A few weeks ago, Germany-based startup Kumovis released a 3D Printer that can manufacture medical products from high-performance plastics, such as PEEK. A premiere for the medical tech company whose 3D Printers are currently being used by pilot customers. In this Opinion of the Week, Stefan Leonhardt, co-founder and CEO, shares more about the company’s story.
Stefan Leonhardt is medical engineer by training. During his PhD at TU Munich, he worked on the development of new materials that could be leveraged in the additive manufacturing of medical products. Miriam Haerst, a mechanical engineer, joined him later by bringing her experience in 3D Printing. Together with the other members of the team, they rapidly became aware of the need for AM in the medical industry.
Roughly 13% of all AM revenue comes from the medical industry, which makes it one of the fastest-growing sectors within the industry. However, with applications that range from patient-specific implants to realistic functional prototypes and advanced medical tools, Leonhardt pointed that, for now, the demand still exceeds the supply, especially for 3D printing systems that could process the PEEK material, hence the development of their recently launched medical 3D Printing system.
Named Kumovis R1, the (FLM) Fused Layer Manufacturing-based 3D printing system integrates a temperature control and filter system that allows operators to achieve a clean room environment right in the build chamber. These features make the R1 a good candidate to meet the requirements for fabricating patient-adapted medical products.
Experts who read us would certainly agree with us: in a laboratory, everything has to be measured. The levels of humidity, temperature, pressure, particles in suspension and lighting are subject to exhaustive inspections so as to give assurance that they would not alter the chemical composition of the product.
That’s exactly the reason why, although it remains optional, Leonhardt said the clean room is one of the features that makes their 3D printing system outstanding:
“Several characteristics enable the R1 to stand out from the crowd. The clean room is of course one of the most important ones. But there is also the temperature management system. The fact that we can manage the temperature up to 250° through the build chamber makes it easy to increase part quality and achieve desired mechanical properties.
Our aim is to ensure that there are no particles in the chamber, no defect in the parts. This is an undisputable requirement in the medical industry. Production machines for instance, have to be cleaned twice per day.
However, a medical application requires much more than a suitable clean room during the production process. It requires a process that would be able to meet the requirements of the entire process, from material properties to the final part control.
That’s what we are able to achieve with Kumovis R1. In the end, that’s what medical professionals are looking for, a system that would be able to achieve both viable production and prototyping applications.”
The medical industry and its wide range of regulatory constraints
In the April Issue of 3D ADEPT Mag (P.39), Khanh Tran Duy from Medical Company 3DSide, said that “just because you can print it, does not mean you can use it.”
It is no secret that the medical industry is subject to a myriad of constraints. According to Kumovis’ co-founder, “operators should go through several stages before getting approval to produce parts. Two of them are machine qualification and process qualification. The process qualification is based on the fact that we are allowed to produce a specific number of parts. As far as Kumovis is concerned, we have already gone through these stages. However, certification remains a big challenge, not only for us but for the whole industry in general. Each company is investing extra miles to address this issue. At Kumovis, we are constantly working with the chemical industry for the improvement of already established filaments and their processing. Right now, a variety of medical-grade filaments is commercially available. Many more are likely to follow in the next few years.”
A closer look at Kumovis: who exactly can use the R1 3D Printer in the medical industry and to create what kind of applications?
“Our first customers are medical device companies and research staff. Two major user groups at the moment are achieving spinal applications. Despite the regulations, the technology evolves at rapid pace. In the long run, users would probably harness it on a decentralized way.
Other applications include models for transplant and anatomical models. We are currently working on some applications that can be used directly in clinics.
3D Printed models produced with a Kumovis could be used inside the body (for cranial or jaw implants) and as a surgery guide. To do so, we will only need to change the production method.”
What’s the next step for the company now?
The delivery of the R1 to other customers is the next step. Releasing our 3D printer backed by a solid group of partners is more than an exciting milestone for us.
Lastly, a lot of 3D Printing systems are only designed for prototyping applications. Today, our primary goal is to show the medical industry that we develop a platform that can be used for production.
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