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Case Study

3D marking of plastic medical products and implants with TRUMPF technology

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Samaplast AG, a Swiss company specialised in manufacturing medical products and implants, faced a significant challenge due to the high vertical range of plastics in various colours in their processes. With an extensive array of materials including thermoplastics like PEEK, PPSU, TPE, POM, and absorbable materials, Samaplast AG must handle a diverse range of parts, from flat to complex 3D shapes. The company primarily focuses on small-batch production, ranging from single units to several thousand pieces, although they also produce large batches of millions of units. Most of their products are manufactured in cleanroom conditions to meet the stringent requirements of the medical technology sector.  

About Samaplast AG: Samaplast AG, based in Switzerland, has been manufacturing products for the medical sector and technical industry for over 60 years. The company guides customers through the process from the initial idea through to the sterile packaged medical product and implant, or complete technical assembly. Amongst other things, the company manufactures meniscus and vertebral prostheses, port and cardiac catheters, and parts for cochlear implants. Samaplast AG achieves its production of injection-moulded plastic products in sterile packaging under cleanroom conditions through vertical integration. This involves controlling or owning elements throughout the value chain, leveraging the technical expertise of its 95 employees, and making significant investments. www.samaplast.ch  

Challenges  

The company specialises in manufacturing small to medium-sized batches, ranging from single units to several thousand, with occasional large-scale productions exceeding millions of units. Most of these parts are manufactured in cleanroom environments, meeting the stringent standards of the medical technology sector, presenting both challenges and excitement, as stated by Okle, a representative of Samaplast AG. 

The challenge faced by Samaplast AG was the limitation of their existing laser marking technology, particularly when marking round-shaped products without distorting the markings. This limitation hindered their ability to effectively mark certain components, potentially impacting traceability, and compliance with regulatory requirements in the medical technology sector. 

 

Solutions  

In 2019, Christopher Hoyle, Software Product Manager at TRUMPF Switzerland, proposed a solution to Samaplast’s challenges. The TruMark Station 5000 equipped with the TruMark 6030 marking laser, the TruTops Mark 3D marking software, and VisionLine image processing system are quickly installed in the production department in St. Margrethen, Switzerland. A clear expectation of the laser solution was to achieve optimum readability and abrasion resistance. Both are of the utmost importance at Samaplast AG.  

Even repeated steam sterilisation (autoclaving) must not have an impact on the markings. The TruMark 6030 seems to be the perfect solution. This is because the system offers a decisive advantage: Thanks to its 3D function, it can also mark workpieces with complex shapes without distorting the marking.  

Samaplast-Stefan-Schaer-Head-of-Finishing-and-Logistics
Stefan Schär, Head of Finishing and Logistics, Samaplast AG

Stefan Schär, Head of Finishing and Logistics, Samaplast AG explains:  

“With TruTops Mark 3D we can easily and quickly mark difficult component shapes. The writing can even be clearly added to a sphere with no distortion.”  

Development partnerships with customers such as Samaplast AG are also important for TRUMPF’s software developers:  

“To ensure our software is optimally adjusted to the requirements of the medtech sector, we need a direct link to practical applications. Due to the wide range of complex parts and high requirements regarding functionality and efficiency, Samaplast AG was a perfect partner to challenge us. The direct feedback was immediately implemented in the further development of our software and the collaboration was extremely valuable.”  

Implementation  

Stefan Schär, Head of Finishing and Logistics, Samaplast AG states:  

“The TruMark 6030 was a real quantum leap in terms of quality. Especially implants with difficult shapes, such as hip ball joints, can now be marked easily and quickly. We load the STEP files for the workpiece into the TruTops Mark 3D marking software, position the marking, and then we are already ready to complete the first marking.”  

Usually, fixtures are required, and the position of the workpiece, device, and laser have to be remeasured. Thanks to VisionLine, this step is no longer required for plastic positioning aids for implants.  

Schär adds: 

“We mark the parts without any fixtures. This provides us with enormous advantages,” “We simply place the part on the worktable and the marking process can be started in just a few steps. This saves us a lot of time and money.”  

The TruTops Mark 3D parameter library is also a great advantage when repeatedly processing a component made of PEEK, for example, you can access the library and load the relevant parameters, which gives you the basis to work with. This speeds up the optimum process and helps process a large variety of materials, explains Schär further.   

The added laser power also speeds up the process with the overall result being that the production time is reduced. Depending on the component, they are now three to four times faster than before,” emphasises Schär. Samaplast AG can now mark the handle of a surgical drill in 30 seconds, a process that used to take more than one minute.  

Forecast  

Okle, Schär, and Hoyle share equal excitement about their collaborative efforts. Christopher Hoyle of TRUMPF emphasises the fruitful partnership with Samaplast AG, praising their innovative approach and challenging demands. He acknowledges Samaplast’s role in advancing marking applications and software requirements. 

Stefan Okle acknowledges the benefits of their 20-year partnership with TRUMPF, which grants them direct access to developers for valuable feedback. He envisions a future where parts can be marked without fixtures, contrasting with Samaplast’s current time-consuming process. Okle’s vision entails AI seamlessly identifying and marking parts automatically, potentially sparking a new collaboration with TRUMPF. 

Do you specialise in producing medical technology products that require meticulous traceability and conformity with rigorous regulatory requirements? 

If your manufacturing operations demand uncompromising quality and compliance, our TRUMPF expert Cameron will help you elevate your processes to the highest levels of precision and regulatory conformity. 

Resources

TRUMPF – TruMark – The individual solution for your industry

pdf2.9 MB

TruMark Station 5000 technical data sheet

pdf117 KB

TruMark Station 7000 technical data sheet

pdf137 KB

TRUMPF TruMicro: Power and precision

pdf2.5 MB

TRUMPF TruMicro Mark 1020

pdf295 KB

TRUMPF TruMark: The individual solution for your industry

pdf2.9 MB

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Our Experts

Cameron Wake

Cameron Wake

Business Unit Leader - Advanced Manufacturing

1300 138 285

cameronw@headland.com.au