12/01/2026
Episode: Why “Patient-Matched” Is Not the Same as “Custom-Made”
“Custom-made” and Patient-Matched are often used as if they mean the same thing.
They are not.
A simple analogy:
Even a tailored suit is always the same suit —
it is only adapted to the person’s body.
Patient-Matched implants work the same way.
They are not improvised designs created from scratch for each case.
They are standardized medical devices, developed within defined and validated thresholds, and adapted to each patient’s anatomy.
What “Patient-Matched” Really Means
A Patient-Matched implant must fulfill all the requirements of a standard implantable medical device, while allowing controlled anatomical adaptation.
This includes documented evidence of:
✔ Design & Development
Defined design envelope, intended use, and limits — not case-by-case improvisation
✔ Biocompatibility Analysis
According to ISO 10993, performed on the final medical device
✔ Mechanical Testing
Validation of strength, fatigue resistance, and failure modes under clinical loads
✔ Manufacturing Contamination Control
Control of core and surface contamination (e.g., SEM / EDS)
✔ Bioburden Evaluation
Defined and controlled microbial load prior to sterilization
✔ Sterilization Validation
Proven, repeatable, and validated sterilization processes
✔ Shelf-Life Validation
Evidence that sterility and device integrity are maintained until the end of the declared shelf life
✔ Clinical Evidence / Clinical Evaluation
Documented safety and performance — not assumptions
What “Custom-Made” Often Means in Practice
In many real-world situations, “custom-made” is used to describe devices that:
Lack defined design limits
Have no mechanical validation
Have no biocompatibility testing on the final implant
Are manufactured outside controlled medical environments
Have no validated shelf life
👉 This is adaptation without validation.
Why This Difference Matters for Surgeons
“Custom” does not mean unregulated
Anatomical fit does not equal biological or mechanical safety
Absence of shelf-life validation means unknown sterility over time
In case of complications, the surgeon is the first point of accountability
Our Position
At BoneEasy, Patient-Matched means:
Standardized safety + validated adaptation + controlled lifecycle.
From design to implantation — and beyond.
Call to Action — For Surgeons
🔹 Ask if the device is Patient-Matched or only “custom”
🔹 Ask for proof of design validation thresholds
🔹 Ask for biocompatibility, mechanical, contamination, and sterilization evidence
🔹 Ask for shelf-life validation documentation
🔹 Choose adaptation without sacrificing standards
Because adaptation is not validation —
and patient safety depends on knowing the difference.
