Medical Device Startup Founded by Alumni Receives FDA Clearance

Category: News

Two University of Tennessee, Knoxville, alumni took an idea for an innovative medical device and developed the product and pitch while enrolled in UT’s MS–MBA program, a dual degree offered through the Tickle College of Engineering and the Haslam College of Business.

Lia Winter (’19) and Preston Dishner (’19) developed EasyWhip, a patented surgical needle designed to increase the speed and accuracy of whipstitching in orthopedic reconstruction surgeries. EasyWhip recently received 510(k) premarket clearance from the US Food and Drug Administration.

“FDA clearance is the biggest milestone we have achieved to date. We spent a lot of time in product development making sure that EasyWhip solves the problems we identified with orthopedic stitching to repair torn ligaments and tendons, like the anterior cruciate ligament (ACL). Now that we have the FDA clearance, we can start marketing the product and its associated speed and ease-of-use benefits to surgeons and hospitals. We are looking forward to the opportunity to launch EasyWhip and positively impact the lives of surgeons and patients,” said Winter.

“UT has been instrumental in our ability to achieve this FDA clearance milestone for EasyWhip just two years after completing our graduate degrees. We have received continued support and encouragement from the Anderson Center for Entrepreneurship and Innovation, the Haslam College of Business, and the Tickle College of Engineering.”

Winter initially thought of the product after watching her mother undergo two ACL surgeries 10 days apart because of complications with the stitching in her first surgery, which quadrupled the recovery process. She created the prototype of EasyWhip—which would later become the flagship product of her company, Winter Innovations—during her senior design engineering project at the University of Pittsburgh.
At around the same time, Winter had a summer internship at an orthopedics company where she worked in product testing and became familiar with surgical stitching products. Through Dishner, who was a fellow intern, she learned of UT’s dual degree program and both enrolled the following year.

At UT, Dishner and Winter teamed up and began refining EasyWhip’s design.

The duo perfected their pitch and entered the Anderson Center for Entrepreneurship and Innovation’s Vol Court Pitch Competition and the Boyd Venture Challenge, through which they won mentorship, legal advice, and a portion of their $150,000 competition-earned capital.
The money was used to file for patents, create a business plan, travel to interview surgeons to gather research, and develop better prototypes.

“The competitions helped prepare us to raise funding from investors. We had the opportunity to present to and receive valuable feedback from expert judges who had experience in running successful businesses. We were able to use the nondilutive grants and in-kind services associated with winning these competitions to advance our business and achieve value-driving milestones before we even completed graduate school,” said Winter.

When Dishner and Winter did graduate, in the spring of 2019, they went on to participate in the nationally recognized ZeroTo510 medical device accelerator, a program that helps entrepreneurs with ideas for innovative medical devices navigate the regulatory environment.

After they completed ZeroTo510, Tony Lettich, managing director of the Angel Round Table, invited them to pitch EasyWhip to his group of investors in East Tennessee. Lettich annually serves as a judge for the Boyd Venture Challenge, where he first heard the duo’s pitch.

“The Angel Roundtable was Winter Innovations’ first investor, and they committed the biggest check the group had invested thus far. I think this speaks to the strength of UT’s entrepreneurship program. The Anderson Center has built an incredibly valuable network to support entrepreneurs, and the fact that those services continue even after graduation helps to ensure the success of young alumni companies like ours,” said Winter.

In addition to receiving FDA clearance last month, Winter Innovations was awarded a $256,000 grant from the National Science Foundation.Through the grant, the company will continue research and development on EasyWhip for orthopedic applications and begin research for other surgical applications that rely on stitching.

Winter’s experience with the Anderson Center came full circle this year as she now serves as an entrepreneur-in-residence, mentoring current student–entrepreneurs. She credits the speed of her own company’s growth to the center’s executive director, Lynn Youngs, who now serves as a board member for Winter Innovations.

“We still get a lot of support from Lynn and leverage his unique expertise in accounting and entrepreneurship,” Winter said.

“The buzz, excitement, and support that the University of Tennessee has generated around entrepreneurs and startups in the Knoxville area have created a powerful network of resources for budding companies that we have been able to tap into. For us, like many startup companies, a key element to our success has been fundraising, and we take pride in the fact that we were introduced to several of our current investors during our time at UT.”


CONTACT
Lindsey Owen (865-974-6375, lowen8@utk.edu)
Laura Rust (865-974-5126, lrust1@utk.edu)