The Austrian manufacturing service provider 1zu1 has developed a complex assembly for a new type of heart valve system in collaboration with the medical technology company MEDIRA. The process demonstrates how additive manufacturing and injection molding can be combined to accelerate product development in medical technology while also meeting regulatory requirements.
The starting point was a resilient 3D printed prototype made of biocompatible polyamide, which enabled functional tests to be carried out at an early stage of development. The additively manufactured components were designed in such a way that they served as a preliminary stage for later series production using injection molding. This early validation shortened the iteration cycles and enabled a rapid transition to tool production. In summer 2022, 1zu1 began implementing the injection-molded components, and the first series parts were available after just three months.
“Sensitive medical technology products with a high risk class require many tests and extensive studies. The sooner the ready-to-use product is available, the faster the innovation is on the market. At 1zu1, we combine speed with quality and precision. This is how we support the industry from 3D printing prototype to injection molding series,” explains CEO Thomas Kohler.
“We have been manufacturing in a cleanroom for many years and have established a reliable quality control system. In CT, we can see even the smallest deviation and can optimize in a targeted manner,” emphasizes 1zu1 project manager Lukas Dilsky.
The assembly is manufactured under clean room conditions. In total, the insertion system for the TRICENTOG2 artificial heart valve comprises sixteen precise plastic parts. The production of a 44-centimetre-long threaded rod, which serves as the central functional element, was particularly challenging. In order to avoid distortion, a special solution had to be implemented on the machine side. In addition, mold flow simulations and CT measurements were used to ensure mold filling, tolerances and geometric stability of the components.
All components are not only manufactured at 1zu1, but also finished. Coloring and pad printing for logos and markings are carried out directly on site. MEDIRA is currently validating the insertion system in practical use. Preparations for approval are underway and 1zu1 is already supplying series quantities for the next steps in the clinical trial. The project shows how closely coordinated manufacturing partnerships can shorten the path to product maturity.
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