Steady Shot founder re-aims for success

Shawn Michaels invented Steady Shot, an insulin injection device, in 2016 while he was an undergraduate student at the University of Wisconsin. By 2020, Michaels received a patent for the device, and he started selling the device directly to customers in 2021.

Steady Shot appeared to be on the trajectory of runaway success. But Michaels ran into many of the problems common to solopreneurs with limited funds.

Now, Michaels is aiming for a second shot at success.

Michaels hopes Steady Shot’s entrance in the Wisconsin Governor’s Business Plan Contest will help the company recapture its former momentum. The founder hopes the contest, coupled with an FDA reclassification of the device, will give the company the push it needs to establish itself in the medical device market.

“One limitation we had was how Steady Shot was classified with the FDA. We are going to switch from a Class I to a Class II device. We are preparing that paperwork, and then once we get it filed, there’ll be like a 12-to-18-month time period until we hear back if it’s approved or not,” Michaels said.

“With that, we’ll be able to expand our marketing claims for Steady Shot, which will help a lot with business-to-business sales. Right now, we’ve mainly been selling direct to consumers through Amazon and our website,” he explained.

Class I devices are considered “low-risk devices” by the FDA, like bandages, handheld surgical instruments, and nonelectric wheelchairs. Class II devices are considered “intermediate-risk devices.”

Additionally, Michaels has plans to help make Steady Shot purchases more convenient for his customers.

“I’m starting to get quotes from manufacturers to private label our own pen needles. We’d have our pen needles as another product line in addition to Steady Shot…we can offer these pen needles at a really low cost without sacrificing quality.”

These changes require funding, and Michaels hopes participation in the statewide pitch contest will garner attention from investors.

“I’ve been silent these past couple years. (It will help to) get back out into the ecosystem and get a gauge on where Steady Shot is in the mind of investors. Is it now more investable because we’ve been on the market for a couple years and we have a pretty decent amount of revenue? We’ve got over 1700 customers,” he said.

“(I want to) get an idea of if this new raise is more feasible for investors and what kind of feedback I’ll get. Ideally, I could win some funding to help with that 510K (FDA reclassification) because that’s the biggest roadblock right now. I’m just clearing anything that could be wrong with the way we have it classified to make it easier to invest in and remove any risk on the investor side and from the Steady Shot side as well,” he concluded.

The Wisconsin Technology Council will announce the finalists for the contest by the end of March.

To learn more about Steady Shot, connect with the company here.