Carbon has MedTech Covered with the Right Materials

In the MedTech industry, additive manufacturing can be the solution for patient-specific applications and geometries that cannot be molded (e.g. lattices), and low-volume runs. In addition, supply chain issues can be addressed quickly with advanced additive manufacturing solutions like the Carbon platform. Companies like Becton, Dickinson and Company, Perceptis, and Viscotec have leveraged these advantages and gone to market with quality products much faster, by using Carbon technology.

Carbon understands the needs of medical device designers and offers materials that meet functional requirements like strength, comfort, and durability, can be sterilized, and have biocompatible properties.

Predictable Mechanical Properties

Conventional Resin-Based 3D Printing Compared to Carbon DLS

Traditionally-made 3D printed parts are known to be brittle and non-isotropic. Their mechanical properties vary depending on the print direction, whereas with the Carbon DLS™ printing process, the oxygen-permeable window supports the production of isotropic parts.

Parts produced with Carbon Digital Light Synthesis™ (Carbon DLS™) 3D printing have a surface finish quality similar to injection-molded parts, with consistent and predictable mechanical properties enabled by our patented dual-cure materials.

Dual-Cure Materials

Carbon’s proprietary dual-cure materials are set with UV light and then thermally cured, which enables a broader set of chemistries to be built into resin formulations. These materials are tougher and more durable because they have an interpenetrating network of UV and thermal systems. (See figure 2.)

In addition to increasing the part’s strength, thermal curing removes any orientation dependencies due to printing. This contributes to more isotropic parts, as discussed earlier (see Figure X, Layerless Carbon DLS-printed parts).

Not only does utilizing dual-cure technology result in a stronger final product, but it also opens up the possibility of using higher-performance raw materials, expanding the range of materials to print with. Learn more about dual-cure technology in the Carbon Dual Cure Materials White Paper.

Carbon Materials for Medical Applications

When it comes to material selection for medical equipment and devices, factors like biocompatibility, chemical resistance, sterilization techniques, disinfecting solvent compatibility, quality, and cost are always taken into consideration. Carbon’s dual cure materials offer a balance across these engineering needs.

Rigids

From our rigid epoxy family of materials, EPX 150 produces high-temperature and chemically-resistant parts with an exceptional combination of strength and toughness comparable to high-performance thermoplastics like PEEK and polyphenylsulphones. Parts produced using EPX 150 pass certain ISO 10993 standards, following standard sample processing protocols, of cytotoxicity, sensitization, irritation, hemolysis, and acute systemic toxicity enabling it to be used in multiple applications with these biocompatibility needs.

It is also compatible with commonly used disinfectants like water, bleach, IPA, Contrad® 70, and Citranox® 1.5%, and reagents used for wiping, cleaning, for long-term use.

In addition, due to the exceptional chemical and hydrolytic stability of EPX 150, it can withstand up to 400+ cycles of standard steam sterilization autoclave (134°C/4min) without any significant degradation in mechanical performance or change in visual appearance such as surface yellowing or cracking. (See figure x.) Post 400+ autoclave cycles, EPX 150 passes cytotoxicity tests as per ISO 10993-5 for post-sterilization biocompatibility.

From our rigid polyurethane family of materials, MPU 100 and RPU 70 produce parts that have high strength and ductility comparable to common thermoplastics like ABS. Parts produced using these resins pass certain ISO 10993 standards, following standard sample processing protocols, of cytotoxicity, sensitization, irritation, hemolysis, and acute systemic toxicity enabling it to be used in multiple applications with these biocompatibility needs.

To further expand the use case, MPU 100 and RPU 70 are sterilizable using Ethylene Oxide (EtO), Gamma, and E-beam techniques. They are also compatible with commonly used disinfectants like water, bleach, IPA, Contrad® 70, and Citranox® 1.5%, and reagents used for wiping or cleaning medical devices.

Elastomers

From our elastomeric polyurethane family of resins, parts produced with EPU 43 and EPU 46 offer soft elastomers with high durability as needed in energy-damping and energy-returning applications. EPU 46 platform offers high-energy return parts with an option for custom colors, varying material stiffness, and 40% bio-based content. Parts produced using these resins pass certain ISO 10993 standards, following standard sample processing protocols, of cytotoxicity, sensitization, and irritation enabling it to be used in multiple applications with these biocompatibility needs. They are also compatible with commonly used disinfectants like water, bleach, IPA, Contrad® 70, Citranox® 1.5%, and reagents used for wiping or cleaning medical devices.

This combination of durability, biocompatibility, and chemical resistance in addition to design freedom of lattice geometries, EPU43 and EPU 46 help enable multiple cushioning applications.

For more details on material properties and testing, check each resin’s TDS and our full chemical compatibility table for a list of all Carbon’s materials and their compatibility with household and industrial chemicals.

Conclusion

Carbon’s technology translates to real solutions in the medical field by providing a range of resins suitable for various medical applications. Parts printed using rigid materials like MPU 100, RPU 70, and EPX 150 pass important biocompatibility and sterilization tests. Elastomers such as EPU 43 and EPU 46 are both relevant for applications in prosthetics and cushioning, pass certain cytotoxicity tests, and demonstrate compatibility with common disinfectants.

On top of these materials, Carbon’s platform includes other features that could also be advantageous for MedTech applications, including:

• A workflow that can meet certain requirements for MedTech applications.
• Carbon’s design software, which can add design attributes like generating novel textures for aesthetics and functional use.
• Carbon’s Print OS, which will determine the most cost-effective, successful, and fastest-to-print orientations and layouts to print your part using Carbon printers.
• Exceptional customer support, which is there for you when you have questions, to help your project continue to move forward.

*It is the responsibility of the manufacturer and/or distributor of the end-use product to determine that the final product, including any products manufactured using Carbon resins, meets relevant testing and biocompatibility requirements and is otherwise safe and effective for its intended use, including any testing, validation, quality control, assurance of safety and effectiveness for such products’ intended uses, and regulatory authorizations required to market or to commercialize any such application or product.

3D as It’s Meant to Be

Interested in utilizing Carbon to accelerate product development? Reach out to us at sales@carbon3d.com to learn more!