Introduction: Biomaterials in Medical Devices

Frederick J. Schoen, Guigen Zhang

Research output: Chapter in Book/Report/Conference proceedingChapterpeer-review


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.

Original languageEnglish
Title of host publicationBiomaterials Science
Subtitle of host publicationAn Introduction to Materials in Medicine
Number of pages3
ISBN (Electronic)9780128161371
StatePublished - Jan 1 2020

Bibliographical note

Publisher Copyright:
© 2020 Elsevier Inc. All rights reserved.


  • Bench-to-bedside translation
  • Device failure
  • Implant retrieval and analysis
  • Legal concepts
  • Moral and ethical issues
  • Product
  • Regulatory constraints
  • Safety and risk
  • Standards
  • Sterilization and disinfection
  • Verification and validation

ASJC Scopus subject areas

  • General Medicine
  • General Biochemistry, Genetics and Molecular Biology


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