1-to-1 is a partner for medical technology with quickly manufactured plastic parts

1zu1 manufactures series components in cleanroom conditions for medical technology companies. (Photo: 1zu1)

High-tech company 1zu1 produced an entire assembly of highly precise injection-molded parts for MEDIRA's implant introduction system within a few months. (Photo: 1zu1)

High-tech company 1zu1 realized an entire assembly of highly precise injection-molded parts for MEDIRA's implant introduction system within a few months. (Photo: 1zu1)

Thomas Kohler is CEO of 1zu1. (Photo: Darko Todorovic)

Quick solutions for functional plastic components in small series: 1zu1 has fully realized a complete injection molding assembly for a new medical technology product from MEDIRA. The innovative treatment method involves the use of an artificial heart valve. 1zu1 produces 16 injection-molded parts for the delivery system in a cleanroom – colored, printed, and highly precise. Prior to this, a test-ready 3D-printed prototype accelerated development.

1zu1 consolidates its role as a reliable manufacturing partner for medical technology. The plastic specialist from Dornbirn creates fully functional injection-molded parts in a cleanroom within a few months, shortening development time with high-quality 3D printing beforehand. MEDIRA from Balingen also benefits from this. The medical technology company is dedicated to new treatment methods for heart diseases. TRICENTOG2 aims to help people with heart valve defects in the future. For this, a stent with a heart valve is positioned and anchored in the vena cava using a delivery system. 1zu1 supplies 16 highly precise plastic parts in cleanroom quality for the system.

After starting with the 3D-printed prototype in 2021, MEDIRA and 1zu1 began finalizing the injection molding in summer 2022. The first components were completed after just three months. Since summer 2023, the assembly has been series-ready. Currently, 1zu1 produces hundreds of units annually for the approval process. "Sensitive medical technology products with high risk classes require many tests and extensive studies. The sooner the functional product is available, the faster the innovation reaches the market. At 1zu1, we combine speed with quality and precision. This is how we support the industry from 3D-printed prototypes to injection molding series," explains CEO Thomas Kohler.

Everything from a single source

With reliable 3D-printed parts made from biocompatible polyamide, 1zu1 was able to give the customer a competitive advantage. The robust and precisely fitting components allowed early functional tests on animals. In designing the injection-molded parts and manufacturing the aluminum tools, 1zu1 relied, among other things, on Mould-Flow analyses. Precise information on tolerances and mass accumulations was provided by computed tomography measurements. "We have been manufacturing in a cleanroom for many years and have established reliable quality control. With CT, we see even the smallest deviations and can optimize targeted," emphasizes 1zu1 project manager Lukas Dilsky.

For the threaded rod, 1zu1 minimized warping. It is the centerpiece of the delivery system and, at 44 centimeters in length, the largest injection-molded part in 1zu1's history. "The record part was achieved thanks to a special solution on the machine," reports Dilsky. The entire assembly is also finished at 1zu1. All visible parts are colored. Components are labeled with logos and pictograms via pad printing. MEDIRA is currently validating the system in practice with the finished delivery system. Clinical studies for market approval are expected to follow soon. If needed, 1zu1 supplies complete assemblies quickly.