It was just over a year ago that greenlight.guru launched the Alpha version of its quality management system (QMS) software specifically designed for medical device companies. Today, greenlight.guru has emerged from a 4-month Beta with paying customers subscribed to its now fully launched core software product, and the fast-growing startup has closed on an oversubscribed $1.25 million seed round of funding from a group of angel investors.
The platform helps entrepreneurs and innovators bring higher quality medical devices to market faster while at the same time reducing risk and simplifying regulatory compliance.
greenlight.guru already tripled the size of its workforce in 2014, but COO Jason McKibbin says the QMS software company will use this influx of capital to hire even more software engineers and product developers, as well as invest in a more robust sales operation.
It’s worth noting that one of greenlight.guru’s co-founders is David DeRam, a 23-year software industry veteran who accepted the 2011 Mira Award in Health Tech for his work with genetic data tracking software company Progeny Software — another company he founded.
What are the three most important features of greenlight.guru? What is your secret sauce?
greenlight.guru’s quality management software is the only platform that provides device makers a single source of truth by integrating the management of design controls, controlled documents, quality processes and more in one, easy to use platform.
- Simple, intuitive & easy to use
- Exclusively for medical device companies
- Medical device expert quality & regulatory consultants are available for consultation if needed
What pain points are most prevalent for customers seeking your software in the marketplace today?
FDA regulatory compliance is the single biggest risk faced by startup medical device companies. Medical device companies are mandated by law to have a quality system in place that meets FDA requirements (ISO requirements in EU).
Greater than 50% of medical device companies still use paper-based quality systems. It’s well documented, and readily known in the medical device community that paper-based quality systems are enormously inefficient, error prone, hinder team based work, and significantly increases risk profile due to lack of traceability, linkability, and document control.
Do you have paying customers already?
Some companies we are currently doing business with include Nexxt Spine, SonarMed, Catheter Research, and NICO.
Can you outline the experience of developing greenlight.guru? What was the genesis?
The seeds for greenlight.guru were planted back in 2006 by a medical device engineer turned consultant as a result of a simple observation: paper-based quality management systems are painful, risky and wildly inefficient. Commercial quality management software solutions have been available for over 20 years now, yet only about 30 percent of medical device companies that should be using them are. But why?
This observation and question led Co-Founder Jon Speer to team up with David DeRam to create the vision for a beautifully simple quality management software platform, which ultimately became greenlight.guru.
Our team conducted over 200 interviews with medical device companies, learning that a majority believe there are no good commercial-quality management software solutions because they are old, clunky and hard to use; they are not built exclusively for medical devices like greenlight.guru, so they take extra time and money to customize; and that there is no one solution to manage their entire quality management system.
Describe your growth trajectory in the short-term and long-term?
Last year was a big year for greenlight.guru. Our team size tripled, we launched the beta version of our product, and we signed up our first handful of paying customers. This year looks to be more of the same. We’ll be using our new capital injection to remain focused on broadening engineering talent, continued product development, and expanding customer acquisition initiatives.
What makes greenlight.guru special or different?
Hands down our team makes us special and different. The individual elements that make up a great business are really hard to get right, but the main thing is getting the people right. Great teams can build a SaaS company, rob a bank, or throw a successful bake sale. The challenge doesn’t matter. They will knock it down if they are the right people coming together under the right leadership.
greenlight.guru’s leadership team includes —
- Co-founder and CEO David DeRam — 23 years of software industry experience as the founder or Progeny Software
- Co-founder and Vice President of Quality Assurance/Regulatory Affairs Jon Speer — 16 years of medical device industry experience as an engineer & consultant
- Chief Operating Officer Jason McKibbin — 10 years as the owner of medical device reprocessing company MEDISISS (acquired by Medline)
Here are a few testimonials from some of greenlight.guru’s paying customers:
“greenlight.guru is exactly what startups need. A lean, mean, compliant system for ensuring quality while allowing them to keep their eyes on the prize. Most quality systems that I’ve looked at are way more complicated than what we need as a small start up. greenlight.guru has helped us implement something that makes sense for where we are but able to grow with us.”
— Sara Naab, Co-founder, Sandstone Diagnostics, Inc.
“This the easiest to use system I’ve ever seen. I’ve used systems that have made no sense. This is actually easy. This is basically like the equivalent of hiring 2 people for a startup.”
— Tom Waddell, Partner & Medical Device Project Manager, Project Leadership Services
“Medical device companies must document Design Controls, yet most struggle with this. greenlight.guru makes this so much easier. Another huge headache for medical device companies is document management. And greenlight.guru takes care of this too.”
— Allan Katz, CEO & President, Long Island Technology Group