Design of biomedical devices and systems

Content: Introduction to Biomedical Engineering Design    What is Design?    What is the Thrust of this Text?    What Might Be Designed?    The Essentials of Design-Overview    Biomedical Engineering Design in Industrial Context    An Overview of the Industrial Design Process    How this text is Structured    The Real Purpose of this Text    Case Study    References    Fundamental Design Tools    Brainstorming and Idea Generation Techniques    Conventional Solution Searches    Function Analysis    Elementary Decision-Making Techniques    Objectives Trees    Introduction to Quality Function Deployment Diagrams    Introduction to Triz    Extended Triz Design Techniques    Case Study: Cancer Clinic Charting    Suggested Reading    Design Team Management, Reporting, and Documentation    Design Team Construction and Management (Industry Based)    Student Design Team Construction and Management    Reporting Techniques: Presentations, Posters, Reports, Websites    Introduction to Databases    Suggested Reading    Product Definition    What is a Medical Device?    The Product Definition Process    The QFD Process    Summary of QFD    Requirements, Design, Verification, and Validation    The Product Specification    Suggested Reading    Product Documentation    Documents    Records    A Comparison of the Medical Device Records    Suggested Reading    Product Development    Product Requirements    Design and Development Planning    System Requirements Specification    Design Input    Design Output    Formal Design Review    Design Verification    Design Validation    Design Transfer    Suggested Reading    Hardware Development Methods and Tools    Design for Six Sigma    Methodologies    Structure    Design for Six Sigma Tools    Component Derating    Safety Margin    Load Protection    Environmental Protection    Product Misuse    Reliability Prediction    Design for Variation    Design of Experiments    Design Changes    Design for Manufacturability    Design for Assembly    Design Reviews    Suggested Reading    Software Development Methods and Tools    Software Design Levels    Design Alternatives and Trade-Offs    Software Architecture    Choosing a Methodology    Structured Analysis    Object-Oriented Design    Choosing a Language    Software Risk Analysis    The Requirements Traceability Matrix    Software Review    Design Techniques    Performance Predictability and Design Simulation    Module Specifications    Coding    Design Support Tools    Design as the Basis for Verification and Validation Activity    Conclusion    Suggested Reading    Human Factors    What is Human Factors?    The Human Element in Human Factors Engineering    The Hardware Element in Human Factors    The Software Element in Human Factors    The Human Factors Process    Planning    Analysis    Conduct User Studies    Set Usability Goals    Design User Interface Concepts    Model the User Interface    Test the User Interface    Specify the User Interface    Additional Human Factors Design Considerations    Fitts's Law    Suggested Reading    Industrial Design    Set Usability Goals    Design User Interface Concepts    Model the User Interface    Test the User Interface    Specify the User Interface    Additional Industrial Design Considerations    Examples    Suggested Reading    Biomaterials and Material Testing    The FDA and Biocompatibility    International Regulatory Efforts    Device Category and Choice of Test Program    Preparation of Extracts    Biological Control Tests    Tests for Biological Evaluation    Alternative Test Methods    Other Considerations for Design    Materials Design Example    Endnote    Reference    Suggested Reading    Risk Analysis-Devices and Processes    Safety    Risk    Deciding on Acceptable Risk    Factors Important to Medical Device Risk Assessment    Risk Management    The Risk Management Process    Tools For Risk Estimation    Risk Analysis and Systems    Other Process Issues    References    Suggested Reading    Testing    Testing Defined    Parsing Test Requirements    Test Protocol    Test Methodology    Purpose of the Test    Failure Definition    Determining Sample Size and Test Length    Types of Testing    Highly Accelerated Stress Testing    Highly Accelerated Life Testing    Other Accelerated Testing    References    Suggested Reading    Analysis of Test Data    The Definition of Reliability    Types of Reliability    Failure Rate    Mean Time Between Failures    Reliability    Confidence Level    Confidence Limits    Minimum Life    Graphical Analysis    Suggested Reading    Product Liability and Accident Investigations    Product Liability Laws    Accident Reconstruction and Forensics    Conclusion    Reference    Suggested Reading    The FDA and Devices    History of Device Regulation    Device Classification    Registration and Listing    The (k) Process    Declaration of Conformance to a Recognized Standard    The PMA Application    IDE    Good Laboratory Practices    GMP    Human Factors    Design Control    The FDA and Software    Software Classification    The FDA Inspection    Advice on Dealing with the FDA    Suggested Reading    Food and Drug Administration History and Relevant Nondevice Regulations    A Brief History of the FDA Relevant to Food and Drugs    Drug Development    Drug Testing    FDA Postproduction Oversight and Enforcement    The Future of Drug Therapy?    The FDA and Combination Products    Veterinary Medicine    The FDA and Cosmetics    Summary and Conclusions    Suggested Reading    Biological Engineering Designs    What is a Biological System?    Special Issues When Dealing with Nonhuman Subjects    Unintended Consequences    Environmental Interactions    Biological Principles    Characteristics of Biomaterials    Design Objectives    Resistance Development    Information Sources    Useful Techniques    Regulations and Standards    Ethics    Biological Engineering Design Examples    Suggested Reading    International Regulations and Standards    Definition of a Medical Device    The Medical Device Directives    Software Standards and Regulations    Rest-of-World Standards    Suggested Reading    Intellectual Property: Patents, Copyrights, Trade Secrets, and Licensing    Patents    Copyrights    Trademarks    Trade Secrets    Licensing    Acknowledgment    Suggested Reading    Manufacturing and Quality Control    A History of GMPS    The GMP Regulation    Design for Manufacturability    Design for Assembly    Highly Accelerated Stress Screening    Highly Accelerated Stress Audit    The Manufacturing Process    Suggested Reading    Miscellaneous Issues    Introduction    Learning From Failure (and Lies)    Design for X    Universal Design    Prevention Through Design    Poka-Yoke    Product Life Issues    Product Testing Issues    References    Suggested Reading    Professional Issues    BME-Related Professional Societies    Standards-Setting Groups    Professional Engineering Licensure    Registration as a Professional Engineer    Rules of Professional Conduct    Codes of Ethics    Forensics and Consulting    Continuing Education    Concept to Product?    Introduction    Prepare Yourself Prior to any Further Developments    Find Funding Sources    Next Steps    Case Study: Pathfinder Technologies    NCIIA Examples    Development of Max Mobility Corp, Mark Richter, PHD, PE, Owner    Conclusion    Suggested Reading    Appendices