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Technology and Workflow: The "Point-of-Care" Shift


In 2026, the workflow has moved closer to the patient. Many large hospitals now have In-House 3D Printing Centers that can produce surgical models and even simple implants on-site.

Regulatory and Ethical Landscape

As of 2026, the EU Medical Device Regulation (MDR) and the FDA have established rigorous "custom-made device" pathways. While these regulations ensure safety, the challenge remains the high initial cost of the technology and the lack of universal insurance reimbursement in some regions. However, the long-term savings—fewer revision surgeries and faster return to work—are making 3D-printed implants a top priority for global health systems.

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