John Swift, head of supply chain at Owen Mumford, explains how to develop an effective operations plan to secure supply resilience alongside product development projects and programs.
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Supply chain concept
The market for injectable drug delivery devices is skyrocketing, with expectations annual growth will be above 10% till 2030. This is unsurprising considering that 60% of drugs in the R&D pipeline are set to be delivered by injectables. Owen Mumford works on several products which will look to capture a share of the expanding market for injectable drug delivery devices in coming years.
Taking advantage of the growing market will rely on manufacturers being able to quickly react to the changing demand for a product throughout its lifecycle, while still maintaining product quality. Responding to these changes requires a robust and meticulous operations strategy that: effectively scales demand and manages assets; works transparently with suppliers; and develops specialised centres of excellence.
Scaling demand and managing assets
To cope with varying demand throughout a combination product’s lifecycle, a clear operations plan for manufacturing the delivery device in both large and smaller quantities is essential. Low volume manufacturing requires single or low cavity moulding and semi-automated assembly, whereas for high volume manufacturing, producers are likely to need high cavitation moulding with fully automated production. To optimise lifecycle planning, manufacturers must understand which of their facilities have the appropriate equipment and resources to undertake different stages of the production process, or instead must look to incorporate these features into existing facilities.
Alongside lifecycle management, companies must also have asset management strategies in place to support capacity growth and ensure equipment and ancillary products are properly maintained. Assets including injection moulded tooling, injection moulding machines, automated assembly machines and all associated software, hardware and ancillary equipment must be assessed on a regular basis to ensure they are fit for purpose.
Manufacturers need to proactively replace assets coming to the end of their lifecycle and monitor spare parts policies, safeguarding against delays in production should equipment falter. As a product gets older and is slowly replaced by newer models, companies must prepare for the end of a product’s lifecycle – scaling down production to appropriate levels until their device reaches obsolescence. It’s important that asset management programs do not neglect mitigation strategies either, ensuring shocks to supply caused by external geopolitical events that could lead to difficulties in acquiring certain raw materials or machinery, are easily absorbed.
Supplier transparency
It is important to work closely with suppliers to define roles, responsibilities, and escalation procedures. This ensures devices are consistently at the agreed level of quality and that suppliers can respond to changes in demand. Auditing suppliers is an essential tool to understand the systems, equipment, method, and skillsets of partners, allowing companies to recognise if anything will hinder their ability to provide devices. Working with suppliers to provide guidance on equipment design and align methodology also reduces the risk of any small differences between products when compared directly.
Following Brexit and the COVID-19 pandemic, Owen Mumford Pharmaceutical Services carried out a review of supply chains to understand the potential risk areas in this challenging landscape and how they could be overcome. Using a ‘virtual factory management’ concept helped them set targets that can be reviewed regularly with suppliers to ensure viability and pre-emptively tackle issues with performance or capabilities.
Developing expertise
Developing centres of excellence is critical both to ensure products are designed and built to the highest possible standards and to allow staff to develop exceptional knowledge of a particular field. These hubs can have specialities in any area of the operations process, such as moulding, assembly or automation.
Creating these centres will make it easier to fulfil order requirements and allow rapid resolution to unforeseen technical issues during production. Ensuring the foremost experts in an area of production are placed together creates key skills and competency coverage in the event of unplanned leave or illness. Teams can establish focused training programmes allowing staff to upskill, creating an environment which helps increase staff retention rates, while also further reducing risks should an expert leave.
Owen Mumford’s new production facility in Oxford was built according to BREEAM certification, aiming for the highest levels of environmental, social, and economic sustainability. It specialises in both assembly and automation, making it the ideal location to produce the innovative Aidaptus autoinjector.
Operational resilience
Establishing effective operations programs helps to create strength within drug delivery device manufacturers, encouraging their growth and development. With lifecycle and asset management plans in place it’s easier to reduce the potential risks that large pharma companies may have when they enter clinical trials or require a rapid scale up in demand. Moreover, having robust supply lines allows focus on future developments, rather than preoccupation with current product lines. In turn, this means more time to create innovative new devices that distinguish companies from competitors and more time to allow for further growth.
