MedCon: Supply chain challenges evolve post COVID-19

Left to right: FDA’s Tammy Beckman and Michael Hoffmann, Meera Bhatia and Aaron Bernstein of Abbott

COLUMBUS, OH – While sky-high demand was one of the key drivers of medical device shortages during the COVID-19 pandemic, today’s supply chain issues are often crosscutting, involving shortages of raw materials that impact multiple manufacturers and devices, according to Tammy Beckham, associate director for the Resilient Supply Chain Program at the US Food and Drug Administration’s Center for Devices and Radiological Health (CDRH).
 
“Shortages and supply chain issues don’t just happen during a public health emergency,” Beckham told attendees at the 2023 MedCon conference, sponsored by the AFDO/RAPS Healthcare Products Collaborative and FDA. “We’ve seen these before COVID, and we’re continuing to see these moving into the future. Many of the issues we’re facing are becoming much more complex and more systemic.”
 
Some of the continuing pressures on the supply chain include sole source suppliers, geopolitical unrest, natural disasters, the Uyghur Forced Labor Prevention Act, market concentration and labor issues. These factors have impacted a variety of device materials and components including resin, silicone, paper, cotton and semiconductors, she said. (RELATED: Study: COVID pandemic triggered spike in device shortages, Regulatory Focus 08 December 2022)
 
One recent example is winter storm Uri, which hit areas of Texas in February 2021. The storm temporarily shut down oil and gas production in the area or greatly reduced capacity, also creating a shortage of resin, which is a byproduct of oil refining. The impact on medical devices was significant, Beckham said, with more than 30 device manufacturers and more than 180 devices impacted.
 
‘Bird’s eye view’
 
In the case of the resin shortage and other similar events, the FDA has acted as the main point of entry to the federal government for device manufacturers, Beckham said. CDRH takes reports of shortages and supply chain disruptions through 506J notifications and other communications and creates patient impact assessments that are used across the government to evaluate mitigation strategies, including regulatory guidance and enforcement discretion.
 
CDRH can also advocate with suppliers for greater allocation of raw materials or components. “Many times, all it took over the last few years, was for us to pick up the phone and explain the impact to the suppliers,” Beckham said.
 
Looking forward, CDRH is seeking to be more proactive, including working with trade organizations, health care systems, distributors and others to develop a critical medical device list, focused on devices that are considered most critical to public health. “That is where we would hope to scope and focus our program and our activities,” she said. “That’s a very collaborative approach.”
 
FDA is in a unique position to see across manufacturers and medical devices and have a “bird’s eye view” of vulnerabilities or interdependencies in the supply chain, Beckham said. “This gives us a unique capability to really work with you to prevent shortages.”
 
Industry perspective
 
On the industry side, device manufacturers are looking at several supply chain challenges, including how to secure components, such as semiconductors, when they are competing with larger buyers like automakers and smartphone manufacturers. One way that device manufacturers have pivoted is by involving the supply chain team early on in the design process, said Aaron Bernstein, divisional vice president for global procurement at Abbott.
 
Just a few years ago, the design process was typically done by scientists and engineers in isolation. Once the design was complete, it was handed off to the supply chain team to source materials. While that approach worked for decades, it is no longer feasible, Bernstein said.
 
“There’s a lot more collaboration happening today between supply chain and product development,” he said, noting that there is now an “ongoing feedback loop through the design cycle” looking at the availability and lifecycle of each component, as well as who else might be buying those components.
 
“If we put a component on a circuit board that’s going to be sought after by a smartphone manufacturer or [the] automotive industry, that might become a difficult component to source,” Bernstein said. “Having that understanding early on in the device cycle, making good choices early on, makes the sustainability of that product much, much greater.”
 
Another approach, which he termed “supply agility,” looks to address potential supply chain issues not by qualifying multiple sources but by qualifying multiple different types of materials. While it is ideal to qualify multiple sources for all components, there are often constraints around development time, time to market, and costs, Bernstein said. Approaching the issue by qualifying different types of materials that create the same functionality within a medical device is one way to create redundancy and a more robust supply chain, he said.