“Partnering with Greenlight Guru provides you with a team that’s on your side, who are all medical device industry pros and understand what companies like ours go through.” - Morris Sherwood, Zyris Inc.
As global needs grow so does the complexity of selling your product in different markets. In turn, this customer fluctuation creates the need for all-new wrinkles to updates to regulatory pathways and documentation needs.
A perfect example of these kinds of changes are with the European Union’s Medical Device Regulations (EU MDR), which creates new regulatory hurdles, especially for international companies looking to make their mark in the EU market.
One company that says they found a compass is Zyris Inc., a dental medical device company based out of Santa Barbara, CA. According to Zyris it all comes down to your quality management system, or more specifically, finding your QMS partner.
Zyris: Empowering Dentists and Making Patients Smile
Founded in 2001, Zyris, Inc. began with a clear mission of elevating dental experiences for patients, providers, and practices. Zyris achieves this mission through conscious design, innovative technology and above all else, a relentless commitment to quality.
Zyris’ Isolite system/s demonstrates these commitments, with patented designs in dental isolation technology to provide both an outstanding functional clinical outcome and much improved patient and provider experiences. This leads to procedures that are quicker, more predictable and less stressful.
Today, Zyris’ solutions are available globally in markets from the United States and Canada to Europe, Australia, Japan, etc.
The Butterfly Effect for Regulated Companies
Of course, having this kind of global footprint doesn’t come without its share of challenges. Morris Sherwood at Zyris can confirm, saying that when adjusting to new standards for documentation, things tend to get exponential fast.
“All device companies have had a lot of challenges in recent times, specifically with EU medical regulations coming online,” Sherwood said. “From that, there are also the challenges of rebranding, changing logos, packaging, and shifting with regulations. We need to be able to pivot very quickly.”
Sherwood’s background in regulatory compliance runs deep and, like many others experienced in the device industry, he has his share of battle scars. Prior to his post at Zyris, Sherwood worked for a medical device company facing one of the industry’s worst nightmares: a consent decree from FDA.
The company let go 125 people but retained Sherwood and others for a core team tasked with mitigating the situation and recovering. The team succeeded, and Sherwood credits the experience for some valuable lessons learned.
Sherwood reflected on how working with a knowledgeable, dynamic team including outside regulatory experts was key to rebuilding the quality management systems. Without the guidance of a regulatory partner, the company would have been unable to navigate through what needed to be done. “Quality systems are complicated animals,” he says. “There’s a lot of inter-dependencies that occur in every part.”
That experience demonstrates a critical tenant Sherwood ascribes to: you need to be able to see the impact of every decision made by a medical device company through a regulatory lens. Once he arrived at Zyris, he quickly integrated his vision for QMS practices into the organization’s mission for providing quality above all else for its customers. Sherwood quickly became known for his ability to see the butterfly effect of each change or decision, earning him a reputation of being hyper analytical and ensuring the long-term impact and goals were considered with every twist and turn.
EU MDR Changes the Playing Field
With the changes brought forth by Regulation (EU) 2017/745, Sherwood and his team realized that they needed to change some of their processes quickly and efficiently. At the time, they were struggling with their chosen QMS software partner, which Sherwood refers to as “a disaster.”
“I learned how not to have an eQMS. I learned how not to work with people with little experience in the medical device industry,” he says. Challenges with their eQMS solution became an obstacle to their future. “We had the inevitable stresses that come with company growth, pushes into additional markets, and a changing regulatory environment,” Sherwood shares. “The solution we had wasn’t helping.”
Zyris began searching for a software solution that could work for them, rather than against them. Sherwood recognized they needed not only a software solution but a partner in regulatory requirements instead of a one-size-fits-all tool. Zyris selected Greenlight Guru and from go-live, everything became much simpler and in-control, Sherwood says, with a platform designed for medical device companies coupled with an amazing customer experience.
“Partnering with Greenlight Guru provides you with a team that’s on your side, who are all medical device industry pros and understand what companies like ours go through. When we use Greenlight Guru with external partners, they immediately recognize the name, and say ‘Ah, you’re working with Greenlight Guru, that’s perfect.’ It is like a status symbol.”
Unlocking Modules with Modularity
Sherwood says the control of the platform is a critical feature. As the team adapted to the changes required by EUM DR as well as product design work, they needed the ability to slow things down and avoid overwhelming everyone.
“Greenlight Guru has been so valuable to us largely because of its modularity. We were able to turn on the different modules one by one and use an agile workflow to take each item and break it into smaller components, making sure each one was handled with critical care.”
Implementing Greenlight Guru into Zyris’ processes felt natural and comprehensive. It also fits perfectly with Sherwood’s butterfly effect philosophy, allowing Zyris to visualize connections and therefore the implications of each decision or change being.
“We use the internal audit modules as a gap analysis to see where we need to make improvements,” he says. “Then we use the CAPA module—which ‘speaks’ to the audit system—to then figure out corrective actions and perform root cause analysis.”
Sherwood praises the platform’s integrated and thorough features that have allowed Zyris to bring together critical processes and data into one single source. “Design controls, inputs, outputs, documentation management, changes and traceability matrices, quality processes such as CAPA—having everything in one place means we can adapt, grow, and innovate.”
Continuous Improvement is a Process of Growth
Of course, no medical device’s journey ends with its production release. From there, Sherwood says, a new product quality process must be managed: Post Market Surveillance and customer complaints.
“Some folks view complaints as negatives, but at Zyris we see them as pearls of wisdom on how our product is performing out in the field, and how to improve our product. It’s really all about continuous integration and improvement.”
At the time of this publication, Zyris is actively in the process of writing and modifying its Quality System for full EU MDR implementation. In addition to this undertaking, Sherwood says they’ve successfully navigated through several Notified Body audits and a week-long surprise audit from Health Canada, which was performed — and passed—remotely.
“Greenlight Guru made it possible for us to maintain organization and document control and provide everything the auditors needed.”
Zyris and Greenlight Guru: A Partnership Built on Quality
Zyris’ selection of Greenlight Guru has resulted in a partnership.
“When we talk about implementing quality systems, it should be something you’re proud of. Starting out in medical device technology, you may have brilliant ideas, but you need to make sure you’re not going to do this on your own. Instead, surround yourself with smarter people who can change with you. There’s a lot of dependencies that occur in every part of a quality system. Greenlight Guru is a fantastic software because it addresses each one.”
At Greenlight Guru, we’re proud to partner with companies like Zyris who have such care for customers and end users across its full product line. Because quality and risk-management shouldn’t be something you have to do but integrate into who you are.
With fine folks like Morris Sherwood and the entire Zyris team, they prove how the right QMS software partner can help you stay safe, even if sometimes it feels like business, regulatory, and Quality System requirements are changing so fast that having a tool that allows you to expeditiously pivot is a necessity.
Learn more about Greenlight Guru and the ability to successfully navigate through regulatory changes and company growth with a free demo of Greenlight Guru →