Back in 2020, when news of Italy’s response to the COVID-19 pandemic showed patients in hospitals being treated with helmet ventilation, the members of COSMIC Medical wondered if there was a way to improve the efficacy of the device for widespread use in BC. Could they create a low-cost, sustainable design without compromising COVID-19 patient outcomes or risking intubation injuries associated with current standard ventilation practices?
With the design approved for a clinical study, COSMIC’s spin-off company, Clarivent Medical, has taken over the next steps in producing a Bubble Helmet that is ready for the BC healthcare market. Arpan Grover, Clarivent Medical’s Co-Founder, and Dr. Philip Edgcumbe, Co-Founder of COSMIC and Clarivent board member (both SBME alumni), have overseen development from ideation to prototyping to trials, and have worked to overcome every engineering and logistical roadblock they encountered along the way. Clarivent is working under the advice of Health Canada and the Food and Drug Administration (FDA) to fine-tune the helmet to meet regulatory requirements.
The first obstacle was the steep learning curve at the project’s outset for Grover and his teammates. “It was difficult to find a manufacturer that was willing to work with us to produce helmets at a small scale for testing and the clinical trials,” Grover recounts. “Also, for many of us, it was our first time drafting a feasible, effective, and time-sensitive clinical study protocol for creating a medical device.”
The COSMIC and Clarivent teams rose to the challenge, drawing on their diverse backgrounds—the teams include biomedical engineers, materials engineers, clinically-based MDs, biologists, and commerce and marketing specialists—to prototype and source materials for the Bubble Helmet, and modify the design even further to maximize end-user comfort and safety.
Dr. Edgcumbe credits the experience, research mentorship, and training he received in SBME’s Engineers in Scrubs (EiS) program for helping move the idea to a finished, operational prototype. “Our team incorporated many of the same biodesign processes and strategies that I first learned about in the EiS program,” says Edgcumbe. “Our design teams were set up to foster inter-disciplinary collaboration and really leverage the interfaces between engineering and medical research, clinical practice, and product development.”
It was this same clinical experience in EiS that ensured Edgcumbe and the entire team put patient wellbeing front and centre at every stage in the Bubble Helmet project. The result is a final product with an improved port design that reduces air leakage better than any other offering on the market. By using a single material, the helmet’s different components can be heat-sealed rather than mechanically joined, which ultimately keeps leak points to a negligible minimum. As well, where other helmet designs can cause a claustrophobic response, the Bubble Helmet is designed with optical clarity in mind. This means that patients will feel less enclosed and claustrophobic, and communication is improved between a patient and their physician.
Possibilities for the Future
Once their helmet design has been met with regulatory approval, COSMIC and Clarivent hope to expand the scope of both production and viable markets for the Bubble Helmet.
The team is already identifying new opportunities where their system can make a difference. With slight technical modifications, it has the potential to be a short-term alternative to intubation during patient transport in rural areas, or help treat divers with decompression sickness, or even function as an alternative breathing support device for patients with facial deformities and burn victims who cannot use a typical mask.
Biomedical Engineering has met the challenge of the pandemic on multiple fronts, from mRNA vaccines to treatment protocols to novel diagnostic tools. The Bubble Helmet isn’t a new idea, but on the other side of the problem-solving mindset instilled in programs like EiS, it has become something with the potential to people far beyond its original intent.
COSMIC and Clarivent have created possibilities for more than just those who need help and care in their fight against COVID-19. They have taken another step forward in a never-ending journey to changing health and healthcare for all.
UBC School of Biomedical Engineering