Neil Ballinger, EMEA Manager at automation parts supplier EU Automation, discusses the challenges facing the industry and how remanufactured and obsolete components can help.
The COVID-19 pandemic has brought unprecedented challenges to the medical device industry, ranging from growing demand for respirators and personal protective equipment (PPE) to staffing 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 shortage of semiconductors has led to an unprecedented supply chain crisis – a challenge that is particularly felt in critical sectors for the security such as the manufacture of medical devices.
Due to the extensive review process for each device, this industry typically requires long lead times for products to be approved and delivered, so even a minor disruption can cause significant delays. This is the case for the components used in the final products, but also for the automation parts of the basic machines on the production and assembly lines. For example, equipment and processes will have to be requalified in the event of major maintenance or substantial modifications to production lines.
The need for compliance
Medical device manufacturers must manage a myriad of paperwork to ensure regulatory compliance. For example, compliance with the European Medical Device Regulation (EU MDR) is mandatory for companies selling their devices in the EU. When dealing with a medical device manufacturing plant, the initial design of the production lines must be validated by the competent authorities, and almost every modification on the line may require additional inspection and validation.
A Validation Master Plan (VMP) outlines the steps required when qualifying a facility for the production of medical equipment, as well as a detailed process for maintaining a qualified facility. By following a VMP, manufacturers can be confident that their processes will only produce compliant items.
This allows medical device manufacturers to succeed, but also forces them to adhere to strict guidelines. For example, if a component fails and is out of stock, it cannot simply be replaced with a compatible component – the same part will need to be purchased. This can become a regulatory nightmare if the component is obsolete and no longer produced by the original equipment manufacturer (OEM), or if the latter is impacted by supply chain disruptions and unable to produce and to deliver as usual.
Dealing with Disruptions
In the short term, the best way to combat the negative consequences of shortages is to monitor inventory and increase 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 shipments, and keep track of which stocks are shrinking the most. rapidly.
It’s hard to avoid obsolescence issues when manufacturing medical devices, but there are steps manufacturers can take to minimize the impact. During the design phase, design engineers should carefully research the expected life of the components they intend to use, as well as monitor how long these have already been on the market.
For manufacturers past the design stage, remanufactured components can be a great way to source parts that perform like new, even when the OEM can’t deliver. An automation parts supplier specializing in remanufactured and obsolete parts, such as EU Automation, can help you source the right product, wherever it is in the world. They can then ship it in record time, saving manufacturers weeks of costly downtime. However, this should be used in combination with other proactive obsolescence management strategies.
With disruptions continuing to affect global supply chains, manufacturers should take the time to implement a good obsolescence management plan. Failure to adapt to these challenging times could cost businesses millions in unnecessary downtime and replacements.