Since its foundation in 2017, Kumovis has been developing 3D printing solutions for highly regulated infrastructures, healthcare in particular. To enable medical technology companies and hospitals to manufacture products in a resource-efficient way and ensure outstanding patient care, the Munich start-up has once more expanded its range of polymers that fit in with medical requirements. Implantable examples include PEEK, PEKK and PPSU. Their biocompatibility and resistance to common sterilization methods are the most important features for being usable in medtech, as well as their chemical and mechanical properties.
“Properties similar to injection molding”
Kumovis technologies and workflows are more cost-efficient and time-saving than using conventional processes such as milling or injection molding, particularly when it comes to manufacturing patient-specific medical devices and small series. The company also offers a variety of resorbable and other polymers in addition to the well-known PEEK for fused layer manufacturing in medicine. The expanded portfolio now includes PEEK reinforced with carbon fiber (PEEK CF), as well as a PPSU material that is mixed with barium sulfate (PPSU + BaSO4) for improved X-ray visibility. PEI and the resorbable polymers PLLA, PLGA, PCL and PDO are also part of the range that is processable by the Kumovis R1 3D printer.
“The positive response from the industry has been steadily growing since the introduction of the Kumovis R1 series in summer 2019,” said Stefan Leonhardt, Co-CEO and co-founder of Kumovis GmbH. “With this dedicated production system, the medical technology industry can process materials such as PEKK and PPSU in addition to the well-known PEEK in a reproducible way. And what is more, we achieve mechanical properties that are currently unique in 3D printing with polymers and can be compared to those of injection molding.”
Kumovis R1: From build chamber to integrated clean room
This is, among other things, due to the laminar air flow that allows for creating a homogeneous build chamber temperature of up to 482 degrees Fahrenheit (250 degrees Celsius). The patent-pending local cooling system helps to cool the molten polymer in a targeted manner, as well as adapted for each strand and layer. In this way, Kumovis takes processing high-performance polymers to an industrial level regarding mechanical properties, aesthetics, reproducibility and usability.
With the built-in filter system, users can turn the R1’s build chamber into a clean room environment that corresponds to ISO Class 7 based on the measured particle count. Kumovis R1 is also suitable for use in existing clean room environments. The start-up moreover reduces the risk of filament or build part contamination with the materials used for building the 3D printer. Kumovis also offers documentation and monitoring software solutions to help companies demonstrate compliance with parameter ranges in process validation.
Application tests successfully completed
The company supports both medical device manufacturers and hospitals in developing products and qualifying plants (IQ, OQ, PQ), as well as validating processes. To do this, Kumovis draws on interdisciplinary expert knowledge in mechanical engineering, medtech and polymers technology, as well as experiences with regard to funding programs. Applications implemented using the Kumovis R1 3D printer have already passed first ASTM testing. An example is the successful completion of worst-case load tests for spinal cages according to ASTM F2077. Another possible application of Kumovis technologies is the additive manufacturing of individualized implants for maxillofacial surgery and neurosurgery.
To further improve the competence of staff, Kumovis keeps expanding its team. From now on, the start-up publishes short explanatory videos called “Kumovis Insights” to offer, among other things, further first-hand insights into the advantages of special materials. At Formnext Connect from November 10 to 12, 2020, and virtual.COMPAMED from November 16 to 19, 2020, visitors to the virtual Kumovis booth will get a comprehensive overview of the new 3D printing ecosystem for medicine and the chance to reach the team directly.