Hi. I'm glad to be here.
I'm John Walmsley, executive vice-president of strategic relationships at StarFish, and I have been leading our ventilator mission.
In March, we were asked by the NGen supercluster to evaluate two potential ventilator technologies that could be manufactured by a collaboration of their industrial partners. On Saturday, March 20, two of our experienced engineers and I flew to Winnipeg from Victoria—a strange thing to be doing as the provinces went into lockdown. We met with Dr. Magdy Younes, the inventor of the Winnipeg ventilator. Dr. Younes's team had pulled two prototypes from deep in his basement and set them up for us to see. We spent the day, wearing masks as we worked, learning all about them. The design seemed an ideal candidate for an emergency ventilator, as the technology was robust and used components that would not compete with the supply chain of modern ventilators. The interface was well-thought-out and simple enough for supervised use in case of “corridor medicine”. The core of the system was a large piston, which we knew would suit any automotive manufacturer who might join the effort. On the plane home, which we shared with high school students glad to be returning from Germany, we were already working on the mechanical and electrical architecture for a new design based on this technology.
By the end of the first week, we had defined the requirements for the system and had offers of assistance from throughout the NGen network of companies and beyond. Linamar-MacDon and General Dynamics were among the first to provide logistical support.
By the end of the second week, we had successfully presented the design to three expert panels: Health Canada, NGen and ISED. A very helpful letter of intent followed. We had over 30 design engineers at this point, turning plans into reality: in mechanics, electronics, software and user interface design.
By the end of April, we had a design that we called “frozen”. It is still changing to react to the availability of parts and testing results, but we knew what we were building in detail. The core of our engineers and sub-assembly suppliers across the country have been working 12 hours a day, seven days a week.
On Friday, at the end of May, we completed the first full testing of our completed units. We will be submitting for Health Canada authorization very shortly. From there, we will continue the ramp-up with our flexible and enthusiastic contract manufacturer, Celestica. This two-and-a-half-month project would normally take three years. How have we moved so fast?
Past clients in Canada and the U.S. helped us define a system that will be truly useful in the ICU, but the system is not fancy. All choices were made to be fast and flexible to allow for change. The StarFish team has a wide variety of experience and is used to rapidly developing new medical devices through a well-proven process. Some on the team have 40 years of experience; for others, this is their first co-op term.
Throughout Canadian industry, any CEO took my call. Many called Scott and me. NRC IRAP and NGen are governmental organizations with personal working relationships with industry and were invaluable in finding solutions. Health Canada's regulatory group has been unfailingly responsive, supporting the push while ensuring that products are safe and effective. Global Affairs, Public Works and PHAC have all contributed wonderfully. The collaboration among ventilator initiatives has been open and refreshing. I check in regularly with peers at other companies. We have also provided regulatory advice to those developing a medical device for the first time, including to Professor McDonald's initiative.
Due to speed, this has not been a cheap enterprise. A common project management phrase is “Cheap, fast, good: pick two.” Normally, in our world, speed is last. Companies need the product to be good and are only willing to spend just enough. In this case, cheap has been last. In order to deliver a safe product fast, we have paid for contingencies that we have not necessarily needed. We have custom-machined parts in Canada rather than ordering ready-made parts from overseas, but we still needed to source some key components internationally. We have used over-specified parts to be sure they will work, and we are leaving much more work than normal to the manufacturing phase.
We are proud to have answered a national call. Our team will be tired when they are done, but they are not done yet.
Scott.