Company insight
The three pillars of medical device manufacturing
With the importance of medical device manufacturing and supply chains becoming all too apparent these last few years, John Swift, head of supply chain at Owen Mumford, offers a trio of areas that ensure strength and efficiency.
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ith 60% of drugs in the R&D pipeline designed for injectable delivery, it is no surprise that the market for injectable drug delivery devices continues to grow at a rapid rate. Manufacturers looking to take advantage of this growing market have the significant task of being able to scale up as required – while meeting necessary regulatory standards and without compromising on device quality. Within operations strategy, there are three areas that need to be robust for secure and optimal production of medical devices: lifecycle and asset management; supplier management; and continual learning programmes.
Lifecycle and asset management As demand for a medical device typically changes across its lifetime, manufacturers must be able to rapidly adapt to prevent any disruption to product supply. New products should therefore be designed for both low and high-volume manufacturing: single/low cavity moulding and manual or semi-automated assembly for smaller, low volume opportunities, and high cavitation moulding with fully-automated production for large scale manufacturing. Lifecycle planning relies on production across a broad manufacturing network, taking into account which facilities have the most appropriate equipment and resources for the level of demand. In short, establishing supply at the right time, to the right level, in the right place in line with the product growth and establishment.
Alongside lifecycle management, it is imperative that firms employ asset management strategies to support capacity growth while making sure crucial equipment, processes and services are maintained in line with planned usage. Manufacturers must be proactive in the
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maintenance, replacement and refurbishment of assets, as well as monitoring of spare parts policies and potential risks with obsolescence so they can cope with demand at each stage of the product lifecycle. Additionally, asset management programmes must include mitigation strategies for external geopolitical factors that may put unexpected pressure on supply chains, so that demand can be met regardless of external circumstances.
Supplier management Managing suppliers effectively is critical to ensuring products are high quality and are supplied consistently. Clear roles and responsibilities, governance and escalation procedures must be laid out in advance so suppliers know when to implement changes and can respond to sudden surges or drops in product demand.
Auditing suppliers is also crucial to gain an understanding of their systems, equipment, methods and skill sets, and if there are any gaps that might prevent them from delivering to agreed levels of quality and quantity. Collaborative working with suppliers to provide guidance on equipment design as well as aligning methodologies to reduce the risk of differences between the components, measurements, processes and settings when direct comparison is required. World events continually affect supplier reliability and management processes. Following Brexit and the Covid-19 pandemic, Owen Mumford carried out a thorough review of risk areas to minimise supply chain vulnerability. Our ‘virtual factory management’ concept entails setting clear and transparent KPIs and reviewing them regularly with
suppliers, allowing us to identify potential issues with performance, capability or strategy and correct these pre-emptively.
Improvement and training programmes There is always more to learn to optimise manufacturing equipment and processes, as technology develops. Owen Mumford’s approach is to create centres of excellence, hubs with specialities in a particular area of operations – whether this be moulding, assembly, automation or another key process. These focused groups have a major impact on efficiency and performance both through the implementation of best practices and by utilising expertise and skills from across the organisation.
Our bespoke new production facility in Oxfordshire, England will be a centre of excellence for automation and assembly, an ideal site for the production of our latest medical devices, including our innovative Aidaptus autoinjector. The site is being built in accordance with the BREEAM certification which recognises the highest levels of environmental, social and economic sustainability performance – so that the building serves as a model example in multiple ways. To develop their own centres of excellence, organisations must clearly define the skills they require and set up focused training to support staff development. This has the added benefits of supporting staff retention and reducing the risks that come with skill gaps, further protecting the organisation in a rapidly evolving medical device landscape. ●
www.owenmumford.com World Pharmaceutical Frontiers /
www.worldpharmaceuticals.net
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