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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 hniques 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 Assemb