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Health Canada Approves the First Medical Implant 3D-Printed by a Canadian Manufacturer

December 02, 2021
Location :
Québec


Contact :
Annie Morin, Communications Advisor This email address is being protected from spambots. You need JavaScript enabled to view it. 418 808-3775

LARA3D COUL.jpg

CHU de Québec-Université Laval and Investissement Québec – CRIQ are proud to announce Health Canada's approval of the first medical implant 3D-printed by the 3D anatomical reconstruction laboratory (LARA 3D) at Investissement Québec – CRIQ's facilities in Quebec City. This is the first time a Canadian organization has been authorized to produce a 3D-printed implantable medical device in Canada. The Specifit 3D mandibular plate, custom-made for each patient, will be used to reconstruct the jaws of people 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 Specifit 3D mandibular plate along with surgical cutting and drilling guides.

3D printing, or additive manufacturing, is revolutionizing the manufacture of medical implants. Surgeons are no longer limited to adapting a patient's physiology to prostheses with predetermined dimensions. Instead, customized implants made before surgery, modelled from the patient's internal imaging, follow the unique contours of the bone to be repaired. LARA 3D uses biocompatible metals for laser and electron beam powder bed fusion 3D printing.

The use of custom-made metal prostheses that are printed instead of traditionally manufactured will improve the quality of healthcare in Quebec by reducing patient surgery and recovery times, hence improving their quality of life.

The approval of the first Specifit 3D 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 was required to construct the facilities and pay for the equipment and human resources needed for R&D and the certification process. The Government of Quebec provided $3,477,873 in funds through Programme de soutien à la recherche, volet 2 - Soutien au financement d'infrastructures de recherche, a research support program that allocated funds for research infrastructure.


This project illustrates the innovation possibilities that arise when professionals from different worlds —namely a university hospital, CHU de Québec-Université Laval, and an applied industrial research center, Investissement Québec – CRIQ — join forces. From the private sector, the orthopedic screw manufacturer Alkom Digital and the producer of metal powders for 3D printing AP&C were also involved. Axelys (formerly SOVAR), an organization supporting researchers and entrepreneurs for the development and transfer of innovation from public research, participated in the financing of about $225,000 through Programme de soutien aux organismes de recherche et d'innovation (PSO), volet 2d, dedicated to technological maturation.

Quotes

“Collaborations between industry and research communities allow Québec to develop more medical innovations. The approval of this implant is an excellent example. By supporting the 3D anatomical reconstruction laboratory, we strive to stimulate collaborative research in leading- edge sectors in order to improve the competitiveness of businesses and the quality of life of the Québec population.”

- Pierre Fitzgibbon, Minister of Economy and Innovation and Minister responsible for Regional Economic Development

“We are extremely proud to announce Health Canada's approval of the Specifit 3D mandibular plate. Not only will it improve patients' quality of life; but thanks to optimized, guided, and personalized surgery; it will also enable the development of a 3D medical equipment centre of expertise at Centre de Recherche du CHU de Québec – Université Laval. We are convinced the approval of this technology marks only the start of innovation, research, and development in 3D medical printing at LARA 3D.”

- Dr. Gaston Bernier D.M.D., Medical chief, Dental Medicine & Oncology, CHU de Québec-Université Laval

“With LARA 3D, Investissement Québec – CRIQ fully embraces its leadership role in additive manufacturing in Québec. The Specifit line of 3D prostheses will meet the needs of the healthcare sector and provide improved quality of life for patients. It also demonstrates the wide range of possibilities 3D printing affords companies that must design complex, light, and durable parts. The expertise acquired by Investissement Québec – CRIQ is accessible to the entire 3D-printing ecosystem in Québec. This will spur the development of innovative products and foster the growth of innovation companies.”

- Lyne Dubois, Vice-President, Investissement Québec – CRIQ

“The work at the Investissement Québec – CRIQ lab is impressive. The team is doing great work in the development of 3D-printed custom mandible implants. The organization's 13485 ISO certification, coupled with an endorsement from Health Canada, reflects the leadership and the quality of design and manufacturing the group is delivering.”

- Terry Wohlers, President, Wohlers Associates, and author of the Wohlers Report

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