Design of Biomedical Devices and Systems

Apply a Wide Variety of Design Processes to a Wide Category of Design Problems Design of Biomedical Devices and Systems, Third Edition continues to provide a real-world approach to the design of biomedical engineering devices and/or systems. Bringing together information on the design and initiation of design projects from several sources, this edition strongly emphasizes and further clarifies the standards of design procedure. Following the best practices for conducting and completing a design project, it outlines the various steps in the design process in a basic, flexible, and logical order. What’s New in the Third Edition: This latest edition contains a new chapter on biological engineering design, a new chapter on the FDA regulations for items other than devices such as drugs, new end-of-chapter problems, new case studies, and a chapter on product development. It adds mathematical modeling tools, and provides new information on FDA regulations and standards, as well as clinical trials and sterilization methods. Familiarizes the reader with medical devices, and their design, regulation, and use Considers safety aspects of the devices Contains an enhanced pedagogy Provides an overview of basic design issues Design of Biomedical Devices and Systems, Third Edition covers the design of biomedical engineering devices and/or systems, and is designed to support bioengineering and biomedical engineering students and novice engineers entering the medical device market.

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

Paul King, PhD, PE, attended Case Institute of Technology for his BS and MS and then obtained his PhD at Vanderbilt University in 1968 (mechanical engineering.) That same year, he became one of the founding members of the Department of Biomedical Engineering at Vanderbilt University. He developed and taught most of the early required coursework in the Department of Biomedical Engineering. In approximately 2001 he and coauthor Richard Fries published the first edition of the textbook Design of Biomedical Devices and Systems. This textbook is being used in multiple universities in the United States and abroad. Richard Fries, PE, CSQE, CRE, is a licensed professional engineer in the state of Wisconsin and certified by the American Society for Quality as a reliability engineer and a software quality engineer. He has degrees from Loyola University in Chicago and Marquette University in Milwaukee. He is co-inventor of patent 5,682,876, entitled "absorber switch locking device." He has authored eight books and chapters in several others on reliability and regulatory compliance. He has also written numerous articles in professional journals on hardware and software reliability, human factors, standards and regulations, and engineering education. Arthur T. Johnson attended Cornell University for his undergraduate and graduate degrees. His PhD was awarded in 1969. He joined the faculty of the University of Maryland in 1975 and was professor from 1986 until 2009, when he became professor emeritus. He has written three books: Biomechanics and Exercise Physiology, Biological Process Engineering, and Biology for Engineers. He has been most recently active in teaching electronic design, transport processes, and engineering in biology courses, and in working to continue development of the airflow perturbation device as a noninvasive measurement of respiratory resistance.