Biomedical Product and Materials Evaluation

Standards and Ethics

P.V. Mohanan

• Publisher: Woodhead Publishing
• Year: 2022
• ISBN:
  9780128241738
• Topic: Technology & Engineering
• Subtopic: Materials Science
• Index: Technology & Engineering

Biomedical Product and Materials Evaluation: Standards and Ethics provides a much-needed overview of the procedures, issues, standards and ethical issues in the early development of biomedical products. The book covers a range of key biomedical products, from 3D printed organs and blood derived products, to stem calls and decellularized tissue products. Each chapter reviews a single product type, associated materials, biomedical applications, proven development strategies, and potential challenges. The core focus of the book is on the standardization and ethical aspects of biomedical product development, with these elements addressed and discussed in chapters dedicated to product evaluation.

This is a useful reference for academics, researchers and industry professionals in R&D groups with an interest in biomaterial research and production, as well as those working in the fields of biomedical engineering, biotechnology and toxicology.

• Covers a variety of biomedical products, including specific biomaterials, organs-on-chips, wound care products, combinational products, and more
• Delves into strategies and considerations for product evaluation, including cytotoxicity assays, microbial and blood compatibility studies
• Discusses standardization and ethical hurdles in biomedical product development and how to overcome them

Table of contents

• Cover image
• Title page
• Table of Contents
• Copyright
• List of contributors
• Preface
• 1. Overview of medical device development
• 2. Biomaterials for medical products
• 3. Evaluation of polymeric biomaterials used as wound care products
• 4. Nanofibers: promising wound-healing material with modifiable flexibility
• 5. Three-dimensional bioprinting of tissues and organs
• 6. 3D printed organ for healthcare applications
• 7. Overcoming the barriers of two-dimensional cell culture systems with three-dimensional cell culture systems: techniques, drug discovery, and biomedical applications
• 8. Blood-derived products
• 9. Medical products from stem cells
• 10. An overview of legal and regulatory challenges of biological products
• 11. The evolving regulatory framework for next-generation stem cell–based pharmaceutical products
• 12. Regulatory issues in biological products
• 13. In vitro cytotoxicity and cytocompatibility assays for biomaterial testing under regulatory platform
• 14. Ethical issues in animal experimentation
• 15. Product evaluation: cytotoxicity assays
• 16. Product evaluation: safety and toxicity studies
• 17. Product evaluation: blood compatibility studies
• 18. Product evaluation: Necropsy and Histopathological methods
• 19. Toxicity studies of biomedical products
• 20. Alternatives to animal testing: concepts, state of art, and regulations
• 21. Toxicity testing of natural products using the zebrafish model system
• 22. Engineered in vitro models: mimicking in vivo physiology
• 23. Organ-on-a-chip for toxicity evaluation
• 24. Therapeutic applications of probiotics and its regulatory framework
• 25. Microbes as biomedicinal minifactories and medical product evaluation models
• 26. Neurotoxicity assays
• 27. Sterilization for biological products
• Index