VENTILATOR FIRMS BATTLE SUPPLY CHAIN BOTTLENECK.
Overwhelming demand to prepare for virus peak
When he retired from his lab at the University of Manitoba in 2001, Dr. Magdy Younes took little more than a set of electronic files, a few books and two bulky, sharp- cornered metal boxes fitted with flick switches and knobs.
Each about the size of a microwave, the boxes were original versions of the Winnipeg Ventilator, a novel device Younes had invented as a young physiologist in the late 1980s, licensed to an international manufacturer, and then left behind to move on to other projects.
“I knew all the stuff in my lab would be junked so I took a couple of units in case someone wanted to put them in a museum some day,” said Younes, 81. “I kept them in the storage locker in my condo when we moved to Toronto and brought them back when we returned to Winnipeg. I really didn’t think about them that much.”
Then a few weeks ago, as authorities scrambled to expand their fleet of ventilators and countries began curbing exports of the life-saving machines, Younes got a call from Next Generation Manufacturing Canada, or Ngen, — the supercluster charged with managing Canada’s rapid response to COVID-19 medical equipment shortages.
“They wanted me to join a committee evaluating ventilator designs, and I said, ‘ oh I have one,’” said Younes, the former head of respiratory medicine at the University of Manitoba.
Within days, a team of engineers from Starfish Medical, the Toronto- based medical device firm, had landed in Manitoba. The Winnipeg Ventilator, pulled from Younes’ basement and hooked up to a lung simulator on loan from Pittsburgh- based Ingmar Medical, immediately sprang to life.
Since then, a team of 25 engineers has been working with Younes’ company Cerebra Health day and night to update the 30- year- old device with new parts, test it for compatibility with Health Canada regulations and prepare it for manufacturing.
“A process that would normally take two to three years, we’re trying to do in two to three months,” said Scott Phillips, president of StarFish Medical. “And all the things that would normally be done in sequence are being done at the same time.”
It’s just one of a handful of ventilator projects unfolding across the country — each battling in its own way to navigate the challenges of buckling global supply chains, overwhelming demand and export controls that have all but cut off access to crucial parts.
Components once sourced from Europe, China or the United States are being engineered and manufactured by local factories, new devices are emerging from companies that have never made ventilators and old designs are being dusted off and brought back to life.
In all, Prime Minister Justin Trudeau said Tuesday that 30,000 new machines would be produced — adding to an existing inventory of 5,000 machines — as the government works with Thornhill Medical, aerospace firm CAE Inc., Ventilators for Canadians and the Starfish Group.
The prime minister did not say when the devices will be made available.
Hanging over the e fforts is not just the looming threat that a wave of cases will overwhelm local hospitals before the machines are ready, but also a severe shortage of parts.
Demand for the valves, pressure sensors, circuit boards and even consumable parts such as hoses — many made by international suppliers — has well exceeded the capacity for specialty medical firms to manufacture them. And what supply does exist has in many cases been placed behind a wall of export controls — policies that allow countries to curb their sale to foreign suppliers.
“This turned very quickly from an engineering to a supply chain challenge,” said Pascal Grenier, vice president of global operations, technology and innovation at Montreal-based CAE.
The company is pushing to produce 1,500 of the machines by May alone, and intends to make a machine out of “95 per cent” Canadian content, Grenier said.
“We have an army of employees looking to procure these parts but some stuff we’ll have to engineer, some we’ll have to somehow get from suppliers. Ultimately we want to get the local supply chain going.”
There are other challenges. Once manufactured, most ventilators require a suite of equipment — suction devices, monitors, a source of oxygen — all things usually limited to intensive care units.
And most COVID-19 patients requiring ventilation have additional illnesses that require more support than a standard hospital room can provide.
Should a wave of cases outnumber the available ICU beds in a hospital, doctors may be forced to move patients into cafeterias, hallways or other spaces, said Dr. Joe Fisher, an anesthesiologist at Toronto General Hospital and cofounder of Thornhill Medical.
“Once you’ve used up your monitors, having more vents doesn’t help you if you don’t have the support systems for them,” Fisher said.
“Suddenly if you have a big surge in demand like we did in 9/ 11 and you run out of oxygen, then what? Now your ventilators don’t work.”
Demand for oxygen to treat COVID-19 patients has peaked so severely in the United Kingdom that one London hospital nearly ran out last week.
Fisher’s answer to the problem is the MOVES SLC, a portable machine, originally developed for the U.S. military, that compresses oxygen from the air, ventilates and provides most other life support functions.
Thornhill Medical currently is working with Guelph, Ont.- based auto parts giant Linamar Corp. to supply 1,200 machines in the next two months.
Like other manufacturers, Thornhill makes a machine that relies on parts from foreign companies.
While obtaining those parts has been “a challenge in a highly competitive environment, we are moving forward and adapting as needed,” company CEO Lesley Gouldie said in an email.
Finding parts isn’t expected to be quite as difficult for the Winnipeg Ventilator. The machine originally was built to test a method Younes called “Pulmonary Assist Ventilation” — essentially a way of allowing patients’ bodies, rather than the machine, to control how much oxygen they receive.
Though most ventilators now use a component called a “blower” to push air into patients’ lungs, Younes found a piston to be most responsive to the patient’s breathing.
What’s more, with hardly any money to work with, he had to find the cheapest way to build it, using widely available parts.
As a result, although 25 per cent of the machine will rely on foreign components, the engineers will not have to compete for the same bits and pieces currently being battled over by other manufacturers in the international marketplace.
“The approach for this device is just different, based on a method that was popular 20 years ago,” said Phillips of Starfish Medical.
“The parts we need are generic enough that no one’s really fighting for them. And we’re not just trying to build a resilient product, we’re trying to build a resilient supply chain.
Though some manufacturers are running into nineweek lead times to get parts, so far, Phillips hasn’t had any trouble, he said.
Still, “what if a part that took three weeks to get here isn’t right or doesn’t work?” Phillips asked. “We have to be very, very careful as we do this.”
Indeed, it took Fisher six years to develop the MOVES SLC, a process that involved “lots of heartache and failures,” he said.
“It took six years and millions and millions of dollars, it wasn’t easy,” he said.
With that in mind, the best way to ensure the supply of ventilators is sufficient — and to buy manufacturers enough time to make them — is to keep demand at a manageable level, he added.
“That means flatten the curve, stay home, social distancing, try not to get this disease, and don’t let more people get it than you can help,” Fisher said.
WE ARE MOVING FORWARD AND ADAPTING AS NEEDED.