Challenged by stringent regulations, vigorous competition, and liability lawsuits, medical device manufactures must develop safe, reliable, and cost-effective products, and managing and reducing risk is a vital element of reaching that goal. These guidelines focus on Failure Modes and Effects Analysis (FMEA) and its application throughout the life cycle of a medical device. It outlines the major U.S. and E.U. standards and regulations and provides a detailed yet easy-to-read overview of risk management and risk analysis methodologies, common FMEA pitfalls, and FMECA-Failure Mode, Effects, and Criticality Analysis.

Guidelines for Failure Modes and Effects Analysis for Medical Devices is written as a practical guide to achieving corporate consistency while dramatically cutting the time required for studies. It will help you prevent patient injuries, costly product recalls, and production department down-time.

Discover how the FMEA methodology can help your company achieve a more cost-effective manufacturing process by improving the quality and reliability of your products. This new FMEA manual from the experts at Dyadem is the ultimate resource for you and your colleagues to learn more about Failure Modes and Effects Analysis and then teach others at your facility. This comprehensive manual is sure to become a standard reference for engineering professionals.

Micro and Nano Systems for Biophysical Studies of Cells and Small Organisms provides a comprehensive introduction to the state-of-the-art micro and nano systems that have recently been developed and applied to biophysical studies of cells and small organisms. These micro and nano systems span from microelectromechanical systems (MEMS) and microfluidic devices to robotic micro-nanomanipulation systems. These biophysical studies range from cell mechanics to the neural science of worms and Drosophila. This book will help readers understand the fundamentals surrounding the development of these tools and teach them the most recent advances in cellular and organismal biophysics enabled by these technologies.

Japan is an example of what is known as a "latecomer" in industrial development. Drawing on case studies of computer and telecommunications and related firms, Donna Doane investigates how intra- and inter-industry cooperation between public and private enterprises pushed rapid technological advancement in Japan. The book places such interlinkage in the context of a historical evolution, starting with prewar industrial house groupings that helped link indigenous and external ideas and form an integrated technological base.Doane focuses mainly on the postwar, catch-up period from the 1960s through the 1980s in which three characteristics associated with late development are examined: multistructured industry, family-based industrial networks, and a distinct government-industry relationship. Implications of the cooperative structure are drawn for other advanced industrial as well as developing countries, where flexible technological networks could help individual enterprises overcome the limitations of isolated organization to survive rapid economic changes.

Over the last two decades one of the great global emerging technological trends has been the shift from chemistry to biology in agriculture. Bitterly contested and enduringly controversial, the shift to biotechnology has nevertheless led to greater sustainability and promises even greater gains in years to come. This Handbook is an invaluable compendium of detailed case study and insight.' - Mark Lynas, Cornell University, US'This important volume analyses the current state of crop biotechnology development and regulation. It establishes a firm basis for understanding the current level of deployment of crops modified by biotechnology and also the uneven and often unscientific bases that have been used to judge their merits for particular regions. This book is an indispensable reference for anyone concerned with the development of this vital area of agriculture.' - Peter H. Raven, Missouri Botanical Garden, US 'With interest in biotechnology surging, this book is a must-read for anyone who wants to learn more about the potential that advancements in modern agriculture have to offer, how they've already changed agriculture around the world and what s coming down the pipeline. Agriculture is about economics, the environment and feeding the world; so too, at the heart of it, is biotechnology, as this book so clearly demonstrates. The authors have years of experience with biotechnology and their expertise shines through on each page.' - Lorne Hepworth, CropLife Canada This book is a compendium of knowledge, experience and insight on agriculture, biotechnology and development. Beginning with an account of GM crop adoptions and attitudes towards them, the book assesses numerous crucial processes, concluding with detailed insights into GM products. Drawing on expert perspectives of leading authors from 57 different institutions in 16 countries, it provides a unique, global overview of agbiotech following 20 years of adoption. Many consider GM crops the most rapid agricultural innovation adopted in the history of agriculture. This book provides insights as to why the adoption has occurred globally at such a rapid rate. This is a rich and varied collection of research, which will appeal to scholars, academics and practitioners worldwide. An invaluable resource, this book will be a first point of reference to anyone with an interest in agbiotech and studies into agriculture, biotechnology and development. Contributors: A.A. Adenle, P. Aerni, C. Alexander, J.M. Alston, V. Beckmann, J. Bognar, C.G. Borroto, D. Brewin, G. Brookes, J. Carpenter, Y. Carriere, D. Castle, M. Chen, P. Conceicao, B. Dayananda, M. Demont, K. Dillen, D. Eaton, E. Einsiedel, J. Falck-Zepeda, J. Fernandez-Cornejo, G.B. Frisvold, C.V. Gonslaves, D. Gonsalves, M. Gouse, G. Graff, R. Gray, A. Gupta, W.O. Hennessey, J.E. Hobbs, W.E. Huffman, L. A. Jackson, C. Juma, N. Kalaitzandonakes, S. Kaplan, V.J. Karplus, W.A. Kerr, G.G. Khachatourians, E.M. Kikulwe, E. Kim, D.E. Kolady, S.P. Kowalski, J. Kruse, L. Levidow, S. Levine, K. Ludlow, X. Ma, A. Magnier, S. Malla, I. Matuschke, J.J. McCluskey, A. McHughen, J. Medlock, D. Miller, L. Nagarajan, A. Naseem, C. Oguamanam, M. Ouattarra, M. Owen, R. Paarlberg, P. W. B. Phillips, M. Qaim, T. Raney, J.M. Reeves, S.D. Rhodes, S.M.H. Rizvi, C.D. Ryan, D. Schimmelpfennig, G.J. Scoles, G. Skogstad, S. J. Smyth, C. Soregaroli, D.J. Spielman, A.J. Stein, J. Thomson, J. Vitale, G. Vognan, G. Waterfield, S. Wechsler, J. Wesseler, A. Williams, W.W. Wilson, L.L. Wolfenbarger, G. Ye, J. Yorobe Jr, D.Z. Zeng, D. Zilberman

Master the design and operation of perfusion cell cultures with this authoritative reference. Discover the current state-of-the-art in the design and operation of continuous bioreactors, with emphasis on mammalian cell cultures for producing therapeutic proteins. Topics include the current market for recombinant therapeutic proteins, current industry challenges and the potential contribution of continuous manufacturing. Provides coverage of every step of process development and reactor operation, including small scale screening to lab-scale and scale-up to manufacturing scale. Illustrated through real-life case studies, this is a perfect resource for groups active in the cell culture field, as well as graduate students in areas such as chemical engineering, biotechnology, chemistry and biology, and to those in the pharmaceutical industry, particularly biopharma, biotechnology and food or agro industry.

In 1896 a young Italian arrived in England with some mysterious scientific apparatus as part of his personal luggage. The Customs officials, who had seen nothing like it before, examined it so thoroughly that the delicate apparatus was completely wrecked. This was the inauspicious beginning of a venture that was destined to remould the pattern of twentieth century living. The book begins with a brief resume of early scientific discoveries up to 1896 and goes on to record the fortunes of the Marconi company. In the course of the book the author covers in detail the story of radio communications from the first wireless signals across the Atlantic to the transmission of colour television programmes via satellite. The narrative includes the development of electronic devices during two world wars and the histories of such specialist fields as sound broadcasting, television, aviation electronics and radar. The technical stories are told against the backcloth of a Company's successes and setbacks and commercial "wars". A lively reading, which can be readily understood by the lay reader. For the technical man, circuit diagrams of early apparatus give added interest. The text is generously illustrated with photographs from the Marconi archives.

The U.S. laser industry is a major player in the country's economy, with its products used in factories, laboratories, offices, homes and motor vehicles around the country. The issues addressed by the laser industry during the past several decades - patent litigation, worker education, export controls, international standardization, and others - are those that any emerging high-tech industry will have to face. Offering a roadmap for future technology development and commercialization, this book chronicles the laser and electro-optics industry and its issues for business executives, scientists and technicians, attorneys, journalists, historians, and others.

Digital Innovation for Healthcare in COVID-19 Pandemic: Strategies and Solutions provides comprehensive knowledge and insights on the application of information technologies in the healthcare sector, sharing experiences from leading researchers and academics from around the world. The book presents innovative ideas, solutions and examples to deal with one of the major challenges of the world, a global problem with health, economic and political dimensions. Advanced information technologies can play a key role in solving problems generated by the COVID-19 outbreak. The book addresses how science, technology and innovation can provide advances and solutions to new global health challenges. This is a valuable resource for researchers, clinicians, healthcare workers, policymakers and members of the biomedical field who are interested in learning how digital technologies can help us avoid and solve global disease dissemination.

Rapid advances in the life sciences means that there is now a far more detailed understanding of biological systems on the cellular, molecular and genetic levels. Sited at the intersection between the life sciences, the engineering sciences and the design sciences, innovations in the biomaterials industry are expected to garner increasing attention and play a key role in future development. This book examines the biomaterials innovations taking place in corporations and in academic research settings today.Biomaterials Innovation offers a comprehensive overview of life science innovation and presents empirical research in the field of biomaterials innovation. Alexander Styhre examines innovation management practices in the field of biomaterials development and explains institutional changes in the biomaterials industry. The demand for accomplishing biocompatibility between the human body and the materials developed is highlighted, as is the relationship between financial markets and biomaterials companies. Finally, the author discusses the therapeutic, regulatory and managerial implications of biomaterials innovation. Biomaterials Innovation will be required reading for any researcher, policy-maker or student interested in innovation management, the life sciences and the development of health care therapies. Contents: 1. Life and Materiality, Nature and Artifice: Transgressing the Divide 2. Bios, Materiality, and Biomateriality 3. Innovation Management and Innovation in the Life Sciences 4. Shifting Institutional Logics in Biomaterial Companies 5. The Epistemology of Biomaterials: How Biomaterials Become Embodied 6. Financing Biomaterials Innovation: Selling Science in Venture Capital Markets 7. Biomaterials Innovation: Re-creating the Human Body Appendix: Methodology of the Studies Bibliography Index

Ever since Schumpeter's groundbreaking work there has been a plethora of new research seeking to extend the direction and dynamics of innovation. Using a rich account of detailed interviews, this book offers new evidence on how latecomers have successfully caught up and leapfrogged incumbent firms. Catching Up and Leapfrogging: the new latecomers in the integrated circuits industry explores how technological transitions affect latecomer catch-up strategies, and vice versa, in a high technology industry. It looks to the East Asian latecomers who, towards the end of the twentieth century, pioneered a new pathway through organizational change by specializing in the key production stages of integrated circuits and pushing technologies further. This volume assesses how latecomer resource acquisition strategies have varied alongside structural industry changes and evaluates the mechanisms through which firms started life as technology followers and rose to become technology leaders. Xiao-Shan Yap and Rajah Rasiah present a unique story about how firm strategies evolve from the catching up phase to the leapfrogging phase, captured from the accounts of managers on the ground. It is the first time firm-level strategies have been systematically analysed to describe twenty-first century strategic management in the integrated circuits industry in particular, and the high tech industry in general. The evidence and analysis in this book offers insights for chief executive officers, policy-makers and researchers to revisit existing approaches to the theory of catching up and leapfrogging.

Scientists in the biotechnology sector have developed a vast array of products and procedures, including drugs, diagnostics, agricultural products and veterinary procedures. This is made possible through various intra- and inter-organizational collaborations between the academic and private sectors, and through the establishment of networks for learning. In Networks for Learning and Knowledge Creation in Biotechnology, Amalya Lumerman Oliver shows how, in many respects, the organizational structure of the industry parallels one of its most important innovations - recombinant DNA (rDNA). She shows how the concept of recombination can be used to explain a number of organizational elements, including biotechnology firms, the form of university-based spin-offs, scientific entrepreneurship, and trust and contracts in learning collaborations and networks. The result is a stimulating account of how multiple theoretical perspectives can be used to understand the structure of the biotechnology industry.

Masters of Doom is the true inside story of the Lennon and McCartney of the video game industry: John Carmack and John Romero. Together they created an empire, ruled a multibillion-dollar industry, and provoked a national controversy. They lived a unique American dream, escaping their broken homes to co-create the most innovative and notoriously successful video games in history - Doom and Quake - until the games they made tore them apart. David Kushner has been covering the video game industry for ten years and knows all the angles. Even those with no interest in video games will be fascinated by this vastly entertaining tale of friendship, betrayal and the genesis of a multibillion-dollar popular art form.

This is a full-length history of the Western Electric Company, which was the manufacturing arm of the Bell System. As manufacturer in the communications revolutions in the nineteenth and twentieth centuries, Western Electric made products that accelerated society's pace, such as telegraphs, telephones, an early computing machine, radios, radar and transistors. Western's history offers numerous examples of the difference between innovation and implementation. The aftermath of Western's 1882 acquisition by Bell Telephone, for instance, reveals vertical integration as a lengthy process rather than a single event. Ironically, although Western transformed business worldwide with innovations in areas such as quality control and industrial psychology, the company was slow to implement these innovations itself. Western's dual role as captive supplier for a regulated monopoly and as government contractor led to its most rapid change, in the area of civil rights.

At present, human society is facing a health care crisis that is affecting patients worldwide. In the United States, it is generally believed that the major problem is lack of affordable access to health care (i.e. health insurance). This book takes an unprecedented approach to address this issue by proposing that the major problem is not lack of affordable access to health care per se, but lack of access to better, safer, and more affordable medicines. The latter problem is present not only in the United States and the developing world but also in countries with socialized health care systems, such as Europe and the rest of the industrialized world. This book provides a comparative analysis of the health care systems throughout the world and also examines the biotechnology and pharmaceutical industries.

Examines the health care structure of the United States, Europe, and the third world, both separately and comparativelyOffers primary source insight through in-depth interviews with pharmaceutical and health care industry leaders from around the worldCarefully explains, in clear terms, the intricacies of the health care and pharmaceutical system and how these intricacies have led to the current crisisOffers concrete, comprehensive solutions to the health care crisis

Novel AI and Data Science Advancements for Sustainability in the Era of COVID-19 discusses how the role of recent technologies applied to health settings can help fight virus outbreaks. Moreover, it provides guidelines on how governments and institutions should prepare and quickly respond to drastic situations using technology to support their communities in order to maintain life and functional as efficiently as possible. The book discusses topics such as AI-driven histopathology analysis for COVID-19 diagnosis, bioinformatics for subtype rational drug design, deep learning-based treatment evaluation and outcome prediction, sensor informatics for monitoring infected patients, and machine learning for tracking and prediction models. In addition, the book presents AI solutions for hospital management during an epidemic or pandemic, along with real-world solutions and case studies of successful measures to support different types of communities. This is a valuable source for medical informaticians, bioinformaticians, clinicians and other healthcare workers and researchers who are interested in learning more on how recently developed technologies can help us fight and minimize the effects of global pandemics.

The COVID-19 pandemic has affected the entire world in an unprecedented way since 2019. However, novel and innovative applications of various omics, computational, and smart technologies have helped manage the pandemic of the 21st century in a very effective manner. Omics approaches and technologies in COVID-19 presents up-to-date knowledge on omics, genetic engineering, mathematical and computational approaches, and advanced technologies in the diagnosis, prevention, monitoring, and management of COVID-19. This book contains 26 chapters written by academic and industry experts from more than 15 countries. Split into three sections (Omics; Artificial Intelligence and Bioinformatics; and Smart and Emerging Technologies), it brings an overview of novel technologies under omics such as, genomic, metagenomic, pangenomic, metabolomics and proteomics in COVID-19. In addition, it discusses hostpathogen interactions and interactomics, management options, application of genetic engineering, mathematical modeling and simulations, systems biology, and bioinformatics approaches in COVID-19 drug discovery and vaccine development. This is a valuable resource for students, biotechnologists, bioinformaticians, virologists, clinicians, and pharmaceutical, biomedical, and healthcare industry people who want to understand the promising omics and other technologies used in combating COVID-19 from various aspects.

Manufacturing the Future: A History of Western Electric is the first full-length history of the Western Electric Company, the manufacturing arm of the Bell System. As a manufacturer in the communications revolutions in the nineteenth and twentieth centuries, Western Electric made new products such as telegraphs, telephones, an early computing machine, radios, radar, and transistors. The book demonstrates, through Western's 1882 acquisition by Bell Telephone, that vertical integration was a lengthy process rather than a single event. It also shows the coming of age of industrial psychology and describes the advent of civil rights in corporate America.

The life sciences is an industrial sector that covers the development of biological products and the use of biological processes in the production of goods, services and energy. This sector is frequently presented as a major opportunity for policy-makers to upgrade and renew regional economies, leading to social and economic development through support for high-tech innovation. Innovation, Regional Development and the Life Sciences analyses where innovation happens in the life sciences, why it happens in those places, and what this means for regional development policies and strategies. Focusing on the UK and Europe, its arguments are relevant to a variety of countries and regions pursuing high-tech innovation and development policies. The book's theoretical approach incorporates diverse geographies (e.g. global, national and regional) and political-economic forces (e.g. discourses, governance and finance) in order to understand where innovation happens in the life sciences, where and how value circulates in the life sciences, and who captures the value produced in life sciences innovation. This book will be of interest to researchers, students and policy-makers dealing with regional/local economic development.

This book is essential reading for electronic consumer-product manufacturers doing business in the European marketplace. Compliance with directives and procedures can be a complex and confusing process, resulting in wasted money and effort. With the help of the CE Marking Handbook, engineers and managers can more easily identify which rules apply to them and pinpoint what they need to do to comply. Dave Lohbeck was formerly the Manager for Seminars and Training at TUV Rhineland, the largest German testing and certification agency. He has worked for many years as an engineer, including nine years in the field of European safety and EMC compliance.
A once complicated topic is made clear as the author addresses the confusion surrounding CE Marking. Lohbeck offers guidance on both legal and design issues. This book includes a step-by-step design guide aimed at both novice and experienced exporters. With its help, engineers and managers can easily identify which rules apply to their products and pinpoint what they need to do to comply. The information presented here is backed up with facts and examples. Many have been misled, unfortunately, but this book presents the real meaning of CE Marking.
Shows design engineers how to comply with CE requirements for product conformity
Explains legal and technical issues concisely and logically
Presents and illuminates US and EU differences

Biomedical Innovations to Combat COVID-19 provides an updated overview on the development of vaccines, antiviral drugs and nanomaterials, and diagnostic methods for the fight against COVID-19. Perspectives on such technologies are identified, discussed, and enriched with figures for easy understanding and applicability. Furthermore, it contains basic aspects of virology, immunology, and antiviral drugs that are needed to fully appreciate these innovations. This book is split into four sections: introduction, presenting basic virologic and epidemiological aspects of COVID-19; vaccines against COVID-19, discussing their different types and applications used to develop them; diagnostic approaches for SARS-CoV-2, encompassing advanced sensing and microfluidic-based biosensors; and drug development and delivery, where antivirals based on nanomaterials or drugs are presented. It is a valuable source for virologists, biotechnologists, and members of biomedical field interested in learning more about how novel technologies can be applied to fasten the eradication of the COVID-19 and similar pandemics.

Bioinformatics for Everyone provides a brief overview on currently used technologies in the field of bioinformatics-interpreted as the application of information science to biology- including various online and offline bioinformatics tools and softwares. The book presents valuable knowledge in a simplified way to help students and researchers easily apply bioinformatics tools and approaches to their research and lab routines. Several protocols and case studies that can be reproduced by readers to suit their needs are also included.

Ever since Schumpeter's groundbreaking work there has been a plethora of new research seeking to extend the direction and dynamics of innovation. Using a rich account of detailed interviews, this book offers new evidence on how latecomers have successfully caught up and leapfrogged incumbent firms. Catching Up and Leapfrogging: the new latecomers in the integrated circuits industry explores how technological transitions affect latecomer catch-up strategies, and vice versa, in a high technology industry. It looks to the East Asian latecomers who, towards the end of the twentieth century, pioneered a new pathway through organizational change by specializing in the key production stages of integrated circuits and pushing technologies further. This volume assesses how latecomer resource acquisition strategies have varied alongside structural industry changes and evaluates the mechanisms through which firms started life as technology followers and rose to become technology leaders. Xiao-Shan Yap and Rajah Rasiah present a unique story about how firm strategies evolve from the catching up phase to the leapfrogging phase, captured from the accounts of managers on the ground. It is the first time firm-level strategies have been systematically analysed to describe twenty-first century strategic management in the integrated circuits industry in particular, and the high tech industry in general. The evidence and analysis in this book offers insights for chief executive officers, policy-makers and researchers to revisit existing approaches to the theory of catching up and leapfrogging.

This book traces how abstract managerial ideas about maximizing production flexibility and employee freedom were translated into concrete, day-to-day practices at the Motorola plant in East Kilbride, UK. Using eyewitness accounts, the book describes how employees dealt with the increased freedom Motorola promoted amongst its employees, how employees adapted to managerial changes, specifically the elimination of large-scale management, and where the 'managerless' system came under strain. This book will be of essential reading for researchers, graduate students, and undergraduates interested in the areas of management studies, human resource management, and organizational studies, among others.

In the fall of 1980, Genentech, Inc., a little-known California genetic engineering company, became the overnight darling of Wall Street, raising over $38 million in its initial public stock offering. Lacking marketed products or substantial profit, the firm nonetheless saw its share price escalate from $35 to $89 in the first few minutes of trading, at that point the largest gain in stock market history. Coming at a time of economic recession and declining technological competitiveness in the United States, the event provoked banner headlines and ignited a period of speculative frenzy over biotechnology as a revolutionary means for creating new and better kinds of pharmaceuticals, untold profit, and a possible solution to national economic malaise. Drawing from an unparalleled collection of interviews with early biotech players, Sally Smith Hughes offers the first book-length history of this pioneering company, depicting Genentech's improbable creation, precarious youth, and ascent to immense prosperity. Hughes provides intimate portraits of the people significant to Genentech's science and business, including cofounders Herbert Boyer and Robert Swanson, and in doing so sheds new light on how personality affects the growth of science. By placing Genentech's founders, followers, opponents, victims, and beneficiaries in context, Hughes also demonstrates how science interacts with commercial and legal interests and university research, and with government regulation, venture capital, and commercial profits. Integrating the scientific, the corporate, the contextual, and the personal, "Genentech" tells the story of biotechnology as it is not often told, as a risky and improbable entrepreneurial venture that had to overcome a number of powerful forces working against it.

The life sciences is an industrial sector that covers the development of biological products and the use of biological processes in the production of goods, services and energy. This sector is frequently presented as a major opportunity for policy-makers to upgrade and renew regional economies, leading to social and economic development through support for high-tech innovation. Innovation, Regional Development and the Life Sciences analyses where innovation happens in the life sciences, why it happens in those places, and what this means for regional development policies and strategies. Focusing on the UK and Europe, its arguments are relevant to a variety of countries and regions pursuing high-tech innovation and development policies. The book's theoretical approach incorporates diverse geographies (e.g. global, national and regional) and political-economic forces (e.g. discourses, governance and finance) in order to understand where innovation happens in the life sciences, where and how value circulates in the life sciences, and who captures the value produced in life sciences innovation. This book will be of interest to researchers, students and policy-makers dealing with regional/local economic development.