To bring its DIVA 3D One spinal implant to market, NovaSpine partnered with 3D Systems’ Application Innovation Group (AIG), based in Leuven, Belgium.
The two companies first began working together in 2015. Since then, they have collaborated on eight separate device lines, taking each from design to the production of implants used in hospitals around the world. To date, more than 30,000 implants have been manufactured through this partnership at the ISO 13485-certified Leuven facility.
For this project, the French company, which specializes in medical devices and advanced implant solutions, wanted to streamline its development process from design review through industrialization. It also needed to compile the regulatory documentation required under the EU Medical Device Regulation (MDR) and complete the necessary validations, all while meeting strict requirements for quality, material certification, inspection, and compliance.
The 3D Systems AIG team provided guidance, technical recommendations, and feedback from the earliest prototyping stages to help define the project scope.
Once the production framework was in place, the first order was manufactured at 3D Systems’ advanced manufacturing facility in Leuven. The team used a fleet of validated DMP Flex 350 Dual multi-laser metal 3D printers and Grade 23 titanium.
Manufacturing medical devices in biocompatible metals
The DMP Flex 350 Dual is a high-performance metal 3D printer built for manufacturing complex medical devices. It can produce intricate monolithic lattice structures that promote osseointegration, which removes the need for secondary surface treatments.
The printer also supports patient-specific designs and a wide range of biocompatible metals.
Less than six months passed between the start of the project and the delivery of the first approved, implantable devices. This timeframe is an indication for a standard application and may vary depending on the device’s complexity, validation requirements, and the number of feedback cycles.
Pascal Khalifé, CEO of NovaSpine SAS, said 3D Systems’ ability to meet the company’s most demanding requirements is a major asset in speeding up industrialization and shortening time to market for complex devices. He added that the expertise of 3D Systems’ engineering team consistently steered decisions toward greater efficiency throughout the design of the production process, while making sure the devices met NovaSpine’s highest performance and safety standards.
Today, NovaSpine offers a flexible range of 3D-printed titanium devices in more than 25 countries. It recently expanded into Brazil after obtaining ANVISA certification in 2025.
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