Winnipeg Ventilator approved

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This article was published 28/09/2020 (1853 days ago), so information in it may no longer be current.

The prototype for a medical ventilator, which had been all but forgotten in the basement of the Winnipeg scientist who invented it, has been revived and redesigned and has now received Health Canada approval giving it the go-ahead for an initial production run of 7,500.

The regulatory approval of the so-called Winnipeg Ventilator comes almost exactly six months after the home-grown ventilator project began when the Canadian government announced plans to mobilize industry to come up with technology to assist Canada’s health-care system to fight COVID-19.

StarFish Medical, Canada’s largest medical device design and manufacturing company based in Victoria, B.C., led the project with the assistance of that former University of Manitoba scientist Dr. Magdy Younes and Winnipeg-based Cerebra Health, a company that Younes is the largest shareholder of.

“I am just elated,” Younes said in an interview. “This is something I did 30 years ago. I had forgotten all about it (until six months ago). I hope it helps some people. I am just delighted to have been involved in this.”

Younes gave much of the credit to the engineers and designers at StarFish who completely redesigned the electronics, software and firmware. All that remains is the original innovation of that 30-year-old device — a frictionless piston that allows patients to control the air intake.

A major part of the project was to design a device that could be made in Canada that would not disrupt the existing supply chain for the medical devices.

When Younes built the first one, he used only off-the-shelf materials, and this time StarFish has assembled a similarly homegrown supply chain that Toronto-based manufacturer, Celestica Inc., will use to embark on the first production run.

“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”, said StarFish Medical CEO, Scott Phillips in a prepared statement.

“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.”

Earl Gardiner, executive chairman and founder of Cerebra, said the clinical trials — which will not hold up the production schedule — will likely take place in Winnipeg

“It has been quite a journey,” Gardiner said. “It seems like we have been at it for a long time but when we retrace our steps it has gone reasonably quick.”

At the same time StarFish was appointed as the leader in the project to develop a homegrown ventilator, Younes had been appointed to an expert panel on ventilators and anecdotally mentioned the prototype that was in his basement.

Within days, senior officials from StarFish flew to Winnipeg to inspect it.

Also, coincidentally Gardiner and Dawson Reimer, CEO of Cerebra, had just been in meetings with StarFish regarding sleep technology it is developing.

“When this came together we already knew each other and there was already a mutual respect,” Gardiner said.

Public Services and Procurement Canada is the exclusive customer for the Winnipeg Ventilator 2.0 and will then control the distribution in the coming weeks and months.

As it stands, the Winnipeg Ventilator has received an interim order from Health Canada that allows it to be produced and sold even though it does not fully comply with Canadian requirements, but is manufactured according to comparable standards.

StarFish plans to seek full Health Canada approval to enable sale and use of the new ventilator beyond the interim order authorization.

martin.cash@freepress.mb.ca