Medical Device Cybersecurity for Engineers and Manufacturers


Book Description

Cybersecurity for medical devices is no longer optional. We must not allow sensationalism or headlines to drive the discussion… Nevertheless, we must proceed with urgency. In the end, this is about preventing patient harm and preserving patient trust. A comprehensive guide to medical device secure lifecycle management, this is a book for engineers, managers, and regulatory specialists. Readers gain insight into the security aspects of every phase of the product lifecycle, including concept, design, implementation, supply chain, manufacturing, postmarket surveillance, maintenance, updates, and end of life. Learn how to mitigate or completely avoid common cybersecurity vulnerabilities introduced during development and production. Grow your awareness of cybersecurity development topics ranging from high-level concepts to practical solutions and tools. Get insight into emerging regulatory and customer expectations. Uncover how to minimize schedule impacts and accelerate time-to-market while still accomplishing the main goal: reducing patient and business exposure to cybersecurity risks. Medical Device Cybersecurity for Engineers and Manufacturers is designed to help all stakeholders lead the charge to a better medical device security posture and improve the resilience of our medical device ecosystem.




Product Lifecycle Management (Volume 4): The Case Studies


Book Description

This book presents some twenty case studies, showing how companies in different industry sectors and of different sizes make advances in Product Lifecycle Management (PLM). Like the author’s previous volumes, this book provides a valuable resource for those wishing to learn about PLM and how to implement and apply it in their companies. Helping readers to · learn about implementing and benefiting from PLM; · learn about good PLM solutions and best practice; · improve their planning and decision-making abilities; · benefit from the lessons learned by the companies featured in the case studies; · proceed faster and further with PLM the book presents effective PLM solutions and best practices. At the same time, the case studies included demonstrate how different companies implement and benefit from PLM. Each case study is addressed in a separate chapter and details a different situation, enabling readers to put themselves in the situation and think through different actions and decisions. A valuable resource for PLM team managers and employees in engineering and manufacturing companies, the book is also of interest to researchers and students in industrial engineering fields.




Product Lifecycle Management for Society


Book Description

This book constitutes the refereed proceedings of the 10th IFIP WG 5.1 International Conference on Product Lifecycle Management, PLM 2013, held in Nantes, France, in July 2013. The 63 full papers presented together with 2 keynote talks were carefully reviewed and selected from 91 submissions. They are organized in the following topical sections: PLM for sustainability, traceability and performance; PLM infrastructure and implementation processes; capture and reuse of product and process information; PLM and knowledge management; enterprise system integration; PLM and influence of/from social networks; PLM maturity and improvement concepts; PLM and collaborative product development; PLM virtual and simulation environments; and building information modeling.




Project Portfolios in Dynamic Environments


Book Description

Project Portfolios in Dynamic Environments: Organizing for Uncertainty is a comprehensive report of research that addresses this important, rising issue. Authors Yvan Petit and Brian Hobbs present the results of their investigation in a report that significantly advances the theory and also offers tips for practice. Currently, those applying project portfolio management tend to focus on the selection, prioritization, and strategic alignment of projects. Little attention is afforded the potential disturbances to project portfolios such as new projects, terminated projects, delayed projects, incorrect planning due to high uncertainty, and changes in the external environment. Yet, these factors can have highly disruptive, even show-stopping influence. This research seeks to answer: How is uncertainty affecting project portfolios managed in dynamic environments?




Product Lifecycle Management. PLM in Transition Times: The Place of Humans and Transformative Technologies


Book Description

This book constitutes the refereed proceedings of the 19th IFIP WG 5.1 International Conference, PLM 2022, Grenoble, France, July 10–13, 2022, Revised Selected Papers. The 67 full papers included in this book were carefully reviewed and selected from 94 submissions. They were organized in topical sections as follows: Organisation: Knowledge Management, Business Models, Sustainability, End-to-End PLM, Modelling tools: Model-Based Systems Engineering, Geometric modelling, Maturity models, Digital Chain Process, Transversal Tools: Artificial Intelligence, Advanced Visualization and Interaction, Machine learning, Product development: Design Methods, Building Design, Smart Products, New Product Development, Manufacturing: Sustainable Manufacturing, Lean Manufacturing, Models for Manufacturing.




Formulation and Device Lifecycle Management of Biotherapeutics


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




Product Lifecycle Management (PLM)


Book Description

As featured on CNN, Forbes and Inc – BookAuthority identifies and rates the best books in the world, based on recommendations by the world's most successful business leaders and experts. Winning the spot of #19 out of 26 on the 2020 Bookauthority Best New Industrial Management Books of All Time. Winning the spot of #3 out of 8 on the 2021 Bookauthority Best New Industrial Management Books to Read in 2021. Winning the spot of #5 out of 11 on the 2021 Bookauthority Best New Product Design Books to Read in 2021. 2020 Taylor & Francis Award Winner for Outstanding Professional Book! Product Lifecycle Management (PLM): A Digital Journey Using Industrial Internet of Things (IIot) provides a summary of the essential topics of Product Lifecycle Management (PLM) and the Industrial Internet of Things (IIoT) in the era of Industry 4.0. The book discusses emerging technologies, their contribution towards enhancing product design, development, and manufacturing. It also presents the integration of PLM, Enterprise Resource Planning (ERP), and Manufacturing Execution System (MES) along with IIoT as well the integration of mechanical, electronic components, embedded systems, firmware and software focusing on smart design, development, and manufacturing in the digital transformation journey. The book provides a high-level overview of how the smart product development through smart manufacturing materializes within the smart ecosystem. Manufacturing professionals, designers, mechanical, electrical, electronics, instrumentation and industrial engineers, information and communication technology consultants and those working in production planning, process control, and operations will find this book invaluable.




Product Lifecycle Management and the Industry of the Future


Book Description

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).




Public Health Effectiveness of the FDA 510(k) Clearance Process


Book Description

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.




Product Lifecycle Management. Green and Blue Technologies to Support Smart and Sustainable Organizations


Book Description

The two-volume set IFIP AICT 639 and 640 constitutes the refereed post-conference proceedings of the 18th IFIP WG 5.1 International Conference on Product Lifecycle Management, PLM 2021, held in Curitiba, Brazil, during July 11-14, 2021. The conference was held virtually due to the COVID-19 crisis. The 107 revised full papers presented in these proceedings were carefully reviewed and selected from 133 submissions. The papers are organized in the following topical sections: Volume I: Sustainability, sustainable development and circular economy; sustainability and information technologies and services; green and blue technologies; AI and blockchain integration with enterprise applications; PLM maturity, PLM implementation and adoption within industry 4.0; and industry 4.0 and emerging technologies: Volume II: Design, education and management; lean, design and innovation technologies; information technology models and design; and models, manufacturing and information technologies and services.