If there was one “most valuable player” that everyone in medical settings relied on during the pandemic, many would name personal protective equipment (PPE). However, while the lack of proper equipment has been felt acutely in every facility, the problem is not yet solved six months into COVID-19, with experts predicting that shortages could persist for years to come.
Calumeo, one of three Stanford Biodesign Summer Extension projects hosted by the Fogarty Institute, aims to alleviate this problem. The startup, the brainchild of six Stanford students who were teammates in the Stanford Biodesign Innovation course, is developing a simple and effective device to quickly disinfect N-95 masks.
The team encompasses three physicians with different specialties, including Jackie Speed, a urology fellow; Jason Qian, an ENT resident; Niki Panich, a family MD with specialized skills in maternal-newborn care who holds a Master’s in Data Science and is an MSX-Sloan Fellow from Stanford Graduate School of Business; two graduate engineering students, Bryce Yao and Lawrence Domingo; and Avril Jiao, a Stanford Graduate School of Business MBA student.
“We are a very complementary team with one key value in common: We are all deeply passionate about what we do. The combination of our diverse medical backgrounds and a thorough understanding of technology and engineering has been tremendously helpful in developing our device,” said Niki.
Improving life for those on the front lines
As part of the Biodesign course, teams research high-need areas, and PPE was an obvious one in the current environment. “As three of our team members, including myself, are physicians, we were well aware of how uncomfortable and cumbersome PPE is, so initially we began looking at ways to redesign the equipment to make it more user friendly,” says Niki.
But as the pandemic unfolded, the groups’ focus shifted to address the dire shortage of N-95 masks. “These masks are intended to be used once per clinician, with one patient, for a maximum of about eight hours,” she explains. “However, the CDC eased its guidelines due to the shortage, extending the length of use with the same patient or patients with the same condition. This has led to extreme circumstances; we are now seeing physicians using the same mask for up to two weeks at a time.”
Currently masks are collected at the hospital and a large quantity—up to 80,000 masks—are shipped to an outside facility to be disinfected at once with hydrogen peroxide, a chemical-based solution, and returned to the hospital.
The concern is that N-95 masks are only effective if they are fitted to an individual’s face, but due to this mass collection, it’s unlikely providers will receive their own mask back. In addition, the process often leaves behind the smell of hydrogen peroxide, which some find nauseating.
To help solve these myriad issues, Calumeo has created a small, nontoxic, heat-driven device that allows providers to sanitize their masks safely up to five times and likely more. Because it can be used at the point of care, providers will receive their own mask back, eliminating issues with fit. The device disinfects the mask in about an hour, which means nurses or physicians can have the mask ready by the time they start their next shift, explains Niki.
“It’s very easy and convenient; since we know how important this device is to us and our colleagues around the world, we are eager to get it to market,” said Niki.
The team entered the Johns Hopkins Biomedical Engineering 2020 Healthcare Design Competition with an initial concept and were among the winners. This first “success” gave them some startup funding, which they supplemented with a grant from Stanford Graduate School of Business and the Stanford Center for Innovation in Global Health to keep the project moving forward.
Joining the Fogarty Institute’s program
Calumeo piqued the attention of Fogarty team members who were on the judging panel when they applied for the Biodesign Summer Extension program. Calumeo was thrilled to not only receive $10,000 from Stanford to continue advancing the project, but also the opportunity to learn from the expertise of the Fogarty leadership team.
“We are very grateful and feel very fortunate we made it into the program,” said Niki. “Fogarty’s expertise has helped us avoid ‘rookie’ mistakes, and leveraging their advice has greatly accelerated our progress, which is vital to meet our fast track. The team really supplemented the skills sets where we most needed support.”
Due to its compact countertop size, the market for the device will be vast—from out-patient clinics, to hospitals, to nursing homes and even barber shops. The current version disinfects up to six masks at a time.
Calumeo is forging ahead quickly and recently partnered with a local company, Phoenix Deventures, which specializes in taking devices from early prototype design to full-scale manufacturing. The team is also in discussions with the FDA to receive Emergency Use Authorization approval.
About the Stanford Biodesign Innovation Course and Summer Extension Programs
Biodesign Innovation is a fast-paced, project-based course for graduate and post-graduate students interested in improving healthcare for patients around the world through technology innovation. Over two quarters, multidisciplinary teams of Stanford students research and validate real-world medical needs, invent new health technology products to address them, and plan for their implementation into patient care.
The Biodesign Summer Extension program provides qualifying teams from the course and the Stanford Biodesign Innovation Fellowship with additional funding and mentoring to pursue their projects through the summer. Recipients use this time to further de-risk their technologies, develop business plans, and line up additional funding to take their projects to the next level.
The Fogarty Institute partners with these young companies to offer its signature hands-on mentoring from each member of the executive team, in addition to a dedicated mentor, along with a comprehensive development plan and opportunity to participate in educational workshops tailored to their specific needs.
From undergoing a full company “physical,” to connecting the companies with the right people and physicians in the industry, program attendees have a unique opportunity to quickly propel with projects forward and get closer to becoming a potentially viable company.