Our understanding of the FDA’s mandate for UDI is focused on driving value through the following: more accurate reporting and analysis of adverse events; reducing medical errors; enhanced analysis of devices in the market; managing recalls; and setting a foundation for a global, secure distribution chain. Each of these components, if realized, will have a positive impact on both patient outcomes and the overall effectiveness of the healthcare system. But should we stop there? Currently, industry is working to achieve literal compliance with the regulation, in order to mitigate the immediate impact on the business. But we are left to wonder: if the industry adopted a proactive, tech-driven approach to creating holistic UDI infrastructure, what would be possible?
What gaps do you see under the current mandate and industry efforts? What value are we missing out on if we focus only on UDI regulatory compliance instead of preparing for a fully scaled system to leverage UDI data? And is that approach even possible in today’s climate?