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Clinical Evaluation Of Medical Devices

Author: Karen M. Becker
Publisher: Springer Science & Business Media
ISBN: 1597450049
Size: 41.27 MB
Format: PDF, ePub
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The original edition of this text, Clinical Evaluation of Medical Devices: Principles and Case Studies, provided the first overview of key pr- ciples and approaches to medical device clinical trials, illustrated with a series of detailed, real-world case studies. The book is designed as a resource for clinical professionals and regulatory specialists working in the field of new medical device development and marketing. Since the first edition of this text was published in 1997, the rapid pace of inno- tion in health care technologies continues to yield exciting and important new products. The regulatory landscape has also evolved, reflecting some of the changes and needs within the medical device industry. The purpose of Clinical Evaluation of Medical Devices: Principles and Case Studies, Second Edition is to provide an updated and expanded presentation of the scientific methods and regulatory requirements applied to the study of new significant risk medical devices. The text now includes (1) new information on the requirements and process for gaining reimbursement of new products from Medicare and private insurers, with case studies of research specifically designed for this p- pose as well as health care technology assessment methods; (2) infor- tion on new statistical methodologies applied to medical device trials; and (3) all new case studies, including examples of combination pr- ucts, three-phase development models (i. e. , feasibility, FDA approval, Medicare reimbursement), and novel study designs.

Clinical Evaluation Of Medical Devices

Author: Karen Becker Witkin
Publisher: Springer Science & Business Media
ISBN: 1475727569
Size: 25.40 MB
Format: PDF, Docs
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The world is changing rapidly, and nowhere is this more apparent than in medicine. The standards are rapidly rising in the field of medical device trials. A few years ago, device developers would look askance if one told them that medical device trials and drug trials should have the same stan dards. Today, such a statement does not seem as outrageous, although there is still a large gap in the design of trials and number oftrials conducted for medical device and drug development programs. More than 20 years after the enactment of the US Medical Device Amendments, we can see that they served as an impetus to raise clinical trial standards for devices. Whether the data to establish the safety and efficacy of a device come from one, two, or even more clinical trials is less important in evaluating the device than whether the data are medically and scientifically support ive of its safety and efficacy. Having at least two separate studies, and at least two sites confirm results, adds a great deal of scientific credibility and support to a conclusion of safety and efficacy, even though a confirmatory trial is not yet a regulatory requirement in most countries.

Medical Device Safety

Author: G.R Higson
Publisher: CRC Press
ISBN: 1420033980
Size: 20.75 MB
Format: PDF, ePub
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Medical Device Safety: The Regulation of Medical Devices for Public Health and Safety examines the prospects for achieving global harmonization in medical device regulation and describes a possible future global system. Unresolved difficulties are discussed while solutions are proposed. An essential book for all those involved in health physics, engineering, and medical regulatory affairs.

Medical Device Technologies

Author: Gail D. Baura
Publisher: Academic Press
ISBN: 012374976X
Size: 37.57 MB
Format: PDF, ePub
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The goal of this textbook is to provide undergraduate engineering students with an introduction 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 8 chapters are medical device laboratory experiment chapters. 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 enables students to 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). Key Features: 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

Diagnostische Und Interventionelle Radiologie

Author: Thomas J. Vogl
Publisher: Springer-Verlag
ISBN: 3540876685
Size: 36.95 MB
Format: PDF, Docs
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Das Fachbuch bietet Informationen zum neuesten Stand der Diagnostik und zu den aktuellen Möglichkeiten für interventionelle Verfahren. Es ist das erste deutschsprachige Fachbuch, das die gesamte Radiologie in einem Band auf Facharztniveau darstellt. In den klinischen Kapiteln werden zunächst die Klinik, dann die diagnostischen und interventionellen Optionen ausführlich dargestellt. Der Band berücksichtigt die Leitlinien der Deutschen Röntgengesellschaft und bietet mehr als 1000 Abbildungen in höchster Qualität zum Abgleich mit eigenen Befunden.

The Design Of Everyday Things

Author: Norman Don
Publisher: Vahlen
ISBN: 3800648105
Size: 27.36 MB
Format: PDF, ePub
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Apple, Audi, Braun oder Samsung machen es vor: Gutes Design ist heute eine kritische Voraussetzung für erfolgreiche Produkte. Dieser Klassiker beschreibt die fundamentalen Prinzipien, um Dinge des täglichen Gebrauchs umzuwandeln in unterhaltsame und zufriedenstellende Produkte. Don Norman fordert ein Zusammenspiel von Mensch und Technologie mit dem Ziel, dass Designer und Produktentwickler die Bedürfnisse, Fähigkeiten und Handlungsweisen der Nutzer in den Vordergrund stellen und Designs an diesen angepasst werden. The Design of Everyday Things ist eine informative und spannende Einführung für Designer, Marketer, Produktentwickler und für alle an gutem Design interessierten Menschen. Zum Autor Don Norman ist emeritierter Professor für Kognitionswissenschaften. Er lehrte an der University of California in San Diego und der Northwest University in Illinois. Mitte der Neunzigerjahre leitete Don Norman die Advanced Technology Group bei Apple. Dort prägte er den Begriff der User Experience, um über die reine Benutzbarkeit hinaus eine ganzheitliche Erfahrung der Anwender im Umgang mit Technik in den Vordergrund zu stellen. Norman ist Mitbegründer der Beratungsfirma Nielsen Norman Group und hat unter anderem Autohersteller von BMW bis Toyota beraten. „Keiner kommt an Don Norman vorbei, wenn es um Fragen zu einem Design geht, das sich am Menschen orientiert.“ Brand Eins 7/2013 „Design ist einer der wichtigsten Wettbewerbsvorteile. Dieses Buch macht Spaß zu lesen und ist von größter Bedeutung.” Tom Peters, Co-Autor von „Auf der Suche nach Spitzenleistungen“

Comprehensive Biomaterials

Author: Paul Ducheyne
Publisher: Elsevier
ISBN: 0080552943
Size: 40.54 MB
Format: PDF, Kindle
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Comprehensive Biomaterials brings together the myriad facets of biomaterials into one, major series of six edited volumes that would cover the field of biomaterials in a major, extensive fashion: Volume 1: Metallic, Ceramic and Polymeric Biomaterials Volume 2: Biologically Inspired and Biomolecular Materials Volume 3: Methods of Analysis Volume 4: Biocompatibility, Surface Engineering, and Delivery Of Drugs, Genes and Other Molecules Volume 5: Tissue and Organ Engineering Volume 6: Biomaterials and Clinical Use Experts from around the world in hundreds of related biomaterials areas have contributed to this publication, resulting in a continuum of rich information appropriate for many audiences. The work addresses the current status of nearly all biomaterials in the field, their strengths and weaknesses, their future prospects, appropriate analytical methods and testing, device applications and performance, emerging candidate materials as competitors and disruptive technologies, and strategic insights for those entering and operational in diverse biomaterials applications, research and development, regulatory management, and commercial aspects. From the outset, the goal was to review materials in the context of medical devices and tissue properties, biocompatibility and surface analysis, tissue engineering and controlled release. It was also the intent both, to focus on material properties from the perspectives of therapeutic and diagnostic use, and to address questions relevant to state-of-the-art research endeavors. Reviews the current status of nearly all biomaterials in the field by analyzing their strengths and weaknesses, performance as well as future prospects Presents appropriate analytical methods and testing procedures in addition to potential device applications Provides strategic insights for those working on diverse application areas such as R&D, regulatory management, and commercial development

Handbook Of Human Factors In Medical Device Design

Author: Matthew Bret Weinger
Publisher: CRC Press
ISBN: 9781420063516
Size: 62.56 MB
Format: PDF, ePub, Mobi
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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.