Can custom foot orthoses be 3D printed to the standard of milled polypropylene?

Yes. Australian podiatry labs already do it in production. iOrthotics, in Mackay, prints custom orthoses on HP Multi Jet Fusion. With the University of Queensland, it tested materials against traditional polypropylene before switching. It now produces more than 100 pairs a day, roughly four times its earlier output, with orders shipped within three to five business days (iOrthotics case study).

Whether a printed device suits a particular patient is a clinical decision. The printer and material are only part of that.

What else can be 3D printed besides insoles?

Most custom orthoses that are moulded or laminated today can be printed. Examples:

• Spinal and cervical: Massons Healthcare in Sydney prints custom Cervical Thoracic Orthoses (CTOs) on an HP Jet Fusion 5200, which we installed (Massons case study).
• Ankle foot orthoses: Crispin Orthotics in the UK prints dynamic AFOs with a leaf spring at the back. They report it costs about half as much to produce as a carbon fibre equivalent (Crispin case study).
• Prosthetic sockets, hand and wrist orthoses, and cosmetic covers: also printed in production elsewhere.

What suits printing best are devices with complex shapes, variable wall thickness or ventilation cut-outs. Those are hard to mould and easy to print.

We already use CNC and vacuum forming. Why change?

Usually labour, waste and consistency. When Massons Healthcare moved its CTOs from double vacuum moulding to HP MJF, we ran a time-and-motion study with them. Hands-on labour per orthosis fell from nearly five hours to about one hour forty minutes, a cut of around 60%. Plastic waste per device fell from about 45 litres to 375 millilitres. Wall thickness also became consistent, which it wasn't with vacuum moulding.

Your numbers will depend on the device and your current process. That's why we start with a benchmark on your own parts (see below).

How much material waste does printing save?

A lot, because you only fuse the material that becomes the device. iOrthotics reported about 1.4 kg of waste per milled polypropylene device against under 5 g printed. Across 10,000 devices a year, that's roughly 14 tonnes against 50 kg. For insoles, HP's customer research puts it at about 2.1 kg of waste for a 77 g pair made by hand, against about 100 g printed.

Unfused powder is reused: HP rates PA 12 and PA 11 Gen2 at up to 80% surplus powder reusability, and first-generation PA 11 at up to 70%.

PA 11 or PA 12 for orthotics?

• PA 11 is the usual choice where a device needs to flex and take repeated impact. HP lists prostheses and insoles among its uses. On HP's Jet Fusion 5200 datasheets it reaches 40% elongation at break (XY) and 25% (Z), against 17% and 9% for PA 12. HP describes it as a "bio-based material, derived from vegetable castor oil". Massons chose PA 11 for its CTOs for that balance of strength and flexibility.
• On the Jet Fusion 5600 series, HP's PA 11 is HP 3D HR PA 11 Gen2, enabled by Arkema, which HP says is "commonly used for orthotics and prosthetics".
• PA 12 is stiffer and is HP's general-purpose production material. iOrthotics and Crispin both print in it.

The right choice depends on the device design. A rigid shell and a spring element want different things. HP's figures are typical values, not specifications (HP materials).

Is the material safe against skin?

At material level, HP states that both HP 3D HR PA 12 and HP 3D HR PA 11 meet USP Class I–VI and US FDA guidance for Intact Skin Surface Devices. HP's certificates list the tests behind this, including cytotoxicity (ISO 10993-5) and irritation and skin sensitisation (ISO 10993-10), on parts printed from fresh powder. PA 11 Gen2, used on the Jet Fusion 5600 series, has its own documentation: ask us for HP's current statement.

That is a statement about the raw material. It doesn't certify a finished device. Dyes, coatings and finishing processes, and the device's design and use, are the manufacturer's to assess.

Does a 3D printed orthosis need TGA approval?

Increasingly, yes, and the rules are tightening.

• The printer isn't a medical device. The device it makes is. The obligations sit with whoever manufactures the device for the patient, usually the lab or clinic.
• Most printed orthoses are patient-matched medical devices. They are made to one patient's scan, within a design envelope the manufacturer has validated. Only a narrow group of truly one-off devices counts as "custom-made".
• Patient-matched devices must be included in the ARTG by 1 July 2029, unless an exemption applies. That's the Australian Register of Therapeutic Goods. Transition arrangements apply until then. Check your own position with the TGA.
• The Essential Principles apply now, not in 2029. They cover safety and performance, including biocompatibility and clinical evidence.
• It reaches past the printer. Some inputs, including software, can be regulated in their own right.

It's complex, and the time to start is well before 2029. We can supply the material documentation (HP datasheets and biocompatibility summaries) for your technical file, and help you plan the workflow. For your specific obligations, talk to the TGA or a regulatory adviser.

Will printed orthoses last?

They can. Crispin Orthotics put its printed PA 12 AFO through more than 500,000 cycles of repetitive loading without visible change. Durability still depends on the design, wall thickness and orientation of each device.

One thing to know: MJF parts have essentially the same properties in every direction, regardless of print orientation. On HP's figures for PA 12, tensile strength (50 MPa) and stiffness (1,900 MPa) are identical across the build (XY) and in the build direction (Z), and impact strength is close (4.2 and 3.8 kJ/m²). Parts made by laser sintering (SLS) typically vary much more with build direction.

The one property that does change with direction in MJF PA 12 is how far it stretches before breaking: 17% across the build against 9% in the build direction (HP figures). SLS nylon shows the same pattern; even so, HP reports MJF parts reach about 50% more elongation at break in Z than parts from SLS printers. Flexing features such as clips and hinges should be oriented and designed with that in mind, or made in PA 11.

The surface matters too. HP describes its PA 12 parts as high-density and watertight without any additional post-processing, whereas SLS parts are typically porous. A dense, watertight device is easier to keep clean, which supports hygiene and infection control in the clinic.

What does the workflow look like?

1. Scan the patient, or scan a cast.
2. Design in your O&P CAD software.
3. Prepare and nest the build.
4. Print.
5. Finish: bead blasting as standard, then dyeing, vapour smoothing or sealing as needed.
6. Fit.

The printer takes over from steps 3 to 5. Because every device is a file, a replacement is a reprint, not a remake.

For insoles, our workflow is built around design software from Artura3D, an Australian insole design software company in Keysborough, Victoria. We'll add other packages as we validate them.

How many devices can one printer make?

It depends on device size and how densely they pack. On MJF, a full build doesn't take longer per layer than a nearly empty one, so packing more devices into a build costs very little extra time.

• iOrthotics reached more than 100 pairs of foot orthoses a day.
• Massons prints up to six prosthetic sockets in a single build.
• HP's own example: one build of about 60 pairs of insoles, or several adult ankle foot orthoses, in about 16 hours.

We work out the real figure for your devices during a benchmark.

Can we test it on our own devices before buying?

Yes, and we'd recommend it. A benchmark is free. For Massons we ran benchmark parts and a workflow simulation, then the time-and-motion study, before the decision was final. Send us a representative, de-identified design file. We'll show you how it prints and finishes, and what it changes in your workflow.

We can also arrange a live demonstration of the printers running. Ask us and we'll suggest the most convenient option.

Which printer suits an O&P lab?

It depends on volume.

• The HP Multi Jet Fusion 1200 is HP's compact industrial MJF system (12-litre build), for labs starting in-house production. It runs PA 12 at launch, and it's on pre-order now, with general availability expected in Q2 2027 (see the 1200 FAQ).
• The HP Jet Fusion 5200 and 5600 Series suit higher, steady production volumes. HP positions the 5600 for production environments of 550+ parts a week.

We'll size it from your device mix and weekly numbers, not from the brochure (compare the printers).

What finishing do printed orthoses need?

At minimum, bead blasting to remove loose powder and even out the surface. Common next steps:

• dyeing (black is typical)
• vapour smoothing, for a sealed, smoother surface
• a lacquer or sealant

Massons added moisture-wicking foam liners and hook-and-loop straps to finish its CTOs.

Vapour smoothing equipment is a separate system (optional extra).

Can you print soft, cushioning insoles, not just rigid orthoses?

Yes. Rigid orthoses suit MJF nylon, but many patients need cushioning, and that calls for a soft, foamed material.

That's what the IdeaFOAMer is for. It's our insole print solution, built on the IdeaFormer IR3 V2 belt printer and set up as a dedicated, controlled production workflow for foaming TPU insoles. The belt lets insoles print one after another, and our setup is designed to help keep foam density and finish consistent from one insole to the next.

A lab can use both: MJF for rigid shells and orthoses, and the IdeaFOAMer for soft insoles and top layers. Results depend on the design and material. Once the first units are available, we can print samples from your de-identified design files.

What should we NOT do when moving to 3D printing?

• Don't just copy a milled or moulded design into the printer. The gains come from redesigning: variable wall thickness, ventilation, fewer parts. Massons and Crispin both redesigned.
• Don't treat a printable shape as a clinically approved device. Validate the device, as Crispin did with its 500,000-cycle test.
• Don't size a printer from the brochure. Benchmark your own devices first.
• Don't assume compliance comes with the printer. Plan your TGA pathway, including your software, from day one (see the TGA question).
• Don't ignore finishing time. Bead blasting, dyeing and smoothing are part of the real labour figure.
• Don't choose a supplier on the machine alone. Look at their after-sales service capability and their application engineering experience. Ask how long they've been in 3D printing, and who they've installed for. When a build fails or a new device needs developing, experience counts.