‘The medical device industry has long assumed that mass production and true personalization are incompatible. FormFit proves they are not.’
Key takeaways:
- Vitacore received a Medical Device Licence from Health Canada for FormFit, a fully custom-fit medical-grade silicone CPAP mask.
- The mask is created using a smartphone facial scan that translates a patient’s facial topography into a 3D model for personalized manufacturing.
- FormFit is compatible with CPAP, APAP, and BiPAP therapy devices and is now available in Canada, with a US FDA submission underway.
Vitacore has received a Medical Device Licence from Health Canada for FormFit, a fully custom-fit medical-grade silicone CPAP mask.
The technology utilizes a smartphone facial scan to create a high-resolution 3D facial model. Vitacore’s proprietary design engine then translates the patient’s facial topography into a unique design, automatically optimizing seal geometry, contact-pressure distribution, structural integrity, and airflow dynamics, and the resulting mask is manufactured in Canada. FormFit is compatible with CPAP, APAP, and BiPAP therapy devices.
“One of the fundamental problems in CPAP therapy is that we’ve been trying to fit an extremely diverse range of facial shapes into a small number of generic mask designs,” says Mikhail Moore, president of Vitacore, in a release. “The medical device industry has long assumed that mass production and true personalization are incompatible. FormFit proves they are not. We’ve built a platform that translates each patient’s unique anatomy into a manufactured, medical-grade product with no compromises, no generic shells, no ‘best available size.’ FormFit is the first product on this platform, and I believe it represents the future of how personalized medical devices will be designed and built.”
The customized seal is designed to reduce air leaks, minimize noise, and eliminate facial pressure marks to improve overall therapy effectiveness and comfort. The masks are manufactured using medical-grade silicone at Vitacore’s ISO 13485 certified facility in Port Coquitlam, British Columbia.
In Canada, FormFit is available immediately:
- Direct-to-consumer on Vitacore’s website
- Through participating sleep clinics and healthcare providers across Canada
Vitacore is also preparing a submission to the US Food and Drug Administration.
A huge concern I have always had and patients I work with often have is the amount of waste the medical world in general produces but specifically CPAP and supplies. Thes masks and other supplies are designed to last for only short periods of time which ends up producing a ton of environmental waste. I would like to see recycling programs or equipment made that is designed to last considerably longer than what manufactures are currently building these things for. Having to replace a cpap cushion every 30 days is ridiculous and so bad for the environment.