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Have you ever wondered what partnering with Greenlight Guru could mean for your business?
We have a partner program for medical device industry service providers with the aim to make their service offerings stand out, accelerate their growth, and create life-long relationships with their clients.
Recently, we sat down with Kyle Rose, President of Rook Quality Systems, a platinum partner of Greenlight Guru, to understand what the partnership has meant to his business. Here’s what he had to say:
About Rook Quality Systems
Rook Quality Systems was started by Kyle Rose in 2012, when he worked part-time in the business, along with a full-time salaried job. In 2014 he switched to full-time with Rook. Rook specializes in quality and regulatory strategy for emerging medical device companies.
Kyle found that many companies, especially larger ones, are slow to move and make changes, particularly as they operate inefficient quality systems. He once worked with a company where it took six months to get a single form rounded and approved!
Along the way, Kyle encountered smaller companies that have implemented these same large quality management systems which are more suited for larger organizations. This not only stifled their time to market, but also introduced risk into the development of their products. Rook’s philosophy is in total alignment with Greenlight Guru’s - keep your QMS lean and efficient, while hyper-focusing on achieving true quality in your processes and products.
For nearly a decade now, Rook has helped pre-market companies establish quality systems, as well as the design control and risk documentation required. They help write test protocols and develop trace matrices, as well as generating reports (and many other pre-market quality activities).
Part of Rook’s clientele are emerging companies who may be inexperienced in medical device quality and regulatory compliance, so Rook helps them with the bulk of their pre-market quality requirements. It is Rook's ultimate goal to help ensure that its clients’ products make it to market through developing and maintaining effective and efficient quality and regulatory practices.
On the post-market side, Rook has many clients who utilize their expertise as a high-level quality or strategy reviewer once Rook’s team has optimized their processes. Rook will oversee the process and sign-off on specific artifacts using Greenlight Guru's part 11 compliant eSig functionality. They have found that distance is no barrier to working with clients if they are utilizing Greenlight Guru. Even with clients around the world, Rook can efficiently collaborate with them using the cloud-based system from their headquarters in Atlanta, GA.
Click here to learn more about what partnership with Greenlight Guru looks like →
Finding a Partner
In 2015, Kyle was evaluating eQMS systems for suitability to partner with and implement as a service to his clients. He recognized that paper-based quality systems were no longer the optimal way to build a medical device quality system, and through partnering with a provider, he could grow both Rook and the partner’s business.
After hearing positive feedback from many industry peers about an emerging eQMS solution named Greenlight Guru, Kyle met Jon Speer at a medical device event in 2015. Following a meticulous evaluation process, Kyle determined that Greenlight Guru set itself apart from other QMS providers in that they were exclusive to the medical device industry, actually addressed product development pains in addition to solving QA/RA issues, and placed a huge amount of effort into fanatical customer support.
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Greenlight Guru also stood out because of its highly collaborative team. When Kyle connected with Jon and David DeRam, he found them open to feedback and truly dedicated to improving quality of life; not only for the end patient, but for the medical device company employees in the trenches developing products. He felt that the software represented the future of QMS, and he wanted to be a part of that success. Since then, he hasn’t looked back, crediting the partnership with helping to expand his reach and rapidly accelerate the growth of Rook Quality Systems.
Getting More Reach
Once Kyle partnered with Greenlight Guru, he found that he had a new secret weapon in his repertoire. He could introduce himself as a partner of Greenlight at conferences and other events, and establish instant credibility. It was a natural segue to introduce Rook at the same time.
“At this point, pretty much everyone had heard of Greenlight Guru, and it was a great ice breaker to start conversations, and transition to discussing their quality system and DHF.”
When Kyle is at a conference, he finds that Greenlight enables Rook to stand out among other quality consulting firms.
Rook has also found that, since Greenlight Guru leads the industry in marketing activity, co-marketing with the solution provider has helped them expand their reach. For example, Kyle has been involved with multiple GG “True Quality” webinars over the years, and has found these (and other co-marketing activities) to be integral to Rook’s growth.
Challenges with QMS
Kyle points to simple day-to-day tasks as being a powerful reason to go with an eQMS. For example, getting things signed can be an absolute hassle. Where companies are using Dropbox or other methods, it’s not the most efficient means of tracking, and they can waste a lot of timejust getting something signed; also, these systems are not part 11 compliant as the FDA requires. Software like Greenlight Guru helps get people on the same page in real-time.
Kyle has clients who still use spreadsheets to manage a quality system, and there are clear differences in their overall company management. Those companies can spend a lot more time simply getting paperwork done or chasing things down, while those using an eQMS can significantly reduce administrative time, and the probability that an error occurs.
If the client isn’t using Greenlight Guru, that means more time on-site working with clients on non-value-add activities. It takes significant time having to route documents, get signatures, and scan documents. This is often done by stringing together separate systems such as Excel, Dropbox, and email versions of risk management.
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Learn about becoming a partner of Greenlight Guru
Another insight that Kyle adds is that being a consultant creates a need to be everywhere at once, across multiple clients. Greenlight Guru- with its cloud-based system- allows him to do just that, as he doesn’t have to be onsite to ensure key tasks get done, signatures obtained, or that a physical piece of paper gets tracked down.
“As consultants, our time is our most valuable commodity, so wasting 20-30 minutes on getting a signature is extremely inefficient.”
Kyle also stresses the importance of companies ensuring that all quality requirements are met with as streamlined an approach as possible:
“Not having your Design Control or Risk Management can be a $20M hair cut on the valuation of your company. I’ve seen first hand smaller companies being courted by a bigger company; they send over a form asking about quality system, DC, RM, and if it’s not in place it’s going to cost you a lot of money.”
Click here to learn more about what partnership with Greenlight Guru looks like →
Results for Rook Quality Systems
Rook has come a long way since partnering with Greenlight Guru. In 2015, they had less than 10 clients and just two full-time employees. Since then, they have grown drastically, adding 18 full-time quality engineers (including 11 Certified Quality Auditors), as well as sales and marketing leadership and administrative support.
As of 2022, they now have nearly 150 medical device clients globally, and are continuing to scale both their client base and employee count. On working with Greenlight Guru, Kyle says:
“It’s been a huge advantage in improving efficiency, training and compliance around quality systems and actions. We’ve been able to improve the buy-in from the whole team, which makes our job easier. Using Greenlight has given me the ability to exponentially expand Rook and our client base, and launch our first international branch in Taiwan in 2020. We couldn’t have grown so much so quickly without Greenlight.”
We wish Kyle and his (growing) team at Rook continued success, and we look forward to many more years of fruitful partnership!
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