Publisher's Note: Products purchased from Third Party sellers are not guaranteed by the publisher for quality, authenticity, or access to any online entitlements included with the product. Cutting-edge medical device design techniques, strategies, and insights This practical textbook helps students and professionals gain perspective while designing medical devices. You will get special and specific design strategies and clear discussions on why each approach works-or doesn't work-in various applications. The book provides a common vocabulary for communicating and understanding the scientific,…mehr
Publisher's Note: Products purchased from Third Party sellers are not guaranteed by the publisher for quality, authenticity, or access to any online entitlements included with the product. Cutting-edge medical device design techniques, strategies, and insights This practical textbook helps students and professionals gain perspective while designing medical devices. You will get special and specific design strategies and clear discussions on why each approach works-or doesn't work-in various applications. The book provides a common vocabulary for communicating and understanding the scientific, regulatory, and business aspects of medical device design. Foundations and Strategies for Medical Device Design contains medical design practices and case studies along with anecdotes that demonstrate how proper oversight can avoid both missed opportunities and catastrophic failures. Current resources are identified where the reader can delve into detail for specific design topics. The book explains ethical, regulatory, and scientific issues to keep in mind when tackling medical device design. * Features best practices, case studies, historical context, and cautionary tales * Contains end-of-chapter open questions and recommended reading for further study * Written by an experienced educator and entrepreneur with over 30 years of experience and six patents
Vikki Hazelwood is an industry professor and director of the biomedical engineering program at Stevens Institute of Technology. She is a fellow in the National Academy of Inventors and recipient of the 2010 Advancement of Invention Award from the New Jersey Inventors Hall of Fame. Dr. Hazelwood has written two books, published articles in almost two dozen journals, and spoken at numerous conferences.
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Message to Students Message to Instructors CHAPTER 1 Just 100 Years Ago Learning Objectives New Terms If You Were Born Just 100 Years Sooner How Things Have Changed Summary Study Questions Thought Questions References CHAPTER 2 President Eisenhower's Heart Attack Learning Objectives New Terms September 1955 Electrocardiogram (ECG) Oxygen Tent Oxygen Therapy A Half Century after the President's Heart Attack Foundations for Medical Device Advancement Ike: Resilience Thanks to Biomedical Engineering Summary Study Questions Thought Questions References CHAPTER 3 Events That Built Our Key Regulations and Practices Learning Objectives New Terms Food and Drug Administration and the Food, Drug, and Cosmetic Act of 1938 Early Good Manufacturing Practices and the National Institutes of Health Elixir of Sulfanilamide Current Good Manufacturing Practices and FDA 21 CFR Part 820 Medical Device Amendments Act of 1976 Safe Medical Devices Act of 1990 and Design Controls International Standards Organization (ISO) 13485 Summary Study Questions Thought Questions References CHAPTER 4 Thalidomide Learning Objectives New Terms Thalidomide Tragedy The Power of One FDA Reviewer Animal Models and Pregnancy Kefauver-Harris Drug Amendments Act of 1962 Advancing Animal Models Summary Study Questions Thought Questions References CHAPTER 5 The Dalkon Shield Learning Objectives New Terms Preamendment Status Dalkon Shield Medical Devices Amendments of 1976 Summary Study Questions Thought Questions References CHAPTER 6 Understanding Today's Food and Drug Administration Learning Objectives New Terms FDA Mission Cost and Time to Market FDA Structure Summary Study Questions Thought Questions References CHAPTER 7 Preparing a Regulatory Strategy Learning Objectives New Terms FDA's Rationale for Medical Device Classification Determining Your Regulatory Strategy Advanced (But Important to Know About) Strategies Summary Study Questions Thought Questions References CHAPTER 8 Foundations of Clinical and Preclinical Research Learning Objectives New Terms Living Subjects Research Animal Research Strategies Clinical Trials Summary Study Questions Thought Questions References CHAPTER 9 Clinical Study Strategies Learning Objectives New Terms Impact of Clinical Study on Design Planning Reasons for Clinical Testing Summary Study Questions Thought Questions References CHAPTER 10 Kyphon and Reimbursement Learning Objectives New Terms The Lawsuit Involving Kyphon, Inc. What Is Reimbursement? Summary Study Questions Thought Questions References CHAPTER 11 Navigating Codes for Reimbursement Learning Objectives New Terms Current Procedural Terminology Codes International Classification of Diseases Codes Diagnosis-Related Groups Healthcare Common Procedure Coding System and Durable Medical Equipment, Prosthetics, Orthotics, and Supplies Summary Study Questions Thought Questions References CHAPTER 12 Device-Associated Infections Learning Objectives New Terms Nosocomial Infection (aka HAI) Biofilms and Implant Failure Surface Treatment to Prevent Infection Summary Study Questions Thought Questions References CHAPTER 13 Designing for Postmarket Safety Learning Objectives New Terms Long-Range Data Come Only After a Product Is on the Market Medical Device Reclassification Summary Study Questions Thought Questions References CHAPTER 14 Designing for Biocompatibility and Infection Prevention Learning Objectives New Terms Biocompatibility Cleaning, Disinfection, and Sterilization Summary Study Questions Thought Questions References CHAPTER 15 Designing for the Use Case Learning Objectives New Terms Equipment Management in the Clinic Patient Adherence Summary Study Questions Thought Questions References CHAPTER 16 The Landscape for Medical Devices in the Twenty-First Century Learning Objectives New Terms Goals for Improving Outcomes Increased Regulation Internet of Medical Things Heart Surgery Data Pandemic/Summary Study Questions Thought Questions References Index
Message to Students Message to Instructors CHAPTER 1 Just 100 Years Ago Learning Objectives New Terms If You Were Born Just 100 Years Sooner How Things Have Changed Summary Study Questions Thought Questions References CHAPTER 2 President Eisenhower's Heart Attack Learning Objectives New Terms September 1955 Electrocardiogram (ECG) Oxygen Tent Oxygen Therapy A Half Century after the President's Heart Attack Foundations for Medical Device Advancement Ike: Resilience Thanks to Biomedical Engineering Summary Study Questions Thought Questions References CHAPTER 3 Events That Built Our Key Regulations and Practices Learning Objectives New Terms Food and Drug Administration and the Food, Drug, and Cosmetic Act of 1938 Early Good Manufacturing Practices and the National Institutes of Health Elixir of Sulfanilamide Current Good Manufacturing Practices and FDA 21 CFR Part 820 Medical Device Amendments Act of 1976 Safe Medical Devices Act of 1990 and Design Controls International Standards Organization (ISO) 13485 Summary Study Questions Thought Questions References CHAPTER 4 Thalidomide Learning Objectives New Terms Thalidomide Tragedy The Power of One FDA Reviewer Animal Models and Pregnancy Kefauver-Harris Drug Amendments Act of 1962 Advancing Animal Models Summary Study Questions Thought Questions References CHAPTER 5 The Dalkon Shield Learning Objectives New Terms Preamendment Status Dalkon Shield Medical Devices Amendments of 1976 Summary Study Questions Thought Questions References CHAPTER 6 Understanding Today's Food and Drug Administration Learning Objectives New Terms FDA Mission Cost and Time to Market FDA Structure Summary Study Questions Thought Questions References CHAPTER 7 Preparing a Regulatory Strategy Learning Objectives New Terms FDA's Rationale for Medical Device Classification Determining Your Regulatory Strategy Advanced (But Important to Know About) Strategies Summary Study Questions Thought Questions References CHAPTER 8 Foundations of Clinical and Preclinical Research Learning Objectives New Terms Living Subjects Research Animal Research Strategies Clinical Trials Summary Study Questions Thought Questions References CHAPTER 9 Clinical Study Strategies Learning Objectives New Terms Impact of Clinical Study on Design Planning Reasons for Clinical Testing Summary Study Questions Thought Questions References CHAPTER 10 Kyphon and Reimbursement Learning Objectives New Terms The Lawsuit Involving Kyphon, Inc. What Is Reimbursement? Summary Study Questions Thought Questions References CHAPTER 11 Navigating Codes for Reimbursement Learning Objectives New Terms Current Procedural Terminology Codes International Classification of Diseases Codes Diagnosis-Related Groups Healthcare Common Procedure Coding System and Durable Medical Equipment, Prosthetics, Orthotics, and Supplies Summary Study Questions Thought Questions References CHAPTER 12 Device-Associated Infections Learning Objectives New Terms Nosocomial Infection (aka HAI) Biofilms and Implant Failure Surface Treatment to Prevent Infection Summary Study Questions Thought Questions References CHAPTER 13 Designing for Postmarket Safety Learning Objectives New Terms Long-Range Data Come Only After a Product Is on the Market Medical Device Reclassification Summary Study Questions Thought Questions References CHAPTER 14 Designing for Biocompatibility and Infection Prevention Learning Objectives New Terms Biocompatibility Cleaning, Disinfection, and Sterilization Summary Study Questions Thought Questions References CHAPTER 15 Designing for the Use Case Learning Objectives New Terms Equipment Management in the Clinic Patient Adherence Summary Study Questions Thought Questions References CHAPTER 16 The Landscape for Medical Devices in the Twenty-First Century Learning Objectives New Terms Goals for Improving Outcomes Increased Regulation Internet of Medical Things Heart Surgery Data Pandemic/Summary Study Questions Thought Questions References Index
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