By Tom Ballard, Chief Alliance Officer, PYA
A Knoxville-based start-up is one of 10 companies participating in this year’s fourth annual “Summer of Acceleration” in Memphis.
Winter Innovations, founded by recent University of Tennessee, Knoxville (UTK) dual master’s graduate Lia Winter, is one of four start-ups in the “ZeroTo510 Medical Device Accelerator” that specializes in developing and commercializing medical devices that typically utilize the U.S. Food and Drug Administration’s (FDA) 510k regulatory pathway.
As teknovation.biz readers know, Winter and her team have been on a roll, winning a number of university-sponsored pitch competitions as she presents her EasyWhipTM device used for orthopedic reconstruction procedures like ACL (anterior cruciate ligament) surgery.
“An alum of the ‘ZeroTo510’ program, Jordan Mykleby, has served as an advisor to us over the past year and a half,” Winter explained. He graduated from UTK in 2015 and joined a start-up that previously participated in the medical device accelerator.
“After we won the ‘Boyd Venture Challenge’ in 2017, he reached out to us and offered to help with our development strategy and prototype optimization,” Winter added. “Jordan was a big proponent of us applying for the ‘ZeroTo510’ program. An accelerator program seemed like a logical next step for us to pursue commercialization and launch of EasyWhipTM full-time after graduation, so we eagerly applied.”
Now in its eighth year, the “ZeroTo510” program assists medical device inventors in developing their idea into a prototype, crafting a plan to gain FDA clearance, and then launching into the marketplace. Founded by Memphis Bioworks, the program has been named one of the top 25 accelerator initiatives in the country for the last four years by the Seed Accelerator Rankings Project.
“ZeroTo510” had a record number of applications for the 2019 cohort, with applications from around the world and device innovations in a broad spectrum of specialties such as diagnostics, pediatrics, orthopedics, cardiovascular and diabetes.
As far as what she hopes to accomplish between now and August 15 when the accelerator ends, Winter said she had a “laundry list,” but there were a few key goals – customer discovery, design freeze, regulatory strategy, and suppliers.
“We are continuing the customer discovery process and interviewing orthopedic surgeons to understand how our EasyWhipTM product can address the pain points they experience during surgery,” she said. “The next step after interviews is to provide surgeons with prototypes to test in a simulated surgical setting and record user inputs. We are also exploring the process necessary to get our product into a hospital or surgery center.”
Winter explained that freezing the design of the EasyWhipTM needles will allow the company to move forward with regulatory filings, an area that has just been started “working with a regulatory expert to help us interface with the FDA and prepare the documentation necessary to file for clearance.”
Finally, on the supplier front, Winter Innovations has started evaluating suppliers and contract manufacturers that have capabilities to produce EasyWhipTM to its design specifications.
“This summer will help us determine when our key milestones can realistically be accomplished and what funding resources we will require,” Winter added. “Our goal right now is to launch EasyWhipTM locally in Tennessee in 2020. “
The “Summer of Acceleration” is a joint effort of Start Co., Epicenter and the “ZeroTo510” organization. Collectively, the three programs are designed to leverage four regional industries of strength in Memphis: smart city, medical device, supply chain and logistics, and home services.
In addition to the medical device accelerator, there are two other accelerator programs.
- “Sky High Civic Technology Accelerator” is designed to fit within the greater Smart Memphis effort by partnering with the City of Memphis information services team and Innovate Memphis. This accelerator is seeking civic and smart city technology-based start-ups to solve problems and create efficiency in the transportation, crime and public safety space.
- “Sparkgap Logistics Accelerator” connects start-ups investing in logistics solutions in intelligent packaging, supply chain visibility and supply chain data analytics, and gives access to expertise and potential customers across the dense and diverse logistics industry in Memphis.
Epicenter, the region’s entrepreneurial hub, makes seed investments in the participating companies through its Formation Fund. In addition, Epicenter will also connect accelerator participants to community-wide resources, including a growing angel investor community and executives-in-residence who support represented industries.