Design Of Biomedical Devices And Systems Third Edition
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| Author | : Paul H. King |
| Publisher | : CRC Press |
| Total Pages | : 520 |
| Release | : 2014-07-29 |
| Genre | : Medical |
| ISBN | : 1466569131 |
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 | : Paul H. King |
| Publisher | : CRC Press |
| Total Pages | : 508 |
| Release | : 2018-10-03 |
| Genre | : Medical |
| ISBN | : 0429786069 |
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
| Author | : Marie Teixeira |
| Publisher | : CRC Press |
| Total Pages | : 258 |
| Release | : 2002-09-20 |
| Genre | : Medical |
| ISBN | : 9780203909386 |
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
| Author | : Richard C. Fries |
| Publisher | : CRC Press |
| Total Pages | : 490 |
| Release | : 2005-11-21 |
| Genre | : Medical |
| ISBN | : 1420027948 |
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.
| Author | : Paul H. King |
| Publisher | : CRC Press |
| Total Pages | : 424 |
| Release | : 2008-08-22 |
| Genre | : Medical |
| ISBN | : 1439878072 |
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
| Author | : Gary Drzewiecki |
| Publisher | : Cognella Academic Publishing |
| Total Pages | : |
| Release | : 2020-08-14 |
| Genre | : |
| ISBN | : 9781516565351 |
Lab Manual for Biomedical Engineering: Devices and Systems examines key concepts in biomedical systems and signals in a laboratory setting. The book gives students the opportunity to complete both measurement and math modeling exercises, thus demonstrating that the experimental real-world setting directly corresponds with classroom theory. All the experiments in the lab manual have been extensively class-tested and cover concepts such as wave math, Fourier transformation, electronic and random noise, transfer functions, and systems modeling. Each experiment builds on knowledge acquired in previous experiments, allowing the level of difficulty to increase at an appropriate pace. In completing the lab work, students enhance their understanding of the lecture course. The third edition features expanded exercises, additional sample data and measurements, and lab modifications for increased ease and simple adaptation to the online teaching and learning environment. Individual activities have also been added to aid with independent learning. Lab Manual for Biomedical Engineering is ideal for undergraduate courses in biomedical engineering comprised of students who have completed introductory electrical and mechanical physics courses. A two-semester background in calculus is recommended.
| Author | : Joseph Tranquillo |
| Publisher | : Academic Press |
| Total Pages | : 529 |
| Release | : 2022-02-19 |
| Genre | : Science |
| ISBN | : 0128166258 |
Biomedical Engineering Design presents the design processes and practices used in academic and industry medical device design projects. The first two chapters are an overview of the design process, project management and working on technical teams. Further chapters follow the general order of a design sequence in biomedical engineering, from problem identification to validation and verification testing. The first seven chapters, or parts of them, can be used for first-year and sophomore design classes. The next six chapters are primarily for upper-level students and include in-depth discussions of detailed design, testing, standards, regulatory requirements and ethics. The last two chapters summarize the various activities that industry engineers might be involved in to commercialize a medical device. - Covers subject matter rarely addressed in other BME design texts, such as packaging design, testing in living systems and sterilization methods - Provides instructive examples of how technical, marketing, regulatory, legal, and ethical requirements inform the design process - Includes numerous examples from both industry and academic design projects that highlight different ways to navigate the stages of design as well as document and communicate design decisions - Provides comprehensive coverage of the design process, including methods for identifying unmet needs, applying Design for 'X', and incorporating standards and design controls - Discusses topics that prepare students for careers in medical device design or other related medical fields
| Author | : |
| Publisher | : Academic Press |
| Total Pages | : 369 |
| Release | : 2012-12-17 |
| Genre | : Technology & Engineering |
| ISBN | : 0123919436 |
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 | : Gail D. Baura |
| Publisher | : Academic Press |
| Total Pages | : 529 |
| Release | : 2011-10-07 |
| Genre | : Medical |
| ISBN | : 012374976X |
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
| Author | : Vinny R. Sastri |
| Publisher | : Elsevier |
| Total Pages | : 289 |
| Release | : 2010-03-05 |
| Genre | : Technology & Engineering |
| ISBN | : 081552028X |
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.
