Exploration of BioMat-X

Table 1. Practical comparison points when choosing off-the-shelf versus patient-specific additively manufactured implants (AM).

Domain	Off-the-shelf (strengths/typical limits)	Patient-specific/AM (potential gains/new risks)
Evidence base	Large registries; established survivorship; predictable instrumentation	Smaller series; indication creep; often mid-term parity
Biomechanics	Well-characterised stiffness; known stress-shielding patterns	Stiffness tuning via lattices; fatigue/process variability
Biological integration	Proven surface finishes/coatings; predictable osseointegration	Porosity/graded structures; vascular barrier risk; assessment heterogeneity
Revision strategy	Standardised explant tools; modular exchange	Over-conformity and deep ingrowth complicate removal; must design exit strategy
Workflow & cost	Short planning time; lower unit cost	Virtual surgical planning (VSP)/design iterations; manufacturing lead time; higher unit cost; QA burden
Regulatory & liability	MDR/FDA cleared for broad use; manufacturer liability	“Custom-made” exemption status; increased institutional & surgeon liability for design

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Declarations

Author contributions

FT: Conceptualization, Validation, Writing—original draft, Writing—review & editing. BJ: Investigation, Writing—review & editing. TB: Investigation, Writing—review & editing. ED: Investigation, Writing—review & editing. FW: Conceptualization, Validation, Writing—original draft, Supervision. All authors read and approved the submitted version.

Conflicts of interest

The authors declare that they have no conflicts of interest.

Ethical approval

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