Global Medical Device Manufacturer Simplifies Compliance Management

“We’ve configured and customized a lot of areas, and it’s been very easy to do. We had a difficult time trying to do this with other PLM systems, but with Aras, we’ve been able to do it and have connectivity with everything. I’m able to tell you which registration is associated with which country, which [product on the market], and which specific finished good part number.”

SUPPLY CHAIN MANAGER

A global leader in patient-focused medical innovations develops and distributes vital medical devices to improve patients’ lives fighting cardiovascular disease and critical illness. To remain compliant with the requirements of a heavily regulated medical device industry, the company wanted a centralized product lifecycle management (PLM) system to consolidate product and regulatory data, adapt to country-specific regulations, and create accurate reports for auditors.

Pain Points

Medical device industry regulatory requirements go beyond the product design itself; companies like this medical device manufacturer must also meet country-specific criteria for product materials, packaging, labeling, permitting, and distribution. Failing to meet just one country’s specific requirements can seriously impact a business and patients. It can lead to complaints, field corrective actions, recalls, revoked licenses, and an overall loss of revenue.

The medical device manufacturer wanted to meet these various requirements while expanding its business. It needed a PLM solution to meet a very specific and niche use case: identifying and meeting the constantly evolving regulatory and distribution compliance requirements from several countries and then applying them to the manufacturing, permitting and distribution processes.

PLM Requirements

While searching for a PLM solution, the team needed a platform that made it simple to meet the above use cases without the slowdowns, bulkiness, and complex updates inherent in most heavily customized PLM platforms.

They needed a PLM platform that was:

• Highly adaptable to meet a complex use case: retaining regulatory and distribution compliance
• Automated to make it easier to meet country-specific compliance regulations
• Configured to automated interaction with ERP systems to halt distribution in case of non-compliance
• Easily adaptable to evolving regulations without requiring expensive or time-intensive upgrades

Successes with Aras Innovator

The medical device manufacturer used Aras Innovator to build a custom platform for managing all of its product and regulatory data. It leaned on the flexibility and adaptability offered by Aras to create a specialized system that managed the relationship between attributes that control the distribution of its products worldwide. The team also went with Aras Innovator because it provides automatic updates, making maintenance far more manageable.

This product attributes control system also offers advanced functionality to support the company as it works to meet compliance requirements across the globe and adapts to changes in regulations over time.

Results: Streamlined regulatory compliance and product distribution management

Creating a specialized PLM system enabled the medical device company to benefit from its key custom features, including:

• Simple information retrieval: The system stores vital information, such as manufacturing data, site labeling, and languages, underneath the correct finished good part number. All finished good parts are then consolidated under the appropriate model (i.e., finished product on the market), allowing team members to retrieve the information on demand.
• Centralization of details on country-specific regulations: The custom PLM system enables the medical device company to centralize these details into a single source of truth by pulling data on regulatory registrations (including approval documentation), distribution requirements, and product data attributes.
• Custom “Allowed To Sell” algorithm: The product attributes control system uses a custom algorithm to determine which products the organization can/cannot distribute to a particular country. It analyzes all products and their attributes and compares these characteristics to the data entered by the functional teams, such as regulatory affairs, marketing, and supply chain.
• Integration with enterprise resource planning (ERP) system: The product attributes control system can automatically open or close distribution based on the customized analysis the “allowed to sell” algorithm provides.
• Automatic permit generation for each product: With the customized PLM system, it’s much easier for the medical device manufacturer to respond to new country-specific permits for each product as they arise.

Because of these powerful features, the company can adhere to regulatory and distribution compliance complexities across several countries. The team can also use the data from the product attributes control system to easily prove compliance to external auditors.

“We are audited by external entities, FDA, TUV, DEKRA. We use the product attributes control system to run reports to prove to them that we have applicable registrations, authorized distributions, and then we back it up with our actual distribution documentation.”

SUPPLY CHAIN MANAGER