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.

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.