Foundations and Strategies for Medical Device Design
1st Edition
126045696X
·
9781260456967
© 2021 | Published: June 1, 2021
Cutting-edge medical device design techniques, strategies, and insightsA 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 …
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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 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
Cutting-edge medical device design techniques, strategies, and insights
A 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. Foundations and Strategies for Medical Device Design contains special and specific design approaches and clear discussions on why each method works?or doesn’t work?in various applications.
The 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 proper oversight can avoid missed opportunities and catastrophic failures.
Coverage includes:
A 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. Foundations and Strategies for Medical Device Design contains special and specific design approaches and clear discussions on why each method works?or doesn’t work?in various applications.
The 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 proper oversight can avoid missed opportunities and catastrophic failures.
Coverage includes:
- Key regulations and practices
- Thaldomide and the Dalkon shield
- Understanding today’s FDA
- Preparing a regulatory strategy
- Clinical and pre-clinical research
- Clinical study planning
- Kyphon and reimbursement
- Navigating codes for reimbursement
- Device-associated infections
- Designing for post-market safety
- Designing for biocompatibility
- Designing for the use case
- The 21st century design landscape