From left to right, Alexander Henhammer, Stefan Fischer, Sebastian Pammer, Miriam Haerst, Stefan Leonhardt
© Kumovis

Kumovis: First 3D Printer for Manufacturing with Clean Room Integration

Last year, the Munich high-tech startup Kumovis not only won the Munich Business Plan Competition from Baystartup, but also landed an investment worth millions. Now the company is introducing the first 3D printer for manufacturing with clean room integration to the market. We spoke with the co-founder and Managing Partner of the startup Kumovis, Stefan Leonhardt.

What applications can your new 3D printer be used for?

In general, our 3D printer can be used to process the most varied kinds of plastics, which means it can be used in different industries.

Our focus, however, is very much on medical technology, and our 3D printers are specialized for the field. In the field of medical technology, the printer can be used for a wide range of applications. That includes disposable surgical instruments, surgical templates for complicated procedures or even individualized implants.

What is very important to us, however, is for our printers not only to be used for research and development, but also for manufacturing. That is what fundamentally differentiates us from other 3D printer suppliers, because a system that is suitable for manufacturing involves various requirements that often cannot be met. This often includes aspects such as the cleanability of the system or the materials used.

Additive manufacturing: Material waste is minimized

What are the advantages of additive manufacturing in the medical field?

In general, we see four major advantages:

Firstly, additive manufacturing makes it possible to decentralize the production or manufacturing of medical products. A printing system like ours requires approximately one square meter (ten square feet) of space, a high-voltage power line and compressed air. That means our system can be set up virtually anywhere and used for manufacturing.

The next point involves the topic of sustainability and economical production. Implantable plastics are very costly. We’re talking up to 2,000 euros a kilogram in some cases. When individualized implants are made with CNC machining, material waste of more than 80 percent is not uncommon. And that leads to enormous costs. With additive manufacturing, we can minimize that material waste and, with a bit of skill in terms of design, even completely eliminate waste in some cases. That means we only need the amount of material that actually turns into the product.

Our third point, and the most exciting one from our point of view, is patient individuality. Additive manufacturing gives us tremendous design freedom, which is why we produce made-to-measure implants. We can also create new structures, such as fine lattice structures for improved bone ingrowth.

The final point is the implementation of digital workflows. Additive manufacturing can be seen as one of the physical arms of digitization. Particularly in medical technology, we can implement automated workflows starting with a patient dataset and ending with the physical product.

Kumovis: Patented tempering system

What makes your 3D printer special?

We’ve developed the first 3D printer that is truly suited for the serial production of medical products from high-performance plastics.

The heart of our printer is our unique, patent-pending tempering system. We’ve developed the first 3D printer that uses a current of air to temper the printing space. We can heat the printing chamber to up to 250°C (roughly 480°F), which allows us to reach significantly higher mechanical properties than has been possible until now with FDM technology (Fused Deposition Modeling).

Moreover, we were also able to equip the ventilation circuit with filter technology, which creates clean room conditions inside the printer. This ensures that no foreign or abraded particles make it into the printed parts, which prevents imperfections or contamination.

A further unique selling point of our printer is, as previously mentioned, its suitability for serial production in the medical field. To achieve that status, there were some specific requirements that we had to meet – and we meet them with the Kumovis R1.

What materials do you use for production and why?

In general, all thermoplastics, meaning plastics that melt, can be used in our 3D printer. But we focus on the materials that are available in “grades” suitable for medical technology. We work closely with material manufacturers, who do excellent work in the field and are putting an increasing number of materials on the market.

For long-term implants, our main focus is on different high-performance plastics that are suitable for medical technology and have been established as implant material for years, such as PEEK and PEKK. Additional interesting materials, particularly in the field of CMF (craniomaxillofacial applications: lower and upper jaw, skull, etc.) are PPSU (a high-performance plastic suitable for medical technology) or also Ultem. An up and coming class of materials are degradable materials, meaning materials that break down in the body over time. Particularly when used to bridge bone defects, these materials will certainly play a role in the future.

“Establishing new technology in medical technology requires more than just a good idea.”

What are the biggest challenges when establishing a new product in the medical field?

From the beginning, our objective was to develop a 3D printer that is suitable for manufacturing medical products. The term “manufacturing” is of particular importance to us. One of the biggest challenges as a result was to develop our printer so that established medical device manufacturers say: Yes, that is a system I can use for manufacturing. We also collected input from the beginning about what needed to be paid attention to. Especially in the medical field, it’s the requirements that are otherwise dismissed as minor details that are often of significant importance. That ranges from the materials used for the machine to its surface finish.

Another major challenge is the topic of regulatory requirements. Qualifying a machine and validating the process in particular are time and resource consuming steps. What helps us in this case is working together with major medical device companies, which obviously have a great deal of experience in the area.

Another major factor is trust. Especially when establishing a new technology in medical technology, you need more than just a good idea on paper. A general understanding of how medical technology works and the challenges faced during the approval process are of great value.

Is your printer already being used?

Yes, our printers have been in operation for a while now. We’ve had some systems set up with pilot customers since the beginning of the year. Since August, we’ve been delivering our first round of printers to larger medical device manufacturers and are naturally pleased they’ve put their trust in us and our technology. That really means a lot to us and gives us extra motivation to continue to develop 3D printing in medical technology.

In addition to collaboration with the industry, our printers are also being used directly in hospitals for different projects. Hospitals in and near Munich in particular are strong partners of ours. In collaboration with the LMU polyclinic for prosthodontics, we’ve already used printed products in the dental field. The University Hospital Rechts der Isar will be starting an animal study in October with printed implants for mandibular reconstruction. These are obviously very exciting projects for us that also make for a great deal of progress while enriching our knowledge.

Kumovis: A vision of sustainable medical products

What is your vision?

Our vision is to change the way medical products are made over the long-term with our technology, which will in turn take patient care to a new level. That most particularly includes point-of-care use of the technology as well as manufacturing brand new medical products that were unconceivable until now. All that requires strong partners on all sides, because it can only succeed in collaboration with hospitals, medical product manufacturers, material manufacturers and technology manufacturers like us.