Digital Design and Manufacturing of Medical Devices and Systems PDF Download

Author: Rajkumar Velu
Publisher: Springer Nature
ISBN: 9819971004
Category :
Languages : en
Pages : 255

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Author:
Publisher: Academic Press
ISBN: 0123919436
Category : Technology & Engineering
Languages : en
Pages : 369

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Book Description
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

Author: Michael Wiklund
Publisher: CRC Press
ISBN: 1351579150
Category : Business & Economics
Languages : en
Pages : 588

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Book Description
How do you prevent a critical care nurse from accidentally delivering a morphine overdose to an ill patient? Or ensure that people don't insert their arm into a hydraulic mulcher? And what about enabling trapped airline passengers to escape safely in an emergency? Product designers and engineers face myriad such questions every day. Failure to answer them correctly can result in product designs that lead to injury or even death due to use error. Historically, designers and engineers have searched for answers by sifting through complicated safety standards or obscure industry guidance documents. Designing for Safe Use is the first comprehensive source of safety-focused design principles for product developers working in any industry. Inside you’ll find 100 principles that help ensure safe interactions with products as varied as baby strollers, stepladders, chainsaws, automobiles, apps, medication packaging, and even airliners. You’ll discover how protective features such as blade guards, roll bars, confirmation screens, antimicrobial coatings, and functional groupings can protect against a wide range of dangerous hazards, including sharp edges that can lacerate, top-heavy items that can roll over and crush, fumes that can poison, and small parts that can pose a choking hazard. Special book features include: Concise, illustrated descriptions of design principles Sample product designs that illustrate the book’s guidelines and exemplify best practices Literature references for readers interested in learning more about specific hazards and protective measures Statistics on the number of injuries that have arisen in the past due to causes that might be eliminated by applying the principles in the book Despite its serious subject matter, the book’s friendly tone, surprising anecdotes, bold visuals, and occasional attempts at dry humor will keep you interested in the art and science of making products safer. Whether you read the book cover-to-cover or jump around, the book’s relatable and practical approach will help you learn a lot about making products safe. Designing for Safe Use is a primer that will spark in readers a strong appreciation for the need to design safety into products. This reference is for designers, engineers, and students who seek a broad knowledge of safe design solutions. .

Author: J. Paulo Davim
Publisher: Elsevier
ISBN: 1908818182
Category : Technology & Engineering
Languages : en
Pages : 382

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Book Description
Medical devices play an important role in the field of medical and health technology, and encompass a wide range of health care products. Directive 2007/47/EC defines a medical device as any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, including the software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes and necessary for its proper application, intended by the manufacturer to be used for human beings. The design and manufacture of medical devices brings together a range of articles and case studies dealing with medical device R&D. Chapters in the book cover materials used in medical implants, such as Titanium Oxide, polyurethane, and advanced polymers; devices for specific applications such as spinal and craniofacial implants, and other issues related to medical devices, such as precision machining and integrated telemedicine systems. - Contains articles on a diverse range of subjects within the field, with internationally renowned specialists discussing each medical device - Offers a practical approach to recent developments in the design and manufacture of medical devices - Presents a topic that is the focus of research in many important universities and centres of research worldwide

Author: Cuie Wen
Publisher: Woodhead Publishing
ISBN: 0081029667
Category : Technology & Engineering
Languages : en
Pages : 606

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Book Description
Metallic Biomaterials Processing and Medical Device Manufacturing details the principles and practices of the technologies used in biomaterials processing and medical device manufacturing. The book reviews the main categories of metallic biomaterials and the essential considerations in design and manufacturing of medical devices. It bridges the gap between the designing of biomaterials and manufacturing of medical devices including requirements and standards. Main themes of the book include, manufacturing, coatings and surface modifications of medical devices, metallic biomaterials and their mechanical behaviour, degradation, testing and characterization, and quality controls, standards and FDA regulations of medical devices. The leading experts in the filed discuss the requirements, challenges, recent progresses and future research directions in the processing of materials and manufacturing of medical devices. Metallic Biomaterials Processing and Medical Device Manufacturing is ideal for those working in the disciplines of materials science, manufacturing, biomedical engineering, and mechanical engineering. - Reviews key topics of biomaterials processing for medical device applications including metallic biomaterials and their mechanical behavior, degradation, testing and characterization - Bridges the gap between biomaterials design and medical device manufacturing - Discusses the quality controls, standards, and FDA requirements for biomaterials and medical devices

Author: Michael E. Wiklund
Publisher:
ISBN: 9781570206894
Category : Human engineering
Languages : en
Pages : 218

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Author: Rajkumar Velu
Publisher: Springer
ISBN: 9789819970995
Category : Technology & Engineering
Languages : en
Pages : 0

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Book Description
This book coherently presents the advances in technological principles, processes, and methods of Additive Manufacturing (AM), Augmented reality (AR), and Internet of things (IoT) in biomedical technology. It offers an overview of these high-impact technologies in terms of materials, processes, and in-situ monitoring of fabricating biomedical devices, implants, and prosthetics. Furthermore, the book also aimed to cover pedagogical applications, including the design and development of high-fidelity anatomical and hybrid physiological human models, for medical and design students and clinicians for learning, understanding, and gaining insights into the structures and functions of human organs and pathology. In turn, the book also discusses the applications of artificial intelligence in the 3-D printing of pharmaceuticals. This book is a useful resource for manufacturers, scientists, engineers, and young research scholars understand disruptive technology's real potential in biomedical applications.

Author: Mary Beth Privitera
Publisher: Academic Press
ISBN: 0128018747
Category : Technology & Engineering
Languages : en
Pages : 307

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Book Description
Contextual Inquiry for Medical Device Design helps users understand the everyday use of medical devices and the way their usage supports the development of better products and increased market acceptance. The text explains the concept of contextual inquiry using real-life examples to illustrate its application. Case studies provide a frame of reference on how contextual inquiry is successfully used during product design, ultimately producing safer, improved medical devices. - Presents the ways contextual inquiry can be used to inform the evaluation and business case of technology - Helps users understand the everyday use of medical devices and the way their usage supports the development of better products - Includes case studies that provide a frame of reference on how contextual inquiry is successfully used during the product design process

Author: Susan Neadle
Publisher: CRC Press
ISBN: 1000874583
Category : Medical
Languages : en
Pages : 439

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Book Description
Combination products are therapeutic and diagnostic products that combine drugs, devices, and/or biological products. According to the US Food and Drug Administration (FDA), “a combination product is one composed of any combination of a drug and a device; a biological product and a device; a drug and a biological product; or a drug, device and a biological product.” Examples include prefilled syringes, pen injectors, autoinjectors, inhalers, transdermal delivery systems, drug-eluting stents, and kits containing drug administration devices co-packaged with drugs and/or biological products. This handbook provides the most up-to-date information on the development of combination products, from the technology involved to successful delivery to market. The authors present important and up-to-the-minute pre- and post-market reviews of international combination product regulations, guidance, considerations, and best practices. This handbook: Brings clarity of understanding for global combination products guidance and regulations Reviews the current state-of-the-art considerations and best practices spanning the combination product lifecycle, pre-market through post-market Reviews medical product classification and assignment issues faced by global regulatory authorities and industry The editor is a recognized international Combination Products and Medical Device expert with over 35 years of industry experience and has an outstanding team of contributors. Endorsed by AAMI – Association for the Advancement of Medical Instrumentation.

Author: Vo Van Toi
Publisher: Springer
ISBN: 9811358591
Category : Technology & Engineering
Languages : en
Pages : 673

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Book Description
This volume presents the proceedings of the 7th International Conference on the Development of Biomedical Engineering in Vietnam which was held from June 27-29, 2018 in Ho Chi Minh City. The volume reflects the progress of Biomedical Engineering and discusses problems and solutions. It aims to identify new challenges, and shaping future directions for research in biomedical engineering fields including medical instrumentation, bioinformatics, biomechanics, medical imaging, drug delivery therapy, regenerative medicine and entrepreneurship in medical devices.