Saskatoon– A few days after the global pandemic was declared, Jim Boire got a text from his daughter. Rebecca Erker, a Royal University Hospital intensive care unit nurse. She is working on her PhD with the respiratory research centre in Saskatoon. As a result, she had a good understanding of what was at stake with COVID-19, and reason to be concerned.
Thankfully, Boire is president of RMD Engineering, a Saskatoon firm whose expertise ranges from beamlines for the Canada Light Source Synchrotron to industrial processes in potash mining, and a whole lot in between. They’ve worked in uranium, agriculture, and a lot of research and development. His company (which Boire owns with four other partners, all employees) had the expertise and capacity to do something about it. And so they did.
“I got my text from my daughter on March 18. March 24, we had our first prototype built,” Boire said by phone on Dec. 3. Now the Saskatchewan Health Authority (SHA) announced on that December day it would be taking delivery of 100 new ventilators, known as the EUV-SK1, in short order. The first 20 are ready to go out the door, and the company has most of the parts in place to build as many as 1,000 units.
RMD Engineering Inc.’s subsidiary, One Health Medical Technologies, recently received COVID-19 Medical Device Authorization from Health Canada for an in-house designed, developed and manufactured ventilator. Collaborating with the University of Saskatchewan and SHA subject matter experts, RMD Engineering was able to successfully prototype an emergency use ventilator for Health Canada certification.
According to a Ministry of Health press release on Dec. 3, there are currently approximately 650 ventilators available in Saskatchewan’s health system, enough to meet the need. They range from high-end critical care type ventilators to more basic sub-acute ventilators. The SHA’s purchase from RMD will increase that number to about 750.
But getting from a text to a prototype for an approved ventilator wasn’t easy, nor was it quick process.
Very early on, the deans of both the University of Saskatchewan College of Engineering and College of Medicine got involved. Top respiratory technologies, respirologists, and ICU nurses were brought in within short order to develop this totally new product. Boire said, “As soon as we asked for them to help, they helped with open arms. And you have a team like that that knows exactly what something is supposed to do. And the capability to build something that can do that, then all you need are the codes and standards and validation equipment to make sure it meets the required level of quality.”
Asked if it was like converting to war production in 1940, Boire said, “I’ll tell you, that’s exactly the way it started.
“It felt like a military operation, if I was ever involved in a military operation, but I wasn’t. However, as soon as we got through the point where this is going to work, this design is going to work, here’s what we have to do now, a group of people said, ‘You know what? We get it. This is like a military operation, everybody’s doing this, let’s just go go go.’
“They stopped and said, “You know what, it’s probably time now that everybody starts looking at this as the biggest humanitarian effort this company has ever done.” And it was just an awesome way to get out of that firefighting mode. And then one of our instrumentation leads said, ‘This is not a sprint. You guys can’t keep working 18 hours a day. This is going to be a marathon.’
“And it really helped pull the whole team back down to the ground, and get them out of that adrenaline mode, and really start focusing on the work breakdown, structure in the tasks at hand, and who’s responsible for what and what’s this timing going look like and when is this going in.”
His references to firefighting are authentic, as the company has built support equipment for water bombers.
Worldwide shortages
They soon realized that the whole world was looking for critical parts, which almost immediately went into short supply and were being hoarded. Some items, like wire, saw huge price spikes. So RMD quickly realized it had to work on this project quietly, and develop a product that avoided critical path component shortages.
Boire said, “Instead of using the newer, more conventional turbine method, we knew those would be a hot commodity, when the world proclaimed they needed over a million of these. As you can imagine, that turbine is a complicated piece of equipment. We went the other way. We went back to being simple,” Boire said. “We have very, very few moving parts in our machine. There’s four moving parts.”
He explained, “This is an emergency use ventilator, so it needs to be used in the hospital or in an emergency hospital situation where they have line medical air and line oxygen so that’ll be running at 50 PSI. And then we control everything with proportional solenoids.”
There are two tubes coming into the device, which is in a large Pelican case, and two tubes coming out. They had them on hand because of another government project they’re working on. The lid includes an IBM screen.
“They’re all high reliability components,” he said. It runs off 110 volt AC power.
You set it up beside the bed, hook up the lines, hook up the power and put in the appropriate prescription.
High standards
They had previously made the biomedical imaging line for the Canadian Light Source, but they weren’t a medical device manufacturer. The list of specifications, protocols and standards was extensive.
And those standards, in some ways, simplify things. Boire said, “We don’t have any proprietary stuff on there, so all of the circuits, all the nebulizers everything fits on there. All that is covered off in standards. And I think that’s one of the biggest things to understand is when you go down this path, it is very prescriptive on everything. The machine has to do all of the standards it has to meet, including operational standards.”
He added, “It’s probably a foot tall, the stack of standards, when you put them together. You have to meet the electrical requirements, the operational requirements, the safety requirements. You don’t get to just build something in your backyard, and then tell everybody you have it. When you go and look at the requirements, when you submit to Health Canada, it is an armful. And I think we’ve spent just about $30,000 on standards. There is a lot of standards that you have to meet.”
It is very unique, he said. “We looked at the critical components like flow meters, how you measure flow and pressure, because we’re talking very low pressures that have to be measured very accurately.”
This is where the consultation with respiratory technicians, anesthesiology repair technicians from the health region made a difference. Because there was such high demand for ventilator components, he said, “You have to figure out how to do that with readily available things that are very safe.”
“So when we started doing our production testing, we had to do accelerated testing on components that, in the period of two or three weeks, we could get an effective 25 million cycles on a component that we designed.”
By the end of December, they’ll likely have the remaining 80 units ready. They’ve also built a training version to be used in remote areas or to train people on a simulation patient or a “test lung.”
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They submitted their application to Health Canada on May 5. “In that period of time is when we refined our design, did our testing, had to send it out to third party,” Boire said.
Commitment
Quality assurance and traceability were very important, he said.
“Since March, we’ve got 40,000 to 45,000 hours in already, in the development and testing and verification side.”
This happened just as the company was in the middle of expanding their facility, much of which was accomplished with their own staff.
“We’re probably going have to hire another 12 to 15 people, and train them,” he said, noting training is a big part when dealing with healthcare devices, especially when it comes to things like quality control.
“We’ve currently got 15 people now on the manufacturing side of it and the programing side, and the testing side.”
They are working on getting their Medical Device Single Audit Program (MDSAP) certification, which he calls a “quality control program on steroids.”
Asked if they were going to stick with it, he said, “We’re going to stay as a medical manufacturer.”
Boire added, “The medical device manufacturing will just be another part of our company. We’re going to stay with theses rugged use ventilators, like this emergency type ventilator. We do not intend to compete with Panasonic or anybody at Philips, anybody that’s making mainstream, high-volume ventilators. We’ll stay with a rugged use ventilator, because unfortunately, when you look at the numbers and look at this type of virus, the feeling is this could be around for a long time. And the government is coming out with a program that those of us that produced a medical device will have the opportunity over the next couple of years to convert that to a full medical device licence. And we’ll take advantage of that just so we can make sure we keep this, here in Saskatchewan. We’ve already spent the money. Whatever happens now, happens.
“So we want to make sure that we leverage that into good technology and good expertise for the years to come, not just, ‘Oh well, there’s no more ventilators to make, we’ll just do something else.’
Boire said they found that Saskatchewan really needs to focus more on trades and “getting trades educated with higher-end things.”
“We have to bring manufacturing back to Saskatchewan,” he said.
They were going to do it
Why did they choose 1,000 units? Boire explained, “Saskatchewan said, ‘Our numbers show we need 1,000 ventilators in Saskatchewan.’
“We’re from Saskatchewan. We said we’re going to pick to do this, based on what we can do in this province. And what we did instead is while we were building this, we’ve built a whole project management system and basically a tool kit that if need be, if this type of ventilator is required in other places, we now have a system that we can go and work with another company very similar to ours, that has similar manufacturing capabilities and get them up and running to produce locally to them.”
Boire said, “If we sold, half of what we had expected to make, we will break even. But again, it’s not why we did it.”
“This initiative exemplifies the spirit of collaboration and entrepreneurship we’re so proud of in our province,” Health Minister Paul Merriman said in a release. “Our government fully supports this work, and we are pleased that residents in Saskatchewan and across the country will have access to this equipment, if they need it.”
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