Solution Architect Scott Segrin Shares 3 Keys to a Successful QMS Implementation

Today, many medical device companies are realizing the benefits of investing in an enterprise quality management system (eQMS) as they look to comply with stringent regulations and introduce safe, life-enhancing products to market. Yet oftentimes they are reluctant to make the leap due to employees’ aversion to change and comfort level with using manual or paper-based systems.

We asked Arena Solution Architect Scott Segrin to explain how his team guides customers in making the switch to a Cloud QMS and provide tips for ensuring a fast and painless implementation.

Shelly: Scott, please tell us about your professional background and how you arrived at Arena.

Scott: I am a retired United States (U.S.) Navy veteran. After active duty, I started working in quality management at TE (formerly Tyco Electronics). That role eventually transitioned to configuration management, where I handled the organization’s change control processes. I continued my career in configuration management for several years with positions at Apple, Sikorsky Aircraft Corporation, and Celestica, a Tier 1 contract manufacturer. Eventually, I started working at Medtronic, one of the world’s largest medical device manufacturers. There, I was a Senior Manager for over 10 years, overseeing multiple divisions across the U.S.

Although I have a diverse background in many different sectors, medical device is my specialty. My experience using Arena PLM as a past customer at Medtronic eventually led me to the solution architect position.

Shelly: Describe your role as a solution architect.

Scott: I’ve been working at Arena as a solution architect for six and a half years. A solution architect is the first stop in the customer’s journey with Arena. The role of a solution architect is to guide customers through the implementation of the Arena QMS or PLM system.

The first critical step is configuring the Arena workspace according to customers’ needs. The next step is importing product and quality data from their existing legacy systems (e.g., Excel) into Arena. After the data is imported, our team performs extensive reviews to ensure that everything is in place. From there, I conduct workshops and provide customers best practices on how to establish processes within the Quality, Training, Projects, Tickets, and Requirements worlds of Arena.

Once the customer is fully trained and comfortable with their production workspace, I connect them with an Arena success coach, who will provide ongoing support to ensure they are achieving the desired results.

In addition to onboarding customers, I help them integrate computer-aided design (CAD), enterprise resource planning (ERP), and other enterprise systems with Arena. Additionally, I conduct monthly Arena QMS overview sessions. These sessions are open to any customer and review standard QMS processes and their uses (i.e., design history file, nonconformance material report, corrective and preventive action [CAPA], supplier collaboration, and auditing). I’m excited to have recently taught four QMS training sessions at this year’s PTC LiveWorx event!

Shelly: What type of customers do you support?

Scott: Most of my customers are medical device companies. Some are in the beginning/trial stages of product development. At this point, they need to build a QMS system that will enable them to comply with FDA, ISO 13485, and other applicable regulations. My experience with FDA and EU medical device audits and inspections enables me to guide these customers in establishing the necessary quality processes to meet regulatory requirements.

My more established customers are looking to expand into the European market. They are now trying to understand all the requirements set forth by the EU MDR. To assist these customers, I partnered with Customer Success Coach Gay Groce and Product Management Director of QMS, Sherry Dickson, to develop an MDR quality template. It helps customers complete the necessary tasks to demonstrate MDR compliance, and it can be customized to meet their unique needs.

We do not claim to be experts on the regulations; however, with our previous experience in the medical device field we understand the challenges that customers face and can help them apply best practices using Arena QMS. We provide medical device customers the tools that they need to meet regulatory requirements and achieve their compliance goals.

That’s what I take the most pride in—getting customers up and running to the point where they can advance their business.

Shelly: What is one fundamental skill that makes a solution architect successful at their job?

Scott: An essential skill for a solution architect is the ability to listen. We play a critical role in getting customers on solid footing as they make the transition to an eQMS.

If we don’t listen to the customer, we can’t address their unique product development challenges. In turn, they will not reap the full benefits of Arena.

Shelly: How do you work with success coaches and other groups across the organization to support the customer?

Scott: I collaborate with customer success coaches and the product management team to develop quality templates, software validation documentation, and other tools that help reduce the burden on customers.

As part of the customer handoff to success coaches, I review what’s going well for the customer as well as their current pain points:

• Is the customer focused on the deployment?
• Is their implementation team fully trained? Do any gaps exist?
• What types of questions/issues will the customer raise?

I pass this information along to the coaches so that they are well prepared and know where they will need to focus their efforts.

I am also closely connected to the Arena engineering department. I submit requests for software enhancements based on feedback that we receive from customers. I also provide my own suggestions to help streamline data imports, configurations, and other back-end processes.

Ultimately, we all work together as a team. Our goal is to support each other so that we can best serve the customer.

“I take the most pride in getting customers up and running to the point where they can advance their business.”

-Scott Segrin, Solution Architect, Solution Delivery

Shelly: What tips do you provide customers to help streamline the Arena onboarding process?

Scott: Customers are typically dealing with many competing priorities as they start the Arena onboarding process. I advise customers to leverage our best practices, workshops, and other training tools to stay on track and deploy the system as quickly as possible. The sooner they go live with Arena, the sooner they will be able to eliminate manual, time-consuming processes and become more productive.

Another tip is to access Arena and start using it. Customers are surprised by just how easy it is to use!

Lastly, I suggest that customers deploy Arena using a phased approach to help ease their transition to the new system. In the first phase, we typically set up Items, Bill of Materials (BOM), and Change Management. If QMS documents are getting loaded into the system, we also focus on setting up the Training world. In phase two of the implementation, we focus on the Tickets, Projects, and Quality worlds. Approximately three to four months later, once the customer is comfortable using these portions of Arena, we will focus on rolling out Analytics and/or Requirements. By then, a good amount of data is in the system.

Shelly: What contributes to customers’ fast deployment and adoption of Arena?

Scott: To ensure the successful deployment and adoption of Arena, organizations should assign one of their senior staff members to be the “owner” of the project and attend regular meetings.

Additionally, they should assign someone the role of a system administrator. This person is responsible for learning the system and training other key stakeholders. They attend all our workshops, watch training videos, and review best practices to learn every aspect of Arena.

Shelly: For medical device companies looking to invest in a QMS solution, what key factors should they keep in mind?

Scott: As part of your search, ensure that the software vendor has a trusted, dedicated team that can provide ongoing educational support and industry best practices on how to use the system. The team should have extensive industry knowledge.

The QMS solution should provide a single source of truth for teams to access product and quality information. Ideally, companies should look for a product-centric QMS, where all their quality processes and records are linked directly to the product BOM. This enables greater traceability and visibility into product nonconformities and helps reduce compliance risks.

It is best to invest in a cloud-native solution that doesn’t require custom coding or expensive IT infrastructure for setup and maintenance. Additionally, companies shouldn’t have to invest in costly IT resources to perform installation qualification (IQ) and operational qualification (OQ) software validation procedures that are essential for FDA compliance.

Shelly: What excites you most about the Arena QMS platform?

Scott: I love the fact that everything is connected. You don’t have to access multiple systems. I also like the fact that Arena is very user-friendly.

Arena, a PTC Business listens to customers’ suggestions and makes them a priority for PLM and QMS software enhancements. We are committed to releasing enhancements three to four times per year.

Shelly: What’s the next significant advancement in Cloud PLM/QMS or other digital technologies that will change how manufacturing companies work?

Scott: As PLM/QMS integrates with shop floor equipment and systems like risk management software, augmented reality, and computer-aided design, it will make everyone’s job much easier and significantly streamline the design and manufacturing process.

Shelly: In three words, how would you describe the culture at Arena, a PTC Business?

Scott: Team-oriented, friendly, and cooperative.

Shelly: What do you like to do in your spare time?

Scott: I am an active motorcyclist. When the weather is nice, I take long rides on my Harley. I also enjoy traveling to tropical destinations with my wife.

Shelly: Scott, thanks for sharing your insights on the Arena QMS implementation. We look forward to catching up with you soon!

Interested to hear more from Scott and the Arena solution architect team? Submit your comments and inquiries on social.