Introduction: Biomaterials in Medical Devices

The chapters that comprise Part 3 of this text summarize key principles and provide a “toolkit” for medical device innovation. They discuss total product life cycle for medical devices, safety and risk management, sterilization and disinfection consideration, verification and validation, bench-to-bedside translation, regulatory pathways and constraints, role of standards for testing of biomaterials, implant retrieval, evaluation and analysis, and legal and ethical concerns over the use of biomaterials in medical devices.