Table 4.
The ideal quality dimensions of porous internal architecture of Ti bone implants.
Quality Approach | Dimension | Description |
---|---|---|
Product-based approach | Performance | The porous microstructure should provide an environment ideal for bone ingrowth and endow the implant with a stiffness similar to natural human bone while maintaining sufficient strength. |
Features | Tailored internal architecture with specific properties, including but not limited to pore size, unit cell, porosity, elastic modulus, interconnectivity, compressive yield, and ultimate strength, as well as fatigue strength. | |
Reliability | Optimised fabrication of porous Ti structures with high mechanical strength as well as a high degree of reproducibility, minimal defects, and zero failure rates (within their life expectancy). | |
Manufacturing-based approach | Manufacturability | The scaffold’s micro-geometry should be designed in such a way that it is easy to manufacture with high accuracy and definition. |
Conformance | The mechanical, geometrical, and dimensional characteristics should comply with medical regulations and quality standards. | |
Durability | Porous Ti structures should withstand mechanical forces experienced during handling, implantation surgery, and operation thereafter in a traumatised bone microenvironment constantly under load. | |
User-based approach | Perceived quality | Clinicians should have access to relevant characteristics through medical reports and statistical data where implant performance can be seen. |