3rd Edition

Reliable Design of Medical Devices

By Richard C. Fries Copyright 2012
    504 Pages 80 B/W Illustrations
    by CRC Press

    502 Pages 80 B/W Illustrations
    by CRC Press

    As medical devices become even more intricate, concerns about efficacy, safety, and reliability continue to be raised. Users and patients both want the device to operate as specified, perform in a safe manner, and continue to perform over a long period of time without failure. Following in the footsteps of the bestselling second edition, Reliable Design of Medical Devices, Third Edition shows you how to improve reliability in the design of advanced medical devices.

    Reliability engineering is an integral part of the product development process and of problem-solving activities related to manufacturing and field failures. Mirroring the typical product development process, the book is organized into seven parts. After an introduction to the basics of reliability engineering and failures, it takes you through the concept, feasibility, design, verification and validation, design transfer and manufacturing, and field activity phases. Topics covered include Six Sigma for design, human factors, safety and risk analysis, and new techniques such as accelerated life testing (ALT) and highly accelerated life testing (HALT).

    What’s New in This Edition

    • Updates throughout, reflecting changes in the field
    • An updated software development process
    • Updated hardware test procedures
    • A new layout that follows the product development process
    • A list of deliverables needed at the end of each development phase

    Incorporating reliability engineering as a fundamental design philosophy, this book shares valuable insight from the author’s more than 35 years of experience. A practical guide, it helps you develop a more effective reliability engineering program—contributing to increased profitability, more satisfied customers, and less risk of liability.

    The Basics of Reliability
    Reliability
    The Concept of Failure
    The Product Design and Development Process

    The Concept Phase
    Defining the Device
    Safety and Risk Management
    Documents and Deliverables

    The Feasibility Phase
    The FDA
    The Medical Devices Directives
    Important Medical Device Standards
    Human Factors
    Requirements Engineering
    Liability
    Intellectual Property
    The Project Team
    The Reliability Goal and Plan
    Documents and Deliverables

    The Design Phase
    Hardware Design
    Hardware Risk Analysis
    Design and Project Metrics
    Design for Six Sigma
    Software Design
    Software Coding
    Software Risk Analysis
    Software Metrics
    Documents and Deliverables

    Verification and Validation
    The Basis and Types of Testing
    Hardware Verification and Validation
    Hardware Data Analysis
    Software Verification and Validation
    Software Data Analysis
    Documents and Deliverables

    Design Transfer and Manufacturing
    Transfer to Manufacturing
    Hardware Manufacturing
    Software Manufacturing
    Configuration Management
    Documents and Deliverables

    Field Activity
    Analysis of Field Data
    Monitored Activity

    Appendices
    Index

    Biography

    Richard Fries, PE, CSQE, CRE, is president of ISORel, Inc., a consulting firm located in Fitchburg, Wisconsin. He is a licensed professional engineer in the state of Wisconsin and is certified by the American Society for Quality as a Reliability Engineer and a Software Quality Engineer. Mr. Fries is a member of the IEEE Software Engineering Subcommittee. He was a member of the AAMI Medical Device Software Committee that developed IEC 62304. He was also a member of the AAMI Technical Committee that developed ISO 13485.

    "This book focuses on an important topic ... that engineers need to understand in all of its aspects—philosophy, design, and testing and evaluation. They also need to know how they fit in to the larger picture (manufacturing, packaging, etc…). This book provides both an overview of those facets, along with details to implement them. It is thus a valuable resource for students, researchers, and industry [professionals] who wish to develop a product."
    —Jon Sensinger, Rehabilitation Institute of Chicago, Illinois, USA


    "… my interest is piqued. I think it can be a very interesting and useful resource for engineers and other stakeholders involved in the medical device design and production process."
    —Carl Nelson, University of Nebraska-Lincoln, USA

    "Don’t let the name fool you– this book is about much more than reliability engineering. While this book opens with a discussion of reliability and failure, it quickly transitions to discussing the entire product development process, from concept through verification, and even includes design transfer and post-market field actions. …There is a lot of wisdom in this book. You can tell that the author has seen a lot of projects and wants the reader to avoid the mistakes that he has encountered."
    ––Reading Room, Biomedical Instrumentation and Technology, September/October 2013