By Jeremy Fallis, Marketing and Communication Maven

A pioneering advancement. A prestigious second-place award. Now a potential commercial launch looms and it all started in a classroom.

The quintet of biomedical engineering master’s students, Kyle Bettinger, Kai Cortright, Kayla Curtis, Scott Haber and Danika Rodrigues, came together in a BME class—599 Graduate Innovative Design—taught by biomedical engineering professors, Jan Stegemann and Tim Bruns.

Along the way, SpecOp ran into road blocks, pivoted at a vital time and rode its ingenuity and resources provided by the Center for Entrepreneurship to achieve its commercialization ambition. The result was a second-place showing at Venture Well’s BMEidea Competition this past June.

The biggest challenge cropped up midway through the process. The team worked on the development of the device throughout the semester only to find their product untenable in the market. While the group could have accepted this conclusion, earned its “A” in the class and moved on, SpecOp decided to pursue a marketable item.

Upon the team’s formation, the students identified an issue in the gynecological field that led to misdiagnoses and difficulties performing certain procedures due to antiquated methods.

Currently, a traditional two-billed speculum is used in cervical exams and other gynecological procedures. The all-too-common issue occurs when the current speculum is unable to provide support to all parts of a vaginal wall leading to a collapse inward known as vaginal wall prolapse.

“We were drawn to this problem because current methods seemed out-of-date,” said Haber. “This provided an opportunity to have the most real impact. We were also interested in having a project that could take us to the commercialization process.”

To mitigate vaginal wall prolapse, which occurs in about 1.6 million women annually, SpecOp developed a specialized speculum, the Circulum. The coil device provides full circumferential support to the vaginal walls in order to prevent prolapse during medical procedures.

SpecOp went through several iterations and failures before deciding to use a coil design. In fact, the team had originally settled on a completely different approach to the problem and had thrown out the coil idea altogether.

That original idea was a manually inflatable device operated by a physician’s hand pump. With the original goal of expanding the vaginal cavity, the team focused on this type of device because a coil design presented a degree of uncertainty in potential success due to materials. The problem the team ran into, however, was that the inflatable device would expand into the direction of least resistance, thus inflating inward and blocking any view.

While the pivot wouldn’t be solved by the end of the semester, SpecOp pushed forward with what would become the Circulum. The advantage of the Circulum, upon second look, is in its flexibility and slender nature.

“In the end, we were kicking ourselves a little for not giving the coil more thought in the beginning,” Cortright added. “Because all it took was a second conversation to realize that this design had a lot of potential.

“Although we spent a lot of time with a design that ended up failing, I think that process was vital to SpecOp because we were able to learn what ideas weren’t going to work and what features our device needed to be successful.”

Consultation with clinicians, including U-M Health System’s Dee Fenner, MD, about prototype options and potential marketability sparked SpecOp to apply for a Jump Start Grant at the CFE. The grant allowed the team to work on a prototype and further the customer discovery process.

“Changing direction is necessary and good,” Curtis added. “Along the way, we received assistance from both within and outside the university that was invaluable and allowed us to succeed.”

The CFE’s Jump Start Grant proved a vital asset as the team was able to receive advising from the CFE staff and funding. The next step led SpecOp to reach out to a wider network of clinicians, who provided positive feedback.

DSC_1817 (1)-attachmentThe ringing endorsements moved SpecOp to be selected as U-M’s representative in June’s BMEidea Competition in New York hosted by the Venture Well conference.

“It was a tremendous experience to be in New York with so many innovative people,” said Rodrigues. “We are very excited that we earned this award.”

The second-place prize of $5,000 will give SpecOp the chance to begin clinical trials. While the trials are not required for FDA approval, they will give the Circulum another avenue to prove its worth. An accompanying publication will enhance the Circulum’s viability and legitimize its technological advancement.

SpecOp won’t stop there. While the process has been a test, there are further hurdles to navigate such as product licensing, incorporation and finding investor support.

Nevertheless, the team has enjoyed their work and working with each other.

“Our advice to students: don’t be afraid to drop it and walk away when it’s not working,” said Bettinger. “It’s easy to get attached to something you’ve created, but that doesn’t mean it will be the best option when applied to the problem or in the market.”