FDA Seeks to Address Future Medtech Supply Chain Challenges

If you were to generate a word bubble from the pandemic based around media coverage, articles, and conversations, you’d have some interesting combinations grouped together. COVID might appear next to toilet paper, coronavirus could be alongside Tiger King, and testing (shameless plug #1: check out page 84) would be near lockdown. Without question, however, one of the big word bubble phrases would be supply chain.

The pandemic wreaked havoc on every supply chain around the globe. Whether consumer electronics, groceries, toilet paper, cars, or critical medical supplies, there were shortages everywhere. The reasons for their shortage were as numerous as the list of supplies in short availability. We experienced everything from lockdowns at manufacturing facilities to overwhelmed shipping ports to a blocked vessel in the Suez Canal.

Now, we’re left scrambling trying to figure out what to do (it still isn’t over) and how to best avoid it for future events. Even if we don’t face events as universal as the pandemic, there will undoubtedly be future supply chain interruptions. Lessons learned over the last two-plus years will hopefully prepare us for those occurrences.

A variety of solutions are being proposed to address future challenges regarding how best to handle material and component shortages, as well as delivery delays due to problems outside a facility’s walls. I’m seeing discussion of how to handle inventory and suppliers—whether lean principles need to be reevaluated, if just-in-time is an appropriate approach (shameless plug #2: turn to page 22), and whether seeking more regional suppliers would be a favorable strategy. Many factors sit on the table for potential revision to help curb the impact of future crises.

Attempting to develop a solution of its own, the U.S. Food and Drug Administration (FDA) took steps to help avoid major shortages of critical supplies in the future. The Coronavirus Aid, Relief, and Economic Security Act (CARES Act) gave the agency authority to help prevent or mitigate medical device shortages. This action, however, did not address supply chain shortages at the material and component level.

In an FDA Voices post from July 21, 2021, Acting FDA Commissioner Janet Woodcock, M.D., said, “To ensure the U.S. is properly prepared now, and in the future, we must take action to secure our medical device supply chain, including related materials, parts, and components. The FDA recognizes that this will take resources and expanded authority.”

As part of its 2022 budget, the FDA’s Center for Devices and Radiological Health (CDRH) was provided $21.6 million for a new Resilient Supply Chain and Shortages Prevention Program (RSCSPP). The program’s goal is to directly address supply chain resiliency for medical device manufacturing. According to Dr. Woodcock, “The funding will help to stand up this program, which will build on the work done to implement the CARES Act during the COVID-19 public health emergency, and will focus on strengthening the domestic supply chain through investments in preventive measures, identifying potential medical product supply short-falls, continuing surveillance, and rapid intervention.”

The acting chief went on to explain the program was important for future occurrences, since, as was learned from the pandemic, supply chain shortages can happen before a public health emergency (PHE) strikes the U.S. “Supply chain disruptions were already beginning to occur before COVID-19 cases were identified in the U.S., as other nations had outbreaks and needed personal protective equipment (PPE), testing supplies, and other equipment in excess of supply. Moreover, there are situations such as hurricanes and other natural disasters that may not ever rise to the level of a PHE, but for which disruptions in device availability could significantly impact patient care.”

Dr. Woodcock did not outline what supplies may specifically be under watch, but explained the strategy that would be used in rolling out this plan. “The RSCSPP will enhance CDRH’s capacity to enable rapid intervention to prevent and mitigate supply chain interruptions through:

• Proactive regulatory measures and partnerships with industry, healthcare providers, patients, and others.
• Development and application of state-of-the-art supply chain intelligence for predictive modeling.
• Early signal detection and continuous surveillance.
• Fostering a more resilient domestic supply chain through investments in preventive measures that help to avert shortages before they occur.