Dense Herzohr thanks to 3D printing: 1:1 realized plastic parts for Qatna Medical

1zu1 has produced six 3D-printed components for the handle of the innovative locking implant from Qatna Medical. (Photo: 1zu1)

1zu1 is a specialist for small and precise plastic components and a partner for medical technology companies. (Photo: Darko Todorovic)

In medical technology innovations, time and quality are crucial. 1to1 is specialized as a manufacturing partner for precise small plastic components. The high-tech company produces complex geometries in rapid succession through 3D printing and cleanroom injection molding. The implant from Qatna Medical closes the left atrial appendage to protect against strokes. 1to1 supplies precise 3D printed components for the delivery system.

Fast and secure plastic solutions for medical technology products: This is achieved by 1to1 through pioneering work in 3D printing, cleanroom injection molding, and EN ISO 13485 certification. With the highest quality standards, the high-tech company positions itself as a reliable partner for European medical technology companies. An insight into practical application is now provided by a project for Qatna Medical. The Swabian company developed an implant made from biological tissue to close the left atrial appendage. It is intended to protect people with atrial fibrillation from strokes.

The vision is that affected patients will only need to take small doses of medication for the heart after the minimally invasive procedure, thereby gaining quality of life. The clinical study will start soon. After successful completion of the studies, the treatment method will be available on the market. Precise and sterile plastic components from 1to1 also make this possible. The Vorarlberg-based company has produced components for the implant delivery system using 3D printing.

Compact, dense, and easy to clean

The compact handle consists of 3D printed components. Six chemically smoothed and partially printed parts fit together perfectly, seal tightly, and are easy to clean. "With such a complex geometry featuring internal threads, undercuts, and large wall thickness differences, injection molding tools would be very expensive and assembly complicated. 3D printing offers complete freedom in design and functionality," says Felix Schneider, Development Engineer at Qatna Medical.

3D printing is ready for series production in sensitive medical technology

Despite all its advantages, 3D printing has not yet been established as a series manufacturing process for medical technology. Specialists like 1to1 aim to change that. "Most often, lack of experience leads to reservations. Many think of fragile prototypes or rough surfaces when it comes to 3D printing. We prove the opposite with stable, smooth, sterilizable, and repeatable components made from biocompatible polyamide," emphasizes Stefan Rädler, Head of Additive Manufacturing at 1to1.

The high technical maturity of the high-tech company also convinced Qatna Medical, as Felix Schneider reports: "Even the sample parts were so precise, stable, and attractive that internal concerns quickly disappeared." Qatna Medical is currently verifying and validating the final design. Around 2,000 units are needed for extensive testing. 1to1 supplies large batch sizes in series quality with the SLS system P500 from EOS. Since summer, 1to1 has also been certified according to EN ISO 13485 — thereby accelerating the approval process.