Inside Arena: Marion Cappadona Discusses eQMS Validations, FDA Regulations, and Industry Trends

The regulatory landscape for medical device companies is highly complex and constantly evolving. Each regulation has its unique set of requirements that impact every stage of a product’s lifecycle, from the initial design and development to validation and post-market surveillance. Despite their nuances, the common goal across all regulatory bodies is to manage risks effectively and ensure patient safety.

In this interview, Arena Product Manager Marion Cappadona discusses how a product-centric eQMS helps medical device manufacturers stay focused on what matters most and establish a strong foundation for compliance. She also highlights some of the latest FDA and EU MDR regulations and industry trends that are reshaping how companies bring new products to market.

MARION, PLEASE TELL US ABOUT YOUR PROFESSIONAL BACKGROUND.

Marion: I have over 30 years of experience in the life sciences industry. My career began as a mechanical engineer, where one of my main tasks was implementing engineering changes. Back then, we had to manually route paper ECOs for signatures, which was a cumbersome process. Because there was no industry standard for design controls, we lacked a clear understanding of how product changes aligned with user needs, intended use, and requirements throughout the design and development process.

It wasn’t until I transitioned to quality engineering that the FDA introduced design controls as part of its new Quality System Regulation (21 CFR Part 820). During this period, I worked for a small startup and gained insights into design controls and risk management through our failure mode and effects analysis (FMEA) processes. I also became familiar with electronic systems through my work with enterprise resource planning (ERP) validations and implementations. The ability of these systems to automate processes resonated with me, ultimately steering my career in a different direction.

Years later, I served as a Software and Systems Senior Consultant at MEDIcept, where I led the development and execution of client non-product software projects. This included design control process development, design history file remediation, risk management, software design development, process validation, and compliance training. I also assisted clients with implementations and validations for various QMS software packages, including Arena.

DESCRIBE YOUR EXPERIENCE WITH ARENA WHEN YOU WERE AT MEDICEPT.

Marion: One of my earliest projects was helping a client transition from Master Control to Arena QMS. This involved verifying the migration of their data and validating their Arena configuration. Additional projects involved assisting clients in streamlining their Arena configurations to enhance efficiency and creating work instructions to facilitate the use of Arena as part of their business practices.

Later, I focused on strengthening MEDIcept’s partnership with Arena. To this end, I helped develop the performance qualification (PQ) templates that are now a part of Arena’s validation package. Additionally, I collaborated with the Arena product team to deliver customer training sessions on software validation.

During these sessions, I highlighted the FDA’s new Computer Software Assurance (CSA) guidance document, which outlines the expectations for validating automated processes within software.

Unlike previous guidance documents that required companies to validate most aspects of software functionality, the new CSA guidance clarifies how to streamline validations by focusing on functions that ensure regulatory compliance and those that could lead to product noncompliance or patient safety issues.

I created decision trees to help Arena customers determine:

• Which parts of Arena are being used to meet FDA regulations?
• What configurations or automations are being implemented?
• How do these process automations impact product performance?

Our comprehensive validation of Arena’s out-of-the-box functionality enables customers to focus on these critical areas, thereby significantly streamlining their validation process and minimizing documentation.

HOW DID YOU EVENTUALLY END UP AT PTC?

Marion: I have always been passionate about software and automation, so working for a company like PTC was a long-standing aspiration of mine. Through my experience at MEDIcept, I fell in love with the Arena by PTC PLM and QMS solutions. When the Arena Product Manager position became available, I eagerly pursued it. Stepping into this role has been a great opportunity for me to explore innovative ways to develop new QMS functionality that delivers value to our customers.

WHAT PROJECTS ARE YOU CURRENTLY WORKING ON?

Marion: Right now, I’m focused on introducing new functionality within Arena’s Quality world. I’m also researching enhancements for Arena Requirements.

WHAT EXCITES YOU MOST ABOUT THE ARENA PLATFORM? WHAT SETS IT APART FROM OTHER PRODUCT DEVELOPMENT SOLUTIONS?

Marion: Arena outperforms the competition in these key areas:

Product-Centric Approach to Quality Management

Many of today’s eQMS systems are document-centric, managing primarily SOPs, work instructions, CAPAs, nonconformance reports, complaints, etc. They fall short when it comes to managing the entire product record comprised of a multilevel bill of materials (BOM).

Arena is unique because it connects PLM and QMS in a single system. This product-centric approach is beneficial for managing risks and meeting regulatory requirements.

Regulatory standards like FDA’s 21 CFR 820, ISO 13485, and EU MDR expect all your decisions to be based on what’s best for the product and patients. By connecting quality documentation and processes directly to the product’s device master record (DMR), Arena provides complete traceability and visibility into all the CAPAs, complaints, and nonconformances that are tied to each product revision. This helps organizations drive continuous improvement and reduce compliance risks.

Highly Configurable

Arena enables users to easily automate processes and create forms to meet their specific quality system requirements, rather than adjusting their QMS to fit their chosen eQMS solution. This simplifies implementation and allows maximum flexibility.

Scalable

As organizations grow and their business evolves, Arena readily scales to meet their needs.

HOW DOES ARENA HELP LIFE SCIENCES COMPANIES STREAMLINE REGULATORY COMPLIANCE AND GET PRODUCTS TO MARKET?

Marion: Arena Validate paves the way for computer software assurance. Companies can leverage the PQ templates and impact assessments included in Arena’s validation package to expedite as configured validations. Arena’s partner, MEDIcept, can also assist with the validation process.

As mentioned earlier, adopting the FDA’s new CSA approach enhances validation efficiency, keeping companies focused on functionality that impacts the product and patient safety.

Moreover, Arena’s product-centric approach helps customers establish strong design controls to comply with 21 CFR Part 820.30. By connecting requirements, verification and validation, risk control measures, and more to the DMR, Arena streamlines the design review process. After bringing a product to market, you can link requirements and customer feedback directly to the DMR to help inform future product enhancements.

Imagine being able to access any product revision and view all its associated requirements with a simple click. You can also see all the CAPAs, complaints, and NCRs that are written against that product revision without leaving the DMR. Plus, you can navigate from one superseded revision to the next and see how the product has evolved in those areas.

In essence, you can evaluate your product’s performance effortlessly every time you access Arena. This is a powerful tool that cannot be matched by paper, spreadsheets, or document-centric systems.

HIGHLIGHT SOME OF THE LATEST MEDICAL DEVICE REGULATIONS OR REQUIREMENTS THAT ARE RESHAPING HOW MANUFACTURERS DEVELOP AND SUSTAIN PRODUCTS.

Marion: We expect an update to the FDA Quality System Regulation (QSR), aligning it more to ISO 13485. This change will further support risk-based decision-making as well as the CSA approach, which is threaded throughout ISO 13485.

Additionally, the transition to EU MDR significantly raises the bar for product safety requirements, clinical evaluation, customer feedback, and supplier controls.

With Arena’s advanced features like compliance BOMs, Supplier Items, user access policies, and the Quality world, customers can easily demonstrate to auditors and notified bodies how they are meeting the new FDA and EU MDR requirements.

ARE THERE ANY CURRENT INDUSTRY TRENDS OR TOPICS THAT EXCITE YOU?

Marion: I’m excited by the proliferation of AI as a tool to help accelerate product development and drive continuous improvement.

I’m also eagerly anticipating the FDA’s Electronic Submission Gateway (ESG) Next Generation set to launch in 2025. It will enable medical device companies to submit their 510(k)s and adverse event reports directly to the FDA through an API connection. Currently, companies can use an API to download public datasets like adverse events and product recall reports via the openFDA portal.

These advancements present an opportunity for the industry to automate data communications with regulatory agencies. In the future, you might be able to prompt AI to incorporate clinical data into your risk-benefit analysis. Ultimately, medical device companies will be able to streamline their regulatory submission process, easily assess risks, and speed product development.

WHAT KEY PIECE OF ADVICE WOULD YOU GIVE TO MEDICAL DEVICE MANUFACTURERS IMPLEMENTING A QMS?

Marion: I would offer this advice:

First, adopt a “less is more” strategy when configuring your eQMS. Avoid overcomplicating things from the start. With Arena, begin with the essentials like BOM Management, Items, Change Management, and Quality. Integrate your CAPAs and complaints into the Quality world and link them to the product record to harness Arena’s power.

Second, when validating your eQMS, concentrate on the functionality that affects product performance and patient safety. Since Arena handles most of the validation, you can focus on your specific configurations.

Lastly, stay connected with us. The more we understand your needs, the better we can assist you with new QMS enhancements and features.

WHAT ACTIVITIES DO YOU ENJOY IN YOUR SPARE TIME?

Marion: I’m an avid football and basketball fan, with the New England Patriots and Boston Celtics being my favorite teams. I also enjoy spending quality time with my family, vacationing in Cape Cod, and splitting my time between Boston and Florida.

Learn more about Arena’s product-centric approach to quality management. Watch demo.