A digital manufacturing solution for a growing number of medical devices, athletic wearables and personalised audio products, has recently been announced.
The solution is hailed as breaking traditional productivity and functionality barriers associated with 3D printing and expanding the world of additive manufacturing, allowing customers to create functional parts across a wide range of applications.
Nexa3D, the maker of ultrafast stereolithography production 3D printers, and Henkel, a leading supplier of high impact functional additive materials, announced the commercial availability of xMED412, a polypropylene-like material that is said to be ideal for manufacturing a variety of biocompatible, medical and wearable devices.
Manufactured by Henkel, xMED412 is entirely based on its Loctite MED412 material and is covered by all of its associated clearances, tests and certifications. xMED412 combines the physical properties and biocompatibility of medical-grade materials and is particularly suited for the production of various devices across industries.
Henkel explains that it developed and tested a multitude of approved workflows with Nexa3D’s NXE400 3D printer, with the objective of realising the full potential of xMED412’s physical properties and biocompatibility. Nexa3D and Henkel assert that the material provides a digital manufacturing solution for a growing number of medical devices, athletic wearables and personalised audio products.
Henkel further confirms that nasopharyngeal swabs manufactured with xMED412 on the NXE400, in accordance with published procedures, have already been cleared through clinical trials and are in compliance with ISO 10993 testing and FDA Class I Exempt classification.
xMED412 was developed by Henkel to deliver highly consistent part performance with extraordinary functionality. The medical-grade material is a very strong and durable photopolymer with mechanical attributes similar to polypropylene with remarkable elongation, impact strength and compression strength. xMED412 parts printed on Nexa3D’s NXE400 require post processing and cleaning in accordance with the company’s recommendations and can be machined, tapped, or polished to deliver desired production finishes.
Nexa3D asserts that bringing the production-grade material to market is particularly important during the Covid-19 pandemic, with the increase in demand for personal protective equipment and other critical medical devices. The company further expresses that it has received an overwhelmingly positive response to xMED412 parts manufactured on the NXE400 3D printer. In the US, it quickly qualified and scaled up single printer production capacity to 5 400 swabs a day, in support of the ongoing demand for nasal swabs. The company is also printing ventilator parts and other medical device parts, including venturis and connectors at productivity and scale which, it says, are fast achieving the new standard for flexible series production.
Additive plastics such as xMED412 are increasingly in high demand, largely owing to its properties as a lightweight yet sturdy material that comes with inherent insulating properties, designed to withstand impact, moisture and vibration. These features make the material ideal for devices that might need to be sterilized or disinfected and that are shipped around the world for use in homecare and healthcare settings.
To advance the miniaturisation of biocompatible, medical and wearable devices, design engineers are incorporating new materials into device designs for added product lifecycle flexibility. For companies that manufacture single-use medical devices, or reusable devices, many critical components need to bend and flex for use on or near a patient’s body. Such components and substrates must be pliable, elastic, and often kink-resistant, which is where the combination of xMED412 as 3D printed on the NXE400 is seen to be a ground-breaking innovation.