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How has the coronavirus pandemic affected the risk profile of medical device manufacturing?
When countries with well-developed health systems scrambled to purchase life-saving ventilators at the start of the COVID-19 crisis, it illustrated just how serious the pandemic would be. Working on a war footing, governments from Australia to China, Europe and the US asked the industry to produce ventilators and personal protective equipment at speed. Companies from gin distilleries to car manufacturers valiantly answered the call to make medical devices to meet global demands. Behind the scenes, however, managing the risks created by this unprecedented situation has been challenging.
Emergency Use Authorisations (EUAs) in the Asia Pacific region, such as Australia, China, Japan and South Korea have allowed anyone wanting to manufacture or market devices such as ventilators, personal protective equipment and COVID-19 tests to apply for temporary approval, bypassing the standard authorisation process, which can take up to a year depending on the product class. However, it can be more commitment and product liability than consumer manufacturers bargained for in an area they are unfamiliar with. As the legal manufacturers of the medical devices, the onus is on them to stay on top of all the associated regulatory burdens, such as conducting market surveillance on the product for its entire lifespan and maintaining it regularly.
For established medical device manufacturers, the desire to answer calls for help may not have created new risks, but it has raised the stakes, with the global supply chain under strain as production ramps up and fresh regulatory complexities become apparent. Even when COVID-19 eventually goes into retreat, the industry will still have its work cut out ensuring the equipment built during an emergency is not used when healthcare systems resume normal service.
Read the “Making Medical Devices During a Pandemic” report to find out more about the liabilities faced by consumer manufacturers pivoting to help in the fight against COVID-19, and the challenges - some of which will linger even after the pandemic is over - that confront specialist manufacturers.
Key takeaways
- Companies producing medical devices under EUAs become the legal manufacturers of those products.
- Market surveillance is more challenging now but still necessary.
- Devices produced under EUAs must be traced and taken off the market after the pandemic.
- Pressures on the supply chain have resulted in sub-standard products, but checks are being done.
- Given the urgent situation, some governments are stepping in to indemnify manufacturers.
Read more reports in the ‘Life Science in the era of pandemics’ series:
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