The problem starts so small -- a little sore on the bottom of the foot, perhaps from wearing shoes that are just a bit too tight -- but in a person with diabetes it can snowball into life-changing complications.
Mohamed Trabia witnessed that first-hand in his father-in-law, who struggled after complications led to his foot being amputated. That horrific result was particularly disturbing to Trabia because the method for diagnosing the problem seemed so bizarrely archaic. He likens it to feeling someone's forehead and expecting an accurate temperature reading.
"It is very much 18th century thinking," Trabia said.
And very much at odds with Trabia's mechanical engineering mind. He couldn't let go the thought that there must be a more precise way to detect foot problems early. Then he happened upon Janet Dufek.
In 2013, he dropped in on a tour of the , a training facility shared by nursing students at 51³Ô¹ÏºÚÁÏ and other state institutions. As associate dean of the Howard R. Hughes College of Engineering, Trabia has to put in appearances at such events, and he always keeps an eye out for ways his college can collaborate with researchers in other areas. There he struck up a conversation with Dufek, a kinesiology and nutrition sciences professor. The conversation quickly reshaped their research for the next couple years.
If all goes as planned, their collaboration could greatly improve the lives of millions of people with diabetes by preventing the world's leading cause of lower-extremity amputations. It may also bring new dollars to 51³Ô¹ÏºÚÁÏ while planting a seed for the region's nascent biotechnology industry.
The Idea
Amputations in people with diabetes generally stem from poor circulation, which leads to a loss of sensation and tissue stiffening. Diagnosis involves running a light filament wire along the bottom of the foot wire to gauge a person's level of foot sensation. The process, Trabia said, is too reliant on how hard the doctor is pushing the filament, the doctor's awareness of the situation at that particular moment, and the patient's willingness to share information.
Dufek, an expert on the mechanics of walking and running, was very familiar with performance-enhancing insoles on the market today that use sensors to analyze and correct an athlete's gait. Why not create insoles that offer people with diabetes and their doctors feedback about potential problem areas?
Monitoring individuals over time would help determine if their tissue stiffness has increased to an unhealthy level where foot ulcerations may occur. Their idea is to use the pressure-sensing insoles to monitor the changes of the plantar tissue stiffness and collect the information through a smart phone app or other device.
"We want to be able to predict where (an ulcer) is going to happen so the physician and patient can work together to prevent it from occurring," Dufek said.
They've enlisted David Samson, an undergraduate kinesiology student, and Jessica DeBerardinis, a mechanical engineering graduate assistant, in the research.
Over the past year, the researchers focused on making sure the data collected by the insoles is accurate and consistent. So far, the team has tested the insoles on 30 healthy people. Next they plan to gather data from pre-diabetics and diabetics with and without ulcers, Trabia added. With a variety of subjects, the team can develop a "stiffness model" with algorithms that help a physician accurately assess if a patient's tissue stiffness is reaching a dangerous level.
Gait Study
Studying someone's gait is tricky, the professors say, and finding what normal tissue stiffness is for any given person can be a huge challenge. People have widely varying gait patterns, and the same person can walk differently from one time to another. The way a person walks directly relates to the amount of pressure being applied to sections of the plantar tissue. How much or how little is applied, and the changes in pressure as a result of different gait patterns, can impact the professors' insights into how normal tissue stiffness should behave.
Mechanical engineers like Trabia are usually concerned with the properties of manmade materials. But in this case, he's analyzing the characteristics of the plantar tissue. "Then (we're) creating a mathematical model to describe the tissue behavior," Trabia said.
The work comes with plenty of trial and error, stops and starts, and reassessing of methods and data. It requires both Trabia's deep engineering knowledge and Dufek's insights into the human anatomy.
"Every step is error-producing and error-correcting," Dufek added with a laugh. "We're a complementary team in that we both have unique strengths, and we can overlap and communicate. We really can't do this without each other."
Nor can they take their idea to market without reaching out beyond their labs. But therein lies the rub: "We are not, by nature, business people," Trabia said. "So how do we balance academic research objectives of furthering knowledge and publication on one side with making some connections with business if we want the idea to grow?"
Commercial Potential
In the past few years, 51³Ô¹ÏºÚÁÏ has been ramping up efforts to foster the commercial development of the ideas that faculty and students develop.
Among its successes have been the Lee Business School's new entrepreneurship programs, which immerse students in the process of launching new businesses. In fall 2014students researched about 50 presentations to assess the commercial viability of the projects. As their coursework continues, these students create the plans necessary to attract investor funding and launch businesses around the ideas generated on campus.
The insole idea struck a chord with John Landrith, an undergraduate taking the class and computer network engineer who has owned his own businesses. Like Trabia, he had a personal interest in the product. "My mother died from diabetes complications and the potential to make a difference in people's lives really drew me to this," he said.
Landrith teamed with graduate students Peter Puglisi, Erin Schroeder, and James Lutz, and graduate certificate student Christine Nolan to create Mov?oMedics, the business entity charged with the challenge of commercializing a technology still very much in its infancy.
The next big step is identifying funding sources for the new venture, Landrith said. "We know that it's very early stage but we're ready for the challenge associated with technology hasn't been proven yet."
With Landrith as the CEO, the group created a winning business plan. Mov?oMedics has won the Southern Nevada Business Plan Competition, the state's Governor's Cup business plan contest, and is competing in the Tri-State business plan competition on May 27. It has won $115,000 in prize money so far.
"Competitions are a quick way to get funds at this point," Landrith added. "Our plan, presentation, and understanding of the product are all insanely detailed, and that's why we're winning these competitions."
The team envisions selling or leasing the insole package to doctors. It would include six sets of insoles in the most common American foot sizes. Mov?oMedics would then provide a precise measurement of the patient's tissue stiffness to the doctors.
Not only would patient outcomes be much improved, the new equipment will ultimately save money. The doctors would recoup the costs of the equipment through insurance reimbursements while the cost of the new test for insurance companies would be comparable to the existing exam. Insurance companies would see a huge savings by avoiding amputations, which can run between $75,000 and $150,000 per person per amputation, according to Landrith's research.
Zachary Miles, executive director of 51³Ô¹ÏºÚÁÏ's technology development and transfer office, said the Mov?oMedics effort is an example of increased focus throughout the university in supporting state economic development efforts. His office is charged with assessing, protecting, bringing to market the intellectual property discovered on campus.
"We look at these things and try to see if there's a market. If there is one, then we'll engage external counsel to file a patent," Miles said. "(Mov?oMedics) was a great opportunity to get students to see if they can build out a business case behind the idea -- and they sure did."
The technology transfer office team has increased patent filings from five in fiscal year 2012 to 28 patents in fiscal year 2014. Currently, about half the patents the office has helped file are gaming-related while the other half has come from science and engineering research efforts. The launch of 51³Ô¹ÏºÚÁÏ's School of Medicine will exponentially increase patent output, Miles predicts.
Miles' team also connects the campus to the dozens of regional business leaders and entrepreneurs on its Technology Advisor Committee (TAC). His team also is building its programs to tie into efforts in the Governor's Office of Economic Development and the Las Vegas Greater Economic Alliance.
Beyond The Plan
Making a big splash at business plan competitions is a great first step, but there's still plenty of steps ahead for Dufek and Trabia. They must amass massive amounts of data to develop the insole. In the short-term, the pair is trying to balance their research with their desire to teach and mentor students. "Not only are we trying to do this, but we are trying to support a small cadre of young, promising academicians who can learn from the process," Dufek said.
As Landrith's team is pursing private funding options, Dufek and Trabia are applying for federal research grants to support the work. Grant-funded research is a major part of 51³Ô¹ÏºÚÁÏ's drive to become a top-tier university while increasing its economic impact in the community. And the medical school opening will only enhance 51³Ô¹ÏºÚÁÏ's current biomedical research and bring further opportunities for collaboration across disciplines.
"Now, we're kind of baby-stepping along, working to bring outside sources of money to 51³Ô¹ÏºÚÁÏ to allow us to free time and focus on this," Dufek said.
The Mov?oMedics business plan estimates about $700,000 is needed to get from the current data collecting point to a prototype. Another $5 million would be needed to get it through FDA approvals and advanced testing, followed by a marketing ramp up into sales distribution. Landrith estimates that process will take about two and half years once funding has been found.
Translating solid research into a new company is seldom a simple process, Miles said. "If the technology is great, it seems like it should be easy," he said. "But there are so many groups you have to engage --business leaders, entrepreneurs, funding sources, strategic public/private partnerships. At the end of the day, it takes an entire team to translate the technology from an answer to a question to a viable product."
But that's not stopping the Mov?oMedics team. The group has been reaching out to different CEOs and venture capital entities that have taken products through the FDA process, Landrith added. They used prize winnings and connections gained through networking to find an FDA consulting firm. And they've started tapping into the all distributors, insurance companies, doctors, and manufacturers they'll eventually need.
They also reached out to the University of Utah spin-off, Veristride, which has developed an insole that can help correct walking problems, for mentorship and to explore business partnership opportunities.
As the project moves from idea to prototype, the process will involve people from a variety of disciplines, including computer science, biostatistics, nursing specialists, software developers and plenty more. One of the most important groups, from both the business development and data collection standpoints, will be medical doctors, Trabia said.
"If we don't have interaction with medical professionals, it can be a very clever idea that will not go anywhere," he added.
