The Leipzig medtech company BellaSeno and the Fraunhofer IPT in Aachen want to set up a fully automated and cloud-based manufacturing platform for medical implants. There is now a BMBF grant of 1,4 million euros for this.
The Leipzig-based medical technology company BellaSeno GmbH is developing resorbable frameworks using additive manufacturing technologies. It has now entered into a cooperation with the Fraunhofer Institute for Production Technology IPT in Aachen to manufacture medical implants in an automated, highly scaled industrial process. For this purpose, the association receives funding from the Federal Ministry of Education and Research amounting to 1,4 million euros from the KMU-innovativ funding initiative.
BellaSeno and the Fraunhofer IPT have set themselves the goal of developing a high-performance industrial scale-up process for GMP-compliant production systems. It is said to include state-of-the-art features such as high-throughput additive manufacturing based on the so-called no-touch approach. This is to ensure a high level of safety and sterility of the medical implants produced.
24-hour production flow in a fully automated environment
In particular, the collaborating partners plan to set up a fully automated, commercial-scale manufacturing platform, supported by robotic systems and intelligent software, that will control polymer feeding, implant handling, QC steps, and labeling and recording of traceability data. This approach enables a constant 24-hour production flow that covers all the necessary process steps, minimizes errors and optimizes the production result. With this process, BellaSeno intends to significantly reduce development and manufacturing times while improving the quality of its medical implants.
Goal: cloud-based factory for 3D printing of implants
"Until now, the most important steps in the additive manufacturing process had to be carried out manually," says Navid Khani, Head of Research and Development at BellaSeno. “With the BMBF funding and the collaboration with the Fraunhofer IPT, we can increase the productivity of commercial-scale manufacturing powered by robotics and automation by 3 to 4 times.” Once the new infrastructure is fully in place, a cloud-based factory will be available, allowing for multi-site manufacturing and design customization at the touch of a button. Khani: “Such a fully scalable, automated, cloud-based additive manufacturing infrastructure for medical implants has never been set up before. "The joint project combines BellaSeno's extensive knowledge in 3D printing of high-quality resorbable scaffolds and their sophisticated Senella implant with Fraunhofer IPT's extensive experience in the development of fully automated production systems for clean rooms," says Ferdinand Biermann, head of the "Life Sciences" business unit Engineering” at the Fraunhofer IPT. “A freely moving, autonomous robot, fully networked processing units and an adaptive, service-oriented software structure enable repeatable and high-quality manufacturing by maintaining full flexibility in the production process. The production facility will not only make it possible to bring products to market that immensely improve the quality of patient care, but also set a new standard for the automated manufacture of medical implants.”
Source: Press release medtech-zwo from March 11.03.2021th, XNUMX
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