorial analyses, all using examples from published research. References and further reading are included, to allow deeper understanding on specific topics. Featuring a new chapter on how to use this book in different medical contexts, the Oxford Handbook of Medical Statistics helps readers to conduct their own research and critically appraise others' work. Read more

Maintaining and regularly testing Automated External Defibrillators (AEDs) is a crucial aspect of ensuring they operate flawlessly during an emergency. The AED Test Log Book, spanning 100 pages in a large print 8.5 x 11 inches format, is meticulously designed to cater to this need. It provides a comprehensive logging system for facilities and organizations equipped with AEDs. Read more

The AI MedicLucrative Opportunities in Medical & Pharma via AI InnovationArtificial Intelligence is no longer a distant frontier—it is the pulse of modern medicine. The AI Medic is your essential guide to understanding and seizing the groundbreaking opportunities that AI is creating in healthcare and the pharmaceutical industry. From intelligent diagnostics and robotic surgery to personalized treatment plans and accelerated drug development, AI is reshaping every aspect of medical science and practice.This book reveals how AI is not just enhancing outcomes but unlocking entirely new career paths, research possibilities, and business models. Whether you're a student preparing to enter the field, a professional seeking to future-proof your career, or an entrepreneur looking to innovate in a high-growth sector, this book is your blueprint for success.Inside, you’ll discover:Real-world applications of AI across clinical and pharmaceutical domainsHigh-demand roles and skills emerging due to AI integrationStartup and business opportunities in healthtech and biotechEthical considerations and regulatory frameworks shaping the future of AI in medicineCase studies and actionable strategies to position yourself at the forefront of changeFar more than a primer, The AI Medic is a strategic playbook. It doesn’t just help you adapt to AI—it empowers you to lead with it. In a world where disruption is inevitable, this book offers not just a tool for advancement, but a shield against being left behind. Read more

This guidebook provides essential informantion for anyone who needs to understand and implement the new U.S. Food and Drug Administration (FDA) law for medical devices and international quality system requirements. Read more

Master the assistive strategies you need to make confident clinical decisions and help improve the quality of life for people with disabilities with the latest edition of this comprehensive text. Based on the Human Activity Assistive Technology (HAAT) model developed by the authors, the book provides detailed coverage of the broad range of devices, services, and practices that comprise assistive technology and focuses on the relationship between the human user and the assisted activity within specific contexts. This new edition has been expanded and updated, and features new multimedia components that further demonstrate how to apply the concepts you've learned to real-world practice.Focus on clinical application guides you in applying concepts to real-world situations.Human Activity Assistive Technology (HAAT) framework demonstrates assistive technology within common, everyday contexts for more relevant application.Review questions and chapter summaries in each chapter help you assess your understanding and identify areas where more study is needed.Assistive Technology for Cognitive Augmentation chapter gives you a foundation in the growing use of assistive technology to enhance human cognitive processes.Technologies that Aid Transportation familiarizes you with the many options of transportation assistance available and helps you determine which are right for your clients.Separate chapters on sensory aid for visual and auditory impairment provide additional strategies in these key assistive areas.Bound-in companion CD-ROM features videos of assessment and device use that helps you visualize procedures and reinforce your clinical application skills.Evolve resources test your understanding of terms and concepts and link you to supplemental sources for further research.Additional case studies throughout the text prepare you for practice with realistic client scenarios.Expanded evidence-based content supports concepts with real-world research data.Additional photographs, illustrations, tables, and boxes provide clear visual references and quick access to important information. Read more

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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 Handbook also includes exclusive interviews with pioneers and leaders in the medical device industry, offering an insider's perspective on issues that are critical to the medical device entrepreneur.Highlights Include…An Introduction to Medical PlasticsCatheter Forming Equipment and OperationsBasics of Catheter ConstructionBasics of Medical NeedlesRapid Prototyping for Medical DevicesReverse Engineering for Medical DevicesUsing Medical Illustration in Product DevelopmentIntroduction to Pre-Clinical StudiesIntroduction to Regulatory AffairsAssessing BiocompatibilityExclusive Interviews with Key Industry Leaders…And MoreThis practical handbook is a unique, insightful guide that helps you design, test, and successfully introduce new medical devices to the marketplace. Read more

Data integrity is a global mandatory requirement for the regulated healthcare industry. It is more than a mere expectation-it's a basic element of good documentation practices, one of the most fundamental pillars of a quality management system. Robustness and accuracy of the data submitted by manufacturers to regulatory authorities when bringing a medical product to market are crucial. The purpose of this book is to consolidate existing data integrity principles and expectations from several regulatory sources-including the U.S. Food and Drug Administration, World Health Organization, and European Medicines Agency-into a single and handy document that provides detailed, illustrative implementation guidance. It serves as a means of understanding regulatory agencies' position on good data management and the minimum expectation for how medical product manufacturers can achieve compliance. Read more

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Learn to maintain and repair the high tech hospital equipment with this practical, straightforward, and thorough new book. Biomedical Instrumentation Systems uses practical medical scenarios to illustrate effective equipment maintenance and repair procedures. Additional coverage includes basic electronics principles, as well as medical device and safety standards. Designed to provide readers with the most current industry information, the latest medical websites are referenced, and today's most popular software simulation packages like MATLAB and MultiSIM are utilized. Read more

While much of the transfer of wealth comes in the form of inheritance, today inter vivos expenditures for a good education may be even more important than intergenerational transfers at death. This accessible resource focuses on Section 529 plans, comparing and contrasting them with other education planning techniques. The authors identify the need to develop strategies for financing K-12, college, graduate, or professional education, detail the rules by which these goals may be accomplished, and explain how to integrate education planning into an individual's comprehensive paradigm for financial, tax, retirement, and estate planning.Although the book's primary focus is on 529 plans, this accessible resource also provides a thorough introduction to the other education savings vehicles that are available. In addition, the book addresses strategies for financing education when savings prove inadequate, including guidance on financial aid planning.Throughout the text, Planning Pointers address some of the critical planning issues that arise in the education planning context. Invaluable appendices contain various materials--glossary, acronyms, abbreviations, statutes, forms, and other resources--to assist the planner.A roadmap for creating effective strategies for education financing, this guide's clear information and practice tips make this a useful and accessible resource for a broad audience, including estate planners, general practitioners, tax lawyers, accountants, financial planners, trust officers, and financial aid administrators. Read more

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Interrupted Time Series Analysis develops a comprehensive set of models and methods for drawing causal inferences from time series. It provides example analyses of social, behavioral, and biomedical time series to illustrate a general strategy for building AutoRegressive Integrated Moving Average (ARIMA) impact models. Additionally, the book supplements the classic Box-Jenkins-Tiao model-building strategy with recent auxiliary tests for transformation, differencing, and model selection. Not only does the text discuss new developments, including the prospects for widespread adoption of Bayesian hypothesis testing and synthetic control group designs, but it makes optimal use of graphical illustrations in its examples. With forty completed example analyses that demonstrate the implications of model properties, Interrupted Time Series Analysis will be a key inter-disciplinary text in classrooms, workshops, and short-courses for researchers familiar with time series data or cross-sectional regression analysis but limited background in the structure of time series processes and experiments. Read more

An essential introduction to conducting the various stages of medical device clinical trials Clinical research continues to be one of the most vital components of pharmaceutical, biostatistical, and medical studies. Design, Execution, and Management of Medical Device Clinical Trials provides a uniform methodology for conducting and managing clinical trials. Written in a style that is accessible to readers from diverse educational and professional backgrounds, this book provides an in-depth and broad overview for successfully performing clinical tasks and activities.Throughout the book, practical examples compiled from both the author's and other researchers' previous clinical trial experiences are discussed in a sequential manner as they occur in the study, starting from the development of the clinical protocol and the selection of clinical sites and ending with the completion of the final clinical study report. Next, readers are guided through the development of important clinical documents, including informed consent forms, case report forms, and study logs. A careful review of the Food and Drug Administration (FDA) and International Conference on Harmonisation (ICH) regulations applicable to medical devices is also featured. Additional coverage includes:Qualification and selection of investigatorsStudy monitoring visitsDefinitions and reporting procedures for adverse eventsThe use of biostatistical methodology in clinical research, including the use of biostatistics for sample size determination and study endpointsThe roles and responsibilities of all members of a clinical research teamThe book concludes with an insightful discussion of special ethical conduct for human research and challenging issues to consider during the design of clinical studies. A glossary lists important clinical and statistical terms used in clinical research, and an extensive reference section provides additional resources for the most up-to-date literature on the topic.Design, Execution, and Management of Medical Device Clinical Trials is an excellent book for clinical research or epidemiology courses at the upper-undergraduate and graduate levels. It is also an indispensable reference for clinical research associates, clinical managers, clinical scientists, biostatisticians, pharmacologists, and any professional working in the field of clinical research who would like to better understand clinical research practices. Read more

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 regulationsConcise and comprehensive information on how to design medical devices to ensure they meet regulations and standardsIncludes a useful case study demonstrating the design and approval process Read more

Implementation of FDA's Design Control requirements (21 CFR 820.30) changed an entire industry. Quality System Requirements defined the approach to medical device validation. Product design, manufacturing process, and test method validation studies must be performed before or as a product is transferred to commercial production. Validation studies must demonstrate that product design, process, and test methods/requirements/specifications determined during development can be met in the environment of intended use. This book provides practical guidance on how to develop and validate product designs, manufacturing processes, and test methods that comply with the requirements of QSR. Read more

This highly respected manual teaches students to perform goniometry properly as a clinical skill with exercises that reinforce good technique. Every testing procedure is detailed for ease of reference, with two-color added to enhance headings, charts, and tables. The 3rd Edition includes many new photographs, and has been updated to be consistent with the APTA's Guide to Physical Therapist Practice terminology. Read more