Just as I was preparing my presentation for last month’s UDI Conference in Baltimore, President Trump announced that the U.S. would withdraw from participation in the Paris Climate Accord. Within days, many American corporations, from Google and Apple to Campbell’s Soup and Pacific Gas and Electric, joined governors, mayors and academic leaders in announcing they would still live up to their commitments to reduce carbon emissions despite the President’s decision. The theme of my presentation was on how both manufacturers and providers can find value in unique device identification (UDI) regulations beyond regulatory compliance.
The response to the Paris agreement decision made me wonder why the broad industry response seemed so unusual. In other words, why is it that businesses, especially those in highly regulated industries like healthcare, rarely go beyond what is required by law? Is it because there are so many regulations that it is hard to do anything more? I suspect that is part of the problem, but I also think it can be attributed to the highly fragmented nature of healthcare organizations; different functions often have very different perspectives and priorities and don’t think about the broader implications of regulations beyond their specific areas. For example, a manufacturer’s regulatory affairs department is understandably focused on what must be done to keep a company in business and able to sell its products. Sales and marketing, on the other hand, thinks about how to sell more of those products, while research and development and clinical trials are thinking about developing and getting approval to sell the next generation product. There is value in the UDI rule to each of these functions, but without a broader understanding of the potential benefits of UDI, companies may approach compliance in a limited manner and miss out on those benefits.
UDI benefits stretch across the board
This year’s UDI conference featured a number of manufacturers talking about how they are seeking to achieve value beyond UDI compliance. Presentations ranged from how UDI can improve supply chain efficiencies internally and with customers, to how healthcare economists and epidemiologists will use data generated by UDI in electronic health records, registries, and claims to improve our understanding of the real world performance of those products.
In many respects, this is the vision of the U.S. Food and Drug Administration’s Center for Devices and Radiological Health (CDRH). In testimony before Congress in 2015, CDRH Director Jeff Shuren stated: “By promoting incorporation of UDIs into electronic health information, a vast quantity of untapped real-world data from clinical experience with devices housed in EHRs and other electronic information sources may become available for use in understanding the benefit-risk profiles of medical devices.”1
Johnson & Johnson healthcare economist Myoung Kim and epidemiologist Katherine Etter noted in their presentation how real world evidence provides a far more cost-effective way to continually gather data on product performance compared to clinical trials that are often very small studies conducted at specific sites. As Kim described it, it’s the gift that keeps on giving. But there’s a caveat: that data will only be available if providers put processes and systems in place to capture the data. Here’s where supply chain can play a very important role, not only in helping meet upcoming regulatory requirements to capture and share UDIs for implantable devices in electronic health records, but also to build the business case to generate further value for provider organizations.
Hospital interest on the rise
Attendance by hospitals was the highest ever for the UDI conference, signally growing awareness of UDIs and what it will take to put them to good use. The Association for Healthcare Resource and Materials Management (AHRMM) also led workshops where providers, suppliers, technology companies and other attendees offered their perspectives on questions related to some of the challenges of UDI adoption. Data collected in those workshops will be fed into various workgroups within the AHRMM Learning Community, which is open to anyone interested in advancing UDI.
Many of the benefits for providers are driven by the continued transition to population health and value-based reimbursement. With UDI in EHRs and other electronic databases, clinical researchers can better understand which products work best on which patient populations and if and when a more expensive product delivers a commensurate level of value to those patients. In turn, manufacturers can garner better data to market their products and to help design future products.
Providers can also use the data to understand the relationship between what they pay for products, what they charge for products and how those costs relate to reimbursement for the procedures in which those products are used. Bill Mosser, vice president of supply chain at Franciscan Missionaries of Our Lady Health System, also spoke at the conference and talked about how they use the data to also understand the contribution of supplies to the total cost of care delivery and are able to scan and charge for products appropriately.
If you are interested in learning more about how to get value from your UDI-related initiatives or to learn more about the Learning UDI Community, feel free to contact me at firstname.lastname@example.org.
1 Jeffrey Shuren, M.D.. Statement to Senate Committee on Health, Education, Labor and Pensions, April 28, 2015. http://www.help.senate.gov/imo/media/doc/Shuren3.pdf.