Design of Electromechanical and Combination Products
Design of Electromechanical and Combination Products

Author: Ali Jamnia

Publisher: CRC Press

Published: 2023-08-31

Total Pages: 461

ISBN-13: 1000930157

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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.

The Combination Products Handbook
The Combination Products Handbook

Author: Susan Neadle

Publisher: CRC Press

Published: 2023-05-16

Total Pages: 439

ISBN-13: 1000874583

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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.

Formulation and Device Lifecycle Management of Biotherapeutics
Formulation and Device Lifecycle Management of Biotherapeutics

Author: Beate Bittner

Publisher: Academic Press

Published: 2022-01-14

Total Pages: 230

ISBN-13: 0128237422

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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

Proceedings of the 6th CIRP-Sponsored International Conference on Digital Enterprise Technology
Proceedings of the 6th CIRP-Sponsored International Conference on Digital Enterprise Technology

Author: George Q. Huang

Publisher: Springer Science & Business Media

Published: 2009-12-12

Total Pages: 1754

ISBN-13: 3642104304

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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.

Applied Human Factors in Medical Device Design
Applied Human Factors in Medical Device Design

Author: Mary Beth Privitera

Publisher: Academic Press

Published: 2019-06-15

Total Pages: 371

ISBN-13: 0128161647

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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

Quality by Design for Biopharmaceutical Drug Product Development
Quality by Design for Biopharmaceutical Drug Product Development

Author: Feroz Jameel

Publisher: Springer

Published: 2015-04-01

Total Pages: 710

ISBN-13: 1493923161

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This volume explores the application of Quality by Design (QbD) to biopharmaceutical drug product development. Twenty-eight comprehensive chapters cover dosage forms, liquid and lyophilized drug products. The introductory chapters of this book define key elements of QbD and examine how these elements are integrated into drug product development. These chapters also discuss lessons learned from the FDA Office of Biotechnology Products pilot program. Following chapters demonstrate how QbD is used for formulation development ranging from screening of formulations to developability assessment to development of lyophilized and liquid formats. The next few chapters study the use of small-scale and surrogate models as well as QbD application to drug product processes such as drug substance freezing and thawing, mixing, sterile filtration, filling, lyophilization, inspection and shipping and handling. Later chapters describe more specialized applications of QbD in the drug product realm. This includes the use of QbD in primary containers, devices and combination product development. The volume also explores QbD applied to vaccine development, automation, mathematical modeling and monitoring, and controlling processes and defining control strategies. It concludes with a discussion on the application of QbD to drug product technology transfer as well as overall regulatory considerations and lifecycle management. Quality by Design for Biopharmaceutical Drug Product Development is an authoritative resource for scientists and researchers interested in expanding their knowledge on QbD principles and uses in creating better drugs.

Sustainability in Manufacturing
Sustainability in Manufacturing

Author: Günther Seliger

Publisher: Springer Science & Business Media

Published: 2007-05-26

Total Pages: 437

ISBN-13: 3540498710

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The challenges of sustainable manufacturing were accepted by several research institutions at the Technical University Berlin and lead to the establishment of the Collaborative Research Center (Sfb) 281 Dissassembly Factories for the Recovery of Resources in Product and Material Cycles funded by the German Research Foundation in 1995. This book details the numerous scientific results that are now available after 12 years of research.

Practical Control Engineering for Mechatronics and Automation
Practical Control Engineering for Mechatronics and Automation

Author: Fernando Martell

Publisher: CRC Press

Published: 2024-06-14

Total Pages: 339

ISBN-13: 1040042996

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Production processes and engineered systems use continuous and discrete variables, as well as the combination of continuous and sequential operations. This volume covers both aspects, thus providing knowledge in continuous and discrete control, logic control, and hybrid control systems. It is a compilation of selected control strategies to automate processes and systems with a practical approach to ease their design, analysis and implementation. The selection of the control schemes is based on the capability to provide desired dynamical response or real time performance. Practicality is required for achieving faster development times of automation projects or system prototypes by comprehensive presentation and direct application of methodologies and techniques for efficient and structured programming of control algorithms. Considered methodologies include model-based design, hardware in the loop simulations and structured programming. Fundamental signals and systems concepts are explained. Systems and controllers are analyzed using discrete-time equations, which ease their implementation in most programmable platforms without requiring sophisticated software. PID based control, internal model control and model reference control are viewed as powerful schemes in terms of performance and suitability for mechatronics systems because of the use of the model in their architecture as a key control element. Finite state machines are presented to solve sequential requirements of direct and supervisory control of many processes and machines. Cyberphysical systems are an industrial technology and an education trend, distinguished by visual and dynamic models or digital twins of the physical systems. The discussed analysis, design and implementation practices are integrated and applied in the context of cyberphysical systems. This book aims to provide multidisciplinary support to engineers and practitioners in the design of control systems, and is a valuable tool for automation teaching and self-learning.

Design of Electromechanical Products
Design of Electromechanical Products

Author: Ali Jamnia

Publisher: CRC Press

Published: 2016-12-08

Total Pages: 0

ISBN-13: 1315352141

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Design, development and life-cycle management of any electromechanical product is a complex task that requires a cross-functional team spanning multiple organizations, including design, manufacturing, and service. Ineffective design techniques, combined with poor communication between various teams, often leads to delays in product launches, with last minute design compromises and changes. The purpose of Design of Electromechanical Products: A Systems Approach is to provide a practical set of guidelines and best practices for driving world-class design, development, and sustainability of electromechanical products. The information provided within this text is applicable across the entire span of product life-cycle management, from initial concept work to the detailed design, analysis, and development stages, and through to product support and end-of-life. It is intended for professional engineers, designers, and technical managers, and provides a gateway to developing a product’s design history file ("DHF") and device aster record ("DMR"). These tools enable design engineers to communicate a product’s design, manufacturability, and service procedures with various cross-functional teams.