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Materialise validates Stratasys and Ultimaker machines for 3D printed medical models

Materialise' FDA-approved software and Stratasys' hardware make up the 'most versatile' 3D printing system for hospitals

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3D printing giants are working together for the common goal of advancing AM for the production of medical models. Materialise—through its FDA-approved Materialise Mimics inPrint software—has validated Stratasys 3D printers and materials for the manufacturing of anatomical models. The validation marks the establishment of what the companies call the “most versatile 3D printing system for point-of-care across hospitals and physicians.” Materialise also certified the Ultimaker S5 3D printer.

Stratasys & Materialise

Working in collaboration with Stratasys, Materialise validated the company’s PolyJet multi-material and multi-color 3D printing solutions, specifically the J750, J735 and Objet30 Prime 3D printers. This means that the Materialise Mimics inPrint software, presently the only 3D printing software to be approved by the FDA for anatomical models for patient care, can be used with the Stratasys machines to make top-of-the-line models for medical professionals.

In the medical field, patient-specific 3D printed models are becoming increasingly common for pre-surgical planning procedures. The custom models enable surgeons and doctors to better visualize a particular patient’s condition before going to the operating table.

“Historically, pre-surgical planning relied on 2D imaging requiring physicians to mentally reconstruct the patient anatomy,” explained Eyal Miller, Head of Healthcare Business Unit at Stratasys. “But 3D printing evolves this approach by putting precise replicas of patient anatomy directly in physician hands. Our collaboration with Materialise is a huge step towards unlocking the potential of this technology for patient care. Now the 3D printer that every hospital needs to power their medical modeling comes with additional options for an FDA-cleared software solution.”

Materialise Stratasys medical models
Stratasys’ J750 3D printer

Materialise Mimics inPrint software equips hospitals with the tools needed to transform medical imaging data into 3D printable models. The software was cleared by the FDA (with 510(k) approval) in March 2018. At present, 16 of the top 20 hospitals in the U.S. (as ranked by U.S. News & World Report) are currently using the innovative software for anatomical 3D printed models.

By validating Stratasys’ J750, J735 and Objet30 Prime 3D printers, Materialise aims to further advance the production of medical models for the medical sector by offering high quality manufacturing solutions.

“By validating Stratasys’ 3D printing technologies through our certification process, we’re giving doctors and hospitals improved access to high-quality anatomical models for personalized care to patients,” said Bryan Crutchfield, Vice President and General Manager of Materialise North America.

“The addition of multi-color and multi-material printers to the list of validated printers is aimed to enable healthcare providers to implement a versatile offering that can support their most complex cases across a wide range of surgical specialties on a single printer,” he added. “At Materialise, we take a hardware-agnostic approach to software development, offering the flexibility to partner with other leaders in the 3D printing industry like Stratasys – a company committed to addressing requirements of the medical community.”

Stratasys’ J50 and J735 machines offer the ability to 3D print multi-material (thus multi-texture and multi-colour) models, making them well suited for producing medical models that mimic human tissue and have easily identifiable anatomical features. For instance, a medical professional could 3D print a transparent organ with various parts of the organ’s interior printed in different colours and textures. The Objet30 Prime, for its part, is an accessible desktop 3D printer that would make a good entry level option for medical centers seeking to integrate a point-of-care printing solution.

Ultimaker & Materialise

The Ultimaker S5 3D printer

Dutch 3D printing company Ultimaker also obtained validation for its S5 3D printer from Materialise. The professional desktop machine can now be used as a certified 3D printing solution for the creation of orthopedic, maxillofacial and cardiovascular models for clinical use in combination with Mimics inPrint.

“More and more frequently, doctors look to 3D printing for pre-operative planning and the fabrication of physical models for patient management, treatment and surgeon-to-surgeon communications. As diagnostic usage of 3D printers continues to revolutionize patient care, safety and quality remain a top concern for hospitals,” said John Kawola, president of Ultimaker North America. “The Materialise certification of the 3D printing workflow when used with Mimics inPrint reduces the safety- and quality-control burden on doctors and hospitals with it’s clearance by the FDA.”

In addition to pre-surgical planning for orthopedic, cardiac, neurosurgery operations, the 3D printed models created using Materialise Mimics inPrint can be used for education and training purposes.



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Tess Boissonneault

Tess Boissonneault is a Montreal-based content writer and editor with five years of experience covering the additive manufacturing world. She has a particular interest in amplifying the voices of women working within the industry and is an avid follower of the ever-evolving AM sector. Tess holds a master's degree in Media Studies from the University of Amsterdam.

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