Assuring supply chain of components is more challenging and more critical than ever.
Find out what steps you can take to reduce the risk of component shortages in medical devices and for the manufacture of drugs and biologics, and their consequences.
The supply chain woes resulting from the COVID-19 pandemic have highlighted the risks of supply interruptions across all industries and products. The medical product industries have not been immune to the impact of these supply chain interruptions. Supply chain management and ensuring continued quality of supplied parts are of paramount importance in industries serving patients. Ensuring adequate supply chain of components used in medical devices and in vitro diagnostic devices or components used for the manufacture of drugs and biologics is more challenging and more critical than ever. Loss of manufacturing continuity may result in shortages of medical products, loss of sales, loss of market share to competitors, design changes requiring additional verification activities and new regulatory submissions, and diversion of resources from other critical areas. In addition to the pressure of these consequences, further regulatory requirements are currently in place or proposed by the FDA.
Regulations under Section 506J of Federal Food, Drug and Cosmetic Act (FD&C)
Section 506J of the FD&C Act requires medical device manufacturers to notify the FDA of permanent discontinuance or interruption in manufacturing that may lead to a supply disruption of a finished device. The FDA has published final guidance related to supply interruptions for devices critical during the COVID-19 pandemic and draft guidance for any other public health emergency1. The FDA maintains a list of medical devices subject to COVID-19 notification requirements and includes, but is not limited to, dialyzers and dialysis accessories, feeding tubes, infusion pumps and infusion pump accessories, and ventilators and ventilator accessories. If a manufacturer fails to perform such a notification, the FDA will notify the manufacturer of a failure to notify, and the manufacturer will have 30 days to respond to the letter. Such a requirement adds to the already onerous task of remediating a supply chain shortage, particularly given the broad scope of the draft guidance.
Steps to reduce the risk of component shortages
To reduce the risk of component shortages and their effects, there are several measures organizations can take:
- Partner with an established component vendor with a wide breadth and variety of components and an established network of suppliers. Work with them in advance to determine alternative components in the event of a component shortage.
- Where feasible, consider including multiple versions of connectors in design verification and validation and regulatory submissions for the product. Performing verification and validation using alternate components will allow a more expeditious implementation in the event of a primary component shortage.
- Strategically select connectors to minimize verification requirements in the event of a component shortage. Where possible based on intended use, select commonly available components and use the same components within a singular device or system.
- Evaluate your organization’s forecasting and supply chain practices to identify where risk mitigation measures may be employed. For example, such measures include maintaining an appropriate inventory of critical components and placing orders well in advance of the production need.
- Partner with vendors who employ business continuity measures to reduce the risk of business disruptions. Qosina is certified to ISO 22301:2019 - Security and Resilience - Business Continuity Management Systems – Requirements. This certification demonstrates that Qosina’s management systems ensure resilience in the face of business disruptions.
- Plan in advance for component shortages by identifying the impact on the following where an alternate component is required:
- Design Verification and Validation
- Process Validation
- Regulatory Strategy (e.g., requirements for regulatory change notification)
- Supplier Approval and Management
- Device Labeling and Instructions for Use
In summary, implementing a supply risk mitigation strategy and partnering with the right component vendor are key actions in improving your own supply chain resiliency and maintaining your market position.
- Additional detail may be viewed in FDA Guidance Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of the FD&C Act which is available for review and comment at https://www.fda.gov/media/155245/download. This draft guidance is in addition to final FDA Guidance Notifying CDRH of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of the FD&C Act During the COVID-19 Public Health Emergency (Revised) which is available at https://www.fda.gov/media/137712/download. ↩