Interviews

In this report they will discuss:

• What the successful realisation of these incoming global UDI regulations mean for healthcare
• The benefits hospitals and clinics can get from UDI's
• The practical challenges during UDI implementation 

This presentation was given by Dawn Fowler, Director UDI & Master Data Management, Masimo, and covers the following topics:

• Building a scalable, sustainable MDM program
• Leveraging MDM data internally
• Who is tracking your data? And why?
• What’s coming next and how to prepare for it 

With Europe facing rapidly-approaching new UDI regulations, plans need to be put in place now in order to meet the deadlines, but the requirements from authorities are not yet clear, therefore manufacturers are unable to commit to costly projects. The question on medical device manufacturers’ minds is – what can we safely be doing right now, to best set ourselves up for the upcoming regulations?

In light of this, Pharma IQ moderated a roundtable conversation between three UDI experts, Tommy Røsholt, Contracting Project Manager for UDI compliance at Oticon, Tom Jones, UDI Program Director for Johnson & Johnson Supply Chain, and Jenny Young, Contact Project Manager MDR at Convatec.

In the context of an increasingly competitive medical device market, implementing the upcoming European Unique Device Identifier will require considerable investment and strategic planning for many organisations. Ahead of the UDIs & Traceability for Medical Devices Conference, Pharma IQ spoke with Graham Francis, Channel Marketing Manager at Kallik to discuss the role of labelling digitalisation across the supply chain and how this can improve efficiency and visibility; moving beyond compliance to drive broader company improvement.

Following the demand for increased accountability and traceability with medical devices to safeguard patient safety, manufacturers must meet the expectation to bring printing, labelling technologies and master data management up to compliance standards. This will involve developing a UDI corporate strategy and policy for all business units and departments.

On the road to meeting compliance deadlines and executing a UDI project one key step will be pinpointing any gaps between existing supply chain systems to UDI requirements. This will involve analysing the supply chain process, transit issues, the mechanics of recalls and reporting on a UDI compliant product and whether the expected benefits are achieved. Then redesigning and integrating management of product labelling and packaging to enable regulatory compliance. With this large task in mind, we spoke to a couple of experts on the subject of filling the gaps within a UDI strategy. Find out more here.