Author: Michael E. Wiklund, P.E.
Publisher: CRC Press
Release Date: 2015-12-23
Usability Testing of Medical Devices covers the nitty-gritty of usability test planning, conducting, and results reporting. The book also discusses the government regulations and industry standards that motivate many medical device manufacturers to conduct usability tests. Since publication of the first edition, the FDA and other regulatory groups have modified their regulations and expectations regarding how medical device manufacturers should approach usability testing. Reflecting these changes, this Second Edition provides updated guidance to readers with an interest or direct role in conducting a usability test of a medical device or system. Key updates involve the 2011 FDA guidance on human factors engineering, requirements set forth by the third edition of IEC 60601 and closely related IEC 62366-1:2015, linking usability test tasks to risk analysis results, and analyzing root causes of use errors that occur during usability tests. Written by seasoned human factors specialists, Usability Testing of Medical Devices, Second Edition is an informative, practical, and up-to-date handbook for conducting usability tests of medical devices. The book helps ensure a smooth and painless development process—and thus, safe and effective medical devices.
Author: Richard C. Fries
Publisher: CRC Press
Release Date: 2000-09-14
The Handbook of Medical Device Design provides a review of regulatory and standards issues in medical device design, including FDA regulations, types of 510 (k), the ISO 9000 series, and medical device directives. It identifies how to determine and document customer needs and device requirements. It also establishes reliability and quality metrics for the duration of the product development cycle. Topics include
The previous edition of the International Encyclopedia of Ergonomics and Human Factors made history as the first unified source of reliable information drawn from many realms of science and technology and created specifically with ergonomics professionals in mind. It was also a winner of the Best Reference Award 2002 from the Engineering Libraries Division, American Society of Engineering Education, USA, and the Outstanding Academic Title 2002 from Choice Magazine. Not content to rest on his laurels, human factors and ergonomics expert Professor Waldemar Karwowski has overhauled his standard-setting resource, incorporating coverage of tried and true methods, fundamental principles, and major paradigm shifts in philosophy, thought, and design. Demonstrating the truly interdisciplinary nature of this field, these changes make the second edition even more comprehensive, more informative, more, in a word, encyclopedic. Keeping the format popularized by the first edition, the new edition has been completely revised and updated. Divided into 13 sections and organized alphabetically within each section, the entries provide a clear and simple outline of the topics as well as precise and practical information. The book reviews applications, tools, and innovative concepts related to ergonomic research. Technical terms are defined (where possible) within entries as well as in a glossary. Students and professionals will find this format invaluable, whether they have ergonomics, engineering, computing, or psychology backgrounds. Experts and researchers will also find it an excellent source of information on areas beyond the range of their direct interests.
Author: Thomas Geis
Publisher: Beuth Verlag
Release Date: 2015-07-14
Die DIN EN 62366:2008-09 und die IEC 62366-1:2015-02 "Medizinprodukte - Anwendung der Gebrauchstauglichkeit auf Medizinprodukte" legen Forderungen an einen vom Hersteller durchzuführenden Prozess zur Analyse, Spezifikation, Entwicklung sowie Verifizierung und Validierung der Gebrauchstauglichkeit fest, soweit sie sich auf die Sicherheit von Medizinprodukten auswirkt. Die Autoren erläutern konkret, welche Informationen im Rahmen der Anforderungen der DIN EN 62366 für ein Medizinprodukt dokumentiert werden müssen und in welcher Form das am besten geschieht (Verzahnung von Regulatory Affairs und Usability-Engineering). So können sowohl die Bereiche Regulatory Affairs als auch das Produktmanagement ihre Effizienz bei der Dokumentation des Usability-Engineering-Prozesses wirksam steigern.
Translating promising discoveries and innovations into useful, marketable medical products demands a robust process to guide nascent products through a tangle of scientific, clinical, regulatory, economic, social, and legal challenges. There are so many human and environmental elements involved in shepherding medical advances from lab to launch that the field of medical product development has been referred to as an ecosystem. The purpose of this book is to help provide a shared foundation from which cross-functional participants in that ecosystem can negotiate the product development labyrinth and accomplish the goal of providing both groundbreaking and iterative new medical products. The book is intended for anyone in industry, the public sector, or academia—regardless of functional specialty, workplace, or seniority—who is interested in medical product development. The years since the publication of the previous edition of this book have seen profound changes in the actions and attitudes of patients, insurers, manufacturers, and the Food and Drug Administration regarding the streamlining of medical product development and approval. What those years have not seen is a concomitant increase in innovative treatments with profound benefits to patients. Despite enormous investments in research by both private and public sources and a surge in scientific and technological advances, new medical products barely trickle into the marketplace. For a variety of reasons, applied sciences necessary for medical product development are not keeping pace with the tremendous advances in basic sciences. Not surprisingly, industry and academia are under substantial pressure to transform discoveries and innovations from the laboratory into safe and effective medical products to benefit patients and improve health. This evolution—from bench to bedside—has become known as translational research and development, and this approach is what this book illuminates.
Author: Paul H. King
Publisher: CRC Press
Release Date: 2008-08-22
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.
The first edition of Handbook of Human Factors and Ergonomics in Health Care and Patient Safety took the medical and ergonomics communities by storm with in-depth coverage of human factors and ergonomics research, concepts, theories, models, methods, and interventions and how they can be applied in health care. Other books focus on particular human factors and ergonomics issues such as human error or design of medical devices or a specific application such as emergency medicine. This book draws on both areas to provide a compendium of human factors and ergonomics issues relevant to health care and patient safety. The second edition takes a more practical approach with coverage of methods, interventions, and applications and a greater range of domains such as medication safety, surgery, anesthesia, and infection prevention. New topics include: work schedules error recovery telemedicine workflow analysis simulation health information technology development and design patient safety management Reflecting developments and advances in the five years since the first edition, the book explores medical technology and telemedicine and puts a special emphasis on the contributions of human factors and ergonomics to the improvement of patient safety and quality of care. In order to take patient safety to the next level, collaboration between human factors professionals and health care providers must occur. This book brings both groups closer to achieving that goal.
This handbook serves as a reference source for the application of quality auditing principles to the biomedical industry, including coverage specifically pertaining to medical devices. The book focuses on the understanding of domestic and international concepts and principles of biomedical quality auditing, and includes information on related regulations, directives, standards, and guidance. The book covers a wide range of subjects that have specific interpretations unique to the biomedical industry. In addition to being a peerless reference for ASQ's Biomedical Auditor certification (CBA), this book is a valuable reference for biomedical professionals who want to execute better audits for medical devices and gain basic knowledge of biomedical technical areas and regulatory requirements.
Unternehmer, Gründer und Teams stehen täglich vor der Herausforderung: Womit soll man zuerst anfangen, worauf sich am meisten fokussieren? Und wie viele Diskussionen und Meetings sind nötig, bevor man ganz sicher die garantiert richtige Lösung hat? Die Folge ist, dass allzu oft das Projekt auf der Stelle tritt und man überhaupt nicht vorwärtskommt. Dafür gibt es eine geniale Lösung: Sprint. Die ist ein einzigartiger, innovativer und narrensicherer Prozess, mit dem sich die härtesten Probleme in nur fünf Tagen lösen lassen – von Montag bis Freitag. Der Entwickler Jake Knapp entwarf diesen Prozess bei und für Google, wo er seither in allen Bereichen genutzt wird. Zusammen mit John Zeratsky und Braden Kowitz hat er darüber hinaus bereits mehr als 100 Sprints in Firmen aus unterschiedlichen Bereichen durchgeführt. Der Sprint-Prozess bietet praktische Hilfe für Unternehmen aller Größen, vom kleinen Start-up bis hin zum Fortune-100-Unternehmen. Die Methode ist auch für alle anderen bewährt, die vor einem großen Problem stehen, schnell eine Idee testen oder einfach eine Möglichkeit schnell ergreifen wollen.
Author: Marie B. Teixeira
Publisher: CRC Press
Release Date: 2013-11-12
The second edition of a bestseller, Design Controls for the Medical Device Industry provides a comprehensive review of the latest design control requirements, as well as proven tools and techniques to ensure your company’s design control program evolves in accordance with current industry practice. The text assists in the development of an effective design control program that not only satisfies the US FDA Quality System Regulation (QSR) and ISO 9001 and 13485 standards, but also meets today’s third-party auditor/investigator expectations and saves you valuable time and money. The author’s continual participation in FDA QSR inspections and Notified Body ISO audits is reflected in updates to all chapters and appendices of the book, now bursting at the seams with: New coverage of ISO 9001 and 13485 design control requirements More real-world examples from the medical device industry Additional detail for greater understanding and clarity Fresh templates for practical implementation Extensive references for further study The book addresses design control elements such as design planning, input, output, review, verification, validation, change, transfer, and history, as well as risk management inclusive of human factors and usability, biocompatibility, the FDA Quality System Inspection Technique (QSIT) for design controls, and medical device regulations and classes in the US, Canada, and Europe.
Author: Norman Don
Release Date: 2016-01-11
Genre: Business & Economics
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“
Author: Richard C. Fries
Publisher: CRC Press
Release Date: 1997-01-30
Presenting the basic concepts and major issues associated with medical device design, this text describes current development processes as well as standards and regulatory information, providing a basis for assessing new technologies. It aims to help manufacturers establish and operate a viable reliability assurance programme, and purchasers to formulate effective methods of vendor evaluation.
Author: Jeffrey Rubin And Dana Chisnell
Publisher: John Wiley & Sons
Release Date: 2008-06-01
Market_Desc: · Product Managers· Designers· Developers Special Features: · The authors are leading authorities on product usability testing; they will actively promote the book at conferences and training seminars· The first edition has sold more than 20,000 copies since it first published in 1994; the new book is 30% revised, with 100 new pages· The book covers testing of consumer products as well as software, so it has a very broad target audience· There is no direct competition About The Book: Handbook of Usability Testing, Second Edition, is a nuts-and-bolts guide for beginners, loaded with tips and tricks for effectively testing products of all types. From software, GUIs, and technical documentation, to medical instruments and exercise bikes, no matter what type of product, readers will learn to design and administer reliable tests to ensure that people find it easy and desirable to use. The Second Edition is fully updated---30% revised, with 100 new pages. Chapters are reorganized to reflect more current industry practices, outdated terminology is updated, and more varied examples are provided.
Author: Paul H. King
Publisher: CRC Press
Release Date: 2014-07-29
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.
Author: John G. Webster
Release Date: 2006
This set is an alphabetically organized compilation of about 300 articles that describe critical aspects of medical devices and instrumentation. The articles emphasize the contributions of engineering, physics, and computers to each of the general areas of anesthesiology, biomaterials, burns, cardiology, clinical chemistry, clinical engineering, communicative disorders, computers in medicine, critical care medicine, dermatology, dentistry, ear, nose, and throat, emergency medicine, endocrinology, gastroenterology, genetics, geriatrics, gynecology, hematology, heptology, internal medicine, medical physics, microbiology, nephrology, neurology, nutrition, obstetrics, oncology, ophthalmology, orthopedics, pain, pediatrics, peripheral vascular disease, pharmacology, physical therapy, psychiatry, pulmonary medicine, radiology, rehabilitation, surgery, tissue engineering, transducers, and urology.