Cervical cancer is easily preventable, but it still kills a quarter of a million women every year. Almost all of them are in the developing world. If you happen to live in Bolivia or Zimbabwe instead of the United States, you're much more likely to get the disease, and much more likely to die from it.
A new low-cost medical device—developed by a team of students—may help change that. Cinluma, a portable, handheld gadget that runs on a rechargeable battery, works by applying heat to pre-cancerous lesions on the cervix. In 45 seconds, the lesions are gone.
While it's becoming easier to cheaply screen patients for early signs of abnormal cells, the treatments that are common in the developed world are expensive and require supplies, maintenance, and access to electricity.
"Detection is not the limiting factor; we can identify pre-cancerous lesions in the developing world using everyday vinegar," says Ashley Langell, a medical student at the University of Utah who was part of a cross-disciplinary team that developed the new device. "The real limitation is the inability to treat these lesions once they have been detected."
The device began with a $500 grant in the university's Bench 2 Bedside medical device competition, a seven-month program that pairs a team of students with a physician and an industry mentor.
The school's Center for Medical Innovation brought together two medical students, two surgical residents, a design student, and an MBA student with a bioengineering degree. Dean Wallace, a doctor and entrepreneur who proposed finding a better treatment for cervical cancer, acted as an advisor.
Within seven weeks, the team 3-D printed a functioning prototype of their device. By the end of the competition, which Cinluma won, the team had filed for FDA approval for the design. Sixteen months later, the FDA gave them the green light—an unusually quick turnaround.
"If you talk to industry, they'll tell you that from the time there's a problem you're going to tackle and come up with a solution, you can easily go five to seven years," says John Langell, a doctor and executive director of the Center for Medical Innovation.
Part of the design process for the students involved documenting everything needed for multiple regulatory processes, to save time later. The design student helped lead a user-centered approach centered on patients; the business student helped make sure the design met low-cost goals.
The final device, priced at $1,500, can treat hundreds of thousands of patients; a similar device on the European market now costs more than $20,000, and a LEEP machine, standard in the U.S., costs even more.
Cinluma is currently in clinical trial in India, and the World Health Organization has a grant to study its efficacy in Zambia. Eventually, it may be in use everywhere, including developed countries such as the United States.
"We have a big focus on delivering high-quality global care," says Langell. "When we say global, we don't mean emerging markets. We mean one really high-quality solution that meets everybody's needs."