Biomedical Engineering Design

Biomedical Engineering Design

1st Edition - February 19, 2022

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  • Authors: Joseph Tranquillo, Jay Goldberg, Robert Allen
  • Paperback ISBN: 9780128164440
  • eBook ISBN: 9780128166253

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Description

Biomedical Engineering Design presents the design processes and practices used in academic and industry medical device design projects. The first two chapters are an overview of the design process, project management and working on technical teams. Further chapters follow the general order of a design sequence in biomedical engineering, from problem identification to validation and verification testing. The first seven chapters, or parts of them, can be used for first-year and sophomore design classes. The next six chapters are primarily for upper-level students and include in-depth discussions of detailed design, testing, standards, regulatory requirements and ethics. The last two chapters summarize the various activities that industry engineers might be involved in to commercialize a medical device.

Key Features

    • Covers subject matter rarely addressed in other BME design texts, such as packaging design, testing in living systems and sterilization methods
    • Provides instructive examples of how technical, marketing, regulatory, legal, and ethical requirements inform the design process
    • Includes numerous examples from both industry and academic design projects that highlight different ways to navigate the stages of design as well as document and communicate design decisions
    • Provides comprehensive coverage of the design process, including methods for identifying unmet needs, applying Design for ‘X’, and incorporating standards and design controls
    • Discusses topics that prepare students for careers in medical device design or other related medical fields

    Readership

    Biomedical engineering students in capstone or junior and lower level design courses; practicing engineers in industry who are searching for a more appropriate, up-to-date design process that may not currently be used in their organization

    Table of Contents

    • Cover image
    • Title page
    • Table of Contents
    • Copyright
    • Dedication
    • Preface
    • To Instructors
    • Acknowledgments
    • Reviewers
    • Chapter 1. Introduction
    • 1.1. Introduction
    • 1.2. The Healthcare Ecosystem
    • 1.3. Industry
    • 1.4. Engineering Design
    • 1.5. Medical Device Design
    • 1.6. The Academic Design Process
    • 1.7. Organization of this Text
    • 1.8. Closing Thoughts
    • Section 1. Design Development and Planning
    • Introduction
    • Chapter 2. Design Teams and Project Management
    • 2.1. Introduction
    • 2.2. Industry Design Teams
    • 2.3. Academic Design Teams
    • 2.4. Peer and Self-Evaluations
    • 2.5. Overcoming Common Problems on Design Teams
    • 2.6. Project Management
    • 2.7. Team Leadership
    • 2.8. Effective External Communication
    • 2.9. Design History File and Documentation
    • Section 2. Project Scope and Specifications
    • Introduction
    • Chapter 3. Defining the Medical Problem
    • 3.1. Introduction
    • 3.2. Project Statements
    • 3.3. Understanding the Medical Need
    • 3.4. Literature for Learning the Medicine
    • 3.5. Interactions With Medical Personnel and Clinical Environments
    • 3.6. Observations and Ethnographic Methods
    • 3.7. Direct Interactions With People
    • 3.8. Current Solutions and Technical Barriers
    • 3.9. Value to the Healthcare Ecosystem and Measurable Goals
    • 3.10. Project Objective Statements
    • 3.11. Drafting and Refining Your Project Statement
    • 3.12. Design Reviews
    • Chapter 4. Defining the Engineering Problem
    • 4.1. Introduction
    • 4.2. Specifications and Requirements
    • 4.3. Converting Needs and Constraints to Specifications
    • 4.4. Creating Value for the Customer and Other Stakeholders
    • 4.5. Tradeoffs Between Metrics
    • 4.6. Documentation of Specifications
    • Section 3. Solution Generation and Selection
    • Introduction
    • Chapter 5. Generating Solution Concepts and Preliminary Designs
    • 5.1. Introduction
    • 5.2. The Transition From Problem to Possible Design Solutions
    • 5.3. Divergence and Generating Solution Concepts
    • 5.4. Brainstorming
    • 5.5. Post-Processing and Confluence of Ideas
    • 5.6. Concept Iteration
    • 5.7. Generating Design Solutions
    • 5.8. Prior Art
    • 5.9. Benchmarking
    • 5.10. Dissection and Reverse Engineering
    • 5.11. Documenting Concepts and Designs
    • Chapter 6. Selecting a Solution Concept
    • 6.1. Introduction
    • 6.2. Initial Screening and Evaluation
    • 6.3. More Detailed Qualitative Screening
    • 6.4. Quantitative Concept Screening
    • 6.5. Prototyping
    • 6.6. Communicating Solutions and Soliciting Feedback
    • 6.7. Diagnosing Bile Duct Cancer
    • 6.8. Design History File
    • Section 4. Prototyping and Detailed Design
    • Introduction
    • Chapter 7. Prototyping
    • 7.1. Introduction
    • 7.2. Crafting
    • 7.3. Materials, Attachments, and Parts
    • 7.4. Three-Dimensional Drawings and Files
    • 7.5. Rapid Prototyping
    • 7.6. Machining
    • 7.7. Molding and Casting
    • 7.8. Microfluidics
    • 7.9. Electronics and Electrical Prototyping
    • 7.10. Programming, Connectivity, and Simulations
    • 7.11. Soliciting Feedback and Testing
    • 7.12. Prototype Review and Documentation
    • Chapter 8. Detailed Design
    • 8.1. Introduction
    • 8.2. Design for Usability
    • 8.3. Material Selection
    • 8.4. Design for Manufacturability
    • 8.5. Design for Sterilization
    • 8.6. Design for Maintenance and Service
    • 8.7. Design for the Environment
    • 8.8. Package Design
    • 8.9. Design Risk Management
    • 8.10. Documentation and Design Reviews
    • Section 5. Validation and Verification Testing
    • Introduction
    • Chapter 9. Testing for Design Verification and Validation
    • 9.1. Introduction
    • 9.2. Reasons for Testing
    • 9.3. Stages and Forms of Testing
    • 9.4. Testing in Industry and Academic Design Projects
    • 9.5. Design Verification
    • 9.6. Design Validation
    • 9.7. Analysis and Interpretation of Test Data
    • 9.8. Engineering Competency and Test Design
    • 9.9. Testing and Risk Management
    • 9.10. Documenting and Communicating Test Results
    • Chapter 10. Testing in Living Systems
    • 10.1. Introduction
    • 10.2. The Purposes and Types of Testing in Living Systems
    • 10.3. In Vitro Testing
    • 10.4. Animal Testing
    • 10.5. Human Testing
    • 10.6. Validating Your Device
    • 10.7. Documenting Living Systems Testing and Results
    • Section 6. Critical Lenses: Standards, Regulations, and Ethics
    • Introduction
    • Chapter 11. Medical Device Standards and Design Controls
    • 11.1. Introduction
    • 11.2. Need For and Types of Standards
    • 11.3. Standards Organizations and Standards Generation
    • 11.4. Design Controls and ISO 13485
    • 11.5. Example in Applying Standards
    • Chapter 12. Regulatory Requirements
    • 12.1. Introduction
    • 12.2. Regulatory Considerations in Academic and Industry Design Projects
    • 12.3. History of FDA Legislation and Regulation
    • 12.4. Product Classifications: Device, Drug, Biologic, or Combination Product?
    • 12.5. Device Classifications and Controls
    • 12.6. Regulatory Requirements of Other Countries
    • 12.7. Quality Requirements
    • 12.8. Pathways to Market in the United States
    • 12.9. Post Market Surveillance and Medical Device Recalls
    • 12.10. Medical Device Labeling
    • Chapter 13. Ethics in Medical Device Design
    • 13.1. Introduction
    • 13.2. Applied Ethics
    • 13.3. Engineering Ethics
    • 13.4. Medical Ethics
    • 13.5. Research Ethics
    • 13.6. Organizational Policies and Corporate Ethics
    • 13.7. Conclusions and Final Scenarios
    • Section 7. Commercialization and Post Market Surveillance
    • Introduction
    • Chapter 14. Beyond Design: The Engineer’s Role in Design Transfer, Commercialization, and Post Market Surveillance
    • 14.1. Introduction
    • 14.2. Regulatory Support
    • 14.3. Design Transfer
    • 14.4. Commercialization
    • 14.5. Post Market Surveillance
    • Chapter 15. Collaborating on Multifunctional Teams to Commercialize Medical Products
    • 15.1. Introduction
    • 15.2. Engineering Economics and Finance
    • 15.3. Protecting Intellectual Property
    • 15.4. Marketing and Sales
    • 15.5. Business Acumen
    • 15.6. Supply and Distribution Chains
    • 15.7. Health Insurance and Reimbursement
    • 15.8. Operations Mangagement
    • 15.9. Documentation of the Stage-Gate Process
    • Index

    Product details

    • No. of pages: 528
    • Language: English
    • Copyright: © Academic Press 2022
    • Published: February 19, 2022
    • Imprint: Academic Press
    • Paperback ISBN: 9780128164440
    • eBook ISBN: 9780128166253

    About the Authors

    Joseph Tranquillo

    Joe Tranquillo Ph.D. is the Associate Provost for Transformative Teaching and Learning and a founding faculty member of the Biomedical Engineering Department at Bucknell University. At Bucknell he has served as the Director of the Teaching and Learning Center, Director of the Institute for Leadership in Technology and Management and co-founded the Bucknell Innovation Group and KEEN Winter Interdisciplinary Design Experience. Off campus Joe is the past chair of the ASEE Biomedical Engineering Division, co-organizer of the BME-IDEA meetings, founder and inaugural chair of the BMES undergraduate research track. He has delivered intensive teaching workshops on five continents and his work, conducted exclusively with undergraduates, has been featured on the Discovery Channel, TEDx, CNN Health, Google, US News and World Report, and the ABET National Symposium. He is an elected Fellow of ASEE, BMES, AIMBE and NSF Frontiers of Engineering Education. Joe has spent time at Trinity College, Duke University, University of Utah, Stanford University and is an international visiting faculty member at Universidad Catolica de Chile in Santiago, Chile.

    Affiliations and Expertise

    Biomedical Engineering Department, Bucknell University, Lewisburg, PA, USA

    Jay Goldberg

    Jay R. Goldberg, PhD, PE, is Professor of Practice in Biomedical Engineering at Marquette University and the Medical College of Wisconsin. He teaches graduate and undergraduate courses involving new product development and medical device design, including senior capstone design. His experience includes development of new products in urology, orthopedics, GI, and dentistry. Prior to moving into academia, he was Director of Technology and Quality Assurance for Milestone Scientific Inc. (Deerfield, IL), a start-up dental product company. Dr. Goldberg is a co-creator of the BME-idea national student design competition and Chair of Industry Involvement for the Capstone Design Conference. He is a Consultant to the Gastroenterology and Urology Therapy Device Panel (FDA Medical Device Advisory Committee), and as Chair of the ASTM International Subcommittee on Urological Materials and Devices, led efforts to develop and revise industry standards for ureteral stents and Foley Catheters, respectively. Dr. Goldberg writes a quarterly column on senior capstone design courses for IEEE Pulse magazine and has published two books on using senior capstone design courses to prepare biomedical engineering students for careers in the medical device industry. In 2012, he was awarded the Engineering Education Excellence Award by the National Society of Professional Engineers for relating engineering education to professional practice. Dr. Goldberg is a Fellow of the National Academy of Inventors and the Biomedical Engineering Society. He is a licensed Professional Engineer in Illinois and Wisconsin and has six patents for urological medical devices.

    Affiliations and Expertise

    Department of Biomedical Engineering, Marquette University, and the Medical College of Wisconsin, Milwaukee, WI, USA

    Robert Allen

    Robert H. Allen, PhD, PE is Research Assistant Professor of Obstetrics & Gynecology and Women’s Health at the Albert Einstein School of Medicine, where he directs training of obstetric providers in managing mechanically difficult deliveries. Prior to that he was the founding Undergraduate Program Director of the Center for Bioengineering Innovation and Design within the Department of Biomedical Engineering at Johns Hopkins University. Prior to coming to Hopkins, Dr. Allen developed and directed team-based design programs since 1984; first at the University of Houston, then the University of Delaware and subsequently at Hopkins. Over this time, he has mentored over 250 design projects, many for the disabled population, with more than 40 teams or design students capturing national and international design competition awards. His research interests include the mechanics of birth, injury prevention and design education. He has authored or co-authored over 60 journal publications, over a dozen book chapters, and has generated over $4M in external support for research and teaching. A retired professional engineer, he is an inventor on three issued patents, and several pending ones, and co-founder of Birth Injury Prevention, LLC, a Maryland-company dedicated to improving maternal-child health.

    Affiliations and Expertise

    Department of Obstetrics & Gynecology and Women's Health, Albert Einstein College of Medicine, New York

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