Shark Tank returns: Which GI innovations will make it to market?

Identifying, classifying small polyps during a procedure

A vexing problem for clinicians is what to do after detecting a colonic polyp, since the majority of those found are not precancerous. Now, Rizkullah “Ray” Dogum, an MS/MBA candidate, and his colleagues are seeking to market a technology that reads the information gathered by elastic scattering spectroscopy to determine whether a sample is dysplastic, essentially creating the first in vivo definitive polyp classification method.

“Using elastic scattering spectroscopy technology, polyps with negligible malignant potential are detected and classified during the procedure, circumventing the routine track to pathology labs,” Mr. Dogum explained in an interview, noting that this adds up to hundreds of millions of dollars savings per year. An important fact, he said, since as our population ages it requires more screening. “As much as $1 billion could be saved annually if diminutive polyps could simply be diagnosed, resected, and discarded in lieu of histopathological processing,” Mr. Dogum said.

Currently being tested in several clinical trials that so far are yielding what Mr. Dogum says are “promising” results, especially when compared with chromoendoscopy and narrow-band imaging, the patented technology uses a white light that is transmitted through fiber optic cables that are integrated into both the snare and forceps tools; the back-reflection is detected by a computer, making polyp classification possible.

An advantage in practice for using the technology is that it does not require any significant alteration in the current standard practice for colonoscopy and does not disrupt the standard flow of work, meaning there is less training required, according to Mr. Dogum.

An audience member who identified himself as a regulator with the FDA told Mr. Dogum that over the years the agency has “struggled” with how to classify imaging technologies, because they are tools, but do not actually change practice, noting that whether to resect and discard is a clinical decision made at the physician’s discretion, not one determined by a device. He expressed his skepticism that the product would qualify as a Class II device but did suggest that it might qualify as a low-risk, de novo product, something that Mr. Dogum said in an interview following the presentation that he and his collaborators would be interested in pursuing.
 

Preventing endoscopic retrograde infections

Mining Big Data for algorithms that can detect endoscopic infection clusters is what Susan Hutfless, PhD, an epidemiologist and assistant professor in the division of gastroenterology and hepatology at Johns Hopkins University in Baltimore, told the shark panel she and her collaborators want to do using Medicare and Medicaid claims.

“Using Medicare and Medicaid billing data, our technology identifies endoscopic errors in a succinct and quantitative way,” Dr. Hutfless said in an interview. She explained that this benefits device manufacturers, health care facilities, and insurers. Included on the as-yet unnamed software program’s dashboard are a range of metrics that allows continuous monitoring of care, risk factors, and sources of infection, all to prevent serious outbreaks and the proliferation of illness.

Dr. Hutfless and her team came upon the idea after a string of deadly endoscope-related infectious outbreaks were linked to closed-channel duodenoscopes.

“We think that our technology helps move the field forward, because it provides a solution to contain endoscopically transmitted infections without re-engineering the endoscope,” Dr. Hutfless said. “For instance, there was an outbreak despite the use of a redesigned scope. Our technology is able to identify gaps in the care pathway that include the endoscope itself as well as the possible human factors that may be playing a role.”

Another plus, she told the panel, is that the product would not require FDA approval.

Despite data Dr. Hutfless said she and her collaborators will be presenting later this year at the annual Digestive Disease Week(R) that show a tight correlation between relevant claims data and data collected by the FDA during the infection outbreaks, the panel concluded that the stronger marketing potential for this product would be as a monitoring system, not a predictive one, used in combination with an engineering solution.
 

Simplifying LED incorporation in scopes

LED is only the fourth lighting technology ever invented, according to Thomas V. Root, president and CEO of Acera Inc. In an interview, Mr. Root said that while LEDs are “overtaking all major lighting markets,” medical device manufacturers have been slow to catch on.

“Acera moves the industry ahead with its elliptical optic that significantly improves the collection efficiency and distribution of the LED light. This optic, provided in a modular assembly, simplifies incorporation of LEDs in the practice of scope design and manufacture,” he said.

By eliminating the light guide tether, the use of LED increases mobility and the potential for low-cost or even single-use devices, Mr. Root said. “The result is that engineers are liberated to reimagine how endoscopes are designed.”

Because half of fires that occur in the endoscopy setting come from malfunctioning light sources, one of the sharks suggested that since the Acera product does not use the infrared wavelengths in its light, and its electrical cord remains cool to the touch while in use, Mr. Root and his colleagues should highlight that as a unique safety feature in their marketing materials.