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.

The cybersecurity of connected medical devices is one of the biggest challenges facing healthcare today. The compromise of a medical device can result in severe consequences for both patient health and patient data. Cybersecurity for Connected Medical Devices covers all aspects of medical device cybersecurity, with a focus on cybersecurity capability development and maintenance, system and software threat modeling, secure design of medical devices, vulnerability management, and integrating cybersecurity design aspects into a medical device manufacturer's Quality Management Systems (QMS). This book is geared towards engineers interested in the medical device cybersecurity space, regulatory, quality, and human resources specialists, and organizational leaders interested in building a medical device cybersecurity program. Lays out clear guidelines for how to build a medical device cybersecurity program through the development of capabilities Discusses different regulatory requirements of cybersecurity and how to incorporate them into a Quality Management System Provides a candidate method for system and software threat modelling Provides an overview of cybersecurity risk management for medical devices Presents technical cybersecurity controls for secure design of medical devices Provides an overview of cybersecurity verification and validation for medical devices Presents an approach to logically structure cybersecurity regulatory submissions

Diabetes Digital Health and Telehealth explains, from technologic, economic and sociologic standpoints how digital health and telehealth have come to dominate the management of diabetes. The book also includes information on improved telemedicine tools and platforms for communicating with patients, reviewing medical records, and interpreting data from wearable devices. In addition, evolving wearable sensors such as continuous glucose monitors, closed loop automated insulin delivery systems, cuffless blood pressure monitors, exercise monitors and smart insulin pens are covered. - Covers advances in the fields of digital health and telehealth, including research methods, relevant types of evidence, and viable endpoints for assessing the clinical and economic benefits of digital health and telehealth for diabetes - Discusses improved telemedicine tools and platforms for communicating with patients, reviewing medical records and interpreting data from wearable devices - Analyzes information gaps, research methods, relevant types of evidence, and viable endpoints for assessing the clinical and economic benefits of digital health and telehealth for diabetes

A concise and accessible overview of the design, implementation and management of medical software.

Clinical Engineering Handbook, Second Edition, covers modern clinical engineering topics, giving experienced professionals the necessary skills and knowledge for this fast-evolving field. Featuring insights from leading international experts, this book presents traditional practices, such as healthcare technology management, medical device service, and technology application. In addition, readers will find valuable information on the newest research and groundbreaking developments in clinical engineering, such as health technology assessment, disaster preparedness, decision support systems, mobile medicine, and prospects and guidelines on the future of clinical engineering.As the biomedical engineering field expands throughout the world, clinical engineers play an increasingly important role as translators between the medical, engineering and business professions. In addition, they influence procedures and policies at research facilities, universities, and in private and government agencies. This book explores their current and continuing reach and its importance. - Presents a definitive, comprehensive, and up-to-date resource on clinical engineering - Written by worldwide experts with ties to IFMBE, IUPESM, Global CE Advisory Board, IEEE, ACCE, and more - Includes coverage of new topics, such as Health Technology Assessment (HTA), Decision Support Systems (DSS), Mobile Apps, Success Stories in Clinical Engineering, and Human Factors Engineering

Careers in Biomedical Engineering offers readers a comprehensive overview of new career opportunities in the field of biomedical engineering. The book begins with a discussion of the extensive changes which the biomedical engineering profession has undergone in the last 10 years. Subsequent sections explore educational, training and certification options for a range of subspecialty areas and diverse workplace settings. As research organizations are looking to biomedical engineers to provide project-based assistance on new medical devices and/or help on how to comply with FDA guidelines and best practices, this book will be useful for undergraduate and graduate biomedical students, practitioners, academic institutions, and placement services.

This volume presents papers on the topics covered at the National Academy of Engineering's 2015 US Frontiers of Engineering Symposium. Every year the symposium brings together 100 outstanding young leaders in engineering to share their cutting-edge research and innovations in selected areas. The 2015 symposium was held September 9-11 at the Arnold and Mabel Beckman center in Irvine, California. The intent of this book is to highlight innovative developments in engineering research and technical work.

With the development of advanced screening procedures and techniques, certain limitations of the existing screening processes for disease methodologies and paradigms have been noted. More accurate and less invasive screening methods are needed to diagnose and treat health disorders and diseases before symptoms appear. Pre-Screening Systems for Early Disease Prediction, Detection, and Prevention is a pivotal reference source that utilizes advanced ICT techniques to solve problems in health data collection, analysis, and interpretation, as well as improve existing health systems for the advanced screening of diseases. Using non-invasive biomedical sensor devices and internet of things technology, this book examines safer methods to accelerate disease detection and effectively treat patients while challenging previously used pre-screening processes. While highlighting topics such as the applications of machine learning, patient safety, diagnostics models, and condition management, this publication is ideally designed for healthcare specialists, researchers in health informatics, industry practitioners, and academics.

Commercializing a knowledge-based product or service requires a realistic, methodical approach combined with a great deal of perseverance. Commercialization Secrets for Scientists and Engineers serves as a high-level guide to answering key questions and critical issues that confront founding entrepreneurs on their quest to commercialize their knowledge-based innovations. It highlights the unique problems shared by all technologists across knowledge-intensive fields and how to overcome the most predictable obstacles faced by technology entrepreneurs. It demystifies the process of commercializing advanced products that require a high degree of specialized knowledge. Typically, these are "disruptive technologies" with the potential to revolutionize whole industries. The book simplifies the launch of high-tech ventures such as pharmaceuticals, genetic and biotechnology products, wireless devices, fuel cells, and minimally invasive medical devices. Additionally, it will help readers bring their disruptive technologies to profitability.

This third edition provides a substantial comprehensive review of the latest design control requirements, as well as proven tools and techniques to ensure a company's design control program evolves in accordance with current industry practice. It assists in the development of an effective design control program that not only satisfies the US FDA Quality Systems Regulation (QSR) and 13485:2016 standards, but also meets today's Notified Body Auditors' and FDA Investigators' expectations. The book includes a review of the design control elements such as design planning, input, output, review, verification, validation, change, transfer, and history, as well as risk management inclusive of human factors and usability, biocompatibility, the FDA Quality System Inspection Technique (QSIT) for design controls, and medical device regulations and classes in the US, Canada, and Europe. Practical advice, methods and appendixes are provided to assist with implementation of a compliant design control program and extensive references are provided for further study. This third edition: Examines new coverage of ISO 13485-2016 design control requirements Explores proven techniques and methods for compliance Contributes fresh templates for practical implementation Provides updated chapters with additional details for greater understanding and compliance Offers an easy to understand breakdown of design control requirements Reference to MDSAP design control requirements