Medical and dental: where does metal 3D printing fit in and what does the regulation require?
Dental is, by far, the sector where additive manufacturing in metal is already routine, not a novelty. Medical is progressing more slowly, and for a reason that isn't technical: here, the product isn't sold until a regulatory body approves it.
Where does it fit in today
Dental prostheses. Crown and bridge structures, cantilevers, implant-supported bars, removable partial dentures. This is the perfect application for this technology: each part is unique, they are small, dozens fit on a build plate, and the digital workflow already existed —intraoral scanner, design, and manufacturing— long before printed metal arrived. A dental lab that mass-produces unique units is precisely the problem that additive manufacturing solves best.
Custom-made implants. Craniofacial, maxillary, reconstruction plates, interbody cages. They are designed based on the patient's specific CT scan. Here, the value isn't the cost: it's that the implant fits into an anatomy unlike any other, and that shortens the operating room time, which is where the real money and risk lie.
Standard implants with a porous surface. Hip cups, vertebral bodies, knee components. And here's what makes this technology irreplaceable: a controlled porosity lattice can be manufactured integrated into the part itself, with the appropriate pore size for bone to grow within it. No subtractive process can do that. The family of structures is in lattices.
Surgical instruments and guides. Patient-specific cutting guides, drilling templates, and specialized instruments for short runs. Many guides are made of polymer, but instruments that need to be sterilized repeatedly and withstand heavy loads are not.
The materials
| Alloy | Where |
|---|---|
| Ti-6Al-4V ELI | Implants. Biocompatible, elastic modulus closer to bone than steel, and accepts porous surfaces. The ELI version is the low interstitial version, which is used in implants |
| Cobalt Chromium (CoCr) | Dental and articular surfaces: hardness and wear resistance |
| Surgical Stainless Steel | Instruments and non-implantable parts |
| Commercially Pure Titanium | When biocompatibility takes precedence over strength |
The complete catalog is in materials.
The three technical details that decide the result
The surface. The goal of an implant is not a smooth surface: it's the correct roughness and porosity needed for bone integration. It's one of the few cases in the industry where a rough finish isn't a defect but a function—but it has to be the finish specified, measured, not just whatever happens to be there.
Loose powder. A porous lattice within an implant is a perfect trap for unmelted particles, and this isn't just a weight issue: it's a clinical problem. The powder removal procedure and its validation are part of the dossier, not a shop floor task.
Orientation and anisotropy. The same geometry manufactured in two different orientations does not have the same properties. In a part that will withstand cyclic loading within a person, this is recorded and documented. It is found in anisotropy and orientation.
What the regulations require
This is the real barrier, and it's best to face it head-on before investing:
| What | What it entails |
|---|---|
| European Medical Device Regulation (MDR) | Product classification, clinical evaluation, technical dossier, and notified body for almost all implantable devices |
| ISO 13485 | Industry-specific quality management system. It's the equivalent of AS9100 in aerospace |
| Biocompatibility (ISO 10993) | Tests on the material and on the actual finished part, not on the starting powder |
| Frozen process | Machine, powder, parameters, heat treatment, and cleaning. Changing any of these requires a review |
| Unit traceability | Each part, with its powder batch and manufacturing record. In custom implants, it's also linked to a patient |
| Cleaning and sterilization validation | And demonstrating it, not just claiming it |
The general map of additive manufacturing standards is in ISO/ASTM standards, and how to qualify a part, in LPBF part qualification.
Where to enter
Just like in aeronautics, with the steps in order: start with what isn't implanted. Anatomical models, guides, instruments, laboratory equipment. You learn the process with real parts, without a regulatory file in between, and when the time comes for implantable procedures, you're no longer learning two things at once.
And a fundamental decision that should be made soon: whether to control the process or outsource it. In a sector where every parameter must be documented, having your own software and parameters ceases to be a convenience and becomes what allows you to sign off on the process. It's the same argument as for proprietary technology, applied where it matters most.
If you want to know what a specific part would cost before getting involved in anything, the quote calculator tells you with the geometry you already have.
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