MEDIRAStable system for artificial heart valves

What must the TRICENTO^G2 insertion system be able to do?

Korbinian Biehler: The product consists of two interlinked components: Implant and delivery system. The cardiologists use the delivery system to place the implant in the heart during the operation. At MEDIRA, we therefore attach great importance to the quality, ergonomics and appearance of the system. The parts must fit together perfectly, fit well in the hand, look high quality and, of course, meet all medical technology requirements.

How can 1zu1 provide support?

Korbinian Biehler: 1zu1 already helped us with the prototype and produced resilient parts from biocompatible polyamide using 3D printing. That saved us a lot of time. With the 3D printed parts, we were able to carry out functional tests on animals early on in the development process. And that is anything but a matter of course. During surgery, large forces act on the parts, so the assembly has to be perfectly coordinated. The components from 1zu1 were in a league of their own. Our concerns quickly evaporated. With the head start, we seamlessly moved on to the implementation of the injection-molded parts. The experience and expertise of 1zu1 came in very handy here.

What exactly does this mean?

Lukas Dilsky: We have been manufacturing in a clean room for years, contributing our expertise and have established reliable quality control with computer tomography. We can see even the smallest deviation and can optimize in a targeted manner. Medical technology products such as those from MEDIRA fit perfectly into our profile with manageable quantities and high demands. Because we know the requirements as well as the expected iteration loops, we can adapt well to the projects. Permanent contact with the customer is very important. The better the communication, the more efficient the process.

Korbinian Biehler: I can only confirm that. We visited 1zu1 right at the start and discussed critical points. That helped us enormously during development. We were able to refine details such as undercuts and injection points together. The flexibility in terms of tolerances was also great. Where it was a matter of hundredths, 1zu1 was able to achieve this and was even more precise than agreed. In return, we turned a blind eye to less important areas and put function before tolerance. It was a productive give and take.

Were there any particular challenges for the assembly?

Korbinian Biehler: The insertion system must fit together like a single piece. Nothing must wobble, nothing must jam. After all, doctors have to have complete confidence in our product. With so many components, some of which are quite large, this is quite an art. As we all know, the devil is in the detail - and the exchange was really worth its weight in gold. Together, we analyzed all 16 individual parts and optimized them for production.

Lukas Dilsky: Many of the components were tough. Large dimensions, tight tolerances and complex geometries demanded everything from us. We used mold flow analyses from our partner units OST to simulate various injection points. The new findings were then used to make design improvements. For example, we were able to reduce the distortion of the threaded rod to a minimum. It is the heart of the system and, with a length of 44 centimetres, is also the largest injection-moulded part in the history of 1zu1. The record component was achieved thanks to a special solution on the machine.

What else could 1zu1 contribute?

Lukas Dilsky: The finish. All visible parts are colored - in MEDIRA turquoise and white. We also provide the lettering. We apply the logo and lock pictogram to two components using our in-house pad printing.

How long did it take from the first sample to the final assembly?

Korbinian Biehler: Just one year, which is truly exceptional for our industry. We started injection molding in June 2022. We agreed on the final design in September and had the first parts on the table by December. Since June 2023, 1zu1 has been producing the complete assembly in batches of several hundred units. Since then, we have been using these for validation as part of the approval process.

What are the next steps?

Korbinian Biehler: It will be some time before TRICENTO^G2 is launched on the market. A long validation phase is common for implants that remain in the body. If everything goes according to plan, we are aiming for clinical trials from 2026.
 

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In conversation: Korbinian Biehler is a Senior Development Engineer at MEDIRA. At 1zu1, he was supported by Lukas Dilsky as project manager for toolmaking and injection molding. Joshua Köb conducted the interview.

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