First Responders Respirator – Proof of Concept Prototype
Updated: May 15, 2020
Prototyping during a Pandemic
There is a surprising similarity between soldiers, entrepreneurs, and engineers that relates specifically to how they approach problems. The characteristics that provokes an entrepreneur to fill a need in a market space are the same that drive an engineer to find a solution to a problem and encourage a soldier to run towards danger instead of away.
This shared characteristic is born from facing a challenge, and results in the determination to find a solution. Challenges are what engineers, entrepreneurs, and soldiers live for… and are often exactly what they find.
In November of 2018, a fellow Canadian forces veteran and new entrepreneur, Graham Irvine approached Enable Innovation with a product idea that would not only provide a significant challenge but would solve a very real problem faced by his target market. Unbeknownst to all involved, this product would come to be in great demand in the near future, as an unforeseen crisis triggered a pivot for Graham’s fledgling endeavor; First Response Health & Safety.
Before engaging Enable Innovation for engineering support, Graham had completed the Prince’s Operation Entrepreneur (POE) Boot Camp as part of his transition from soldier to entrepreneur. His background with the Canadian Forces, as well as his spouse’s background working with law enforcement and first responders, provided Graham with insight into the unique challenges faced by first responders in the field, as well as the psychological repercussions they face from exposure to hazardous working environments.
These perspectives drove Graham to pursue the development of Personal Protective Equipment specifically designed to mitigate a first-responders exposure to specific environmental factors which pose a risk to both physical and mental well-being. The goal being to provide protection from immediate environmental hazards using conventional barrier and filtration technologies, as well as to develop technology to provide a prophylaxis against sensory stimulants commonly associated with operational stress injuries (OSI), such as PTSD.
Graham’s company, First Response Health & Safety, would start with the development of a mask intended to be semi-reusable, cleanable, and flexible enough to be stored in a small pouch carried by first responders. Design and engineering requirements included a NIOSH N95 minimum requirement, as close to 100% Canadian manufactured as possible, and the inclusion of technology designed to mitigate exposure to OSI triggering environmental factors.
As a combat veteran who has faced the challenge of PTSD, with related sensory triggers, I could immediately appreciate the application of this product.
The first step in our process is gathering all relevant information, determining the milestones, and developing the path. In December of 2018, we provided Graham with an initial budget report and timeline which outlined the time and funding required to produce a functional prototype, ready for manufacturing. This report also included research into the industry, medical, and legal requirements for the product, as well as the estimated timeline and budget needed for certification.
Armed with this information, Graham began the arduous process of seeking funding, applying for grants, and engaging investors; a process which has its own steep learning curve for new entrepreneurs.
By late 2019, it had been decided that the best way to engage with potential investors would be to produce a “Proof of Concept Prototype” of the mask, allowing investors to physically engage with the product. If a picture is worth a thousand words, then a 3D model, even with limited functionality, is worth a million.
In January 2020, a project charter for the demonstration masks was developed, including technical and design specifications defining the fit, form, and limited function of the proof of concept prototype, which included the design and production of a mask using 3D printed plastic components as well as rubber components made using 3D printed molds and commercially available RTV silicone rubber. The caveat to these specifications being that the mask will provide no functional protection to the wearer, and due to the materials used, will not be as rugged as the final product. The demonstration mask would merely provide a physical model to demonstrate the design intent of the larger project.
And with that information, we began the design phase. After a few iterations, the proof of concept design was ready to be prototyped.
Then along came COVID 19.
With the spread of this virus came shortages of PPE, creating significant challenges for all front-line workers, first responders, and the general population. There was an obvious deficiency in our national, provincial, and regional supply chains, as the flow of PPE from foreign manufacturers decreased or stopped completely. As local companies began to retool and step up to fill in the gaps in the supply chain, it became glaringly obvious that things needed to change in the future. This crisis exposed a need. A need which Graham instantly recognized. Not a short-term stopgap, but a long-term supply chain solution which First Response Health & Safety could easily pivot into. A need for domestically produced, semi-reusable PPE with local stockpiles ready for emergencies.
As Graham began the process of redefining his company’s priorities, the work on his proof of concept prototypes continued.
To begin production of the prototype, molds of the masks rubber components were designed and produced using a desktop 3D printer.
The mold was designed specifically for use with Smooth-on OOMOO 30, room temperature vulcanizing silicone rubber. This rubber is commonly used to produce hobby grade molds for resin casting, which makes it very easy to work with, sets in 24 hours, and is relatively inexpensive.
To produce the rubber mask components, 3D printed molds for the mask body and flange were sealed, coated with mold release, and assembled. The RTV silicon rubber was mixed with a pigment to produce a ‘medical blue’ colour and injected into the mold spout.
As this is a very manual, and messy, process; acceptable results required some trial and error.
The expected challenges inherent with prototyping were compounded by supply chain issues, delaying delivery of materials, as well as the necessity to reduce the number of staff in the office / shop, which left all the prototyping work to one person.
Nevertheless, after a few weeks of toil, failure, frustration, and learning; acceptable mask bodies and flanges were successfully produced.
The mask components were then trimmed to remove flash from the molding process and assembled using silicone epoxy.
Concurrent to the molding process; plastic components, such as the filter and vent housings, buckles and strapping guides were produced using a 3D printer, and strap material was acquired from a local fabric store.
When fully assembled, the demonstration models were shipped to First Response Health & Safety. Included with the prototypes were the molds, iterative models of the mask, extra 3D printed fittings, test shots of the rubber in the molds, as well display heads and stands.
This development reflects only the first steps in developing this product for First Response Health & Safety. The road ahead is long and filled with many known and unknown challenges. We stand ready to face these challenges with First Response Health & Safety, as well as any of our clients who have identified a real problem and have chosen to meet it with a solution.