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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:
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