{"product_id":"foundations-and-strategies-for-medical-device-design-9781260456950","title":"Foundations and Strategies for Medical Device","description":"\u003cb\u003eBook Synopsis\u003c\/b\u003e\u003cbr\u003e\u003cb\u003ePublisher'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.\u003c\/b\u003e\u003cb\u003e\u003cbr\u003e\u003c\/b\u003e\u003cbr\u003e\u003cb\u003eCutting-edge medical device design techniques, strategies, and insights\u003c\/b\u003e\u003cbr\u003e\u003cbr\u003eA complete curriculum, this practical book provides the novice design engineer of devices with a rounded exposure to unique medical device design practices. The text contains key medical device design strategies and offers real-world insights, analysis, and rationale. \u003ci\u003eFoundations and Strategies for Medical Device Design\u003c\/i\u003e contains special and specific design approaches and clear discussions on why each method worksâor doesnât workâin various applications. \u003cbr\u003e\u003cbr\u003eThe book includes a common vocabulary for communicating and understanding the scientific, regulatory, and business aspects of medical device design. Detailed case studies along with enlightening anecdotes demonstrate how prope\u003cbr\u003e\u003cbr\u003e\u003cb\u003eTable of Contents\u003c\/b\u003e\u003cbr\u003eMessage to Students\u003cbr\u003eMessage to Instructors\u003cbr\u003eCHAPTER 1 Just 100 Years Ago\u003cbr\u003e   Learning Objectives\u003cbr\u003e   New Terms\u003cbr\u003e   If You Were Born Just 100 Years Sooner\u003cbr\u003e   How Things Have Changed\u003cbr\u003e   Summary\u003cbr\u003e   Study Questions\u003cbr\u003e   Thought Questions\u003cbr\u003e   References\u003cbr\u003eCHAPTER 2 President Eisenhower’s Heart Attack\u003cbr\u003e   Learning Objectives\u003cbr\u003e   New Terms\u003cbr\u003e   September 1955\u003cbr\u003e   Electrocardiogram (ECG)\u003cbr\u003e   Oxygen Tent\u003cbr\u003e   Oxygen Therapy\u003cbr\u003e   A Half Century after the President’s Heart Attack\u003cbr\u003e   Foundations for Medical Device Advancement\u003cbr\u003e   Ike: Resilience Thanks to Biomedical Engineering\u003cbr\u003e   Summary\u003cbr\u003e   Study Questions\u003cbr\u003e   Thought Questions\u003cbr\u003e   References\u003cbr\u003eCHAPTER 3 Events That Built Our Key Regulations and Practices\u003cbr\u003e   Learning Objectives\u003cbr\u003e   New Terms\u003cbr\u003e   Food and Drug Administration and the Food, Drug, and Cosmetic Act of 1938\u003cbr\u003e   Early Good Manufacturing Practices and the National Institutes of Health\u003cbr\u003e   Elixir of Sulfanilamide\u003cbr\u003e   Current Good Manufacturing Practices and FDA 21 CFR Part 820\u003cbr\u003e   Medical Device Amendments Act of 1976\u003cbr\u003e   Safe Medical Devices Act of 1990 and Design Controls\u003cbr\u003e   International Standards Organization (ISO) 13485\u003cbr\u003e   Summary\u003cbr\u003e   Study Questions\u003cbr\u003e   Thought Questions\u003cbr\u003e   References\u003cbr\u003eCHAPTER 4 Thalidomide\u003cbr\u003e   Learning Objectives\u003cbr\u003e   New Terms\u003cbr\u003e   Thalidomide Tragedy\u003cbr\u003e   The Power of One FDA Reviewer\u003cbr\u003e   Animal Models and Pregnancy\u003cbr\u003e   Kefauver-Harris Drug Amendments Act of 1962\u003cbr\u003e   Advancing Animal Models\u003cbr\u003e   Summary\u003cbr\u003e   Study Questions\u003cbr\u003e   Thought Questions\u003cbr\u003e   References\u003cbr\u003eCHAPTER 5 The Dalkon Shield\u003cbr\u003e   Learning Objectives\u003cbr\u003e   New Terms\u003cbr\u003e   Preamendment Status\u003cbr\u003e   Dalkon Shield\u003cbr\u003e   Medical Devices Amendments of 1976\u003cbr\u003e   Summary\u003cbr\u003e   Study Questions\u003cbr\u003e   Thought Questions\u003cbr\u003e   References\u003cbr\u003eCHAPTER 6 Understanding Today’s Food and Drug Administration\u003cbr\u003e   Learning Objectives\u003cbr\u003e   New Terms\u003cbr\u003e   FDA Mission\u003cbr\u003e   Cost and Time to Market\u003cbr\u003e   FDA Structure\u003cbr\u003e   Summary\u003cbr\u003e   Study Questions\u003cbr\u003e   Thought Questions\u003cbr\u003e   References\u003cbr\u003eCHAPTER 7 Preparing a Regulatory Strategy\u003cbr\u003e   Learning Objectives\u003cbr\u003e   New Terms\u003cbr\u003e   FDA’s Rationale for Medical Device Classification\u003cbr\u003e   Determining Your Regulatory Strategy\u003cbr\u003e   Advanced (But Important to Know About) Strategies\u003cbr\u003e   Summary\u003cbr\u003e   Study Questions\u003cbr\u003e   Thought Questions\u003cbr\u003e   References\u003cbr\u003eCHAPTER 8 Foundations of Clinical and Preclinical Research\u003cbr\u003e   Learning Objectives\u003cbr\u003e   New Terms\u003cbr\u003e   Living Subjects Research\u003cbr\u003e   Animal Research Strategies\u003cbr\u003e   Clinical Trials\u003cbr\u003e   Summary\u003cbr\u003e   Study Questions\u003cbr\u003e   Thought Questions\u003cbr\u003e   References\u003cbr\u003eCHAPTER 9 Clinical Study Strategies\u003cbr\u003e   Learning Objectives\u003cbr\u003e   New Terms\u003cbr\u003e   Impact of Clinical Study on Design Planning\u003cbr\u003e   Reasons for Clinical Testing\u003cbr\u003e   Summary\u003cbr\u003e   Study Questions\u003cbr\u003e   Thought Questions\u003cbr\u003e   References\u003cbr\u003eCHAPTER 10 Kyphon and Reimbursement\u003cbr\u003e   Learning Objectives\u003cbr\u003e   New Terms\u003cbr\u003e   The Lawsuit Involving Kyphon, Inc.\u003cbr\u003e   What Is Reimbursement?\u003cbr\u003e   Summary\u003cbr\u003e   Study Questions\u003cbr\u003e   Thought Questions\u003cbr\u003e   References\u003cbr\u003eCHAPTER 11 Navigating Codes for Reimbursement\u003cbr\u003e   Learning Objectives\u003cbr\u003e   New Terms\u003cbr\u003e   Current Procedural Terminology Codes\u003cbr\u003e   International Classification of Diseases Codes\u003cbr\u003e   Diagnosis-Related Groups\u003cbr\u003e   Healthcare Common Procedure Coding System and Durable Medical Equipment, Prosthetics, Orthotics, and Supplies\u003cbr\u003e   Summary\u003cbr\u003e   Study Questions\u003cbr\u003e   Thought Questions\u003cbr\u003e   References\u003cbr\u003eCHAPTER 12 Device-Associated Infections\u003cbr\u003e   Learning Objectives\u003cbr\u003e   New Terms\u003cbr\u003e   Nosocomial Infection (aka HAI)\u003cbr\u003e   Biofilms and Implant Failure\u003cbr\u003e   Surface Treatment to Prevent Infection\u003cbr\u003e   Summary\u003cbr\u003e   Study Questions\u003cbr\u003e   Thought Questions\u003cbr\u003e   References\u003cbr\u003eCHAPTER 13 Designing for Postmarket Safety\u003cbr\u003e   Learning Objectives\u003cbr\u003e   New Terms\u003cbr\u003e   Long-Range Data Come Only After a Product Is on the Market\u003cbr\u003e   Medical Device Reclassification\u003cbr\u003e   Summary\u003cbr\u003e   Study Questions\u003cbr\u003e   Thought Questions\u003cbr\u003e   References\u003cbr\u003eCHAPTER 14 Designing for Biocompatibility and Infection Prevention\u003cbr\u003e   Learning Objectives\u003cbr\u003e   New Terms\u003cbr\u003e   Biocompatibility\u003cbr\u003e   Cleaning, Disinfection, and Sterilization\u003cbr\u003e   Summary\u003cbr\u003e   Study Questions\u003cbr\u003e   Thought Questions\u003cbr\u003e   References\u003cbr\u003eCHAPTER 15 Designing for the Use Case\u003cbr\u003e   Learning Objectives\u003cbr\u003e   New Terms\u003cbr\u003e   Equipment Management in the Clinic\u003cbr\u003e   Patient Adherence\u003cbr\u003e   Summary\u003cbr\u003e   Study Questions\u003cbr\u003e   Thought Questions\u003cbr\u003e   References\u003cbr\u003eCHAPTER 16 The Landscape for Medical Devices in the Twenty-First Century\u003cbr\u003e   Learning Objectives\u003cbr\u003e   New Terms\u003cbr\u003e   Goals for Improving Outcomes\u003cbr\u003e   Increased Regulation\u003cbr\u003e   Internet of Medical Things\u003cbr\u003e   Heart Surgery\u003cbr\u003e   Data\u003cbr\u003e   Pandemic\/Summary\u003cbr\u003e   Study Questions\u003cbr\u003e   Thought Questions\u003cbr\u003e   References\u003cbr\u003eIndex\u003cbr\u003e","brand":"McGraw-Hill Education","offers":[{"title":"Default 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