Zfx e Bruker Alicona - un'amicizia di lunga data

Zfx about Medical Device Regulation — Werner Weithaler and Lukas Breitenberger

Nel corso di una generosa visita alla sede e al sito produttivo di Zfx, non solo abbiamo potuto vedere come e cosa si lavora. Lukas Breitenberger, direttore generale di Zfx, ci ha anche fornito una panoramica sul mondo della tecnologia medica. Abbiamo appreso come il regolamento sui dispositivi medici (MDR), in vigore dal 2017, abbia cambiato la gestione della qualità. Non che Zfx dovesse recuperare terreno in questo settore. Ma l'impegno burocratico si è moltiplicato. Come ha spiegato lo stesso Breitenberger, gli ostacoli per il lancio di nuovi prodotti sul mercato sono diventati estremamente elevati. Ma anche le modifiche al processo produttivo sono ormai difficili da attuare e richiedono molto tempo e denaro. In passato, come oggi, venivano misurati i pezzi di collegamento tra l'impianto e la corona (i cosiddetti abutment o basi in titanio), gli impianti stessi e le viti. Poiché alcuni di questi componenti sono estremamente piccoli, con lunghezze di 10 mm e diametri inferiori a 2 mm, le tolleranze sono altrettanto strette. Si aggirano intorno ai 2 µm. L'MDR non ha modificato questa situazione.

Zfx and ZimVie - international giants in dentistry

Incidentally, Zfx is part of the US group ZimVie, which specializes in dental and spinal medicine. Together, parent company ZimVie and subsidiary Zfx are strong competence partners in the field of dentistry. Their areas of application range from implant technology to the latest dental prosthesis materials and state-of-the-art production processes. Zfx has two company headquarters: in Dachau, Germany and in Gargazon, Italy. Quality control takes place exclusively at the Gargazon site and focuses on incoming products as well as prototyping.

optical probing of an abutment, titanium base

strict quality regulations due to the MDR

accurate and precise measurement in the µm-range

The µCMM from Bruker Alicona for maximum accuracy with the smallest components

We learned so much during our stay at Zfx that we really had to think about what we actually wanted to talk about, namely the use of the µCMM . Zfx put an InfiniteFocus G5 from Bruker Alicona into operation five years ago. Werner Weithaler, Sr. Engineering Manager Zfx, described the decision situation for the µCMM as follows: "The InfiniteFocus G5 has met our quality assurance requirements from the very beginning. We can neither complain about defects nor about inadequate measurements. And because we were already so satisfied with the G5, it was clear that Bruker Alicona would be our first point of contact again." It must be said, however, that the CMM delivers greater accuracy in the room and can significantly reduce the duration of the extensive measurement plan thanks to local optical probing. Incidentally, the G5 is still in use.

Pick and place as an automation boost

And then there is one more thing, namely automation. A few months after the µCMM was commissioned, it was given an update in terms of automation and capacity utilization by entrusting a pick and place with loading. This allows the measuring device to run 24/7, without an employee having to be on site. The workflow is therefore never interrupted.

The Success Story, there was something else

Of course, we were also really impressed by the use of the µCMM at Zfx. But behind-the-scenes customer insights are particularly valuable. You can read the whole success story here. Below you find the press release for download.