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Plain metallic biomaterials: opportunities and challenges
Jiazhen Zhang1, Bao Zhai1, Jintao Gao2
1Center for Medical Device Evaluation, National Medical Product Administration, Beijing 100081, China.
Regenerative Biomaterials
|January 23, 2023
Summary
Plain metallic biomaterials (PMBs) are introduced for sustainable development, focusing on pure titanium and magnesium. This research explores their features, benefits, challenges, and regulatory aspects for medical devices.
Area of Science:
- Materials Science
- Biomaterials Engineering
- Sustainable Materials Development
Background:
- The concept of 'plainification of materials' aims to enhance sustainable material development.
- Existing biomaterials often involve complex compositions or processing.
- There is a need for simpler, high-performance biomaterials.
Purpose of the Study:
- To propose and define 'plain metallic biomaterials (PMBs)' for the first time in the biomaterials field.
- To present research and application case studies of PMBs.
- To analyze the technical and regulatory challenges associated with PMBs.
Main Methods:
- Conceptualization and definition of PMBs.
- Review of research and application case studies for pure titanium and magnesium.
- Analysis of technical challenges and regulatory landscapes.
Main Results:
- Demonstrated research and application cases of pure titanium (high strength, toughness) and magnesium (biodegradable, fine-grained, high-purity) as PMBs.
- Identification of key features, benefits, and opportunities of PMBs.
- Analysis of technical hurdles and regulatory considerations for PMB commercialization.
Conclusions:
- PMBs offer a promising avenue for sustainable biomaterial development.
- Addressing technical and regulatory challenges is crucial for the successful adoption of PMBs in medical devices.
- Further research and development are supported by regulatory perspectives provided.
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