The sobering image on the evening news of dozens of massive container ships waiting off the coast of California is all anyone needs to know about the state of the supply chain today. Nothing is moving.
Medical device manufacturing is just one of the many industrial victims of this far-reaching effect of the COVID-19 pandemic. Cargo ships aren’t getting into port because there aren’t enough dock workers. Tractor trailers aren’t getting on the road because there aren’t enough drivers. And components aren’t getting into inventory because there aren’t enough distribution personnel.
This situation is bad enough for manufacturers of consumer products, but it’s far worse in many ways for medical device manufacturers due to additional regulatory compliance issues. Medical devices are subject to tight FDA regulations that govern everything, including purchasing, receiving, designing, producing, storing, testing, shipping, and labeling. These processes must be compliant from start to finish. And ultimately, each finished device must have a unique device identifier (UDI). This can be tricky for supply chains that are distributed, in which certain components aren’t an “end product” when they move from one facility to another.
One strategy that seems to be taking shape in response to the current situation is a desire to shorten the supply chain, which in recent decades has become increasingly complex and global, designed for lower cost and greater efficiency. What perhaps was not anticipated were the significant weaknesses in this approach exposed by the pandemic-induced disruption.
COVID’s impact is causing some manufacturers to rethink resources and consider moving supply and production closer to home to improve flexibility and versatility. To further boost faster and more flexible performance, other manufacturers are turning to advanced techniques such as 3D printing and smart manufacturing to support more agile production systems and reduce dependency on a fragile supply chain.
This desire to modernize the supply chain underscores a general lag in capabilities, according to a report by McKinsey which revealed how the pandemic has exposed medical device manufacturing as too reliant on historical demand data, and how many companies lack pertinent intelligence about their most immediate supply base. These gaps made their supply chains incredibly vulnerable and challenged their ability to plan properly, pointing to the industry’s significant supply-chain technology deficit.
At some point – hopefully soon – the current supply chain woes will be resolved. Fortunately, there are indications that medical device manufacturing will be ready and willing to address its specific supply chain shortcomings and modernize to be ready for the next crisis, whenever that comes.
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MEDIcept is an international consulting firm offering a full portfolio of services to the medical device and IVD industry. For over 25 years, our unique consulting practice and multidisciplinary team of former FDA, Notified Body, and industry experts have assisted hundreds of companies of all sizes with innovative, compliant, trusted, and cost-effective Regulatory, Quality, Clinical, and Engineering solutions.
For additional information, please contact Susan Reilly at SReilly@MEDIcept.com.