Foundations and Strategies for Medical Device Design

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 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 practicesThaldomide and the Dalkon shieldUnderstanding today’s FDAPreparing a regulatory strategyClinical and pre-clinical researchClinical study planningKyphon and reimbursementNavigating codes for reimbursementDevice-associated infectionsDesigning for post-market safetyDesigning for biocompatibilityDesigning for the use caseThe 21st century design landscape