From Kick-off to the Delivery of the First Regulatory Approved and Implantable Devices Took Under 6 Months
Overview
NovaSpine is a France-based medical device company with over 20 years of experience in advanced implant solutions and a solid reputation for precision engineering, focused on improving patient outcomes while simplifying surgical procedures. As a growing family-run organization located in Amiens, NovaSpine combines French manufacturing expertise with a commitment to innovation and quality. Their portfolio includes one of the broadest ranges of spinal stabilization devices designed to address a wide spectrum of pathologies.
To scale production and accelerate time to market, NovaSpine has partnered for over a decade with 3D Systems, a global leader in additive manufacturing solutions that delivers 3D printing technologies, materials, and software across key industries including healthcare.
The Challenge
NovaSpine set out to build on the success of its previous cervical spinal fusion cages and develop a next generation Titanium implant featuring integrated screw locking springs and a threaded instrumental interface known as the DIVA 3D One.
Offering a single, flexible device combining key features of two existing ones was ambitious, but also in line with their strategy of delivering pragmatic, value-added solutions to the industry in an ever-competitive landscape.
This was an interesting, though not unfamiliar, challenge for the Application Innovation Group (AIG) of 3D Systems Leuven, Belgium.
- Bring a new implant to market faster with a streamlined development pathway, from drawing review to industrialization
- Complete all required regulatory documentation and validation under European Union Medical Device Regulation (EU MDR)
- Maintain strict quality control requirements, including material certification, inspection plans, and compliance documentation
The Solution
NovaSpine leveraged 3D Systems’ additive manufacturing and engineering expertise, enabling a streamlined process from design to production:
- 3D Systems’ Application Innovation Group (AIG) provided advice, guidelines and early prototyping feedback to scope the project
- Collaboration through agile and focused iterations ensured timely adaptations benefiting costs and quality outcomes
- A validated production framework using in-house tools and processes with more than fifteen years proven expertise supporting medical device development was leveraged, ensuring capability, repeatability and compliance
- Launch order production was executed using a fleet of validated DMP 350 Dual multi-laser 3D printers running Titanium Grade 23 materials, located at the 3D Systems Leuven Advanced Manufacturing site.
NovaSpine DIVA 3D One
NovaSpine DIVA 3D One Titanium Build Plate
With its Leuven manufacturing site acting as a center of excellence, 3D Systems supported rapid product development while maintaining high-quality standards for medical devices. Together, a solution-driven collaboration and a ready-to-scale industrialization environment ensured an impressive time-to-market for these kinds of innovative applications.
The entire process from kick-off to the delivery of the first regulatory approved and implantable devices took under 6 months. This timeline is a representation for standard application development; it may vary based on device complexity, validation requirements, and implementation of feedback loops.
The Partnership
NovaSpine and 3D Systems have built a long-term collaboration rooted in trust and proven results since 2015, working across eight different devices ranges, from concept to implantable products in hospitals worldwide.
To date, this partnership has led to over 30,000 implants produced via the Leuven ISO13485 certified facility. This ongoing collaboration enables NovaSpine to offer a flexible portfolio of 3D printed titanium devices in over 25 countries, with recent expansion into Brazil following ANVISA certification in 2025
3D Systems brings four decades of experience in additive manufacturing, with millions of medical devices produced and hundreds of thousands of patient-specific cases delivered globally.
With this depth of expertise, Novaspine is able to scale its operations while sustaining a strong focus on next-generation (implant/device) solutions.
“To collaborate with a customer like NovaSpine and to see how an idea can evolve from a draft drawing to a fully validated industrial-scale production line is always an exciting and engaging process. Swift and pragmatic decision making is key to breaking paradigms, and this can be said for both the medical device and the additive manufacturing industry. We take pride in the idea that solutions we deliver improve people’s lives and our know-how offers an edge to our customers.” – Lothaire Milion (AIG Engineer, 3D Systems Leuven)
"The ability of 3D Systems to adapt to our stringent requirements is a real asset to accelerate the industrialization process and reduce time-to-market for complex devices. The expertise of 3D Systems' engineering team has consistently guided decisions toward greater efficiency throughout the design of the production process while ensuring compliance with our requirements of highest performance and safety of our devices." – Pascal Khalifé (Director General, NovaSpine SAS)
Surgeon with NovaSpine DIVA 3D One
The Results
The collaboration enabled NovaSpine to achieve rapid innovation and sustained market impact, bringing the DIVA 3D One to a wide distribution network.
Using a Quality by Design phase-gate approach, key 3D Systems teams - including Quality, Production, Supply Chain, and Customer Service - ensure projects are feasible, scalable, and successful both internally and for customers.
This outcome exemplifies how a partnership with 3D Systems can accelerate development and enable scalable production in regulated environments, delivering high-quality results that drive innovation and market growth.
3D Systems DMP Flex 350 Dual 3D Printer
DMP 350 Dual
The 3D Systems DMP Flex 350 Dual is a high-performance metal 3D printer designed to accelerate production of complex medical devices while lowering overall costs, combining dual-laser technology with a precision-controlled vacuum chamber to deliver superior part quality and repeatability.
Built for healthcare applications, it enables manufacturers to produce intricate, monolithic lattice structures that promote bone in-growth and eliminate secondary surface treatments, while also supporting patient-specific designs and a wide range of biocompatible metals.
The system’s advanced oxygen control and optimized materials ensure exceptionally strong, high-purity parts, and its seamless integration with 3DXpert software drives consistent, scalable workflows. By reducing build times by up to 50% or more compared to single-laser systems and enabling multiple part sizes on a single build plate, the DMP Flex 350 Dual significantly boosts throughput, improves design flexibility, and lowers per-part costs, making it a compelling solution for organizations looking to scale additive manufacturing in medical device production.
Looking Ahead
NovaSpine and 3D Systems continue to collaborate on new 3D printed spinal solutions aimed at improving patient safety and surgical efficiency. By combining NovaSpine’s clinical insight with 3D Systems’ manufacturing and certification expertise, the partnership is well positioned to drive ongoing innovation in spinal care.
3D Systems’ fleet of DMP machines provides a flexible base which can meet and adapt to market demand fluctuations, in both time and quantity.
Together, the Leuven (Belgium) and Littleton (Colorado, USA) production sites offer process consistency and dual manufacturing capabilities, providing customers like NovaSpine with greater supply chain resilience.
Summary
This collaboration highlights how additive manufacturing can transform medical device development
- Faster time to market
- Scalable production for growing companies
- Repeatable quality and regulatory readiness
- Long term partnership driving continuous innovation
By combining NovaSpine’s specialized expertise with 3D Systems’ advanced additive manufacturing capabilities, both organizations are helping deliver next-generation spinal solutions to patients faster and more efficiently.
