Patient-Specific 3D-Printed Implants
Mapping the printer-material stacks, QA tools, and regulatory strategies to enable CE- and FDA-cleared patient-specific titanium implants for complex orthopaedic reconstruction.
Client
UK Orthopaedic Firm
Objective
Enable Cleared Patient-Specific Implants
Timeline
10-Week Program
Key Focus
Reproducibility & Sterilisation
The Challenge: From Digital Twin to Sterile Implant
While 3D printing can perfectly replicate a patient's anatomy, three intertwined barriers keep these "digital-twin" implants from routine clinical use: ensuring consistent mechanical properties, validating sterility for porous structures, and navigating the complex regulatory pathways for software-defined medical devices.
Key Outcome: A Validated, Cost-Effective Production Stack
Our analysis ranked five end-to-end production pathways. The top-ranked solution met all mechanical, sterility, SaMD, and cost targets, providing a clear path to commercialisation.
Top-Ranked Solution: LPBF + In-Process AI + Low-Temp X-Ray
118 MPa
Compressive Yield (±7%)
<12 EU
Endotoxin Level
IEC 62304
SaMD Class B Compliant
~£2,900
All-In Cost Per Implant
Strategic Impact
Based on our findings, the client is proceeding with a 50-implant pilot across two UK trauma centres. A clear regulatory path has been defined, including an FDA Breakthrough Device request.
Successful validation will establish a robust pathway for patient-specific implants, unlocking new revenue streams and saving an estimated 2 hours of operating room time per procedure.