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 Handbook of Human Factors in Medical Device Design written by Matthew Bret Weinger and published by CRC Press. This book was released on 2010-12-13 with total page 822 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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

Download or read book Health Design Thinking written by Bon Ku and published by MIT Press. This book was released on 2020-03-17 with total page 228 pages. Available in PDF, EPUB and Kindle. Book excerpt: Applying the principles of human-centered design to real-world health care challenges, from drug packaging to early detection of breast cancer. This book makes a case for applying the principles of design thinking to real-world health care challenges. As health care systems around the globe struggle to expand access, improve outcomes, and control costs, Health Design Thinking offers a human-centered approach for designing health care products and services, with examples and case studies that range from drug packaging and exam rooms to internet-connected devices for early detection of breast cancer. Written by leaders in the field—Bon Ku, a physician and founder of the innovative Health Design Lab at Sidney Kimmel Medical College, and Ellen Lupton, an award-winning graphic designer and curator at Cooper Hewitt Smithsonian Design Museum—the book outlines the fundamentals of design thinking and highlights important products, prototypes, and research in health design. Health design thinking uses play and experimentation rather than a rigid methodology. It draws on interviews, observations, diagrams, storytelling, physical models, and role playing; design teams focus not on technology but on problems faced by patients and clinicians. The book's diverse case studies show health design thinking in action. These include the development of PillPack, which frames prescription drug delivery in terms of user experience design; a credit card–size device that allows patients to generate their own electrocardiograms; and improved emergency room signage. Drawings, photographs, storyboards, and other visualizations accompany the case studies. Copublished with Cooper Hewitt, Smithsonian Design Museum

Download or read book The Design and Manufacture of Medical Devices written by J. Paulo Davim and published by Elsevier. This book was released on 2012-10-16 with total page 382 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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

Download or read book Contextual Inquiry for Medical Device Design written by Mary Beth Privitera and published by Academic Press. This book was released on 2015-05-29 with total page 307 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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

Download or read book Applied Human Factors in Medical Device Design written by Mary Beth Privitera and published by Academic Press. This book was released on 2019-06-15 with total page 371 pages. Available in PDF, EPUB and Kindle. Book excerpt: Applied Human Factors in Medical Device Design describes the contents of a human factors toolbox with in-depth descriptions of both empirical and analytical methodologies. The book begins with an overview of the design control process, integrating human factors as directed by AAMI TIR 59 and experienced practice. It then explains each method, describing why each method is important, its potential impact, when it's ideal to use, and related challenges. Also discussed are other barriers, such as communication breakdowns between users and design teams. This book is an excellent reference for professionals working in human factors, design, engineering, marketing and regulation. Focuses on meeting agency requirements as it pertains to the application of human factors in the medical device development process in both the US and the European Union (EU) Explains technology development and the application of human factors throughout the development process Covers FDA and MHRA regulations Includes case examples with each method

Download or read book Medical Instrument Design and Development written by Claudio Becchetti and published by John Wiley & Sons. This book was released on 2013-07-29 with total page 612 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book explains all of the stages involved in developing medical devices; from concept to medical approval including system engineering, bioinstrumentation design, signal processing, electronics, software and ICT with Cloud and e-Health development. Medical Instrument Design and Development offers a comprehensive theoretical background with extensive use of diagrams, graphics and tables (around 400 throughout the book). The book explains how the theory is translated into industrial medical products using a market-sold Electrocardiograph disclosed in its design by the Gamma Cardio Soft manufacturer. The sequence of the chapters reflects the product development lifecycle. Each chapter is focused on a specific University course and is divided into two sections: theory and implementation. The theory sections explain the main concepts and principles which remain valid across technological evolutions of medical instrumentation. The Implementation sections show how the theory is translated into a medical product. The Electrocardiograph (ECG or EKG) is used as an example as it is a suitable device to explore to fully understand medical instrumentation since it is sufficiently simple but encompasses all the main areas involved in developing medical electronic equipment. Key Features: Introduces a system-level approach to product design Covers topics such as bioinstrumentation, signal processing, information theory, electronics, software, firmware, telemedicine, e-Health and medical device certification Explains how to use theory to implement a market product (using ECG as an example) Examines the design and applications of main medical instruments Details the additional know-how required for product implementation: business context, system design, project management, intellectual property rights, product life cycle, etc. Includes an accompanying website with the design of the certified ECG product (www.gammacardiosoft.it/book) Discloses the details of a marketed ECG Product (from Gamma Cardio Soft) compliant with the ANSI standard AAMI EC 11 under open licenses (GNU GPL, Creative Common) This book is written for biomedical engineering courses (upper-level undergraduate and graduate students) and for engineers interested in medical instrumentation/device design with a comprehensive and interdisciplinary system perspective.

Download or read book Medical Device Design and Regulation written by Carl T. DeMarco and published by Quality Press. This book was released on 2011-01-01 with total page 369 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book Design Controls for the Medical Device Industry written by Marie Teixeira and published by CRC Press. This book was released on 2002-09-20 with total page 258 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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 utilize

Download or read book Design and Development of Medical Electronic Instrumentation written by David Prutchi and published by John Wiley & Sons. This book was released on 2005-01-28 with total page 479 pages. Available in PDF, EPUB and Kindle. Book excerpt: Design and Development of Medical Electronic Instrumentation fills a gap in the existing medical electronic devices literature by providing background and examples of how medical instrumentation is actually designed and tested. The book includes practical examples and projects, including working schematics, ranging in difficulty from simple biopotential amplifiers to computer-controlled defibrillators. Covering every stage of the development process, the book provides complete coverage of the practical aspects of amplifying, processing, simulating and evoking biopotentials. In addition, two chapters address the issue of safety in the development of electronic medical devices, and providing valuable insider advice.

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

Download or read book Handbook of Medical Device Design written by Richard C. Fries and published by CRC Press. This book was released on 2019-08-15 with total page 795 pages. Available in PDF, EPUB and Kindle. Book excerpt: First published in 2001: This handbook has been written to give those professionals working in the development and use of medical devices practical knowledge about biomedical technology, regulations, and their relationship to quality health care.

Download or read book Reliable Design of Medical Devices written by Richard C. Fries and published by CRC Press. This book was released on 2005-11-21 with total page 490 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Download or read book Design for Care written by Peter Jones and published by Rosenfeld Media. This book was released on 2013-05-01 with total page 377 pages. Available in PDF, EPUB and Kindle. Book excerpt: The world of healthcare is constantly evolving, ever increasing in complexity, costs, and stakeholders, and presenting huge challenges to policy making, decision making and system design. In Design for Care, we'll show how service and information designers can work with practice professionals and patients/advocates to make a positive difference in healthcare.

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 Humanizing Healthcare Human Factors for Medical Device Design written by Russell J. Branaghan and published by Springer Nature. This book was released on 2021-02-21 with total page 395 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book introduces human factors engineering (HFE) principles, guidelines, and design methods for medical device design. It starts with an overview of physical, perceptual, and cognitive abilities and limitations, and their implications for design. This analysis produces a set of human factors principles that can be applied across many design challenges, which are then applied to guidelines for designing input controls, visual displays, auditory displays (alerts, alarms, warnings), and human-computer interaction. Specific challenges and solutions for various medical device domains, such as robotic surgery, laparoscopic surgery, artificial organs, wearables, continuous glucose monitors and insulin pumps, and reprocessing, are discussed. Human factors research and design methods are provided and integrated into a human factors design lifecycle, and a discussion of regulatory requirements and procedures is provided, including guidance on what human factors activities should be conducted when and how they should be documented. This hands-on professional reference is an essential introduction and resource for students and practitioners in HFE, biomedical engineering, industrial design, graphic design, user-experience design, quality engineering, product management, and regulatory affairs. Teaches readers to design medical devices that are safer, more effective, and less error prone; Explains the role and responsibilities of regulatory agencies in medical device design; Introduces analysis and research methods such as UFMEA, task analysis, heuristic evaluation, and usability testing.