Silicone 3D printing has gained ground faster in aerospace, audiology, consumer electronics, and soft robotics than in healthcare. Its healthcare uses remain concentrated in training models, surgical devices, and early research.
Meanwhile, other 3D printing technologies have entered implant production, medical device manufacturing, and everyday clinical practice. Silicone AM seems a natural fit for healthcare. Yet this is one of the sectors where adoption remains most cautious.
With that in mind, this opinion piece explores why that gap persists. It also examines the companies building the ecosystem that could help close it.
A material that defies easy printing
Silicone is a thermoset elastomer. Unlike thermoplastics, it cannot melt and then re-solidify. This rules out widespread AM processes such as FFF, SLS, and most standard SLA workflows.
Silicone starts as a liquid. Vulcanization then gives it structure, using heat, UV light, or a chemical catalyst, depending on the system.
Its viscosity differs from that of a photopolymer resin, and it collapses without support. In two-part extrusion systems, the materials must mix at precise ratios during printing. The process also needs tight control of temperature, humidity, and nozzle pressure. Standard AM workflows do not normally provide that level of control.
Many silicone formulations are transparent, which also makes visual checks of layer quality unreliable. Consequently, the process requires dedicated machines and materials. This demanding setup remains uncommon in clinical environments.
Who is building this space: a market update
Despite these barriers, a small group of companies has spent years developing silicone AM’s technical and commercial foundations. The field has matured. However, it remains far from mainstream, including in healthcare.
Lynxter: a decade of development
Lynxter (France) celebrates its tenth anniversary this year as a globally recognized leader in the field. The company began in the Basque Country in 2016, with healthcare among its earliest interests.
Co-founder Thomas Batigne initially modified a printer to produce prototype dressings. These supported wound-healing research at Rangueil University Hospital in Toulouse.
A decade later, Lynxter’s S300X – LIQ21|LIQ11 processes medical-grade RTV2 silicone. Lynxter describes this material as compliant with ISO 10993-5 cytotoxicity testing.
Its machines now operate within AP-HP’s PRIM3D platform in Paris. This hospital-based AM hub develops medical simulators to reduce reliance on cadavers and animals in surgical training. Today, Lynxter operates in 43 countries and serves both aerospace and medical markets.
Spectroplast: a chemistry-first approach
Spectroplast (Switzerland) began in 2018 as an ETH Zurich spinoff. Its proprietary SAM technology uses light-cured silicone to produce 100% pure silicone parts. The process offers resolution and surface quality that extrusion struggles to match.
As a contract manufacturer, Spectroplast manages the process for its customers.
The TrueSil series includes formulations tested for cytotoxicity and skin irritation under ISO 10993. Audiology has become one of its strongest clinical entry points, including hearing aids and custom ear protection.
In late 2024, Spectroplast closed a Series A funding round backed by AM Ventures and HZG Group.
3Deus Dynamics: finished models for hospitals
3Deus Dynamics (France) focuses its offering on healthcare and aerospace. Rather than sell machines, it supplies finished silicone anatomical models directly to hospital procurement teams. These include vascular, cardiac, and patient-specific models.
The company also works with medical device manufacturers during R&D and preclinical testing. In this way, it takes on the process complexity that clinicians would otherwise face.
Axtra3D: silicone on a photopolymerization platform
Axtra3D (USA) announced general availability of its silicone AM solution in April 2025. The launch introduced TrueSilX50, a formulation developed with Spectroplast for Axtra3D’s photopolymerization platform.
TrueSilX50 works with the Lumia X1 HPS platform. Target applications include anatomical models, wearable medical devices, and vascular models. Although silicone is not a core offering, the launch represents a step toward scalable, production-grade silicone AM.
However, Axtra3D’s April 2025 announcement described biocompatibility testing as ongoing. Spectroplast’s May 2025 X50 data sheet also listed cytotoxicity and skin irritation as not yet tested. Neither document establishes suitability for a finished medical device.
InnovatiQ: liquid silicone rubber
InnovatiQ (Germany) was formerly German RepRap and is now part of the Arburg group. It has processed liquid silicone rubber for years using LAM, or Liquid Additive Manufacturing. Its commercially available LiQ320 supports medical-grade LSR formulations.
Prayasta: working toward implant-grade silicone
Prayasta (India) focuses on implant-grade silicone. Its Silimac P250 uses IR laser curing to process materials too viscous for conventional silicone printers.
The company targets personalized breast prostheses and, further ahead, other soft tissue implants. It works with the Indian Institute of Science to bridge research and clinical deployment.
Stratasys: skin-contact applications
Stratasys recently partnered with silicone manufacturer Shin-Etsu to develop P3 Med Silicone 25A BioComp. The material targets medical production parts, including patient skin-contact devices and wearables.
Stratasys reports compliance with ISO 10993-5, -10 and -23. The Origin P3™ platform can process the material without tooling.
Why the adoption gap persists
Overall, the outlook is not entirely pessimistic. Companies have entered the field over the past decade, even as others have closed. There has been progress. Nevertheless, several factors still limit adoption in clinical settings.
Regulation and reimbursement
Soft implantable materials face demanding regulatory requirements. A technically successful printed part is only a starting point. The path to a cleared, reimbursable medical device can be long and uncertain.
Class III devices, including breast implants under the EU Medical Device Regulation, require clinical evidence as well as biocompatibility data. Other implants may fall into different classes.
Reimbursement has not caught up, and the dossier of this healthcare 3D printing edition helps to understand why.
Validated manufacturing workflows
General AM quality frameworks exist, but silicone-specific workflows still need validation. Hospital procurement and quality teams can already assess documented workflows for titanium powder bed fusion or photopolymer-based dental printing. Silicone AM needs comparable validated processes.
However, each vendor’s approach produces parts that behave differently under testing. Without a shared technical language, clinical validation becomes harder. Adoption therefore slows.
Silicone’s properties are both an advantage and a challenge. Its softness, elasticity, and transparency suit implants and simulators. At the same time, those properties make quality control difficult.
Hospital infrastructure
Many healthcare institutions cannot yet bring the technology in-house. AP-HP’s PRIM3D model stands out because it is exceptional. A dedicated AM platform operates inside a major hospital network, with professional staff.
Most clinical environments lack that infrastructure. Hospitals therefore rely on external service providers. This can add lead time, limit customization, and reduce clinicians’ awareness of the technology. For most use cases, the workflow is not yet point-of-care.
Where silicone 3D printing can change patient outcomes
Nevertheless, within the constraints above, several application categories are worth watching closely.
Surgical training and pre-operative planning
This is where silicone 3D printing has made its clearest progress. For example, the PRIM3D/Lynxter collaboration uses printed anatomical models to replicate tissue texture, compliance, and tactile behaviour. Rigid polymer models cannot reproduce those properties in the same way.
Leading hospitals already use silicone aortas for vascular surgery training and cardiac phantoms for interventional cardiology. Pediatric airway models also support anesthesia practice.
These training tools and planning aids do not require implant-grade clearance. Consequently, they face a lower barrier to adoption. 3Deus Dynamics has built its commercial model around this category.
Custom external prosthetics and epithetics
Traditional mold-casting has long produced silicone prostheses for ears, noses, facial reconstruction, and ocular applications. Digital scanning combined with silicone 3D printing offers a different workflow.
It removes iterative casting and trimming steps, shortens lead times, and can create geometries that a mold cannot produce.
Soft implantable and contact devices
Appropriate medical-grade silicone formulations have decades of use in breast prostheses, cochlear implant housings, and cardiovascular seals. That experience establishes their biocompatibility.
The challenge is whether AM can meet the requirements for implant-grade parts. These include dimensional precision, surface quality, and long-term mechanical stability.
Prayasta is working on the materials science behind this challenge. Meanwhile, Spectroplast documents specific ISO 10993 test results for its TrueSil A-series formulations. Those results do not establish implant suitability.
Wearable and monitoring devices
Flexible electronics, patient-worn sensors, drug delivery patches, and soft orthotic interfaces form a growing application area. Appropriately tested silicone formulations offer skin-contact properties. Combined with AM’s design freedom, they support conformable geometries that rigid housings cannot achieve.
For example, Axtra3D lists wearable medical devices among TrueSilX50’s key applications. Depending on their intended use, some devices face fewer regulatory demands than high-risk implants. They may therefore offer a faster commercial pathway for silicone AM in healthcare.
Pharmaceutical and lab-on-chip applications
Microfluidic devices support diagnostics, drug testing, and research. They commonly use PDMS, or polydimethylsiloxane, a silicone variant.
Researchers in academia and industry are exploring how to print these structures. Their work includes internal channels, membranes, and integrated flow-control elements.
Where is the market headed?
Silicone 3D printing in healthcare is in transition. It is more mature than five years ago, although considerable work remains. Investment is flowing, new materials are expanding printing capabilities, and hospital infrastructure is beginning to emerge.
Lynxter’s anniversary offers a reason for optimism. However, regulatory frameworks, reimbursement, and process standardization still need attention.
At the same time, most technology providers in this field are small and have limited influence on clinical decisions. They need to move beyond material biocompatibility testing toward full clinical-grade manufacturing qualification.
They must also work proactively with regulators and hospital partners. Finally, their economic models need to fit hospital budgets. We explore these challenges in the dossier of this edition of 3D ADEPT Mag.
*This opinion piece was first published in the March/April edition of 3D ADEPT Mag.
Update on August 31st: This article has been updated to reflect the correct credit of the featured image and to add Stratasys to the list of players navigating this field.
Sources and supporting documents
- Stratasys — P3 MED Silicone 25A, specific ISO 10993 test parts.
- Spectroplast — TrueSil X50, May 2025 data sheet.
- Spectroplast — TrueSil A60, material test results.
- EU Medical Device Regulation 2017/745 — Annex VIII, rule 8.
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