Overcoming supply chain disruptions in medical device manufacturing
Neil Ballinger, head of EMEA at automation parts supplier EU Automation, discusses the challenges facing the sector and how reconditioned and obsolete components can help.
The COVID-19 pandemic brought unprecedented challenges for the medical device industry, from skyrocketing demand for respirators and personal protective equipment (PPE) to staff shortages. Since the second half of 2020, another major challenge has been procurement. A combination of pandemic-related factors, socio-political instability and a major semiconductor shortage has led to an unprecedented supply chain crisis — a challenge that is particularly felt in safety critical sectors like medical device manufacturing.
Due to the extensive review process for each device, this sector usually needs long lead times for products to get approved and delivered, so even a minor disruption can result in major delays. This is the case for components used in the final products, but also for automation parts in core machinery on production and assembly lines. For example, equipment and processes will have to be re-qualified in case of major maintenance or substantial modifications to the production lines.
The need for compliance
Medical device manufacturers must navigate an abundance of red tape to ensure regulatory compliance. For instance, compliance with the European Medical Device Regulation (EU MDR) is compulsory for companies that sell their devices in the EU. When it comes to a medical device manufacturing plant, the initial design of production lines needs to be validated by the relevant authorities, and almost every change on the line may require additional inspection and validation.
A validation master plan (VMP) outlines the necessary steps when qualifying a facility for producing medical equipment, as well as a detailed process for maintaining a qualified facility. By following a VMP, manufacturers can be sure that their processes will produce only conforming items.
This sets medical device manufacturers up for success, but also requires them to adhere to strict guidelines. For example, if a component fails and is in short supply, it cannot just be replaced with a compatible one — the same part will have to be sourced. This can become a regulatory nightmare if the component is obsolete and no longer produced by the original equipment manufacturer (OEM), or if the latter is impacted by supply chain disruptions and unable to produce and deliver as usual.
Coping with disruptions
In the short term, the best way to combat the negative consequences of shortages is keeping track of stock and increasing inventory whenever possible. On the other hand, investing in supply chain management (SCM) software can be a good long-term strategy to help track inventory, manage shipping, and keep updated on which stocks are decreasing fastest.
It is hard to avoid obsolescence issues when manufacturing medical devices, but there are some steps manufacturers can take to minimise the impact. In the design phase, design engineers should carefully research the expected lifespan of the components they intend to use, as well as monitor how long these have already been on the market.
For manufacturers who are past the design stage, refurbished components can be a great way to source parts that perform like brand new ones, even when the OEM cannot deliver. An automation parts supplier that specialises in reconditioned and obsolete parts, like EU Automation, can help source the right product regardless of where in the world it is located. They can then ship it in record times, saving manufacturers weeks of costly downtime. However, this should be used in combination with other proactive obsolescence management strategies.
With disruptions continuing to impact global supply chains, manufacturers should take the time to implement a good obsolescence management plan. Failure to adapt to these challenging times could cost companies millions in unnecessary downtime and replacements.