Idea for Cleaner Instruments Spawns New Company

Aug 13, 2014 at 04:03 pm by admin


Zeroto510 program provides needed boost to get product to market

Ryan Ramkhelawan remembers the exact moment the idea came. Frustrated by seeing surgical instruments returning to the operating room dirty despite several steps of decontamination, he thought there had to be a better way.

And then he thought of one. One he believed could save time and money. The idea became a customized instrument washing tray that made the journey to prototype, proposal and then a Bioworks Zeroto510 project, which then became the foundation product of Restore Medical Solutions – all in a three-year time span.

Zeroto510 is a program enabling entrepreneurs with innovative medical device ideas to learn the business and take a fast track to market. At the time of his idea, Zeroto510 was not on Ramkhelawan’s radar.

He was a surgical first assistant and then became credentialed as an organ transplant perfusionist. He was trying to get surgical instruments into an automated tray after the hand-washing stage for the autowasher stage – so that they might get optimal cleaning before sterilization and packaging. Positioning was crucial.

“There is a way to get these instruments through the pre-clean cycle in an upright and open position in optimal angles to get them the cleanest possible. It also allows technicians to put things together faster in the highest quality possible and get it back to surgery 60 percent faster,” he said.

The selling points: Dirty instruments are a liability and harmful. Delays due to dirty instrument replacement during surgery are costly. The reduction in time used to clean instruments means higher efficiency and less overtime.

Ramkhelawan partnered with his friend Shawn Flynn, manager of the sterile processing department at the trauma center in Georgia where he worked. A prototype was built in Ramkhelawan’s garage. It was called a modular sterilization tray. They rolled out their invention to potential customers for feedback. There were suggested revisions, from small ones to huge ones. The partners filed for a provisional patent, putting up $50,000 of investment money.

“I filed the original patent and had the first run of units made – 25 prototypes,” Ramkhelawan said. “From idea to research to product was eight months. I knew it wasn’t going to be perfect, but the goal was to get it in my hand so I could move forward faster.”

Flynn and Ramkhelawan needed more capital. They didn’t realize most people didn’t have the money to get to the point they were and had no patent filed.

“We had the prototypes in the trunk and went to meet with venture capitalists in the Atlanta area. We couldn’t get past the secretaries,” Ramkhelawan said. “A friend’s friend had a marketing company just outside of Memphis. We came here to get marketing materials, and he just kept telling us about Memphis and the medical community here.”

After some research, the founders made a return trip to Memphis for meetings with some people of influence. One told them about Bioworks. This was right before the Zeroto510 program launched. There were two meetings with Bioworks before Allan Daisley, director of entrepreneurship and sustainability, told them to complete an application for Zeroto510. The next month was May 2012, and they started with the inaugural class of six groups.

The program is an intense 12-week “boot-camp style” adventure, Daisley said, including classroom activity, mentoring and hands-on exercises. Mentors guide participants on manufacturing at top efficiency, with a machine shop on site at Bioworks. Zeroto510 groups spend most of their time on market validation and proofs of concept. Since Flynn and Ramkhelawan had already moved forward in those areas, they spent a lot of time on venture capital, presentations and preparing for the U.S. Food and Drug Administration’s 510(k) approval and even opted to seek ISO certification. They eventually received both approvals.

Medical devices just made sense for Zeroto510 and the Memphis area, with a thriving medical center and Medtronic, Smith and Nephew and Wright Medical. The goal of the program is economic growth. It also draws on the medical brain trust available. The program is focused on clear, simple innovation and movable ideas on the fast track. It is in its third year.

“It takes a village to grow a startup,” Daisley said. “We don’t go for more complex ideas that require $100 million to execute, but those smaller, focused things that can reach significant gains quickly. We would like for a project to be able in a year or so to file financial papers and be in the market within months after that.”

Innova and MB Venture Partners back Zeroto510, which gives each participating group $50,ooo to get started and get through phase I of the program. Investors decide whether participants go to phase II and receive an additional $100,000.

Zeroto510 has several physicians and hospital administrators who do sessions, mentor participants, and determine if there is a viable product. Sometimes physicians are even participants themselves, Daisley said. The first program of its kind, Zeroto510 comes at a good time.

“Increasing regulation has made more startups hesitant to move ahead, but it has raised the value of programs like ours,” he added.

Applicants come from all over the country and beyond. Applications have come from Spain, Russia and Algeria, along with a visit from an Australian group considering the program model.

Thanks to opportunities through Zeroto510, Restore Medical Solutions got its big break. They did not make the phase II $100,000 prize. Instead, they were awarded $2.5 million from Innova and MB Venture Partners to take their product all the way to production. Nearly a whole floor of the Bioworks building is devoted to the RMS Modular Sterilization Tray’s assembly and distribution, as are facilities in Rhode Island and Atlanta. Company offices are located at One Commerce Square downtown.

Restore Medical Solutions and one other company from the inaugural class, Ecosurge, a manufacturer of foam positioners for patients undergoing surgery, are at the end point of selling product and helping patients. RMS has four hospitals using its products, with three in Memphis and one in Durham, N.C.

“At one hospital, we were able to go from an initial meeting to a full trial in three days,” Ramkhelawan said. “When we meet with a hospital, we assess the department for free and show them our product costs, but we also identify exactly where they are going to save money and increase quality.”

About 15 other hospitals are in various states of proposal, he added. RMS has 10 employees and anticipates hiring five more in the next two quarters. It will be launching another product line next year and another to follow that.

What are the best things Zeroto510 taught Flynn and Ramkhelawan? How to talk with venture capitalists, how to maximize dollars and how to move super-fast strategically, Ramkhelawan said.

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