Supply Chain Resiliency for Medical Devices

The FDA is pressing for new authorities to help mitigate disruptions and shortages.

The medical device supply chain has many vulnerabilities. Weather conditions, transportation bottlenecks, energy crises, geopolitical conflicts, raw material shortages, labor disputes, device recalls, regulatory pressures, and other factors can all cause supply chain failures that could put lives at risk.

• In 2019, the closure of two major sterilization facilities caused a shortage in pediatric tracheostomy tubes. Three years later, the same devices were in short supply due to a silicone shortage.
• In August 2021, a recall of saline flush syringes from a single manufacturer—which left the market a short time later—led to a U.S. shortfall of 260 million syringes.
• Later that year, winter storm Uri made it harder for more than 30 medical device manufacturers to obtain resin, a key ingredient in the manufacture of diagnostic tests, catheters, syringes, and other devices. The Food and Drug Administration’s (FDA’s) Center for Devices and Radiological Health (CDRH) was able to work with suppliers, manufacturers, and U.S. government partners to provide access to resin for the continued production of those devices.

In 2022, by exercising regulatory flexibility, sharing information, and developing conservation plans, the CDRH took or informed mitigation action on more than 350 potential and actual medical device shortages.

Back in 2020, the Coronavirus Aid, Relief, and Economic Security Act (CARES Act) gave the CDRH the authority to require medical device manufacturers to notify the FDA regarding certain supply chain disruptions “during, or in advance of” a Public Health Emergency (PHE).

Read the FDA Guidance around supply chain resiliency

Now that the COVID-19 PHE is officially over, what have come to be known as “506J notifications” are currently voluntary and the expectation is that most medical device manufacturers won’t be forthcoming with supply chain information. Prior to the pandemic, the CDRH had requested supply chain information from more than 1,000 manufacturers but about two-thirds ignored the voluntary request.

Calls are being made to revise the FDA’s statutory authority to compel medical device manufacturers to be more collaborative when it comes to preventing shortages and avoiding disruptions. The FDA is requesting that the temporal limitation associated with 506J notifications be lifted and that manufacturers be required to develop and share risk management plans for their most critical devices.

Writing for HealthAffairs in May 2023, Suzanne Schwartz and Tammy R. Beckham, both with the FDA, urged patients and caregivers to lobby Congress to “require manufacturers to develop and conduct risk assessments of potential supply chain vulnerabilities; to require them to develop and implement risk management plans to prevent or mitigate future shortages; and to require them to notify the CDRH of shortages regardless of whether we’re in the midst of a public health emergency.”

The logic is simple: Rather than learning about critical device shortages from “desperate clinicians and patients,” the industry should work with the FDA to prevent shortages and minimize the consequences felt by vulnerable individuals.

Offering to work with manufacturers in the pursuit of more widespread information sharing, the FDA established the Resilient Supply Chain Program (RSCP) for medical devices to:

• Develop strategies, analyses, and informational products to help prevent and mitigate medical device disruptions and shortages
• Identify supply chain risks and provide actionable information to manufacturers, distributors, health care delivery organizations, patients, health care workers, and government partners
• Develop communication channels across the medical device ecosystem to enhance collaborations for the development of prevention and risk reduction strategies
• Collaborate with government partners and medical device stakeholders to triage supply chain disruption and/or shortage signals, determine potential impacts, and provide public health information to support an informed response

Advanced Supply Chain Management Is Good for Medical Device Manufacturers

Whether the FDA requires information sharing or not, establishing risk management plans and acting as soon as a possible supply chain disruption is identified are the best defenses against medical device shortages.

Manufacturers with digitalized supply chain management systems are in the best position to identify signals of potential shortages—and share them with the CDRH through 506J notifications.

Using modern data management technologies—in combination with physical actions like supplier diversification, long-term contracts, and open communication with regulatory bodies—manufacturers can reduce their vulnerabilities and ensure a more stable supply chain. Digitalized supply chain management systems make it easy to:

• Track and manage inventory
• Forecast demand and optimize ordering
• Assess risks from raw materials through commercialized product
• Make contingency plans
• Respond to regulatory requests
• Monitor performance metrics
• Minimize defects and recalls through improved quality management

By leveraging technology, such as automation, artificial intelligence, and data analytics, manufacturers can optimize production processes and improve supply chain visibility. This can help to identify potential bottlenecks and enable faster response to mitigate shortages.

Learn more about Microsoft AI-powered Supply Chain Platform

Choose a Supply Chain Management System That’s Purpose-Built for Life Sciences

At STAEDEAN, our mission is to give life sciences organizations the advanced technology they need for tackling the operational challenges and regulatory changes they face every day. As leaders in business process engineering and improvement, we’ve become a trusted partner for leading pharmaceutical companies, biotech firms, and medical device manufacturers in the U.S., Europe, and Australia.

STAEDEAN knows precisely what you need to optimize and transform your medical device manufacturing operations. Built on the robust foundation of Microsoft Dynamics 365, STAEDEAN delivers the most comprehensive Enterprise Resource Planning (ERP) solution for life sciences organizations, with plug-and-play modules specifically designed for every aspect of your business.

Our skilled team will seamlessly implement a system that delivers all the tools you need—from core ERP functions and supply chain management to advanced quality management, warehouse management, and more—guaranteed to conform with standards and regulations such as GMP, GAMP5, FDA 21 CFR Part 11, and EU Annex 11. Modules can be added as needed, making it easy to scale the solution so it grows with your specific needs.

The STAEDEAN Life Sciences solution is a powerful, state-of-the-art solution used by life sciences companies worldwide to track products and raw materials from a growing number of suppliers. The pre-configured, out-of-the-box solution meets or exceeds all Good Automated Manufacturing Practice (GAMP) standards.

Here are just a few of the benefits life sciences companies receive from STAEDEAN Life Sciences software:

• Automated processes for greater accuracy
• End-to-end, real-time product traceability that reduces waste, enables granular unit tracking, and increases trust among stakeholders
• Advanced analytics for better, data-driven decision-making
• Immutable record-keeping that reduces the burden of audits and inspections

Make Your Supply Chain More Resilient Today

As pressure grows to mandate greater visibility into medical device manufacturer supply chains, now is the time to embrace the digital technologies that optimize your supply chain management. By adopting cloud-based, digital supply chain, warehouse, and quality management systems, medical device manufacturers can optimize operations, foster collaboration, and ensure compliance.

To learn how STAEDEAN can help your business drive growth, innovation, and efficiency