More than UDI Compliance – Balancing Regulation with Innovation

10,000 products. 150,000 customers. For six decades, this company has provided high-quality products that improve healthcare and advance scientific discovery. Learn more how Innovit enables better data management.

The Customer

A leading global medical device provider needed to balance an ever-increasing number of government regulations and compliance requirements with innovative and scalable processes.

The Customer

The UDI Challenges

The global adoption of Unique Device Identification (UDI) policies presents a major challenge for enterprise medical device manufacturers trying to understand and comply with a growing list of regulations. In addition, manufacturers must still submit UDI data to a myriad of country-specific regulatory agencies, each with a variation to this standard.

Trying to build, configure and maintain individual solutions for each country that will support the local attribute definitions, code value lists, and validation rules can be costly and non-scalable.

There are also additional government regulations surrounding product identification, track & trace, pre- market registration, and post-market surveillance. It becomes increasingly difficult to keep up with the skills and knowledge required to comply with each jurisdiction’s unique requirements for high quality data throughout a product’s lifecycle. Manufacturers are also expected to offer more affordable pricing to healthcare providers, lowering supply chain costs overall. This gives healthcare providers the ability to deliver better patient care and safety.

The Data Challenges

10,000 products can yield high volumes of product information and accompanying data. With 36 offices and over 8,000 employees across several continents, the initial challenge was clear – what data exists and where is it stored? The company discovered that data was scattered throughout many different systems and manually maintained in a variety of formats. Additionally, no specific data governance process was in place.

“The adoption of UDI policies around the world presents a major challenge for global medical device
manufacturers trying to understand and comply with this flurry of country specific regulations.”

Innovit PIM Solutions

The Company implemented Innovit’s PIM solution to address their product master data management challenges and establish best practice processes. The solution ultimately:

  • Enabled the aggregation of all data into a single source of truth for publication to
    1WorldSync and submission to the FDA GUDID
  • Ensured syndication of trusted product information on a global scale while
    supporting patient safety
  • Improved resource efficiency to lower healthcare costs
  • Improved trading partner collaboration and supply chain efficiency



A critical success factor for any healthcare provider is having the right medical products, at the right time, in the right place, for physicians to provide the services that their patient’s demand. This is only possible with high-quality product data – rich, validated, authentic, accurate, up-to-date and complete. Leveraging product master data via Innovit’s PIM solutions for a highly efficient supply chain helps ensure that every patient has a seamless healthcare experience with a positive outcome.

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