Company insight
Assuring supply chain of components when it counts
Though shortages and issues abound at the moment, maintaining a sturdy and reliable supply chain of components is essential to manufacturers. Qosina, a leading supplier of OEM medical device components, offers some advice on how to make sure a supply chain is protected and running smoothly.
T
he 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.
draft guidance for any other public health emergency. The FDA maintains a list of medical devices subject to Covid-19 notification requirements and includes, but is not limited to, dialysers and dialysis accessories, feeding tubes, infusion pumps and infusion pump accessories, as well as ventilators and ventilator accessories. If a manufacturer fails to perform such a notification, the FDA will alert 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adds to the already onerous task of remediating a supply chain shortage, particularly given the broad scope of the draft guidance.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 organisations can take: ■
Partner with an established component provider with a wide breadth and variety of components and an established network of suppliers. Work with them in advance to determine
“Supply chain management and ensuring continued quality of supplied parts are of paramount importance in industries serving patients.”
Regulations under Section 506J of Federal Food, Drug and Cosmetic Act
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
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alternative components in the event of a component shortage.
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Where feasible, consider including multiple versions of components 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.
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Strategically select components to minimise 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.
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Evaluate your organisation’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.
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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.
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Plan for component shortages by identifying the impact on the following where an alternate component is required: design verification and validation; process validation; regulatory strategy; supplier approval and management; and device labelling 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. ●
www.qosina.com Medical Device Developments /
www.nsmedicaldevices.com
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