Press
Six months “a very limited window” for medical device shortage flagging
written by
Robert Barrie
The medical device industry is grappling with supply chain vulnerabilities highlighted by recent shortages, like the saline bag crisis following Hurricane Helene. Experts, including Marcel Botha, who led a rapid ventilator development during the COVID-19 pandemic, stress the dangers of hyper-concentrated manufacturing and the need for more resilient, distributed production.
Regulatory bodies like the FDA and EU are responding with stricter reporting requirements to anticipate and mitigate shortages. The FDA aims to amend pandemic-era laws to ensure continuous reporting, while the EU mandates six-month advance warnings. Botha advocates for a collaborative approach involving policy, regulation, and private sector investment to diversify manufacturing and leverage digital tools for better supply chain visibility.
Looking ahead, he predicts a shift towards localized manufacturing, driven by US policy and technological advancements like AI, which can accelerate development and address future demands. This evolving landscape underscores the importance of proactive measures to ensure medical device availability and patient safety.
Link to the full article: Medical Device Network - Post-Pandemic Medical Device Shortages
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ABOUT THE Author
Robert Barrie
Reporter for Pharmaceutical Technology
Robert Barrie is a news and features reporter for Pharmaceutical Technology and Medical Device Network. Robert holds a BSc in Neuroscience and holds interests in neurological devices, infectious diseases, and company investment such as initial public offerings (IPOs).
