By Javan Rivera
A collaboration between the University of Utah’s College of Engineering, Health Sciences Center, Technology Venture Development Program, and the David Eccles School of Business, The Center for Medical Innovation [CMI], is every entrepreneurial medical student’s wildest dream come true.
The center provides not only the seed grants necessary to pursue new solutions to medical issues across the globe, but the facilities and equipment to take ideas from concept to prototype and beyond.
This was the exact path that the CinLuma project has been propelled down since it was first proposed by CMI’s Founder Dr. John Langell in 2014.
CinLuma was a student project that was part of the Bench to Bedside competition held annually by the center. The goal of the project: engineer a portable, cost-effective medical device for the preventative treatment of cervical cancer.
“One of the great things about working in the medical device industry is the opportunity to work in addressing problems and unmet clinical needs,” said Timothy Pickett, Director of Engineering for CMI, and the engineering student on the original CinLuma team. “In global health there is a huge inequality between developing countries and developed countries. One that has become increasingly clear is cervical cancer.”
There are roughly 480,000 cases of cervical cancer reported each year, with 90% of those cases being in the developing world. The statistics are so heavily skewed toward developing countries due to the fact that they are often lacking the treatments necessary to eradicate the disease.
Cervical cancer, when caught early is highly treatable, often starting out as a pre-cancerous tumor with a 10 to 20 year development.
The current methods for treating pre-cancerous cervical tumors include the Loop Electrosurgical Excision [Leep] Procedure, cryogenic procedures, or thermal coagulation treatment.
“All of these methods require a stable electrical grid or access to medical grade cryogenic gasses such as liquid nitrogen. These requirements make it virtually impossible to perform these procedures in most places,” Pickett said. “CinLuma takes an existing technology that is expensive and depends on stable electricity [thermal coagulation], and makes it portable.”
The device is so portable in fact, that it can be transported in a backpack and used by hand, consuming only rechargeable lithium batteries. The unit uses thermal coagulation to heat up cervical tumors until their proteins denature and die.
As is the case with virtually all of CMI’s interdepartmental projects, CinLuma consisted of a team of students from across the academic disciplines. The team for the project included students from the fields of engineering, business, design, and medicine, as well as one surgical resident. Dean Wallace acted as a mentor for the team.
“One of the best things about the center for medical innovation is that it provides a place not only for innovation, but also collaboration,” Pickett said. “The partnerships that we can create between students, faculty, and industry people can help to address a number of unmet needs both here in the U.S. and globally.”
The CinLuma project began development in January 2015, and has since seen rapid growth, with the team currently applying for a CE Mark to market the device in Europe, as well as a 510(k) through the FDA for distribution in the United States.
“What has really been beneficial has been the collaboration between Dean Wallace, who has experience in the industry, and us students, allowing us to accelerate the design schedule by working together,” Pickett said. “That collaboration has been the key to getting the project to its current state.”
Prototypes of the device have been sent to doctors in France and India who have been testing the device and providing feedback.
“The response has been really positive. They’ve given us great feedback on how to improve the design,” Pickett said. “Getting this out into the field has been essential.”
In addition to the existing prototypes in use, the CinLuma team hopes their new partnership with the University of Utah’s Office for Global Health and Dr Bernhard Fassl will help to get more prototypes of the device to India.
According to Pickett one of the major goals with the clinical trials isn’t so much to test the efficacy of the device, but rather to improve upon its design and gain experience dealing with the medical treatment in other cultures.
“We already know that the device works and is as safe and as effective as similar, more expensive and non-portable technology,” Pickett said. “But it’s helpful to have that infrastructure to learn how to adapt to some of the more culturally sensitive issues around women’s health. That’s where this partnership will be very helpful in finding ways to make people feel comfortable in seeking the treatment they need.”
The existing technology for the treatment of pre-cancerous cervical tumors typically costs between $2,000 to $15,000, however the CinLuma project aims to distribute their portable treatment device for as little as $1,600.
“We are looking at distribution in low and middle income countries and low resource areas, but the device is not limited to that,” Pickett said. “What we’re seeing is that as we’re developing devices that address global needs through treatments that are equal to U.S. levels of care, but at a lower cost, it is causing beneficial disruption in the U.S. market as well.”
Once CE Mark and 510(k) approval go through for the device, the team is hopeful to have clinical trials complete and have it on the market as early as 2016.
The Center for Medical Innovation was founded with the intent of making medical entrepreneurial projects a reality, and is known for funding a number of student and faculty programs including the Bench to Bedside Competition that gave life to the CinLuma Project.
The center just opened a new prototype lab in March 2015 that is currently overseen by Pickett.
“Even if people have just what they consider to be a problem, and not necessarily an idea, the great thing about the center is that we can validate that problem and start to generate ideas about how to solve it,” Pickett said. “We would love to invite people to come and see the lab and participate in some of the medical innovation programs.”
For Pickett, CinLuma is only the beginning of what he hopes to see come out of CMI. He sees the innovative possibilities of the center and the prototyping lab, not only as an opportunity to change the face of medical treatment in the developing world, but as an opportunity to explore and create as well. It’s a place where the mere pursuit of solutions is just as important as the solutions themselves.