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E-raamat: Biomedical Engineering Design

(Biomedical Engineering Department, Bucknell University, Lewisburg, PA, USA), (Department of Obstetrics & Gynecology), (Department of Biomedical Engineering, Marquette University, and the Medical College of Wisconsin, Milwaukee, WI, USA)
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  • Sari: Biomedical Engineering
  • Ilmumisaeg: 19-Feb-2022
  • Kirjastus: Academic Press Inc
  • Keel: eng
  • ISBN-13: 9780128166253
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  • Formaat: EPUB+DRM
  • Sari: Biomedical Engineering
  • Ilmumisaeg: 19-Feb-2022
  • Kirjastus: Academic Press Inc
  • Keel: 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.