Biomedical Engineering Design

1st Edition - February 19, 2022
Authors: Joseph Tranquillo, Jay Goldberg, Robert Allen
Language: English
Paperback ISBN:
9 7 8 - 0 - 1 2 - 8 1 6 4 4 4 - 0
eBook ISBN:
9 7 8 - 0 - 1 2 - 8 1 6 6 2 5 - 3

*Textbook and Academic Authors Association (TAA) Most Promising New Textbook Award Winner, 2024*Biomedical Engineering Design presents the design processes and practices used in… Read more

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*Textbook and Academic Authors Association (TAA) Most Promising New Textbook Award Winner, 2024*

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.

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

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