Foundations and Strategies for Medical Device Design

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