Georgia Tech recently completed its Fall 2020 (virtual) Capstone Design Expo. From the project’s website, “The Capstone Design Expo showcases Georgia Tech’s graduating seniors as they present their innovative projects designed and built during the Capstone Design Course. Students work in teams to solve either an industry problem, develop innovative tools to assist researchers, or work on their own entrepreneurial idea.

“Past expos have witnessed projects which have yielded significant results for our industry sponsors, saving some of them upwards of millions of dollars in research and development costs. The networking experience for students gives them the opportunity to make a lasting first impression on potential employers, while others have even walked away with an invitation to come and visit a potential employment opportunity with some of our sponsors.”

One of the two teams connected to the School of Biomedical Engineering worked to solve for shortcomings in retraction devices for surgeons. “Hand-held retractors require assistance from a surgical assistant, which often overcrowds the surgical area and obstructs the surgeon’s field of view. Self-retaining devices retract only in one plane, are bulky, do not interact with additional instruments used during surgical procedures, and do not indicate the magnitude of pressure being exerted on the patient’s tissue.

“[The] product is aimed at reducing the risk factors associated with these shortcomings. These include: scarring, nerve damage, necrosis, and, in the case of orbital surgery, blindness through accidental optic nerve manipulation.”

Dubbed “Incisionizers,” the team designed a self-retaining retractor for use in surgeries requiring incisions less than or equal to five centimeters. The team’s Leila Hollis, daughter of an orthopedic surgeon, an EMT and newly minted BME alumna spoke with Write2Market’s Paul Snyder about the support GCMI provided for developmental testing ‘beyond the bench’ for their device.

A problem based on clinical need 

The problem was brought by Dr. Sarah Avila at Emory Univ. Hospital based on her identified clinical need. Even though they had never met, the team of two biomedical and four mechanical engineers came together around their common interest in the problem and its collective potential to solve it.

“When developing new devices or technologies for healthcare, there must be a clinical need to meet first and foremost,” Leila said. “It doesn’t pay to develop a device you ‘saw in a dream’ which may lack clinical impact. We spoke with 30 or more professionals in the field prior to starting our design work.”

“[Team member] Galo Arias, a mechanical engineer, had prior professional experience in oculoplastics. Sam [Robison], who majored in applied physics and mechanical engineering, had experience in optical diagnostics, mechatronics and mechanical design which are obviously useful when designing a largely mechanical device. Victor [Nguyen] contributed his  clinical knowledge and experience as well as design skills. Dorian’s engineering and business knowledge through his minor helped translate our work to the marketing side of the project. Soowhan is great with CAD and provided to the project with finite element analysis.”

The value in testing beyond the bench

GCMI provided facilities and resources that showed the team what was needed and what was possible in a way that bench testing simply could not. There are silicon skin models medical students use to practice incisions and suture technique. But Leila said a good approximation in a silicon model form would have been far beyond the team’s budget.

“No one on the team had experience with cadaveric testing,” Leila told us. “By doing this type of testing with the early stage of the device, we learned about strengths and weaknesses we couldn’t learn from bench testing regarding aspects such as assembly, disassembly and force testing on a human model. Testing on human tissue validated our design and development work to a point we could not have achieved other ways.

“Setting up the device when trying to retract a real incision is more cumbersome than we anticipated,” she said. “We did anticipate some issues posed by asymmetric, curved surfaces. But while our cadaveric testing actualized our stability problems, it also showed that the device works as designed when assessing it as a whole, making the test somewhat of a success. We would never have known that the device is effective on human tissue in such a constrained time period without GCMI’s help. This kind of validation testing is, and will continue to be, essential in showing others down the road our device has real commercial potential.”

Incisionizer’s design and development path forward

“Everything we learned from the testing we did at GCMI, we will apply to the continued iteration of our design, adjusting based on what we’ve seen. We will almost certainly conduct more tests and refine our design until we feel we have ‘maxed out’ its potential,” she said.

“We couldn’t have asked for a better experience thanks to Evan, Brandon and Rhonda at GCMI,” she said. “The support and resources were both invaluable and everything we could have asked for at that time.”

What’s next and what can others learn from the team’s experience?

The team is working towards a provisional patent and continues to receive encouragement from industry professionals and clinicians who believe the project is worth continuing to pursue. They will also be attending the semi-final round of Georgia Tech’s Inventure Prize innovation competition for which they won a “Golden Ticket” at the Capstone Design Expo.

“When you’re in  the design process, don’t be afraid to make drastic changes if you believe it will result in meaningful improvement,” Leila said. “We overhauled our design with three weeks to go until  our deadline and gained significant improvements in the end product performance. If you see a way to improve, don’t be afraid to take the chance to do it.”

GCMI congratulates the Incisionizers team on its accomplishments and wishes them all the best in their future endeavors.

About GCMI

GCMI’s mission is to bring new medical technologies to market that improve quality-based outcomes and delivery of care for patients worldwide. This certainly includes supporting development of medical technologies born in our backyard from faculty, researchers and students with whom we share our institutional affiliation. We congratulate the 2020 teams and eagerly anticipate what the 2021 teams have to show us later this year.