The first comprehensive guide to the integration of Design for Six Sigma principles in the medical devices development cycle <p> <i>Medical Device Design for Six Sigma: A Road Map for Safety and Effectiveness</i> presents the complete body of knowledge for Design for Six Sigma (DFSS), as outlined by American Society for Quality, and details how to integrate appropriate design methodologies up front in the design process. DFSS helps companies shorten lead times, cut development and manufacturing costs, lower total life-cycle cost, and improve the quality of the medical devices. Comprehensive and complete with real-world examples, this guide: <ul> <li> <p> Integrates concept and design methods such as Pugh Controlled Convergence approach, QFD methodology, parameter optimization techniques like Design of Experiment (DOE), Taguchi Robust Design method, Failure Mode and Effects Analysis (FMEA), Design for X, Multi-Level Hierarchical Design methodology, and Response Surface methodology <li> <p> Covers contemporary and emerging design methods, including Axiomatic Design Principles, Theory of Inventive Problem Solving (TRIZ), and Tolerance Design <li> <p> Provides a detailed, step-by-step implementation process for each DFSS tool included <li> <p> Covers the structural, organizational, and technical deployment of DFSS within the medical device industry <li> <p> Includes a DFSS case study describing the development of a new device <li> <p> Presents a global prospective of medical device regulations </ul> <p> Providing both a road map and a toolbox, this is a hands-on reference for medical device product development practitioners, product/service development engineers and architects, DFSS and Six Sigma trainees and trainers, middle management, engineering team leaders, quality engineers and quality consultants, and graduate students in biomedical engineering.
The demand for clinical evidence has become an increasingly important issue in the development of medical devices. This demand is reflected not only in regulatory requirements but also by healthcare purchasers as healthcare reforms occur worldwide. Thirteen renowned experts have drawn on their practical experience in industry to provide you with this "recipe" book of how to plan, prepare, implement, and close out a medical device clinical investigation--regardless of where the trial site may be located. While many chapters reference the Medical Device Directive, the principles, philosophies, and methodologies explained are equally applicable to Active Implantable Medical Devices (AIMD) and In-vitro Diagnostic (IVD) products.
To view sample pages please click on the "Sample Materials and Chapters" link on the left. Biomedical devices undoubtedly represent one of the most striking examples of the revolutionary developments, in both medicine and technology, in the 21st century. The explosive growth of research, scientific output, industrial market development, and investments in today's global applications of scientific and technological knowledge to health care is staggering, and all indications point to the continued increase in all these developments in the years to come. Although a significant number of already existing sources try to address the scientificinical/technological aspects of biomedical devices, there is practically no reference that illustrates to researchers the commercial potential of the results of their research. The SAGE Sourcebook of Modern Biomedical Devices: Business Markets in the Global Environment is the first accessible, broadly available source of information that presents and quantifies the commercial success of numerous types of biomedical devices available in the global market. It is of great importance, for both the research and the business communities, to identify specific biomedical device types, per major therapeutic areas, most commercially successful in today's global economic markets, such as in the biggest market (U.S.), in the Pacific Rim, and in the newly expanded European Union. Currently, such vital information is not available anywhere else, definitely not in a unified source and not in a detailed, well-substantiated, reliable, and easy-to-read form. Key Features - Presents, for the first time in one reference source, unique quantitative data and brief comparative analysis of the commercial performance of more than 180 types of biomedical devices. - Covers devices from practically all major therapeutic areas of application, such as orthopedic devices, cardiovascular devices, gastrointestinal devices, cancer treatment devices, imaging devices, and spinal implants, as well as emerging markets for cardiac surgery devices. - Offers global analysis of markets per device per therapeutic area, including North America, Pacific Rim, and the European Community. - Examines commercial success, market shares, and business potential of the rapidly changing new technologies and the new markets. Thus, this Encyclopedia will be useful as a possible indication of further direction of research, development, and investments in the biomedical device areas globally. - Reflects the latest changes in the marketplace. The information will be periodically updated. - Presents data in a concise, clear, and reader-friendly way, with emphasis on graphs, tables, and charts. The SAGE Sourcebook of Modern Biomedical Devices: Business Markets in the Global Environment is a truly unique resource not only for academic and corporate libraries and working groups but also for researchers and graduate students working in all fields of biomedical devices, in both physical and life sciences, including departments of Engineering, Materials Science, Applied Physics, Chemistry, as well as medical schools and business schools (with the all important emphasis in health care economics). Businesspeople, government organizations, funding agencies, health care providers, and hospital libraries will also find this a welcome addition to their reference collection. Decision Resources, Inc. Decision Resources is a firm that specializes in creating reports regarding drug therapies used for cancer and other disease research. These reports are very detailed and are written by medical professionals, peer reviewed over three rounds and then sold to major pharmaceutical firms. Each report costs $20,000. Decision Resources do not in any way consider themselves a publisher although they create valuable content. Therefore, they are eager to partner with an academic reference publisher in order to sell their content in new markets. The SAGE Handbook of Current Therapies and the SAGE Handbook of Emerging Therapies will serve as two very important resources for medical students at any level that are researching the key drug therapies involved with cancer research. Each set will contain four volumes which will include 60 chapters which will cover respectively the current and emerging drug therapies which tie in all important applications to today's pharmaceutical and biotechnical industries. Each chapter is a synthesis of a previously published detailed report on a particular therapy which has been through several rounds of peer review to insure the utmost accuracy and relevance. Areas covered include: CARDIOVASCULAR DEVICES CARDIOVASCULAR - PERIPHERAL VASCULAR CARDIOVASCULAR - TRANSCATHETER EMBOLIZATION OCCLUSION CARDIOVASCULAR - VASCULAR ACCESS CARDIOVASCULAR - CARDIAC SURGERY ORTHOPEDIC DEVICES ORTHOPEDICS - TRAUMA IMPLANTS ORTHOPEDICS - SPINAL IMPLANTS ORTHOPEDICS - ORTHOPEDIC BIOMATERIALS ORTHOPEDICS - DENTAL IMPLANTS ORTHOPEDICS - OTHER ORTHOPEDICS ENDOSCOPY DEVICES UROLOGY & GYNECOLOGY DEVICES AESTHETIC DEVICES OPHTHALMIC DEVICES DIAGNOSTIC IMAGING HEALTH CARE INFORMATION TECHNOLOGY
In clear, easy-to-grasp language, the author covers many of the topics that you will need to know in order to win your dream job and be the first in line for a promotion.
This book presents a detailed summary of research on automatic layout of device-level analog circuits that was undertaken in the late 1980s and early 1990s at Carnegie Mellon University. We focus on the work behind the creation of the tools called KOAN and ANAGRAM II, which form part of the core of the CMU ACACIA analog CAD system. KOAN is a device placer for custom analog cells; ANANGRAM II a detailed area router for these analog cells. We strive to present the motivations behind the architecture of these tools, including detailed discussion of the subtle technology and circuit concerns that must be addressed in any successful analog or mixed-signal layout tool. Our approach in organizing the chapters of the book has been to present our algo- rithms as a series of responses to these very real and very difficult analog layout problems. Finally, we present numerous examples of results generated by our algorithms. This research was supported in part by the Semiconductor Research Corpora- tion, by the National Science Foundation, by Harris Semiconductor, and by the International Business Machines Corporation Resident Study Program. Finally, just for the record: John Cohn was the designer of the KOAN placer; David Garrod was the designer of the ANAGRAM II router (and its predeces- sor, ANAGRAM I). This book was architected by all four authors, edited by John Cohn and Rob Rutenbar, and produced in finished form by John Cohn.
Biotechnology, Nanotechnology and Medical Electronics Articles
Biotechnology, Nanotechnology and Medical Electronics Books
Biotechnology, Nanotechnology and Medical Electronics