They’re still out there, says Indianapolis-based Greenlight Guru: dusty corporate basements with 50 fireproof filing cabinets, storing medical device quality management paperwork held together with bubblegum, rubber bands and hot glue-gunning. For some medical device makers, it’s too terrifying to switch to an electronic Quality Management System (eQMS)—some 60 percent in the industry still use paper, says Greenlight Guru co-founder and Chief Executive Officer David DeRam. But the number is shrinking, because business is booming for the young firm as it helps companies embrace its eQMS tailor-made for medical devices.
“Lots of companies have built general purpose electronic quality management systems that work for every industry and can be modified,” says DeRam. “But we created something that’s really special to the medical device world, because medical device companies have realized general purpose tools don’t help them.”
The amount that must be managed and documented for medical device companies is mind-boggling; it includes product design, risk management, supplier relationships and operating procedures, among others. And unlike some industries, tracking all of these elements is required by the law for medical device makers, which are regulated by the U.S. Food and Drug Administration (FDA).
“Paper-based documents get lost all the time,” writes Greenlight Guru co-founder Jon Speer on the company’s blog. “What happens when you lose something and it’s never recovered? What happens if an auditor asks for a document and you can’t find it?”
Greenlight Guru says its cloud-based eQMS software is secure, integrated, easy to use—and most importantly—designed especially for medical device manufacturers before, during and after their product introduction to the market. The firm operates on a SaaS (software as a service) model and says it has clients in more than 600 cities and 35 countries, including Fortune 250 and Fortune 500 companies, as well as Indiana clients, such as West Lafayette-based Cook Advanced Technologies.
“There’s a full ecosystem inside a QMS that has to be linked together. We’ve linked all of those pieces and allow executive teams to see data they’ve never seen before and do things they’ve never done before, because they have full visibility into their QMS—and that’s just never been the case,” says DeRam. “There’s so much regulatory change, you can’t really manage that level of complexity with paper; it has to be done electronically.”
Greenlight Guru is reporting exponential growth. Founded in 2013, the company had 29 employees at the end of 2017 and expects to have 60 by the end of this year. Its goal is to employ 120 by 2020. The company also touts a 125 percent increase in year-over-year new subscription revenue growth.
“We’ve focused on bringing in team members who are excited about what they do and love their profession,” says DeRam. “Medical devices are the way that innovation comes to market, and we have a team that’s dedicated to improving [patients’] quality of life. We have a lot of joy and energy; that energy is what drives the machine, and it’s contributed to so much of our growth.”
Greenlight Guru believes Indianapolis’ reputation as a blossoming tech hub is also contributing to its rapid growth. The company moved in 2017 to The Union 525 downtown, which offers space for startup and scale up companies.
“Just on our executive team, we’ve moved people back to Indy from both coasts to be part of our team,” says DeRam. “Initiatives in Indy like The Union 525 are really helping tech companies grow; Powderkeg is a great example of a company, plus TechPoint. The resources are here, so it makes it that much easier to grow a really strong team.”
DeRam believes that team is why Greenlight Guru is perceived as more than just a software provider, but also as experts in the industry.
“We have the number one podcast, the number one blog, the number one webinar in the industry, and [we] speak centerstage at conferences; it’s our combination of knowledge plus software,” says DeRam. “There’s modernization in the [medical device] industry that’s been long overdue, and people are modernizing with an eQMS. It really makes sense to modernize with an eQMS that’s specific for your industry.”
DeRam says Greenlight Guru’s culture is deeper than office perks that are often associated with tech companies.
DeRam says business is growing at Greenlight Guru as a list of factors pushes medical device companies to switch to an eQMS.
Greenlight Guru is collaborating with the FDA to host a webinar series to increase awareness of the FDA’s Case for Quality program; DeRam says the partnership is a bit unusual.