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El. knyga: Biomedical Engineering Design

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(Department of Obstetrics & Gynecology), (Department of Biomedical Engineering, Marquette University, and the Medical College of Wisconsin, Milwaukee, WI, USA), (Biomedical Engineering Department, Bucknell University, Lewisburg, PA, USA)
  • Formatas: PDF+DRM
  • Serija: Biomedical Engineering
  • Išleidimo metai: 19-Feb-2022
  • Leidėjas: Academic Press Inc
  • Kalba: eng
  • ISBN-13: 9780128166253
Kitos knygos pagal šią temą:
Biomedical Engineering DesignDidesnis paveikslėlis
  • Formatas: PDF+DRM
  • Serija: Biomedical Engineering
  • Išleidimo metai: 19-Feb-2022
  • Leidėjas: Academic Press Inc
  • Kalba: eng
  • ISBN-13: 9780128166253
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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.

    • 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
    Chapter 1 Introduction
    		1(20)
    1.1 Introduction
    		2(1)
    1.2 The Healthcare Ecosystem
    		3(1)
    1.3 Industry
    		4(4)
    1.4 Engineering Design
    		8(3)
    1.5 Medical Device Design
    		11(2)
    1.6 The Academic Design Process
    		13(1)
    1.7 Organization of this Text
    		14(3)
    1.8 Closing Thoughts
    		17(4)
    SECTION 1 Design Development and Planning
    Chapter 2 Design Teams and Project Management
    		21(42)
    2.1 Introduction
    		22(1)
    2.2 Industry Design Teams
    		23(1)
    2.3 Academic Design Teams
    		23(8)
    2.4 Peer and Self-Evaluations
    		31(1)
    2.5 Overcoming Common Problems on Design Teams
    		32(3)
    2.6 Project Management
    		35(16)
    2.7 Team Leadership
    		51(2)
    2.8 Effective External Communication
    		53(3)
    2.9 Design History File and Documentation
    		56(7)
    SECTION 2 Project Scope and Specifications
    Chapter 3 Defining the Medical Problem
    		63(40)
    3.1 Introduction
    		64(1)
    3.2 Project Statements
    		64(4)
    3.3 Understanding the Medical Need
    		68(3)
    3.4 Literature for Learning the Medicine
    		71(5)
    3.5 Interactions With Medical Personnel and Clinical Environments
    		76(4)
    3.6 Observations and Ethnographic Methods
    		80(2)
    3.7 Direct Interactions With People
    		82(6)
    3.8 Current Solutions and Technical Barriers
    		88(1)
    3.9 Value to the Healthcare Ecosystem and Measurable Goals
    		89(4)
    3.10 Project Objective Statements
    		93(1)
    3.11 Drafting and Refining Your Project Statement
    		94(3)
    3.12 Design Reviews
    		97(6)
    Chapter 4 Defining the Engineering Problem
    		103(22)
    4.1 Introduction
    		103(1)
    4.2 Specifications and Requirements
    		104(1)
    4.3 Converting Needs and Constraints to Specifications
    		105(6)
    4.4 Creating Value for the Customer and Other Stakeholders
    		111(2)
    4.5 Tradeoffs Between Metrics
    		113(3)
    4.6 Documentation of Specifications
    		116(9)
    SECTION 3 Solution Generation and Selection
    Chapter 5 Generating Solution Concepts and Preliminary Designs
    		125(38)
    5.1 Introduction
    		126(1)
    5.2 The Transition From Problem to Possible Design Solutions
    		126(3)
    5.3 Divergence and Generating Solution Concepts
    		129(3)
    5.4 Brainstorming
    		132(4)
    5.5 Post-Processing and Confluence of Ideas
    		136(1)
    5.6 Concept Iteration
    		137(1)
    5.7 Generating Design Solutions
    		138(8)
    5.8 Prior Art
    		146(4)
    5.9 Benchmarking
    		150(5)
    5.10 Dissection and Reverse Engineering
    		155(4)
    5.11 Documenting Concepts and Designs
    		159(4)
    Chapter 6 Selecting a Solution Concept
    		163(34)
    6.1 Introduction
    		164(1)
    6.2 Initial Screening and Evaluation
    		164(9)
    6.3 More Detailed Qualitative Screening
    		173(6)
    6.4 Quantitative Concept Screening
    		179(5)
    6.5 Prototyping
    		184(3)
    6.6 Communicating Solutions and Soliciting Feedback
    		187(3)
    6.7 Diagnosing Bile Duct Cancer
    		190(2)
    6.8 Design History File
    		192(5)
    SECTION 4 Prototyping and Detailed Design
    Chapter 7 Prototyping
    		197(38)
    7.1 Introduction
    		198(5)
    7.2 Crafting
    		203(1)
    7.3 Materials, Attachments, and Parts
    		204(2)
    7.4 Three-Dimensional Drawings and Files
    		206(2)
    7.5 Rapid Prototyping
    		208(4)
    7.6 Machining
    		212(4)
    7.7 Molding and Casting
    		216(2)
    7.8 Microfluidics
    		218(1)
    7.9 Electronics and Electrical Prototyping
    		219(5)
    7.10 Programming, Connectivity, and Simulations
    		224(2)
    7.11 Soliciting Feedback and Testing
    		226(1)
    7.12 Prototype Review and Documentation
    		227(8)
    Chapter 8 Detailed Design
    		235(54)
    8.1 Introduction
    		236(1)
    8.2 Design for Usability
    		237(14)
    8.3 Material Selection
    		251(8)
    8.4 Design for Manufacturability
    		259(5)
    8.5 Design for Sterilization
    		264(5)
    8.6 Design for Maintenance and Service
    		269(2)
    8.7 Design for the Environment
    		271(3)
    8.8 Package Design
    		274(2)
    8.9 Design Risk Management
    		276(6)
    8.10 Documentation and Design Reviews
    		282(7)
    SECTION 5 Validation and Verification Testing
    Chapter 9 Testing for Design Verification and Validation
    		289(28)
    9.1 Introduction
    		290(1)
    9.2 Reasons for Testing
    		290(3)
    9.3 Stages and Forms of Testing
    		293(2)
    9.4 Testing in Industry and Academic Design Projects
    		295(2)
    9.5 Design Verification
    		297(11)
    9.6 Design Validation
    		308(1)
    9.7 Analysis and Interpretation of Test Data
    		309(1)
    9.8 Engineering Competency and Test Design
    		310(1)
    9.9 Testing and Risk Management
    		310(1)
    9.10 Documenting and Communicating Test Results
    		311(6)
    Chapter 10 Testing in Living Systems
    		317(44)
    10.1 Introduction
    		318(1)
    10.2 The Purposes and Types of Testing in Living Systems
    		318(4)
    10.3 In Vitro Testing
    		322(7)
    10.4 Animal Testing
    		329(8)
    10.5 Human Testing
    		337(10)
    10.6 Validating Your Device
    		347(6)
    10.7 Documenting Living Systems Testing and Results
    		353(8)
    SECTION 6 Critical Lenses: Standards, Regulations, and Ethics
    Chapter 11 Medical Device Standards and Design Controls
    		361(28)
    11.1 Introduction
    		361(1)
    11.2 Need for and Types of Standards
    		362(6)
    11.3 Standards Organizations and Standards Generation
    		368(7)
    11.4 Design Controls and ISO 13485
    		375(6)
    11.5 Example in Applying Standards
    		381(8)
    Chapter 12 Regulatory Requirements
    		389(30)
    12.1 Introduction
    		390(1)
    12.2 Regulatory Considerations in Academic and Industry Design Projects
    		390(1)
    12.3 History of FDA Legislation and Regulation
    		391(1)
    12.4 Product Classifications: Device, Drug, Biologic, or Combination Product?
    		391(4)
    12.5 Device Classifications and Controls
    		395(2)
    12.6 Regulatory Requirements of Other Countries
    		397(2)
    12.7 Quality Requirements
    		399(2)
    12.8 Pathways to Market in the United States
    		401(4)
    12.9 Post Market Surveillance and Medical Device Recalls
    		405(6)
    12.10 Medical Device Labeling
    		411(8)
    Chapter 13 Ethics in Medical Device Design
    		419(22)
    13.1 Introduction
    		420(1)
    13.2 Applied Ethics
    		420(3)
    13.3 Engineering Ethics
    		423(2)
    13.4 Medical Ethics
    		425(1)
    13.5 Research Ethics
    		426(6)
    13.6 Organizational Policies and Corporate Ethics
    		432(1)
    13.7 Conclusions and Final Scenarios
    		433(8)
    SECTION 7 Commercialization and Post Market Surveillance
    Chapter 14 Beyond Design: The Engineer's Role in Design Transfer, Commercialization, and Post Market Surveillance
    		441(14)
    14.1 Introduction
    		441(1)
    14.2 Regulatory Support
    		442(1)
    14.3 Design Transfer
    		443(4)
    14.4 Commercialization
    		447(1)
    14.5 Post Market Surveillance
    		448(7)
    Chapter 15 Collaborating on Multifunctional Teams to Commercialize Medical Products
    		455(42)
    15.1 Introduction
    		456(1)
    15.2 Engineering Economics and Finance
    		456(10)
    15.3 Protecting Intellectual Property
    		466(9)
    15.4 Marketing and Sales
    		475(4)
    15.5 Business Acumen
    		479(7)
    15.6 Supply and Distribution Chains
    		486(1)
    15.7 Health Insurance and Reimbursement
    		487(3)
    15.8 Operations Mangagement
    		490(2)
    15.9 Documentation of the Stage-Gate Process
    		492(5)
    Index 497
    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. 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. Robert H. Allen, PhD, PE is Research Assistant Professor of Obstetrics & Gynecology and Womens 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.
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