Additively manufactured applicator for cancer therapy goes into series production with CE marking
Customer Success Story: BEBIG
OUR MISSION
Empowering the medical field with innovative 3D printing solutions, Dreigeist collaboratively developed and optimized a unique applicator for cervical cancer brachytherapy, facilitating a more efficient treatment process and ensuring CE approval for market entry.
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Collaborative development with Eckert & Ziegler Bebig GmbH.
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Creation of a 3D-printed applicator for cervical cancer brachytherapy.
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Successfully received CE approval, allowing market entry.
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Nearly three-year comprehensive development period.
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Involved detailed material selection, geometric development, quality and risk management.
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Addressed complex regulatory aspects crucial for the medical field.
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Overcame challenges in integrating additive manufacturing into existing company processes.
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Provided 360-degree support, from product design to CE marking assistance.
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Facilitated the establishment of independent 3D printing processes for the partner.
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Assisted in making the applicator ready for series production, ensuring it meets the sensitive requirements of the medical industry.
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Supported the transition of applicator production to Berlin for enhanced development capacity.
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DETAILED INSIGHTS
Revolutionizing Brachytherapy with 3D Printing
We at Dreigeist had the opportunity to significantly contribute to advancing cervical cancer treatment. We developed an additively manufactured applicator for Eckert & Ziegler Bebig GmbH, designed specifically for internal radiation therapy (brachytherapy). This device, unique in its application of 3D printing technology, received CE approval, marking a milestone as it was the first of its kind in the global market.
Our team was intricately involved in every step of bringing this innovation to life: from product development to preparation for CE approval, and finally, launching series production. Following the green light from the notified body, the series production of this additively manufactured temporary plastic implant kicked off for the European market, with the US market set to follow.
This project not only showcased the potential of 3D printing in medical device manufacturing but also underscored our commitment and capability at Dreigeist to navigate and lead complex, groundbreaking projects in the additive manufacturing landscape.
While 3D printing is undoubtedly a game-changer across various industries, the journey towards successful implementation is often intricate and time-consuming.
As Christopher König, our Managing Director at Dreigeist, would attest, the introduction of 3D printing in sensitive sectors—like medicine, pharmaceuticals, and food—demands meticulous planning and adaptation. Regulatory considerations often occupy a significant portion of the project.
Delving deeper, the challenge lies not just in redefining numerous parameters to transition a product from being additively manufactured to being ready for series production. The true hurdle is integrating additive manufacturing seamlessly into established company processes. Traditional production methods and procedures don't necessarily align with those of 3D printing, making the integration phase all the more complex.
In the case of the additively manufactured applicator, the development process was even more intricate than initially anticipated.
Thanks to our expertise and strategic approach at Dreigeist, we provided Eckert & Ziegler Bebig GmbH with comprehensive support—covering everything from product design and risk management to quality assurance and CE marking support. This 360-degree backing enabled a smoother, more targeted setup from the outset.
More on this topic in the 02/2020 issue of medizin & technik (only in German):