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Building Medical Device Supply Chain Resilience

Published in: FDA Public Workshop

The Food and Drug Administration (FDA) hosted a virtual public workshop entitled "Building Medical Device Supply Chain Resilience: A Healthcare and Public Health Ecosystem-Wide Collaboration" from June 7-9, 2022.

The workshop’s purpose was to discuss ways to foster resiliency in the medical device supply chain and to seek input on the new Resilient Supply Chain Program (RSCP) – whose mission is to strengthen public health supply chains by proactively monitoring, assessing, and communicating risks and vulnerabilities to help prevent and mitigate device shortages.

Premier’s Soumi Saha, Senior Vice President of Government Affairs, was invited to participate in the workshop’s June 7 panel discussion: "Resilience Defined and Measured." Soumi discussed lessons learned from the pandemic as well as the stakeholder collaboration, data, and other key strategies necessary to mitigate and prevent medical device shortages:

“The key moving forward is going to be continued public private collaboration, no sector can do it on their own or individual entity can do it on their own. We must continue to work together. This allowed us to share data with one another, innovate together in order to move forward. Each entity must have to have a seat at the table to make a change.”

“One thing I do want to point to is new authority the FDA received in March of 2020 around collecting supply chain disruption information as it relates to medical devices. FDA has since stood up a device shortage list. The key is being able to collect that information and being able to communicate out that information is currently contingent upon the public health emergency. One thing Premier has been working on is looking at how we ensure that those authorities are extended beyond just the public health emergency, so the FDA can continue to grow their work in the device shortage realm and continue to be more robust with their communications. However, speaking of burden, burden goes both ways. Burden can be on a provider, but burden can also be on a supplier from a regulatory perspective. We are also mindful that much of this reporting can’t increase the burden on the supplier to a level where it’s no longer feasible for them to do so or it requires increasing prices to a point where providers cannot absorb those costs. There are nuances, but we do think that the FDA play a critical role in being that centralized collector of supply chain disruption information and a broad communicator. They started that work; it can grow, and it can be further refined.”

“There is some work that needs to be done behind the scenes to standardize that data nomenclature, make sure we are comparing apples to apples, so that as we are reporting out supply chain data, there is consistency in how that reporting occurs.”

For Soumi’s remarks and the full panel discussion, tune in here.

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