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MERIT: USF, Draper Lab Create Next Gen Medical Tools





Concerned about the potential risk of injury to the urinary tract and bladder in women undergoing a hysterectomy, Phil Hipol and Stuart Hart decided to do something about it. The two, experts in their respective fields of engineering and medicine, began meeting weekly with colleagues to brainstorm possible solutions.

Months later, Hipol, engineering/operations manager of the Bioengineering Center for Draper Lab in Tampa, and Hart, a USF assistant professor of OB/GYN and co-director of the USF Center for the Advancement of Minimally Invasive Pelvic Surgery, have created a prototype medical device that shows much promise.

Their concept, an electronic catheter stethoscope, converts a standard catheter, a tube inserted in a body cavity, into an electronic stethoscope, which electronically amplifies internal body sounds and displays them as signals on a computer screen.

"What's unique about this device is it's completely noninvasive; it's just hooked up to a traditional catheter," says Hart.
 
A change in sound or signal coming from the electronic catheter stethoscope in the urinary tract may alert the surgeon that the tissues have been accidentally cut, says Hart.  Knowing this, the surgeon can take immediate steps to correct the damage, preventing infection and other complications from setting in later.

"We are essentially using advanced acoustic signal processing techniques long used by the military for surveillance and intelligence and translating it into medical applications," says Hipol. 

Unlike the current technology, which requires an individual with specialized training to interpret the signals, Hipol and Hart hope to create software that will automate the process, making it easier to use, speeding up results and reducing the potential for error.

Inventors At Work

The innovative new stethoscope is just one of several prototypes that Hipol and Hart have been working on for the past 18 months through a collaboration called MERIT (Medical Engineering Research Innovation and Technology).

When USF's Center for Advanced Medical Learning and Simulation opens in downtown Tampa in 2012, MERIT will transition there as the center's high-tech R&D lab. USF officials hope that MERIT's work will set the stage for the CAMLS to become a major hub of biotechnology discovery.

"Having an onsite medical device development program side by side with physicians being trained and credentialed in minimally invasive surgery is unique in the country," says Hipol. "One of the benefits is that it will allow us to 'vet' our products with the users (the physicians) and work out the bugs through testing."

The team isn't wasting any time in discovering new inventions. According to Hart, the group has already filed six provisional patents on various concepts. A full patent was filed for the electronic catheter stethoscope in mid-March, which paves the way for it to be tested further in clinical trials.

USF's collaboration with Draper is what makes a center like this work, says Hipol. It's ideal for creative problem-solving.

"As a nonprofit organization, we're able to look at things more objectively, to consider many alternatives and to really think outside the box," says Hipol. "Innovation is what we do."

The goal is to develop breakthrough technologies that improve patient safety, reduce surgical complications, shorten recovery time, or any number of medical-related benefits.

"We're essentially tackling problems or looking for deficiencies in the current surgical instrumentation, and brainstorming how to fix them, then designing a solution," says Hart.  

For example, the MERIT team is also evaluating how to improve instrumentation used in minimally invasive surgery, making it possible for surgeons to create such a tiny incision in the body that stitches won't be needed – the tissues would heal and close on their own.

 "What we typically do is go through a brainstorming session and come up with something novel," says Hipol.  "Then once we have a concept, we document it, create a computer model, and work with USF Connect to file a provisional patent."

Business Savvy Market

One of the criteria for evaluating new ideas is marketability. "We're looking at products with a big impact both from a technology and business standpoint," says Hipol. "We're very market-driven."

The electronic catheter stethoscope is one such product.  In addition to pelvic surgery in women, it has the potential to be used for monitoring fetal heart beat and contractions during childbirth, heart and lung problems and gastrointestinal conditions.

Long-term, the device may even help reduce health care costs. "There may be application in Third World countries where they cannot afford advanced imaging and diagnostic technologies," says Hipol. "There is also the possibility for this type of instrumentation to replace some of the more expensive technology that we now use routinely in the U.S."

Eventually, Hipol expects MERIT to become self-sustaining, to have a full-time staff and to be a "great place for physicians, engineers and students to come together for new discoveries."

Discussion is also underway about including USF business development experts from the School of Business and the USF Center for Entrepreneurship, as well as medical device manufacturers through the Florida Medical Manufacturers Consortium.

"No one person has the background to do it all, we need a team effort to do this the right way," says Hart. "We think of ourselves as the center for bringing together engineering, medicine and business. Not only will we have this great collaborative spirit on the MERIT team, but we'll be housed inside the most state-of-the-art medical simulation center out there."

Hipol agrees. "Our model starts with clinicians identifying problems and presenting it to the engineers who come up with a unique concept that is marketable.  Then once we have a patented-prototype, we can pass it along to business." 

But the businesses he's referring to are most likely not going to be the large established corporations. Instead, this is the type of technology embraced by entrepreneurs, the small biotech startups that are willing to license the new technology and run with it, putting the prototype into the product development pipeline and taking it through FDA approval.

 "Some of these technologies are so different from what is out there and there is some risk involved," says Hipol. "But for the small startup companies, this is the sort of potential payback that could be huge if it turns out to be a good idea.  And that's the business model of Silicon Valley."

Janan Talafer is a St. Petersburg-based freelance writer with a passion for springtime in Tampa Bay.  She shares a home office with her faithful cats Milo and Nigel and her dog Bear. Comments? Contact 83 Degrees.

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Read more articles by Janan Talafer.

Janan Talafer is a feature writer for 83 Degrees Media in the Tampa Bay region of Florida.
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