UltiMaker and MedTech startup Bioactivx have signed a Memorandum of Understanding (MOU) to co-develop a scalable, on-demand, medical printing solution for regenerative wound care.
The partnership highlights the growing role of UltiMaker’s open, reliable print technology in enabling next-generation medical manufacturing, from prototyping to certified end-use production.
The announcement coincides with two major milestones for Bioactivx: the opening of its medical-grade filament production and cleanroom print farm facility, and its obtainment of HSA approval for their flagship product Bioactiv Matrix, which is manufactured via 3D printing – a facility built on UltiMaker’s 3D printing platform.
Regenerative Medicine
Bioactiv Matrix, is a synthetic, animal-free regenerative medical solution designed to accelerate wound closure and promote scar-free healing. To bring it to market at scale, Bioactivx built an end-to-end digital manufacturing process – compounding a proprietary active-ingredient filament in-house, then mass-producing the final product on a fleet of UltiMaker 3D printers within a certified cleanroom.
“We chose UltiMaker because of its reliability, ease of use, and open architecture,” said Dr. Teo Peili, CEO of Bioactivx. “That openness was essential – it let us develop and fine-tune our own proprietary print process rather than working around the limitations of a closed system.”
That process has earned Bioactivx the ISO 13485 certification and HSA approval, for end-use medical implant manufacturing – validating that products 3D printed on UltiMaker systems can meet rigorous medical-grade manufacturing standards. Regulatory submissions for the Bioactiv Matrix in key countries/regions such as USA, EU, Australia and the rest of ASEAN are ongoing.
“Bioactivx’s certification and regulatory approval is a powerful proof point for the medical 3D printing industry,” said Mr. Michiel Alting von Geusau, CEO of UltiMaker “It demonstrates that with the right process and quality controls, 3D printing on UltiMaker platforms can meet the exacting standards required for certified, end-use medical devices – not just prototypes. ”
Singapore’s HSA is classified as WHO maturity level 4 for medical device regulations, indicating extremely high standards for medical device approvals.
“This collaboration is about more than one product,” said Michiel Alting von Geusau. “It’s a blueprint for how distributed, on-demand 3D printing can transform medical manufacturing – making critical treatments faster to produce and easier to deliver, wherever they’re needed.”
“This is just the starting point,” added Dr. Teo. “Our vision is a future where advanced, scar-free healing is available to every patient, wherever they are – and UltiMaker is a key partner in making that possible.”
Find out more here: https://ultimaker.com/ and https://bioactivx.com/
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