Digital Design And Manufacturing Of Medical Devices And Systems

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Digital Design and Manufacturing of Medical Devices and Systems

Author : Rajkumar Velu,Karupppasamy Subburaj,Anand Kumar Subramaniyan
Publisher : Springer
Page : 0 pages
File Size : 49,6 Mb
Release : 2023-12-15
Category : Technology & Engineering
ISBN : 9819970997

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Digital Design and Manufacturing of Medical Devices and Systems by Rajkumar Velu,Karupppasamy Subburaj,Anand Kumar Subramaniyan Pdf

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.

Biomedical Devices

Author : Tugrul Özel,Paolo Jorge Bártolo,Elisabetta Ceretti,Joaquim De Ciurana Gay,Ciro Angel Rodriguez,Jorge Vicente Lopes Da Silva
Publisher : John Wiley & Sons
Page : 212 pages
File Size : 46,8 Mb
Release : 2016-10-24
Category : Science
ISBN : 9781118478929

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Biomedical Devices by Tugrul Özel,Paolo Jorge Bártolo,Elisabetta Ceretti,Joaquim De Ciurana Gay,Ciro Angel Rodriguez,Jorge Vicente Lopes Da Silva Pdf

Biomedical Devices: Design, Prototyping, and Manufacturing features fundamental discussions of all facets of materials processing and manufacturing processes across a wide range of medical devices and artificial tissues. Represents the first compilation of information on the design, prototyping, and manufacture of medical devices into one volume Offers in-depth coverage of medical devices, beginning with an introductory overview through to the design, manufacture, and applications Features examples of a variety of medical applications of devices, including biopsy micro forceps, micro-needle arrays, wrist implants, spinal spacers, and fixtures Provides students, doctors, scientists, and technicians interested in the development and applications of medical devices the ideal reference source

Design of Biomedical Devices and Systems Second edition

Author : Paul H. King,Richard C. Fries
Publisher : CRC Press
Page : 424 pages
File Size : 55,7 Mb
Release : 2008-08-22
Category : Medical
ISBN : 9781439878071

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Design of Biomedical Devices and Systems Second edition by Paul H. King,Richard C. Fries Pdf

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

Reliable Design of Medical Devices

Author : Richard C. Fries
Publisher : CRC Press
Page : 490 pages
File Size : 45,8 Mb
Release : 2005-11-21
Category : Medical
ISBN : 9781420027945

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Reliable Design of Medical Devices by Richard C. Fries Pdf

As medical devices increase in complexity, concerns about efficacy, safety, quality, and longevity increase in stride. Introduced nearly a decade ago, Reliable Design of Medical Devices illuminated the path to increased reliability in the hands-on design of advanced medical devices. With fully updated coverage in its Second Edition, this practical guide continues to be the benchmark for incorporating reliability engineering as a fundamental design philosophy. The book begins by rigorously defining reliability, differentiating it from quality, and exploring various aspects of failure in detail. It examines domestic and international regulations and standards in similar depth, including updated information on the regulatory and standards organizations as well as a new chapter on quality system regulation. The author builds on this background to explain product specification, liability and intellectual property, safety and risk management, design, testing, human factors, and manufacturing. New topics include design of experiments, CAD/CAM, industrial design, material selection and biocompatibility, system engineering, rapid prototyping, quick-response manufacturing, and maintainability as well as a new chapter on Six Sigma for design. Supplying valuable insight based on years of successful experience, Reliable Design of Medical Devices, Second Edition leads the way to implementing an effective reliability assurance program and navigating the regulatory minefield with confidence.

The Design and Manufacture of Medical Devices

Author : J Paulo Davim
Publisher : Elsevier
Page : 386 pages
File Size : 45,6 Mb
Release : 2012-10-16
Category : Medical
ISBN : 9781908818188

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The Design and Manufacture of Medical Devices by J Paulo Davim Pdf

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

Design Controls for the Medical Device Industry

Author : Marie B. Teixeira,Richard Bradley
Publisher : CRC Press
Page : 253 pages
File Size : 41,7 Mb
Release : 2002-09-20
Category : Medical
ISBN : 9780824743550

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Design Controls for the Medical Device Industry by Marie B. Teixeira,Richard Bradley Pdf

This reference provides real-world examples, strategies, and templates for the implementation of effective design control programs that meet current ISO 9000 and FDA QSR standards and regulations-offering product development models for the production of safe, durable, and cost-efficient medical devices and systems. Details procedures utilized by leading companies to successfully meet FDA and end-user requirements, manufacture high-quality products, and improve and generate profit. Design Controls for the Medical Device Industry contains valuable guidelines that enable readers to prepare for an FDA audit identify consumer needs, resolve project objectives, and process inconsistencies and discrepancies determine the compatibility of design specifications and manufacturing, installation, and servicing demands ensure that proper design, function, and performance stipulations are understood and met verify and validate design criteria and production schemes eliminate confusion and prevent communication breakdowns allocate and conserve resources perform risk assessment analyses predict potential hazards under normal and fault conditions Presenting blueprints for the application, evaluation, and refinement of quality assurance and performance practices-from product launch through engineering and assembly-Design Controls for the Medical Device Industry is a clear and indispensable source for biomedical, quality assurance, reliability, software, product design, manufacturing, research and development, and industrial engineers; project directors and managers; biomedical technicians; and upper-level undergraduate and graduate students in these disciplines.

Medical Device Design

Author : Peter J. Ogrodnik
Publisher : Academic Press
Page : 538 pages
File Size : 44,6 Mb
Release : 2019-10-30
Category : Technology & Engineering
ISBN : 9780128149638

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Medical Device Design by Peter J. Ogrodnik Pdf

Medical Device Design: Innovation from Concept to Market, Second Edition 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; this book fills that need. It addresses medical devices' regulatory (FDA and EU) requirements, shows the essential methodologies medical designers must understand to ensure their products meet requirements, and brings together proven design protocols, thus enabling engineers and medical device manufacturers to rapidly bring new products to the marketplace. This book is unique because it takes the reader through the process of medical device development, from very early stages of conceptualization, to commercialization on the global market. This rare resource can be used by both professionals and newcomers to device design. Provides a reference to standards and regulations that have been updated, including ISO 13485:2016, FDA regulations and the European Medical Device Regulation Includes new case studies in the areas of classifying medical devices, the design process, quality, labeling, instructions for use, and more Presents additional content around software and biocompatibility concerns

Design of Biomedical Devices and Systems, 4th edition

Author : Paul H. King,Richard C. Fries,Arthur T. Johnson
Publisher : CRC Press
Page : 725 pages
File Size : 46,8 Mb
Release : 2018-10-03
Category : Medical
ISBN : 9780429786051

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Design of Biomedical Devices and Systems, 4th edition by Paul H. King,Richard C. Fries,Arthur T. Johnson Pdf

This fourth edition is a substantial revision of a highly regarded text, intended for senior design capstone courses within departments of biomedical engineering, bioengineering, biological engineering and medical engineering, worldwide. Each chapter has been thoroughly updated and revised to reflect the latest developments. New material has been added on entrepreneurship, bioengineering design, clinical trials and CRISPR. Based upon feedback from prior users and reviews, additional and new examples and applications, such as 3D printing have been added to the text. Additional clinical applications were added to enhance the overall relevance of the material presented. Relevant FDA regulations and how they impact the designer’s work have been updated. Features Provides updated material as needed to each chapter Incorporates new examples and applications within each chapter Discusses new material related to entrepreneurship, clinical trials and CRISPR Relates critical new information pertaining to FDA regulations. Presents new material on "discovery" of projects "worth pursuing" and design for health care for low-resource environments Presents multiple case examples of entrepreneurship in this field Addresses multiple safety and ethical concerns for the design of medical devices and processes

Medical Device and Equipment Design

Author : Michael E. Wiklund
Publisher : CRC Press
Page : 402 pages
File Size : 50,6 Mb
Release : 1995-02-15
Category : Technology & Engineering
ISBN : 0935184694

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Medical Device and Equipment Design by Michael E. Wiklund Pdf

The key to profitability and success in both the medical device and the equipment markets often relates to how easy your products are to use. User acceptance and preference frequently is dependent upon ergonomic design. Medical Device and Equipment Design helps you enhance your product design, maximize user acceptance, and minimize potential problems in the marketplace. It provides practical guidance on how to plan and incorporate ergonomic design principles into medical devices and equipment so users intuitively feel comfortable with the product. Design engineers, usability and reliability engineers, software programmers, documentation specialists, product managers, quality engineers, and market/product managers will find this text invaluable in getting usability built into products from the very beginning.

Six Sigma for Medical Device Design

Author : Jose Justiniano,Venky Gopalaswamy
Publisher : CRC Press
Page : 152 pages
File Size : 44,9 Mb
Release : 2004-11-15
Category : Science
ISBN : 9780203485743

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Six Sigma for Medical Device Design by Jose Justiniano,Venky Gopalaswamy Pdf

For designers of medical devices, the FDA and ISO requirements are extremely stringent. Designers and researchers feel pressure from management to quickly develop new devices, while they are simultaneously hampered by strict guidelines. The Six Sigma philosophy has solved this dichotomous paradigm for organizations in other fields, and seeks to do

Handbook on Advanced Design and Manufacturing Technologies for Biomedical Devices

Author : Andrés Díaz Lantada
Publisher : Springer Science & Business Media
Page : 381 pages
File Size : 54,8 Mb
Release : 2014-07-08
Category : Technology & Engineering
ISBN : 9781461467892

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Handbook on Advanced Design and Manufacturing Technologies for Biomedical Devices by Andrés Díaz Lantada Pdf

​The last decades have seen remarkable advances in computer‐aided design, engineering and manufacturing technologies, multi‐variable simulation tools, medical imaging, biomimetic design, rapid prototyping, micro and nanomanufacturing methods and information management resources, all of which provide new horizons for the Biomedical Engineering fields and the Medical Device Industry. Advanced Design and Manufacturing Technologies for Biomedical Devices covers such topics in depth, with an applied perspective and providing several case studies that help to analyze and understand the key factors of the different stages linked to the development of a novel biomedical device, from the conceptual and design steps, to the prototyping and industrialization phases. Main research challenges and future potentials are also discussed, taking into account relevant social demands and a growing market already exceeding billions of dollars. In time, advanced biomedical devices will decisively change methods and results in the medical world, dramatically improving diagnoses and therapies for all kinds of pathologies. But if these biodevices are to fulfill present expectations, today’s engineers need a thorough grounding in related simulation, design and manufacturing technologies, and collaboration between experts of different areas has to be promoted, as is also analyzed within this handbook.

Design of Biomedical Devices and Systems

Author : Dragan Primorac
Publisher : CRC Press
Page : 515 pages
File Size : 40,8 Mb
Release : 2014-07-29
Category : Medical
ISBN : 9781466569140

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Design of Biomedical Devices and Systems by Dragan Primorac Pdf

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.

Medical Device Design for Six Sigma

Author : Basem El-Haik,Khalid S. Mekki
Publisher : John Wiley & Sons
Page : 528 pages
File Size : 50,6 Mb
Release : 2011-09-20
Category : Medical
ISBN : 9781118210413

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Medical Device Design for Six Sigma by Basem El-Haik,Khalid S. Mekki Pdf

The first comprehensive guide to the integration of Design forSix Sigma principles in the medical devices development cycle Medical Device Design for Six Sigma: A Road Map for Safetyand Effectiveness presents the complete body of knowledge forDesign for Six Sigma (DFSS), as outlined by American Society forQuality, and details how to integrate appropriate designmethodologies up front in the design process. DFSS helps companiesshorten lead times, cut development and manufacturing costs, lowertotal life-cycle cost, and improve the quality of the medicaldevices. Comprehensive and complete with real-world examples, thisguide: Integrates concept and design methods such as Pugh ControlledConvergence approach, QFD methodology, parameter optimizationtechniques like Design of Experiment (DOE), Taguchi Robust Designmethod, Failure Mode and Effects Analysis (FMEA), Design for X,Multi-Level Hierarchical Design methodology, and Response Surfacemethodology Covers contemporary and emerging design methods, includingAxiomatic Design Principles, Theory of Inventive Problem Solving(TRIZ), and Tolerance Design Provides a detailed, step-by-step implementation process foreach DFSS tool included Covers the structural, organizational, and technical deploymentof DFSS within the medical device industry Includes a DFSS case study describing the development of a newdevice Presents a global prospective of medical device regulations Providing both a road map and a toolbox, this is a hands-onreference for medical device product development practitioners,product/service development engineers and architects, DFSS and SixSigma trainees and trainers, middle management, engineering teamleaders, quality engineers and quality consultants, and graduatestudents in biomedical engineering.

Metallic Biomaterials Processing and Medical Device Manufacturing

Author : Cuie Wen
Publisher : Woodhead Publishing
Page : 606 pages
File Size : 55,7 Mb
Release : 2020-08-20
Category : Technology & Engineering
ISBN : 9780081029664

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Metallic Biomaterials Processing and Medical Device Manufacturing by Cuie Wen Pdf

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