Download or read book Update on Life Cycle Strategy for New Implants and Medical Devices written by Marvi Sri Harwoko and published by Smithers Rapra. This book was released on 2012-10-31 with total page 124 pages. Available in PDF, EPUB and Kindle. Book excerpt: With the emergence of new therapies for diseases which affect vital organs either partially or as a whole, the complexity of the parameter interaction and the variety of new discoveries opens many possibilities to implement these proposals into clinical use. Unfortunately, this diversity can also handicap an efficient design process.Therefore, a practical tool has to be developed, which in the early development stages, systematically supports the product and process optimization by preparing and providing information and knowledge.This book details such a methodology for systematizing the product design process, which uses a knowledge-based design process, a customer-oriented engineering process, and a business supporting life cycle model.This book describes how this methodology can be used as a product design guidance tool for supporting the development of a new implant. The methodology resolves the development complexity by using a series of logical steps and provides researchers with the means to assess these steps as soon as possible for anticipating and removing subsequent useless steps.
Download or read book Medical Device Product Lifecycle written by Bernadette White and published by Independently Published. This book was released on 2022-03-11 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book is intended to provide an introduction to the application of a lifecycle approach to product design and development for medical devices. Medical Device Product Lifecycle management provides a framework to develop, design maintain user requirements and ensure the safety and performance of medical devices. Application of a Medical Device Product Lifecycle Management benefits the business aspects of manufacturing, fosters alignment across design and development teams and incorporates the voice of the customer, taking into account their needs and safety that is inherent in the design of products. The Medical Device Product Lifecycle (MDPL) relies upon several distinct quality management elements and processes in order to function effectively. These include; principles and establishment of a quality management system, regulatory processes, validation processes, engineering processes, change management and risk management processes. The MDPL process itself requires procedures and documentation to facilitate product realization. For the reader to gain the maximum benefit from this book, the following points should be considered. To begin with-Regulations are mandatory. Medical devices range in their application (intended use and indications), technologies, principles of operation, complexity and value. However, regulation in addition to standards need to be consulted and applied within organizations. The manufacturer has a legal responsibility in this regard and the classification and commercial strategy may require regulations such as FDA 21 CFR 820, (United States), and Medical Device Regulations EU MDR (2017/745) or Regulation 2017/746 on In-Vitro Diagnostic Devices (IVDR) (in Europe). Introduction Establishing a Medical Device Product Development Process is necessary to for medical device manufacturers to meet FDA regulations and regional regulations applicable to the products for sale. Beyond the legal stipulation, an additional purpose is to realize and deliver safe and effective medical devices that meet the intended use and user needs which provides medical solutions that enhance and preserve quality of life. To achieve safe and effective products, the guiding principles and techniques not only need to be applied in the design and development stages, but maintaining and monitoring the performance through the product lifecycle is required. It is easily to compartmentalize product performance and safety as a development and design-based activity, however, an effective medical device lifecycle process must ensure design safety and continuity until product retirement and discontinuation. The introduction of new medical device products or changes to existing medical device products necessitate design and development activities in order to plan and deliver the appropriate verifications and validations to demonstrate safety and performance of products. Device manufacturers in establishing and applying a Medical Device Product Lifecycle Process must continually ensure the process is fit-for-purpose and that is fulfils its legal and regulatory obligations (e.g. meeting the requirements of 21 CFR 820.30: Medical Devices - Quality System Regulation and ISO 13485: Medical Devices- Quality Management Systems etc.) A Medical Device Product Lifecycle process must be a comprehensive, end-to-end process that encompasses the entire life cycle of a product from project initiation through to product discontinuation and retirement of a marketed product. Making a comprehensive and detailed process intuitive and easy-to-apply should also play a role in designing and maintaining a MDPL process. Structuring the process into specific stages and the use of design review or gate reviews also provides for a format that has milestones and a stage by stage approach that makes it easier for engineers to work with.
Download or read book Public Health Effectiveness of the FDA 510 k Clearance Process written by Institute of Medicine and published by National Academies Press. This book was released on 2010-10-04 with total page 141 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Food and Drug Administration (FDA) is responsible for assuring that medical devices are safe and effective before they go on the market. As part of its assessment of FDA's premarket clearance process for medical devices, the IOM held a workshop June 14-15 to discuss how to best balance patient safety and technological innovation. This document summarizes the workshop.
Download or read book Corporatizing American Health Care written by Robert W. Derlet and published by JHU Press. This book was released on 2021-02-02 with total page 217 pages. Available in PDF, EPUB and Kindle. Book excerpt: Tracking the evolution of medical care from an individualized small cottage profession to a giant impersonal corporate industry costing Americans over $3 trillion each year. Over the past three decades, the once-efficient American health care system has evolved into a complex maze of monopolies and a racket of bureaucratic checks, approvals, denials, roadblocks, and detours. This shift has created a massive and at times redundant workforce that frustrates patients, as well as physicians, nurses, and administrative staff. Health care costs the United States over $3 trillion each year and consumes over 18% of the country's gross domestic product. That's more than $11,000 for each person in the country each year—more than double what it costs in most Western European countries to deliver equal or even better care. In Corporatizing American Health Care, Robert W. Derlet, MD, traces the progression of health care policy in the United States. How, he asks, has US health care transformed from bedside medicine—a model of small practices and patient-focused care—into corporate medicine, which prioritizes profit and deals with both patient care and outcomes as billing codes? Arguing that the US Congress is the root of the problem, he describes how Congress has failed to enact legislation to prevent corporate monopolies in the health care industry. Instead, corrupted by large campaign donations and corporate lobbyists, Congress has crafted loopholes benefiting corporations and harming people. Drawing on his decades as a practicing physician caring for thousands of patients, as well as his university and medical school teaching experience, Derlet follows changes to both policy and practice across many sectors of health care. Scrutinizing how hospitals work, he also takes a hard look at high prescription drug prices, unresponsive insurance companies, problems with the Affordable Care Act, the growing medical implant device industry, and even nursing homes. Finally, he explains why the dominance of corporations and their lobbyists over health policy means that we now pay more for our care and our medications but have less choice both in what doctors we see and in what drugs we take. Breaking down the complex ABCs of health care to reveal the unscrupulous practices of the health care industry, Corporatizing American Health Care is perfect for both students and general readers who want to understand the changes in our system from the perspective of an actual doctor.
Download or read book Cardiovascular Therapeutics E Book written by Elliott M. Antman and published by Elsevier Health Sciences. This book was released on 2012-09-17 with total page 833 pages. Available in PDF, EPUB and Kindle. Book excerpt: Manage cardiovascular problems more effectively with the most comprehensive resource available! A trusted companion to Braunwald's Heart Disease, Cardiovascular Therapeutics, 4th Edition addresses pharmacological, interventional, and surgical management approaches for each type of cardiovascular disease. This practical and clinically focused cardiology reference offers a balanced, complete approach to all of the usual and unusual areas of cardiovascular disease and specific therapies in one concise volume, equipping you to make the best choices for every patient. Consult this title on your favorite e-reader with intuitive search tools and adjustable font sizes. Elsevier eBooks provide instant portable access to your entire library, no matter what device you're using or where you're located. Understand current approaches to treating and managing cardiovascular patients for long-term health, for complex problems, and for unusual cardiac events. Benefit from the substantial experience of Elliott M. Antman, MD, Marc S. Sabatine, MD, and a host of other respected authorities, who provide practical, evidence-based rationales for all of today's clinical therapies. Expand your knowledge beyond pharmacologic interventions with complete coverage of the most effective interventional and device therapies being used today. Easily reference Braunwald's Heart Disease, 9th Edition for further information on topics of interest. Make the best use of the latest genetic and molecular therapies as well as advanced therapies for heart failure. Cut right to the answers you need with an enhanced focus on clinically relevant information and a decreased emphasis on pathophysiology. Stay current with ACC/AHA/ESC guidelines and the best ways to implement them in clinical practice. Get an enhanced visual perspective with an all-new, full-color design throughout.
Download or read book Polymeric Materials with Antimicrobial Activity written by Alexandra Muñoz-Bonilla and published by Royal Society of Chemistry. This book was released on 2014 with total page 432 pages. Available in PDF, EPUB and Kindle. Book excerpt: A comprehensive overview of different antimicrobial polymeric materials, their antimicrobial action modes and applications.
Download or read book Handbook of Strategy and Management written by Andrew M Pettigrew and published by SAGE. This book was released on 2006-04-27 with total page 542 pages. Available in PDF, EPUB and Kindle. Book excerpt: Now available as a 60 day review copy in Paperback! ISBN: 1-4129-2121-X"Finally! We have a comprehensive, reflective and critical overview of the field of strategy in the new Handbook of Strategy and Management." -Cynthia Hardy, Head of Department of Management, University of Melbourne Presenting a major retrospective and prospective overview of strategy, this Handbook is an important benchmark volume for management scholars worldwide. The Handbook frames, assesses and synthesizes the work in the field. Chapters are grouped under four specific areas of strategy and management: Mapping a Terrain; Thinking and Acting Strategically; Changing Contexts; and Looking Forward. Within these parts, leading international scholars provide historical overviews of the key themes, address the central approaches which have characterized these themes, critically assess the quality of current theory and knowledge, and set out agendas for future theoretical and empirical development. The resulting volume is a unique overview of the inputs and dynamics to shape strategy and management and will be crucial reference for academics and students.
Download or read book Product Lifecycle Management and the Industry of the Future written by José Ríos and published by Springer. This book was released on 2017-12-19 with total page 732 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book constitutes the refereed post-conference proceedings of the 14th IFIP WG 5.1 International Conference on Product Lifecycle Management, PLM 2017, held in Seville, Spain, in July 2017. The 64 revised full papers presented were carefully reviewed and selected from 78 submissions. The papers are organized in the following topical sections: PLM maturity, implementation and adoption; PLM for digital factories; PLM and process simulation; PLM, CAX and knowledge management; PLM and education; BIM; cyber-physical systems; modular design and products; new product development; ontologies, knowledge and data models; and Product, Service, Systems (PSS).
Download or read book Long Life Strategy written by Ronald M. Caplan and published by Springer Nature. This book was released on 2024-02-09 with total page 331 pages. Available in PDF, EPUB and Kindle. Book excerpt: The second edition of Long Life Strategy builds upon the practical tips and knowledge in the first edition by providing readers with an outline to living a longer, healthier, more enjoyable life and late life. The book elaborates on three major areas, which include what you can do to live a long life, what your doctor should be doing to help you achieve this goal, and what society, of which we are all part, should be doing to better accommodate a growing number of older people in the coming decades. Dr. Caplan begins by introducing what it means to live a longer life and explaining the current research on delaying, preventing, and reversing aging in our cells. The next chapters detail how to prevent diseases and conditions commonly associated with aging, including diabetes, cancer, osteoporosis, mental health decline, sexual dysfunction, and heart disease. The author provides instruction for good diet and exercise choices. The concluding chapters provide useful advice for managing a fixed income, becoming a grandparent, dealing with the sickness and loss of a life partner, and how to maintain social relationships into late life. No matter where you are on life’s journey, Long Life Strategy can provide a roadmap to living a longer, healthier, and more fulfilling life.
Download or read book Technology and Strategy written by Richard A. Goodman and published by Oxford University Press. This book was released on 1994-10-06 with total page 302 pages. Available in PDF, EPUB and Kindle. Book excerpt: In today's complex, dynamic competitive landscape, management of technology can mean the difference between success and failure. Managers and researchers alike need effective ways to conceptualize and develop technology strategies. Richard Goodman and Michael Lawless provide tools needed to integrate firms' technology capabilities with their competitive direction. Technology and Strategy presents models that help put technology and its market impacts into perspective. It addresses the broad questions of how technology and markets evolve, how technology can re-order the "rules" of competition, and how it can shift the balance of individual firms' competitive advantage. It also blends topics currently capturing attention in business circles--such as Total Quality Management and the resource-based view of the firm--into a clear view of technology management programs. Technology and Strategy also describes methods to develop specific strategies to cope with challenges facing executives--like evaluating promising, but untried, new technologies. Using actual case studies from the electronics and bio-tech industries, Goodman and Lawless demonstrate the use of new techniques to formulate strategy, including Technology Mapping and the Innovation Audit. Both were created to help executives choose the approach to technology best suited to their firms' particular capabilities. Offering clear, practical guidance through a complex, fast-changing world of competition, this new analysis of technology and strategy is a valuable guide for general managers, R&D and manufacturing managers, strategic planners, and academics.
Download or read book Safety Evaluation in the Development of Medical Devices and Combination Products written by Shayne C. Gad and published by CRC Press. This book was released on 2008-10-20 with total page 314 pages. Available in PDF, EPUB and Kindle. Book excerpt: Capturing the growth of the global medical device market in recent years, this practical new guide is essential for all who are responsible for ensuring safety in the use and manufacture of medical devices. It has been extensively updated to reflect significant advances, incorporating combination products and helpful case examples of current real-l
Download or read book Registries for Evaluating Patient Outcomes written by Agency for Healthcare Research and Quality/AHRQ and published by Government Printing Office. This book was released on 2014-04-01 with total page 385 pages. Available in PDF, EPUB and Kindle. Book excerpt: This User’s Guide is intended to support the design, implementation, analysis, interpretation, and quality evaluation of registries created to increase understanding of patient outcomes. For the purposes of this guide, a patient registry is an organized system that uses observational study methods to collect uniform data (clinical and other) to evaluate specified outcomes for a population defined by a particular disease, condition, or exposure, and that serves one or more predetermined scientific, clinical, or policy purposes. A registry database is a file (or files) derived from the registry. Although registries can serve many purposes, this guide focuses on registries created for one or more of the following purposes: to describe the natural history of disease, to determine clinical effectiveness or cost-effectiveness of health care products and services, to measure or monitor safety and harm, and/or to measure quality of care. Registries are classified according to how their populations are defined. For example, product registries include patients who have been exposed to biopharmaceutical products or medical devices. Health services registries consist of patients who have had a common procedure, clinical encounter, or hospitalization. Disease or condition registries are defined by patients having the same diagnosis, such as cystic fibrosis or heart failure. The User’s Guide was created by researchers affiliated with AHRQ’s Effective Health Care Program, particularly those who participated in AHRQ’s DEcIDE (Developing Evidence to Inform Decisions About Effectiveness) program. Chapters were subject to multiple internal and external independent reviews.
Download or read book Pharmaceutical Lifecycle Management written by Tony Ellery and published by John Wiley & Sons. This book was released on 2012-06-05 with total page 412 pages. Available in PDF, EPUB and Kindle. Book excerpt: A comprehensive guide to optimizing the lifecycle management of pharmaceutical brands The mounting challenges posed by cost containment policies and the prevalence of generic alternatives make optimizing the lifecycle management (LCM) of brand drugs essential for pharmaceutical companies looking to maximize the value of their products. Demonstrating how different measures can be combined to create winning strategies, Pharmaceutical Lifecycle Management: Making the Most of Each and Every Brand explores this increasingly important field to help readers understand what they can—and must—do to get the most out of their brands. Offering a truly immersive introduction to LCM options for pharmaceuticals, the book incorporates numerous real-life case studies that demonstrate successful and failed lifecycle management initiatives, explaining the key takeaway of each example. Filled with practical information on the process of actually writing and presenting an LCM plan, as well as how to link corporate, portfolio, and individual brand strategies, the book also offers a look ahead to predict which LCM strategies will continue to be effective in the future. While the development of new drugs designed to address unmet patient needs remains the single most important goal of any pharmaceutical company, effective LCM is invaluable for getting the greatest possible value from existing brands. Pharmaceutical Lifecycle Management walks you through the process step by step, making it indispensable reading for pharmaceutical executives and managers, as well as anyone working in the fields of drug research, development, and regulation.
Download or read book Excellence in Communicating Organizational Strategy written by Donald P. Cushman and published by State University of New York Press. This book was released on 2001-07-19 with total page 284 pages. Available in PDF, EPUB and Kindle. Book excerpt: Effectively communicating an organization's strategy is at the heart of achieving high performance. Organizational strategy manifests itself in different ways, employing differing tactics at the competitive, crisis, marketing, research and development, manufacturing, training, management, and leadership levels. This book explores each of these processes and provides case studies in the ways in which excellent organizations perform in each of these contexts. The essays focus on the what, when, where, and how aspects of excellence in communicating organizational strategy and explore effective practices in large organizations like Microsoft, medium-sized organizations like E-land, and small firms within the pharmaceutical industry.
Download or read book Federal Register Index written by and published by . This book was released on 2010 with total page 968 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Federal Register written by and published by . This book was released on 2012 with total page 202 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Rare Diseases and Orphan Products written by Institute of Medicine and published by National Academies Press. This book was released on 2011-04-03 with total page 442 pages. Available in PDF, EPUB and Kindle. Book excerpt: Rare diseases collectively affect millions of Americans of all ages, but developing drugs and medical devices to prevent, diagnose, and treat these conditions is challenging. The Institute of Medicine (IOM) recommends implementing an integrated national strategy to promote rare diseases research and product development.
