Empowering Success: Arena Coach Chloe Stabler Helps Medical Device Companies Embrace eQMS

Arena Customer Success Coach, Chloe Stabler, is no stranger to the stress of getting through an FDA audit. Like many quality professionals in the medical device industry, she often spent hours digging through filing cabinets to retrieve stacks of training records and other documentation for an assessment. It wasn’t until the implementation of Arena QMS that Chloe’s organization streamlined compliance and realized the benefits of embracing an electronic quality management system (eQMS).

I sat down with Chloe to learn more about her experience as a previous Arena customer. We also discussed how she helps medical device companies get over the hurdle of moving away from paper in her current role.

CHLOE, PLEASE TELL US ABOUT YOUR BACKGROUND AND JOURNEY TO ARENA, A PTC BUSINESS.

Chloe: Previously, I was a quality engineer working primarily at medical device startups. In that role, I wore many hats from document control and training management to corrective actions and complaints.

Just prior to joining Arena, I worked at ArcherDX, a leading genomics company specializing in precision oncology. There, my focus was software design, development, and validation. I was also tasked with finding and implementing a new enterprise QMS and eventually chose Arena’s cloud-native solution. My experience implementing Arena and interacting with the support team was very rewarding. It led me to pursue the customer success coach position.

CAN YOU TELL US MORE ABOUT YOUR ARENA QMS ONBOARDING EXPERIENCE WHEN YOU WORKED AT ARCHERDX?

Chloe: I collaborated regularly with the Arena solution architects and success coaches throughout the implementation to ensure that our data was successfully loaded and that our team was fully trained on how to use the system.

Arena’s hands-on approach was refreshing! Previous vendors would provide us a system and say, “Good luck. Let us know if you have any questions.” In contrast, Arena’s experienced team guided us through each phase of the process to ensure that our needs were addressed. We were able to successfully implement and onboard Arena QMS in less than three months.

I liked the fact that Arena was highly configurable. It didn’t require complex coding to meet our unique business requirements. As an admin, I could easily add custom fields or new categories without having to consult with IT or call customer support.

For a startup company like ours, this was a game-changer. We needed to get our product FDA-approved and introduced to market fast. Arena’s easy setup and deployment enabled us to stay focused on meeting our product launch milestones.

DESCRIBE A TYPICAL DAY IN YOUR ROLE AS A CUSTOMER SUCCESS COACH.

Chloe: I’ve been with Arena, a PTC Business for two and a half years. As a success coach, I’m focused on problem solving. My day revolves around the customer. I address their questions and help them figure out the most efficient way to perform processes in Arena. This could be through email or a 15-minute phone conversation.

Sometimes I set up more extensive meetings with customers to discuss their long-term business strategies and goals and show them how they can leverage Arena to achieve those goals.

WHAT TYPES OF MEDICAL DEVICE COMPANIES DO YOU SERVE?

Chloe: I work mostly with small to midsized medical device companies. They are at the point where they have developed the product and the technology. Now they need to get it FDA-approved for market.

WHAT ARE THE COMMON PRODUCT DEVELOPMENT CHALLENGES THAT YOU ADDRESS WITH CUSTOMERS?

Chloe: Some of my customers are at the beginning stages of implementing an eQMS. Previously, they were accustomed to maintaining all their product and quality documentation via paper. In many instances, Arena QMS is the only business software that they have in place. Although the transition to digital may seem daunting, I reassure customers that the time invested in making the switch is made up for in volumes by the efficiencies that they gain.

Also top of mind for many of my customers is the management of their design history file (DHF), which is a requirement of the FDA. The DHF is an index of all the different elements of your design process (planning, risk management, design inputs, design outputs, testing, etc.). It represents the full journey from the initial conceptualization and crafting of requirements to the final design. The DHF must demonstrate that the product is safe and performs as intended.

HOW SHOULD CUSTOMERS FAMILIARIZE THEMSELVES WITH THE ARENA PLM/QMS PLATFORM?

Chloe: I direct customers to the Help section within Arena. This self-service portal contains a wealth of information for any type of user—how-to videos, user guides, best practices, and more.

I also point customers to our Arena Influencers hub. There, they can access on-demand tech sessions covering topics like user access policies, Item compliance, and training record management. Customers can also connect with each other to ask questions and exchange ideas.

WHAT ADVICE DO YOU TYPICALLY OFFER TO CUSTOMERS TO HELP MAXIMIZE THEIR INVESTMENT WITH ARENA?

Chloe: I offer customers this advice:

• Deploy Arena using a phased approach. Don’t try to roll out everything all at once. Start with what you can manage and expand from there. Begin with the basics (Items, BOMs, Changes). Then follow with your corrective and preventive actions (CAPAs), Requirements, Training, Tickets, Analytics, etc.
• The more information that Arena has and the more connected it is, the better it’s going to work for you. When all your quality processes, requirements, and other essential information are in Arena, you can establish relational links with the product BOM for closed-loop traceability. Integrating Arena with other systems like enterprise resource planning (ERP) or customer complaint management solutions drives even greater efficiencies throughout the product lifecycle.

“Whether you’re just getting started or you’ve been using Arena for years, you always have a trusted partner to rely on.”

-Chloe Stabler, Customer Success Coach

HOW DOES YOUR TEAM MEASURE CUSTOMER SUCCESS?

Chloe: We gauge our customer’s success by their feedback. How often do they access Arena and how does it impact their daily work routine? Also, we evaluate how much of the system they are using. Are they leveraging all of Arena’s functionality? These insights guide our conversations with customers to help them get the most value from the system.

CAN YOU TELL US ABOUT ONE OF YOUR PROUDEST MOMENTS WORKING AS A SUCCESS COACH?

Chloe: I onboarded a customer that was transitioning from a paper-based QMS. Initially, they were overwhelmed because they didn’t have set goals for implementing Arena. Without a clear vision, it was difficult to identify the right processes and system configurations to put in place.

For the first couple of months, I met with the customer at least once a week, providing the extra level of support that they needed. I helped them determine not only how to configure Arena, but what was needed as part of their quality system.

The customer has been using Arena for two years, and their knowledge of the system has matured tremendously. I’m proud to see how much they have progressed since implementing Arena.

WHAT IS THE FIRST THING YOU WOULD WANT A COMPANY TO KNOW ABOUT JOINING THE ARENA CUSTOMER COMMUNITY?

Chloe: Whether you’re just getting started or you’ve been using Arena for years, you always have a trusted partner to rely on. Our team of experts understands your business. We work with you for the duration of your journey with Arena to help you reap the full benefits of the system. That way, you can deliver life-enhancing products to market faster.

ARE THERE PARTICULAR INDUSTRY TRENDS OR TOPICS THAT EXCITE YOU AT THE MOMENT?

Chloe: I’m excited by the advancements in medical technology over the last decade. For instance, the integration of robotics with prosthetics is restoring the functionality of a healthy human limb, helping patients to regain their motor capabilities and perform more complex movements.

WHAT ACTIVITIES DO YOU ENJOY IN YOUR SPARE TIME?

Chloe: I’m based in Denver, Colorado. In my spare time, I enjoy hiking, listening to live music, and experiencing the city’s vibrant craft brewery scene.

Interested to hear more from Chloe and the Arena customer success team? Submit your comments and inquiries on social.