Where the grass is greener

reprinted with permission from South Dakota School of Mines & Technology

Successful entrepreneurs share a key trait: they excel at managing risk. In 2017, Amanda (CEE 12) and Travis (ME 13) Davis faced the challenge of a giant leap into entrepreneurship head on. The couple left successful jobs at NASA and moved to Dublin, Ireland, to launch two medical device companies. Amanda is leading Diaspense™, which specializes in patient centric diabetic products. Travis is the chief technical officer for Starling Surgical. The startup is developing a new wound closure device that could fit well into the $7 billion global market for this procedure.

The couple didn't make the decision to leave secure jobs lightly. "We're engineers, so we overthink many of our decisions," jokes Travis. In fact, the couple found their engineering background at South Dakota Mines key to their continued success as entrepreneurs. "It's a balancing act between careful planning, research, and bold leaps," says Amanda.

In the medical device field, there are countless unknowns. "Do you understand the needs of the market? Do you need patents? Do you need FDA approval? When should you hire someone who knows the process to help?" says Amanda.

"It's not for the faint of heart. The research and the regulatory process can be a real bear, but if you take it step-by-step and follow a plan, you can achieve success" says Travis.

The Quest for Pain

The first step in developing a new medical device is knowing the market. As a type 1 diabetic, Amanda's own experience as a patient gave her personal knowledge of the "pain points" in the marketplace.

"It was early morning and my blood sugars were low-I was shaking and struggling to set up my blood glucose meter," remembers Amanda. "My struggling woke my husband and he hurried to help. I had a brand-new vial of test strips and my husband, fully awake, still had a tough time hurriedly retrieving a single test strip for my meter. Finally, after dumping the entire container of test strips on the counter, we were able to check my blood glucose. Not surprisingly, I had very low blood sugar. Travis sprinted to the kitchen to get a juice box to bring my blood sugar back into range, then asked, 'Isn't there an easier way to get those out?'"

This is how Amanda's company, Diaspense, was born. The couple's invention, a cap on the bottle of test strips that dispenses one strip at a time, is now available for sale, and it's receiving rave reviews from users. The lesson here, says Amanda, is "stop thinking that someone else will find a solution." She knew the need for a new product and she had the engineering expertise and the entrepreneurial drive to create a patient-centered solution. Her product is a textbook example of the best way to get a foothold in the medical device field.

"Find a need that needs to be filled," says Travis. This phase of medical device business development generally requires careful observation and a lot of research. "It's an additional skill above our engineering degrees. To be successful, you spend a lot of time observing patients."

Capitalizing Opportunity

Travis is the CTO of Starling Surgical. The company is tackling the challenge of wound closure with a product called "QuickStitch." This is no small market. There are 250 million surgeries each year - 450 every second. The idea behind the technology came from Travis's partner, Starling Surgical CEO Cyrus Doctor, a trauma and orthopedic surgeon who saw a need for better ways to close a wound after performing thousands of surgeries.

During an operation, such as a hip replacement, closing the laceration quickly and then limiting infection risk during healing can dramatically improve patient survival rates. There are two primary options on the marketplace-sutures, which are slow to administer but have a lower infection rate, and staples, which are fast but have a higher infection rate. QuickStitch provides superior sutures at stapler speed. The device allows surgeons to quickly close a wound with optimal post-operative healing.

The product is making a big splash. The pre-clinical results of the patent pending device have received rave reviews from industry leaders. Starling Surgical has also secured about $1 million in funding from Enterprise Ireland and EIT health. QuickStitch is in the FDA approval process with plans to spin out of Trinity College Dublin (where Travis is based) in late 2020. Starling Surgical is maintaining the momentum needed to carry their product to market as it continues to seek investors to help make the leap into manufacturing.

Growing Greener Grass

Ireland is well known for its mind-blowing level of green. Parts of the country receive annual rainfall best measured in feet, not inches. The lush landscape underpins Ireland's traditional economic mainstays agriculture and tourism. About twenty years ago, medical technology industry leaders in Dublin and the surrounding cities made a move beyond medical device manufacturing and into research and development. They cultivated a cooperative ecosystem that allowed various players to work together for the benefit of everyone. Today, Ireland's biomedical sector is recognized as a global hub that touts centers for major industry leaders such as Johnson & Johnson, Medtronic, Pfizer, and Boston Scientific.

"It's grown into the main driver of the area's economy," says Travis. "They started by building an environment that allowed small companies to thrive and that attracted larger firms." Travis and Amanda see potential in this model for the Black Hills. "If we looked at all our strengths in South Dakota we could do this as well, as long as we can make sure everyone complements each other's efforts," adds Amanda.

"The human capital is here thanks to South Dakota Mines and area universities," says Travis. The couple sees promise in the building of the new Ascent Innovation campus in Rapid City. They also give praise to programs on the South Dakota Mines campus like the Entrepreneurs in Residence, CEO Business Competition, and the Braun Inventors Award. "These weren't at Mines when I was a student eight years ago. I encourage current students to take advantage of these opportunities," says Travis.

Bend, Don't Break in the Wind

Travis and Amanda welcomed their first child on March 11, a healthy boy, Rory Floyd Davis. Like any good entrepreneurs, they are flexible in molding their plans to conform with their life goals.

The couple has moved back to the United States be closer to family Amanda keeps very busy wrangling new baby Rory while also answering emails from Diaspense.com and DavisD4.com, which helps its clients build prototypes, develop websites, and create marketing plans.

"We were lucky to be in and out of the hospital before things began getting too crazy with the COVID-19 outbreak. We are thankful to be able to work from home during this time, especially with our new little family member," says Amanda.

Travis writes "Starling Surgical is transitioning to a point that I had completed a large part of the exploratory research and design. We have grown the team and I have stepped back from full time to free up more of our budget for manufacturing and hiring. I still have periodic calls with the team to work with them on the overall vision and continued fundraising efforts. It is great to see the company growing and we have a long way to go, but it is exciting to see how far we have already come."

Travis accepted a position with Blue Origin as a test engineer II in Huntsville, Alabama, at the Marshall Space Flight Center Test Area. He is on the team that test fires the BE-3 and BE-4 rocket engines for Blue Origin. He has transitioned to working from home.

Travis Davis is a Harding County, South Dakota native and graduated from Harding County High School. Amanda Davis is an Ekalaka native and graduated from CCHS in 2006.

About SD Mines

Founded in 1885, the South Dakota School of Mines & Technology is a science and engineering research university located in Rapid City, S.D., offering bachelor's, master's and doctoral degrees. The university enrolls 2,529 students with an average class size of 24. The SD School of Mines placement rate for graduates is 97 percent, with an average starting salary of more than $63,350.

Contact: Mike Ray, [email protected]