Inside the FDA: The Cost of Supply Chain Silence

Earlier this year, it was reported that medical device shortages are leaving hospitals across the US without critical tools for neonatal and paediatric patients. The consequences are severe, often forcing clinicians to make substitutions or delay care, but the shortages are not caused by any single point of failure. Instead, they stem from deeper structural weaknesses. 

The US Food and Drug Administration (FDA) says it is increasingly concerned about the impact of these shortages. Its data shows that, while disruptions to adult device supply chains can usually be absorbed, shortages in paediatrics can cause far more disruption. That’s partly because fewer manufacturers make these specialised devices and production is often not prioritised due to low profit margins. However, there exists a wider issue: the system for identifying and responding to supply chain problems is fragmented. 

Where engagement fails, shortages follow

Stakeholder engagement is vital to ensure a strong supply chain, with each supplier, manufacturer, regulator and NGO playing a different role. Some act as drivers, setting expectations or applying pressure; others are facilitators, offering resources or expertise; then some act as inspectors who ensure standards are met and risks are properly managed. 

Engaging with these groups is essential to building resilience. The earlier a manufacturer or regulator hears about an issue – whether it be raw material shortages or cyber attacks – the faster a coordinated response can be put in place. It also makes collaboration during crises more effective because relationships and lines of communication already exist.

Michelle Tarver, Director of the FDA’s Center for Devices and Radiological Health (CDRH), explains: “While the vulnerabilities in the medical device supply chain are not new, we're growing increasingly concerned that the rise in shortages is having a significant adverse impact on neonatal and paediatric patients.”

Without adequate stakeholder input, the FDA only learns about shortages when they reach hospitals. 

“In recent months,” Michelle continues “the FDA has had to rely mostly on hearing about medical device shortages from healthcare providers and clinical professional societies. Given this often occurs at the point-of-care, it is typically far too late to put measures into place that would otherwise avert these shortages.”  

For example, in 2022 the US experienced a shortage of paediatric tracheostomy tubes. Triggered by production problems and sterilisation delays, the lack of early alerts for the shortage meant hospitals had to improvise by reusing devices beyond recommended limits or substituting adult versions – increasing the risk of complications. 

Engaging stakeholders through formal supply chain partnerships, community forums or real-time inventory data sharing helps build trust in these scenarios and allows innovation from the ground up. Clinicians can point out usability issues with devices whilst NGOs can highlight ethical concerns in sourcing and governments can respond with policy support. 

The pitfalls of reactive regulation 

One of the core reasons the FDA struggles to act early is because it lacks the authority to require advance notification of medical device shortages, except during an official public health emergency. In contrast, the European Union introduced a rule in January 2025 requiring manufacturers to notify regulators of anticipated shortages, a proactive model which gives governments more time to intervene.

“We know from experience that reliance upon voluntary notifications to the FDA about device supply chain disruptions has not been effective,” Michelle adds. “We are often the last to know and by then the consequences are already being felt in neonatal intensive care units (NICUs) and children’s hospitals.” 

To improve matters, the FDA created the Office of Supply Chain Resilience (OSCR). The OSCR performs risk assessments, collaborates with manufacturers and coordinates emergency production efforts. When tracheostomy tubes ran short, the OSCR used the Defence Production Act to expedite raw material supply and issued guidance to help hospitals identify safe alternatives. However, without stronger regulatory tools, these interventions happen after the fact. 

There has been some support for this type of regulation, but so far this is inconsistent. With no amendments passed, Michelle says: “Failing to ensure the US government and healthcare providers in the US have the same information as our European counterparts poses harm to providers, patients, caregivers and consumers in the US.”

Trade policies and political cuts 

Beyond supply chain engagement and reporting, global trade policies are also shaping the availability of medical devices and drugs. 

The majority of ingredients for generic drugs in the US, including 95% of ibuprofen and nearly all acetaminophen, come from China. If tariffs are imposed or diplomatic tensions escalate, these products may become more expensive and difficult to obtain. 

Gene Seroka, Executive Director of the Port of Los Angeles, says he is already seeing a steep fall in Chinese imports: “We’ll start to see shortages in five to seven weeks if things don’t improve.”

Meanwhile, political uncertainty around the structure of the FDA could pose further risks. Health and Human Services Secretary Robert F. Kennedy Jr has proposed a reorganisation that includes the loss of 3,500 staff—many of whom are responsible for approving new therapies and monitoring supply chains.

Kennedy has also called for an end to the FDA’s reliance on user fees from pharmaceutical companies, which currently fund nearly half of its US$7.2bn annual budget. 

In response, industry bodies have raised concerns. John Murphy of the Association for Accessible Medicines, warns that any combination of tariffs and weakened oversight would “pile onto the factors driving the scarcity,” particularly for lower-cost, high-need medications.

Arthur Wong, Healthcare Managing Director at S&P Global Ratings, notes: “Generics account for roughly 90% of all US prescriptions and tariffs would potentially raise costs for a significant portion of the market.”

Companies like Roche and Merck are preparing for disruptions by increasing domestic investment. Roche has pledged US$50bn in US production over five years and is seeking exemptions for critical imports. However, even with this commitment, executives admit that shifting manufacturing entirely to the US would sharply raise costs. 

“Making all goods in the US that are used there would inflate manufacturing costs,” Roche CEO Thomas Schinecker points out.

Building a proactive system

The issues plaguing the US’ medical device supply chain are not isolated. They reflect a broader need for strategic investment, political cooperation and regulatory clarity.

What’s clear is that a reactive approach to medical device supply chains is not working. The FDA and other health bodies need stronger tools – legal authority, financial support and stakeholder input – to move from last-minute crisis management to long-term planning.

Engaging stakeholders from every level of the supply chain allows early risk identification and builds trust in public health systems. Better laws are part of the answer, but so is a shift in culture – to treat resilience as a shared responsibility rather than a task delegated to regulators alone.

To read the full article in the magazine, click HERE.

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