Indianapolis is known for its business-to-business software innovations. Some have made national headlines and become, more or less, household names while others have quietly gone about revolutionizing their industries. What they have in common is changing the ways we do business by applying technology to essential, but antiquated or ignored processes.

Greenlight Guru, the only quality management software (QMS) designed specifically for the medical device industry, seems bent on being the kind of company that makes headlines and becomes a household name — in part because of its fast-selling products and rapid growth, and in part because of its “alligator blood” culture built on trust and grit.

“You don’t just stand in the culture and enjoy it like rain pouring down on you, you have to participate,” said David DeRam, co-founder and CEO of Greenlight Guru. “One of the reasons there hasn’t been any innovation in our space — the medical device space — is because it’s really hard. It’s a complicated product in a complex regulatory environment that’s constantly changing. So the alligator blood culture concept comes from knowing it’s hard, doing it anyway and never giving up. We take pride in the fact that we’re succeeding in a very difficult market and taking on the tough challenges.”

As difficult as the medical device space may be, the opportunity is equally as grand. The global medical device market brings in between $400 billion and $520 billion according to various sources, with the U.S. medical device market alone accounting for one-third up to one half of that ($180-$220 billion). While Greenlight Guru does have some competition in the software space among non-specific quality and project management platforms, the scale-up company’s primary competition, about 50 percent of the market, is with paper processes and a myriad of disjointed, non-integrated systems.

“There just aren’t any other tools out there for quality and regulatory professionals and for engineers in the medical device industry to do their jobs better,” DeRam said. “It seems like every other industry has a few options for cloud-based, integrated and easy-to-use systems, but for whatever reason it didn’t exist for medical devices. That’s where Greenlight Guru comes in.”

The U.S. Food and Drug Administration (FDA) has taken note and partnered with Greenlight Guru to promote the FDA’s Case for Quality initiative and its benefits to the medical device industry. This free 90 minute webinar is presented by FDA Case for Quality Program Manager Cisco Vicenty and moderated by Greenlight Guru’s Co-founder and VP of QA/RA Jon Speer.

DeRam, who has 27 years experience in software including more than 20 years with his own ventures, joined forces with top medical devices engineer and thought leader Jon Speer (co-founder and VP of QA/RA)  to introduce Greenlight Guru at the 2011 Innovation Showcase in Indianapolis.

“To say that first outing at Innovation Showcase was a huge success is underselling it,” DeRam said. “People had this look in their eyes just like Jon did, this excitement over something that could make them more effective, that would result in safer medical devices and bring them to market faster to help more people — we knew we were on to something big and set out to build a great company around Jon’s idea of revolutionizing the medical device space.”

Greenlight Guru has since recruited top talent from both Coasts and locally reaching 40+ employees and expanding into multiple spaces at The Union 525 tech hub in downtown Indianapolis. Hiring initiatives are on target to meet 120 employees by 2020, a deal with the state of Indiana begun before the company doubled in size and had only 19 employees. Just last week, the company announced more explosive growth having achieved a 45 percent increase in quarter-over-quarter new subscription revenue, as well as a 125 percent increase in year-over-year, new subscription revenue growth.

According to DeRam, the interesting trend in software right now is building tools for specific vertical industries, just like Greenlight Guru has done for medical devices. “Software is so much more valuable right out of the box if it looks and feels like your company looks and feels and you don’t have to hire a bunch of people or spend a year configuring it,” DeRam said.

He compared it to buying an automobile that arrives in your driveway in a box that could end up being a race car or a minivan or a bus. “Nobody wants that,” he said. “They just want to drive the car they want off the lot. It’s the same with software right now. Buyers don’t want to spend time and resources configuring a general purpose tool, not when there’s a platform available for their specific market. And that’s why Greenlight Guru is gaining so much traction so fast, especially since there’s really no other software that’s purpose-built for medical devices.”

This winning strategy coupled with a genuine desire to do some good and built a great company is attracting new employees and several Fortune 500 customers, in addition to a growing roster of small to medium sized businesses that use the Greenlight Guru’s Go and Grow platforms and Guru services to bring their medical devices to market.

“One of the things that sets us apart is we really live that vision of improving the quality of life every day,” DeRam said. “I think that comes from Jon’s vision and from our origins and the way that we built this company with a real purpose to help people. It’s part of our DNA.”