Design of Biomedical Devices and Systems

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.

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