Reliable Design of Medical Devices

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