In late April I attended a couple of medical device industry conferences which were both eye-opening in different ways. The looming issue of UDI compliance was at the heart of both conferences, though they took contrasting approaches.
UDI Conference 2016, Baltimore MD, April 18-19
This was an official FDA-sponsored event, where a large number of delegates from medical device manufacturers, health care industry professionals and distributors, hospitals and health care providing organizations met to discuss UDI management and compliance.
The main impression that I got from the delegates here was a sense of panic. The deadline for UDI compliant labeling and submission to GUDID is almost upon us, and people are nowhere near ready!
So for them, understanding the routes to compliance was really important. Since NiceLabel has worked hard to devise solutions for companies (large and small) to take the pain out of UDI compliance, this was a great opportunity to tell people about our work.
For many, implementing a UDI compliance system can be an opportunity to refresh and modernize their whole label content management operation. With an up-to-date, smart way to centrally manage labeling, companies can deal far more quickly, efficiently and accurately with revisions, approvals and the full audit trail of who has approved a label, when and where it was printed and much more. Plus, companies can introduce label templates that business users can update, which saves a lot of time and expense – and involves less IT resources.
Among the topics discussed at the conference was how a UDI compliant system can help to reduce medical errors, improve medical device reports, assist with the recall of medical devices and enhance asset utilization. It also looked at reimbursement, compatibility, post-market surveillance and inventory control.
Medical Device and Diagnostic Labeling Conference, Alexandria VA, 25-26 April
This conference focused more on content management systems (CMS), with some highly relevant sessions relating to FDA compliance, version control, and the move away from paper records.
I found that there were many similarities in the way people talk about CMS and how they discuss label management – of course labels are a form of content. There were sessions on the global implications of label management, and the issues surrounding translation of label content and IFUs into other languages. If you get this wrong, there can be serious implications.
A common view expressed by delegates at this conference was: “We have information stored in a million different places. We need to control it before we can even start to become compliant.”
Again, NiceLabel can offer ways to address this problem, as I explained to people. For example, if they have information stored in a business system like an ERP (Enterprise Resource Planning) system or home grown solution, we can integrate into that system, helping them to collate their data and apply it to medical device labeling.
Once again, we were able to demonstrate to medical device companies how we can offer a broader service to them, bringing additional value and looking beyond UDI compliance.
Among the issues presented and debated here (this was a very interactive conference), we discussed the FDA’s expectations for medical device packaging design, making packaging more user-friendly, meeting sterility and product integrity concerns and challenges in device label translation management.