Winnipeg Ventilator 2.0 manufacturer receives device approval from Health Canada

StarFish Medical has received authorization from Health Canada for its Winnipeg Ventilator 2.0 to be classified as a COVID-19 medical device.

The device was approved under an interim order allows the Minister of Health to permit the exceptional importation and sale of drugs, medical devices (including ventilators), and foods for special dietary purposes that do not fully comply with Canadian requirements, but are manufactured according to comparable standards.

The approval allows Canadian Emergency Ventilators Inc. (CEV), as the manufacturer of record, to ship ventilator units to the Public Health Authority of Canada (PHAC) starting immediately.

PHAC is working with the company to review the devices that come into the National Emergency Strategic Stockpile (NESS) so they are ready to be shipped across the country if and when they are needed.

“Our goal with the Winnipeg Ventilator 2.0 is to deliver a fully featured ICU ventilator that could save patients’ lives, be manufactured in Canada in the shortest time possible, and not disrupt the supply chain for existing ventilators,” says Scott Phillips, StarFish Medical CEO and founder.

“To do that, we started with proven technology (original Winnipeg Ventilator designed by Dr. Magdy Younes), updated the design to incorporate technical advances and use non-medical supplier components, all while drawing upon a network of companies we have worked with for over 20 years. The pioneering work of Dr. Younes, and the support of Cerebra Health with clinical input and upcoming clinical trials, is invaluable.”

StarFish presented the ventilator design to expert review panels convened by NGen and ISED to positive and encouraging feedback.

Dr Younes tested the updated version of his ventilator calling it a “masterpiece indeed.”

“The Winnipeg Ventilator 2.0 project led by StarFish Medical is a shining example of how Canadian companies have responded rapidly to the COVID-19 crisis, combining their engineering, technology and manufacturing capabilities to develop and produce an innovative solution that will help save lives,” says Jayson Myers, NGen’s chief executive officer.

“NGen has been a proud supporter of the Winnipeg Ventilator project since we funded its launch in the early days of the pandemic. Health Canada’s approval will now let the project partners move into manufacturing and get their ventilator into the hands of the patients who need them most.”

John Walmsley, StarFish Medical EVP strategic relationships, says teamwork was important in the project’s rapid progress.

“Our supply chain moved quickly and diligently to discover what supplies and services were available, while our engineers worked with available components to create and build the design,” he says.

“We used 106 StarFish employees on the project and over 100 people at key vendors including Dometic, Advanced Test Automation, Yorkville, Dorigo Systems, Powersonic Industries and EM Dynamics. Having designed the product, we were very happy to have Celestica on board to coordinate with our supply chain and begin to bring on board their vendor network for manufacture.”

Kevin Walsh, vice-president, HealthTech at Celestica, says, “As soon as we received the StarFish innovative and manufacturable design for the new Winnipeg Ventilator, we leveraged our engineering, supply chain, and certified manufacturing expertise to source critical parts and begin production of 7,500 units without delay.

“These ventilators are essential to treating critically-ill COVID-19 patients, so speeding time-to-market has never been more critical.”