Supply Chains Disrupted in the Manufacture Of Medical Devices
Many companies are currently struggling with disruptions to supply chains, and stock shortages. Highly regulated sectors, such as the medical device industry, have been majorly impacted by these supply disruptions.
Many unprecedented challenges to the medical device industry were brought about by the COVID-19 pandemic. These included demand for respirators sky-rocketing, as well as a drastically increased need for PPE (Personal Protective Equipment), colossal staff shortages and disruptions to supply chains.
Because each device needs an extensive review process, longer lead times are necessary within this sector for the approval and delivery of products, meaning even minor disruptions can cause major delays.
When China was first hit by the virus, many component suppliers closed, meaning parts for essential devices, such as ventilators, were practically impossible to locate. The pandemic caused critical cash-flow issues, affecting SMEs (Small and Medium sized Enterprises) the most, although larger companies also faced an impact regarding the supply-demand ratio.
More so than other manufacturers of electronics, medical device manufacturers need to work past an abundance of red tape in order to ensure regulatory compliance, meaning that if a component is lacking in supply, it can’t just be replaced with a similar device, as each component needs to be separately approved by a regulatory board.
There are, however, various ways to lessen the impact of disruptions to supply chains. When a medical device is being designed, the creator should aim to be as vague as possible regarding the specs of the device’s components. This makes it easier to locate spare requirement-approved components without compromising safety or efficiency.
Once the design stage has been passed, one way of combating the negative results of shortages is to keep track of stock, while increasing inventory wherever applicable – for example, if a component becomes popular and available, buy as much as possible within budget.
As many companies were forced to close due to the pandemic, some component lines have become obsolete. As a result of regulatory measures set by organisations such as EMA, obsolescence issues are tough to avoid when dealing with the manufacture of medical devices.
However, manufacturers are able to take certain steps to minimise the impact, such as studiously researching the predicted lifespan of potential components, along with keeping tabs on how long they’ve been available on the market. Manufacturers can also mitigate the risk of potential obsolescence by sourcing a vendor who can help in sourcing obsolete parts.
Considering the ongoing pandemic, manufacturers are cautioned to implement good obsolescence management plans, and failure to do so could lead to losses of millions in down-time and replacement parts.