For so many innovations, the biggest question is not how to do it once, but how to make it repeatable, scalable and sustainable. This is certainly the case with Universal Device Identifier (UDI) requirements for medical devices. Manufacturers of Class III devices such as heart valves and pacemakers have already complied with these new requirements, and this year, many other device manufacturers are getting their products labeled, marked and registered in the FDA Global UDI Database (GUDID). The requirements are ultimately an important and very positive development for the medical community and patients, but keeping this complex process manageable and scalable for the medical device industry remains a challenge.
Medical device companies are taking steps to ensure they comply. The question is… how much time, effort, and scrambling are involved? How much more will it take to get all products and variants compliant, now and in the future? While medical device manufacturers are accustomed to creating new standard operating procedures, UDI requirements pose a larger challenge. It seems most can master the label changes that UDI requires, despite some tricky challenges.
The most significant issue is likely to be creating new standard operating procedures for assembling, normalizing and validating the data for the GUDID database. This process is not local. It will touch nearly every department of a medical device company. The data required is almost certainly scattered in a large number of systems and some may even exist only on a label today, and not in a digital format in a system at all. Finding and organizing all of this data is tedious work.
Those are just a few of the things I came to understand more deeply in moderating the UDI Lessons Learned webcast with UDI author Jay Crowley, now of USDM Life Sciences, and Cathi Crist of Kalypso. Sponsored by Dassault Systemes, we set forth to discuss what these leading consultants had already learned in working with clients. The short answer is: most medical device manufacturers have not taken a systematic approach to comply profitably, let alone to succeed over the long haul.
Jay and Cathi also made it clear that, like other regulations, UDI is not likely to be static. As it is used, the FDA will change, improve, and possibly expand it. So, a company’s compliance approach must have the flexibility to keep up with those regulatory changes as well as any product line changes, whether organic or by mergers and acquisitions. Our discussion also touched on international regulations that are likely to be similar but not identical.
If it sounds like just another regulatory headache, I recommend you change your point of view. In this blog I wrote at the time of the webcast, I point to the benefits of creating a strong set of systems to comply with UDI. Mainly, you can analyze and understand your business much better when the information about each product is well organized and easily accessible to everyone who might need to understand it.
My sincere wish – both as a medical device industry observer and as a patient in the US medical system – is that medical device companies master this UDI data flow comprehensively. Less opportunity for error, risk and confusion was the FDA’s objective, and it can truly be achieved by streamlined UDI compliance. The name of the database itself even suggests it: Good ID, even if it’s spelled GUDID.