For years and years, big technology companies have been walking in to major industry analyst firms and ordering up some research. Still, it never ceases to amaze me just how often the research results favor the company footing the bill. Now I’m not saying that is how or why a recent article got written by an industry analyst about the FDA’s coming Unique Device Identification (UDI) thrust. The article is called Pushing Med Device UDI Systems: Congressional Interest In Legislation May Be Misguided. It is by Perry De Fazio who is an analyst at Nerac, Inc. In his bio blurb at the end of the article, Nerac is identified as a research and advisory firm for companies developing innovative products and technologies. And, it says, Mr. De Fazio advises medical device companies on subjects ranging from technology licensing, development and patenting to medical device regulations and competitive technical intelligence.
Towards the end of the piece there’s a brief section which essentially summarizes Mr. De Fazio’s view of UDI: While it is acknowledged that improvements can and should be made to the processes of device recalls and adverse event reporting, a far greater benefit would be realized from creating devices that improve patient safety and outcomes rather than making it easier to track those that do not.
Citing ‘preliminary estimates’ that Mr. De Fazio does not further identify or explain, he says the first year of UDI implementation will cost healthcare facilities about $2 billion in return for an estimated savings of $35 million. He says he finds the congressional push for UDI ‘curious;’ that labeling small devices or devices with unusual geometries could be challenging; and, he believes barcodes are becoming obsolete anyway (due to RFID).
I’m posting this in hopes that a major Group Purchasing Organization (GPO), for example, would like to provide a measured response. Or, perhaps, someone from GS1 Healthcare US would like to weigh in? How about you?