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Case Studies
Scaling 3D Printed Medical Devices for Global Health Impact
Challenges
The manufacturer sought to leverage 3D printing technology to produce medical devices at scale, with a mission to improve access to care in remote and conflict-affected regions in Canada and internationally.
While manufacturing was centralized, the use of additive manufacturing introduced regulatory challenges, including:
- Demonstrating process consistency and repeatability for 3D printed devices
- Validating printers, materials, and software as part of the manufacturing process
- Managing design changes inherent to digital manufacturing
- Aligning regulatory expectations for an emerging manufacturing technology across global markets
As a Canadian medical device manufacturer, the client required a regulatory strategy that supported innovation.
Solutions
We developed a risk-based regulatory and quality strategy tailored to additive manufacturing, including:
- Clear regulatory positioning under Canadian medical device regulations
- A robust quality management system addressing risk, production controls and process validation
- Regulatory documentation designed for reuse in support of a fast-growing portfolio of devices
- A post-market surveillance and feedback framework to monitor real-world performance and inform
continuous improvement
This approach ensured regulatory confidence while preserving the flexibility and speed of 3D printed manufacturing.
Successful establishment of a compliant 3D printing manufacturing framework in Canada
A scalable regulatory foundation supporting future global market expansion
Results
CONCLUSION
This case study shows that 3D printed medical devices, when supported by a fit-for-purpose regulatory and quality strategy, can be manufactured safely, consistently, and at scale. By aligning innovative manufacturing technology with regulatory expectations, the manufacturer was able to advance its goal without compromising compliance or patient safety.
TESTIMONIAL
"It's been such a pleasure working with you. Your expertise and guidance have been invaluable, allowing us to move fast on this critical aspect of our business and gain a deeper understanding of how regulators work. You kept us focused and streamlined in our approach, our quick MDEL certification is a testament to how well your guidance worked. We've also been privileged to have the team trained by you through this foundational process, which is a huge benefit moving forward." Fatima Ahmed, COO Building Bloc