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Author: Ali Jamnia
Publisher: CRC Press
ISBN: 1000930157
Category : Technology & Engineering
Languages : en
Pages : 461
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Book Description
The second edition of this work, now with the expanded title of Design of Electromechanical and Combination Products, covers the design and development of electromechanical products, updated throughout to focus not only on an Agile Systems approach but also its application to disposables and consumables. Providing a practical set of guidelines and thorough examination of best practices, this book focuses on cutting-edge research on sustainability of electromechanical and combination products. Key Features Presents the design, development, and life cycle management of electromechanical and combination products Provides a practical set of guidelines and best practices for world-class design Explains the role of costing and pricing in product design Covers Design for X and its role in product life-cycle management Examines the dynamics of cross-functional design and product development teams Develops DHF and DMR as tools and inherent components of configuration management Includes numerous real-world examples of electromechanical and combination product designs This book is intended for scientists, engineers, designers, and technical managers, and provides a gateway to developing a product’s design history file (DHF) and device master record (DMR). These tools enable the design team to communicate a product’s design, manufacturability, and service procedures with various cross-functional teams.
Author: Ali Jamnia
Publisher: CRC Press
ISBN: 1000930203
Category : Technology & Engineering
Languages : en
Pages : 406
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Book Description
The second edition of this work, now with the expanded title of Design of Electromechanical and Combination Products, covers the design and development of electromechanical products, updated throughout to focus not only on an Agile Systems approach but also its application to disposables and consumables. Providing a practical set of guidelines and thorough examination of best practices, this book focuses on cutting-edge research on sustainability of electromechanical and combination products. Key Features Presents the design, development, and life cycle management of electromechanical and combination products Provides a practical set of guidelines and best practices for world-class design Explains the role of costing and pricing in product design Covers Design for X and its role in product life-cycle management Examines the dynamics of cross-functional design and product development teams Develops DHF and DMR as tools and inherent components of configuration management Includes numerous real-world examples of electromechanical and combination product designs This book is intended for scientists, engineers, designers, and technical managers, and provides a gateway to developing a product’s design history file (DHF) and device master record (DMR). These tools enable the design team to communicate a product’s design, manufacturability, and service procedures with various cross-functional teams.
Author: Susan Neadle
Publisher: CRC Press
ISBN: 1000874583
Category : Medical
Languages : en
Pages : 439
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Book Description
Combination products are therapeutic and diagnostic products that combine drugs, devices, and/or biological products. According to the US Food and Drug Administration (FDA), “a combination product is one composed of any combination of a drug and a device; a biological product and a device; a drug and a biological product; or a drug, device and a biological product.” Examples include prefilled syringes, pen injectors, autoinjectors, inhalers, transdermal delivery systems, drug-eluting stents, and kits containing drug administration devices co-packaged with drugs and/or biological products. This handbook provides the most up-to-date information on the development of combination products, from the technology involved to successful delivery to market. The authors present important and up-to-the-minute pre- and post-market reviews of international combination product regulations, guidance, considerations, and best practices. This handbook: Brings clarity of understanding for global combination products guidance and regulations Reviews the current state-of-the-art considerations and best practices spanning the combination product lifecycle, pre-market through post-market Reviews medical product classification and assignment issues faced by global regulatory authorities and industry The editor is a recognized international Combination Products and Medical Device expert with over 35 years of industry experience and has an outstanding team of contributors. Endorsed by AAMI – Association for the Advancement of Medical Instrumentation.
Author: George Q. Huang
Publisher: Springer Science & Business Media
ISBN: 3642104304
Category : Technology & Engineering
Languages : en
Pages : 1754
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Book Description
This Proceedings volume contains articles presented at the CIRP-Sponsored Inter- tional Conference on Digital Enterprise Technology (DET2009) that takes place December 14–16, 2009 in Hong Kong. This is the 6th DET conference in the series and the first to be held in Asia. Professor Paul Maropoulos initiated, hosted and chaired the 1st International DET Conference held in 2002 at the University of D- ham. Since this inaugural first DET conference, DET conference series has been s- cessfully held in 2004 at Seattle, Washington USA, in 2006 at Setubal Portugal, in 2007 at Bath England, and in 2008 at Nantes France. The DET2009 conference continues to bring together International expertise from the academic and industrial fields, pushing forward the boundaries of research kno- edge and best practice in digital enterprise technology for design and manufacturing, and logistics and supply chain management. Over 120 papers from over 10 countries have been accepted for presentation at DET2009 and inclusion in this Proceedings volume after stringent refereeing process. On behalf of the organizing and program committees, the Editors are grateful to the many people who have made DET2009 possible: to the authors and presenters, es- cially the keynote speakers, to those who have diligently reviewed submissions, to members of International Scientific Committee, Organizing Committee and Advisory Committes, and to colleagues for their hard work in sorting out all the arrangements. We would also like to extend our gratitude to DET2009 sponsors, co-organizers, and supporting organizations.
Author: Ronald A. Walsh
Publisher: McGraw Hill Professional
ISBN: 9780071386579
Category : Technology & Engineering
Languages : en
Pages : 1192
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Book Description
A-Z guide to electrical/electronic and mechanical engineering design data. The ultimate sourcebook of electro-mechanical engineering design data is now better than ever, with thoroughly updated material, new discussions of engineering economics and elastomer springs. and a bounty of new drawings. Electro-Mechanical Design Handbook, Third Edition, by Ronald A. Walsh, gives you the know-how you need to develop parts, mechanisms, and assemblies, with thorough explanations of: *Properties, uses, and strength of engineering materials *Machine element design and mechanisms *Basic pneumatics, hydraulics, air handling and heat *Fastener and joining techniques *Layout and fabrication practices, including castings, moldings, extrusions and powder metal technology *Finishes and plating practices *Dimensioning and tolerancing practices *Much, much more!
Author: Beate Bittner
Publisher: Academic Press
ISBN: 0128237422
Category : Medical
Languages : en
Pages : 230
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Book Description
Today, the pressure on healthcare costs and resources is increasing, and especially for biopharmaceuticals that require parenteral administration, the inherent complex and invasive dosing procedure adds to the demand for efficient medical management. In light of the COVID-19 pandemic the value of drug delivery technologies in enabling a flexible care setting is broadly recognized. In such a setting, patients and their caregivers can choose the place of drug administration based on individual preferences and capabilities. This includes not only dosing in the clinic but also supervised at-home dosing and self-administration for eligible patients. Formulation and Device Lifecycle Management of Biotherapeutics: A Guidance for Researchers and Drug Developers covers the various aspects of improving drug delivery of biological medicines with the ultimate goal to reduce dosing complexity associated with parenteral administration and, thus, enhance patient experience and drug administration-related healthcare capacity. The target audience are multidisciplinary researchers and drug developers in the pharmaceutical industry, biotech companies, and academia involved in formulation and device development. This includes pharmacology and medical experts in charge of generating nonclinical and clinical data to support approval of novel dosing regimens, and drug delivery scientists and engineers responsible for technical particulars of product optimizations. Moreover, professionals in market access and commercial functions are expected to benefit from the discussions about the impact of patient and healthcare provider needs and country-specific reimbursement models on realizing a truly convenient and cost and resource efficient drug delivery solution. - Summarizes formulation and device lifecycle management activities that enable customer-centric and sustainable drug delivery for biotherapeutics - Describes the pharmacokinetic-based clinical development pathway for subcutaneous dosing alternatives to established intravenous formulations for monoclonal antibodies - Details established clinical development pathways supporting the approval of automated subcutaneous injection devices and proposes novel concepts - Discusses how to realize home- and self-administration of biotherapeutics in cancer care - Highlights aspects of multidisciplinary formulation and device lifecycle management that can be leveraged across different disease areas and introduces a decision architecture on when and how drug developers should embark into related development activities
Author:
Publisher:
ISBN:
Category : Trademarks
Languages : en
Pages : 1026
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Book Description
Author:
Publisher:
ISBN:
Category : Electronic apparatus and appliances
Languages : en
Pages : 400
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Book Description
Author: Mary Beth Privitera
Publisher: Academic Press
ISBN: 0128161647
Category : Science
Languages : en
Pages : 371
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Book Description
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
Author: Way Kuo
Publisher: John Wiley & Sons
ISBN: 111877342X
Category : Science
Languages : en
Pages : 208
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Book Description
Provides a personal yet scientific comparative study of nuclear energy and a spectrum of other energies from a reliability point of view, as well as outlining guidelines for developing energy policies The Fukushima nuclear accident made people ponder and question nuclear safety again, resulting in national decisions to phase out nuclear power completely. Is this the right decision? Are there better ways to deal with this important issue of the 21st century? Critical Reflections on Nuclear and Renewable Energy examines both the real and unreal potential dangers of nuclear power as well as a range of other energy sources, including coal, oil, gas, and renewable energies like solar, hydro, wind, and wave energy sources. The book analyzes the pros and cons of a spectrum of energies in the wake of the Fukushima nuclear accident in March 2011. It maintains that we should look at nuclear energy from a rational point of view instead of being influenced by emotions or politicians’ arguments. The book also examines policies that concern science and technology, energy resources, environmental protection, and occupational safety, emphasizing the need to deepen the general populace’s understanding of the concept of reliability. Critical Reflections on Nuclear and Renewable Energy provides both perspective and detail on the relative merits and state of the various energies and the real-life cost of new energies. The analysis considers mining, emissions, sustainability, cost implications, and energy security and safety. Through the discussion of the real cost and impact on environment of individual sources, this book provides a valuable insight into prospects for future energy development.
Author: Raghu Garud
Publisher: John Wiley & Sons
ISBN: 1405141948
Category : Business & Economics
Languages : en
Pages : 424
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Book Description
This book brings together seminal articles by leading scholars of technological and organizational systems, exploring the impact of 'modularity'. Modularity refers to an ability to take apart and put together differenct products and networks, or to 'mix and match' components in order to meet different user specifications. This is of key importance today where new systems such as the World Wide Web and many areas of the computer industry depend on it. The volume pulls together and defines an exciting new area of inquiry: into how our 'modular age' is reshaping the business eco-system. Includes contributions from leading scholars of technology and organization Modularity refers to an ability to take apart and put together different products and systems, or to 'mix and match' components in order to meet different user specifications. Consolidates and defines an area of inquiry that is becoming increasingly important with the development of web-based and 'network' industries. Sensitizes readers to the complexity of issues surrounding new modular products and systems created by e-business Encourages readers to make connections among different levels and disciplines. Initiates a debate around issues of modularity. Includes a commentary co-authored by the late Nobel Laureate Herbert A. Simon to whom the book is dedicated.
