The case for optimising operations in medical device manufacturing

Apr 26, 2023

by John Swift

8 June 2023

10:20

With the injectable drug delivery device market predicted to grow from $39.93 billion in 2022 to $43.54 billion in 2023, 60% of drugs in the R&D pipeline designed for injectable deliveryii, and patients increasingly administering their own medication wherever possible, drug delivery device manufacturers must ensure continuity of supply for existing devices.

This means being able to supply at the required volumes and in line with the relevant quality and regulatory standards, even while development programmes for other products are ongoing.

To ensure this goes smoothly and to avoid supply issues during the early launch phases and subsequent product growth, it is essential that Operations is involved at an early stage, ahead of the phased design approvals from Research & Development.

This article will demonstrate how an effective operations plan can contribute to supply chain resilience and eliminate vulnerabilities by focusing on two key notions: adaptability, and continuous tracking and improvement.

For drug delivery devices, the road to commercialisation can be both long and challenging – from defining user requirements and early design concepts, going through building and testing prototypes, human factors testing and finally device verification and validation. In addition, devices must be designed correctly for volume scale up using principals such as design for assembly (DfA) and design for manufacture (DfM).

Starting at the design phase, each device component and process must be considered from a risk management perspective, allowing for changes in demand throughout the product's life –particularly in the product launch or growth phases, and at end of life. Manufacturers must be able to scale up manufacturing to produce devices in large quantities (often in millions), while ensuring that quality and performance are consistently and rigorously maintained. Both low and high-volume manufacturing should be taken into account, ranging from single cavity moulding and low volume manual to semi-automated assembly for smaller scale, low volume opportunities and high cavitation moulding with fully automated production for large scale manufacturing.

Manufacturing locations must also be considered strategically so that facilities are utilised effectively, ensuring that the most suitable site, with the most appropriate equipment and resources, is used at each stage of the product lifecycle. An adaptable approach to manufacturing location can also contribute to an effective asset management strategy, allowing for crucial equipment, processes and services to be maintained in line with planned usage without disrupting product supply. Such strategies may cover equipment such as injection moulded tooling, injection moulding machines and automated assembly machines and all software, hardware, ancillary equipment along with any spare parts associated with them.

An operations plan characterised by adaptability and agility also mitigates the risk of external supply incidents, including geopolitical events, impacting supply chains. Recent world events including the COVID-19 pandemic and the war in Ukraine have demonstrated the need for optimised strategies to ensure continuity of supply regardless of the situation.

With factors to monitor for supply security, it is essential that manufacturers track potential vulnerabilities through supplier audits and risk registers to assess the likelihood of risks impacting the supply chain and implement corrective action where necessary. Owen Mumford relies on two tools to do this: Process Failure Mode Effects Analysis (PFMEA) to track and mitigate residual manufacturing risks, changes and potential impacts, and our "virtual factory management" concept – a specific initiative for monitoring supply chain vulnerability.

This entails setting clear and transparent KPIs which are shared and regularly reviewed with key strategic suppliers, facilitating the detection and pre-emptive correction of potential vulnerabilities caused by suppliers’ performance, capability or strategies. It can also be useful for manufacturers to provide guidance on equipment design and methodology alignment across suppliers, reducing the risk of any differences when direct comparison of components, measurements, processes and settings is required.

Lastly, sustainability audits may also indirectly benefit supply chain resilience. As they must include overall end-to-end processes, logistics, and value stream mapping, this holistic approach may reveal previously overlooked areas of risk, and enable manufacturers to drive improvements to supplier systems, equipment, and methods.

As with any complex process, there are always improvements to be made to optimise drug delivery device manufacturing. At Owen Mumford, we centralise expertise in specific areas of operations - whether this be moulding, assembly, automation or another key process – in Centres of Excellence. Once the key skills and tools needed at each individual centre have been defined, teams can create focused training programmes, allowing staff to progress and upskill. This encourages improved staff retention which in turn contributes to a reduced risk profile. Through Centres of Excellence, operations teams can also establish and implement best practices and capitalise on expertise and skills from across the organisation.

Owen Mumford's bespoke new production facility in Oxfordshire, UK, is set to become a Centre of Excellence for automation and assembly, manufacturing the company's latest and most prominent medical devices and setting a benchmark for world-class design. In keeping with Owen Mumford's strong commitment to sustainability, the facility has been designed to meet the highest levels of environmental, social and economic sustainability performance, as well as to conform with the Building Research Establishment Environmental Assessment Method (BREEAM) certification, a sustainability assessment method.

In order for manufacturers to ensure excellence and manage risk during the industrialisation of medical devices, they must establish operations strategies that are both carefully planned and effectively executed, covering lifecycle and asset management, supplier management and risk tracking and mitigation measures. An adaptable, strategic approach ensures supply chain resilience while providing flexibility for pharmaceutical companies during drug development and lifecycle management.

by John Swift

8 June 2023

10:20