Health Canada Approves First Medical Implant 3D-Printed By Canadian Manufacturer

CHU de Québec-Université Laval and Investissement Québec – CRIQ have announced Health Canada’s approval of the first 3D-printed medical implant by the 3D anatomical reconstruction laboratory (LARA 3D) at Investissement Québec – CRIQ’s facilities in Quebec City, Canada. This is the first time a Canadian organization has been authorized to produce a 3D-printed implantable medical device in Canada. The 3D Specifit mandibular plate, patient-specific device, will be used for mandibular reconstruction of patients with oral cancer.

Launched last year, LARA 3D has been ISO 13485 certified since April 2021, which confirms that its manufacturing process for new medical devices meets the most rigorous quality management standards. With Health Canada’s approval issued in September, the green light has been given to treat patients and produce the 3D Specifit mandibular plate along with surgical cutting and drilling guides.

3D printing or additive manufacturing (AM) is revolutionizing the manufacturing of medical implants, the company says. Surgeons are no longer limited to adapting a patient’s physiology to prostheses with predetermined dimensions. Instead, patient-specific implants made before surgery, designed from the patient’s internal imaging, follow the unique contours of the bone to be repaired. LARA 3D uses biocompatible metals for 3D printing by laser and electron beam powder bed fusion.

The company says the use of patient-specific metal prostheses that are printed instead of traditionally manufactured will improve the quality of health care in Quebec by reducing patients’ surgery and recovery times, hence improving their quality of life.

The approval of the first 3D Specifit product signals the recognition of Quebec’s expertise in medical 3D printing. Other innovations are in the pipeline in partnership with the private sector, which will benefit from the knowledge and facilities available at LARA 3D. Nearly $8 million in investments were required to construct the facilities and pay for the equipment and human resources needed for R&D and the certification process.