Download or read book The Medical Device R D Handbook written by Theodore R. Kucklick and published by CRC Press. This book was released on 2005-11-21 with total page 376 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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
Download or read book Medical Device Design written by and published by Academic Press. This book was released on 2012-12-17 with total page 369 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book provides the bridge between engineering design and medical device development. There is no single text that addresses the plethora of design issues a medical devices designer meets when developing new products or improving older ones. It addresses medical devices' regulatory (FDA and EU) requirements--some of the most stringent engineering requirements globally. Engineers failing to meet these requirements can cause serious harm to users as well as their products’ commercial prospects. This Handbook shows the essential methodologies medical designers must understand to ensure their products meet requirements. It brings together proven design protocols and puts them in an explicit medical context based on the author's years of academia (R&D phase) and industrial (commercialization phase) experience. This design methodology enables engineers and medical device manufacturers to bring new products to the marketplace rapidly. The medical device market is a multi-billion dollar industry. Every engineered product for this sector, from scalpelsstents to complex medical equipment, must be designed and developed to approved procedures and standards. This book shows how Covers US, and EU and ISO standards, enabling a truly international approach, providing a guide to the international standards that practicing engineers require to understand Written by an experienced medical device engineers and entrepreneurs with products in the from the US and UK and with real world experience of developing and commercializing medical products
Download or read book Medical Device Innovation Handbook written by William Durfee and published by Lulu.com. This book was released on 2014-03-23 with total page 148 pages. Available in PDF, EPUB and Kindle. Book excerpt: A short handbook for the medical device innovator who wishes to understand the innovation process for new medical devices.
Download or read book Medical Regulatory Affairs written by Jack Wong and published by CRC Press. This book was released on 2022-01-27 with total page 806 pages. Available in PDF, EPUB and Kindle. Book excerpt: This handbook covers medical device regulatory systems in different countries, ISO standards for medical devices, clinical trial and regulatory requirements, and documentation for application. It is the first to cover the medical device regulatory affairs in Asia. Experts from influential international regulatory bodies, including the US Food and Drug Administration (FDA), UK Medicines and Healthcare Products Regulatory Agency, Japan Pharmaceuticals and Medical Devices Agency, Saudi Food and Drug Authority, Korea Testing Laboratory, Taiwan FDA, World Health Organization, Asian Harmonization Working Party, Regulatory Affairs Professionals Society, and British Standards Institution, have contributed to the book. Government bodies, the medical device industry, academics, students, and general readers will find the book immensely useful for understanding the global regulatory environment and in their research and development projects.
Download or read book Biodesign written by Stefanos Zenios and published by Cambridge University Press. This book was released on 2010 with total page 779 pages. Available in PDF, EPUB and Kindle. Book excerpt: Recognize market opportunities, master the design process, and develop business acumen with this 'how-to' guide to medical technology innovation. Outlining a systematic, proven approach for innovation - identify, invent, implement - and integrating medical, engineering, and business challenges with real-world case studies, this book provides a practical guide for students and professionals.
Download or read book Innovation and Protection written by I. Glenn Cohen and published by Cambridge University Press. This book was released on 2022-04-07 with total page 295 pages. Available in PDF, EPUB and Kindle. Book excerpt: A detailed analysis of the ethical, legal, and regulatory landscape of medical devices in the US and EU.
Download or read book The Oxford Handbook of Innovation Management written by Mark Dodgson and published by . This book was released on 2014 with total page 722 pages. Available in PDF, EPUB and Kindle. Book excerpt: While innovation is widely recognised as being critical to organisational success and the well-being of societies, it requires careful management to ensure that innovation processes have the best possible impact. This volume provides a wide range of perspectives on the nature of innovation management and its influences.
Download or read book The Inventor s Guide for Medical Technology written by Patrick Kullmann and published by Two Harbors Press. This book was released on 2012 with total page 90 pages. Available in PDF, EPUB and Kindle. Book excerpt: "The Inventor's Guide for Medical Technology: From Your Napkin to the Market--What Innovators Need to Know" offers a series of clearly defined steps, guiding inventors in the process of taking their idea "from concept to market." In chapters such as "The Invention," "Research and Development," "Manufacturing," “Finance and Accounting,” “Launching in the U.S.” and “The Exit,” Paul Kullmann discusses trademarks and patents, clinical trial designs, funding, choosing the right team, and so much more. Each chapter ends with a tidbit of personal advice, based on Kullmann's insight and indisputably expert knowledge. With Kullmann's guidance, inventors and entrepreneurs alike can sidestep the pitfalls and increase their probability of success. See the free tool library information available inside the book. With his over twenty-eight years in the medical technology field and a long history as an entrepreneur, speaker, educator, and angel investor, Patrick Kullmann is the voice of experience.
Download or read book Materials and Coatings for Medical Devices written by and published by ASM International. This book was released on 2009-01-01 with total page 453 pages. Available in PDF, EPUB and Kindle. Book excerpt: "The Materials Information Society, MPMD-Materials and Processes for Medical Devices."
Download or read book Medical Device Technologies written by Gail D. Baura and published by Academic Press. This book was released on 2011-10-07 with total page 529 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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
Download or read book Plastics in Medical Devices written by Vinny R. Sastri and published by Elsevier. This book was released on 2010-03-05 with total page 289 pages. Available in PDF, EPUB and Kindle. Book excerpt: No book has been published that gives a detailed description of all the types of plastic materials used in medical devices, the unique requirements that the materials need to comply with and the ways standard plastics can be modified to meet such needs. This book will start with an introduction to medical devices, their classification and some of the regulations (both US and global) that affect their design, production and sale. A couple of chapters will focus on all the requirements that plastics need to meet for medical device applications. The subsequent chapters describe the various types of plastic materials, their properties profiles, the advantages and disadvantages for medical device applications, the techniques by which their properties can be enhanced, and real-world examples of their use. Comparative tables will allow readers to find the right classes of materials suitable for their applications or new product development needs.
Download or read book Engineering in Medicine written by Paul A. Iaizzo and published by Academic Press. This book was released on 2018-11-07 with total page 602 pages. Available in PDF, EPUB and Kindle. Book excerpt: Engineering in Medicine: Advances and Challenges documents the historical development, cutting-edge research and future perspectives on applying engineering technology to medical and healthcare challenges. The book has 22 chapters under 5 sections: cardiovascular engineering, neuroengineering, cellular and molecular bioengineering, medical and biological imaging, and medical devices.The challenges and future perspectives of engineering in medicine are discussed, with novel methodologies that have been implemented in innovative medical device development being described.This is an ideal general resource for biomedical engineering researchers at both universities and in industry as well as for undergraduate and graduate students. Presents a broad perspective on the state-of-the-art research in applying engineering technology to medical and healthcare challenges that cover cardiovascular engineering, neuroengineering, cellular and molecular bioengineering, medical and biological imaging, and medical devices Presents the challenges and future perspectives of engineering in medicine Written by members of the University of Minnesota’s prestigious Institute of Engineering in Medicine (IEM), in collaboration with other experts around the world
Download or read book Handbook of Measurements written by Adedeji B. Badiru and published by CRC Press. This book was released on 2018-10-08 with total page 706 pages. Available in PDF, EPUB and Kindle. Book excerpt: Planning, measuring, and paying attention to details form the basis for all successful engineering operations. Measurements pervade everything we do and must be viewed from a systems perspective. A comprehensive all-encompassing guide to measurements, Handbook of Measurements: Benchmarks for Systems Accuracy and Precision focuses on high-level engineering computations essential for benchmarks and technical innovation. The book uses a systems framework and a technically rigorous approach to systems linking of measurements—an approach that sets it apart from other handbooks. The popular saying "measure twice and cut once" bears out the importance of measurements in human endeavors. This handbook covers both qualitative and quantitative topics of measurement. It opens with a chapter on the fundamentals of measurement and includes coverage of human-centric measurements, such as measurement of personnel productivity and contractor performance. It concludes with three appendices on measurement, references, conversion factors, equations, formulas, and statistics for measurement. It is well understood that humans cannot manage anything that cannot be measured. All elements involved in our day-to-day decision making involve some form of measurement, whether in the kitchen, retail, sports, service operations, geographical exploration, health care delivery, worker productivity, clothing design, engineering product design, or space craft launching. Measuring an attribute of a system and then analyzing it against some standard, some specification, some best practice, or some benchmark empower a decision maker to take appropriate and timely actions. This book gives you a guide for sustainable practices to ensure accurate measurements, helping you make decisions backed by metrics.
Download or read book Global Innovation Science Handbook written by Praveen Gupta and published by McGraw Hill Professional. This book was released on 2014-02-05 with total page 897 pages. Available in PDF, EPUB and Kindle. Book excerpt: Publisher's Note: Products purchased from Third Party sellers are not guaranteed by the publisher for quality, authenticity, or access to any online entitlements included with the product. A GROUNDBREAKING GUIDE TO THE ART, SCIENCE, TOOLS, AND DEPLOYMENT OF INNOVATION "It has never been more important to educate people and organizations how to out-imagine, out-create, and out-innovate....The insight and experiences captured by [this book] make an important contribution toward reaching this goal." -- From the Foreword by Deborah Wince-Smith, President, Council on Competitiveness Developed by the editors of the International Journal of Innovation Science and featuring contributions from more than 40 innovation experts and thought leaders, Global Innovation Science Handbook presents a proven approach for understanding and implementing innovation in any industry. This pioneering work is based on a defined body of knowledge that includes intent, methodology, tools, and measurements. It challenges the popular paradigm that "learned" innovation is impossible, and lays out a systematic process for developing innovation skills. Each chapter can be independently read and utilized in the daily practice of innovation. Real-world case studies from financial, government, and education sectors illustrate the concepts discussed in this definitive resource. Global Innovation Science Handbook covers: Preparing for innovation--establishing a framework and creating a culture for innovation Key innovation concepts, such as creativity, neuroscience, biomimetics, benchmarking, and ethnography Creativity tools, including Kano analysis, storyboarding, absence thinking, Lotus Blossom, SCAMPER, and others Techniques essential to innovation science, such as Six Thinking Hats, mind mapping, social networks, market research, and lead user analysis Innovation radar, indices, and other measurements Idea management--the process of creating, screening, exploring, and evaluating ideas to bring those most valuable from concept to reality Innovation methodologies, including TRIZ, Brinnovation, crowdsourcing, Eureka, stage gate, and others Deployment--a life-cycle approach involving inspiration, strategy, organization, excellence, culture, measurement, protection of intellectual property, and launch Case studies featuring cutting-edge technological innovations in finance, government, and education
Download or read book Technology Innovation and Healthcare written by Bernadette J. Richards and published by . This book was released on 2022-02-15 with total page 192 pages. Available in PDF, EPUB and Kindle. Book excerpt: This timely book emphasizes the importance of regulation in enabling and channelling innovation at a time when technology is increasingly embedded in healthcare. It considers the adequacy of current regulatory approaches, identifying apparent gaps, risks and liabilities, and discusses how these might be collectively addressed. The authors present possible solutions that balance the protection and promotion of public trust in healthcare against enabling technological progress and disruptive innovation. Offering both a theoretical and practical approach to challenges at the intersection of healthcare, law and technology, this thought-provoking book explores broad questions of regulation and innovation before analysing contextual applications of these topics. It moves from a wide-ranging consideration of the polycentric and changing nature of health regulation through to a more specific examination of topics including patient consent, the role of device representatives, privacy, artificial intelligence and big data. Providing an international perspective, Technology, Innovation and Healthcare will be a valuable resource for scholars and students of health law, innovation, technology law, law and development and law and society. It will also be of benefit to lawyers, healthcare professionals, technology developers and policy makers, seeking to better integrate technology with healthcare.
Download or read book Handbook of Medical Device Regulatory Affairs in Asia written by Jack Wong and published by CRC Press. This book was released on 2018-03-28 with total page 475 pages. Available in PDF, EPUB and Kindle. Book excerpt: Medical device regulation in Asia has gained more importance than ever. Governments and regulatory bodies across the region have put in place new regulatory systems or refined the existing ones. A registered product requires a lot of technical documentation to prove its efficacy, safety, and quality. A smooth and successful registration process demands soft skills for dealing with various key stakeholders in the government, testing centers, and hospitals and among doctors. This handbook covers medical device regulatory systems in different countries, ISO standards for medical devices, clinical trial and regulatory requirements, and documentation for application. It is the first to cover the medical device regulatory affairs in Asia. Each chapter provides substantial background materials relevant to the particular area to have a better understanding of regulatory affairs.
Download or read book Designing Usability into Medical Products written by Michael E. Wiklund and published by CRC Press. This book was released on 2005-02-11 with total page 285 pages. Available in PDF, EPUB and Kindle. Book excerpt: Advocating a user-centered approach to medical technology design, Designing Usability into Medical Products covers the essential processes and specific techniques necessary to produce safe, effective, usable, and appealing medical systems and products. Written by experts on user-centered research, design, and evaluation, the book provides a range o
