Strategies to optimise the manufacturing of medical devices

Main image: John Swift, Head of Supply Chain, Owen Mumford Pharmaceutical Services

Bringing a new drug delivery device to the market is a complex operation. Each stage of the design, development and industrialisation process must be considered carefully to produce a device that works first time, every time. The challenges range from defining user requirements and creating early design concepts, to building and testing prototypes, human factors testing and finally device verification and validation. Each step requires careful planning and consideration if the end result is to be a drug delivery device that ensures each patient can successfully administer the correct dose of medication when they need it. That's not all. Manufacturing operations need to be capable of scale-up to produce the device in large quantities– often millions – with consistently high quality and performance.  Setting the scale-up rate relies on receiving as accurate forecast as possible from pharmaceutical companies of the projected drug sales to ensure these are fully aligned with those of the device.

Effective operational planning underpins all these activities, ensuring successful product launch and growth by overseeing risk, lifecycle, asset and supply chain management, while also building a culture of continual improvement.  

Owen Mumford Pharmaceutical Services has developed its own tool based on – Process Failure Mode Effects Analysis (PFMEA) – to track and mitigate residual manufacturing risks, changes, potential impacts and likelihood of occurrence. Combining the PFMEA with a design for manufacture and assembly approach helps reduce the risk of failures on the production line. Creating and regularly updating a risk register is also important. This ensures potential risks that could affect project delivery timescales are assessed and any necessary corrective actions taken without delay.

With demand for any drug delivery device likely to change during its lifetime, new products need to be designed for both low and high-volume manufacturing – so that production can be adapted rapidly to prevent supply disruption. A typical change would be from low/single-cavity moulding and manual assembly for low-volume manufacturing to multi-cavity moulding and automated production for large volumes. Lifecycle planning needs to factor in such changes as a product matures – taking into account which manufacturing facilities have the right infra-structure, equipment and resources for different levels of demand.

Alongside lifecycle management, there is also a need for proactive asset management – covering asset maintenance, refurbishment and replacement – to avoid supply disruption. This needs to align with product lifecycle changes – such as product launch, growth phases, as well as towards the end of a product's life – when there may be large changes in demand. Equipment such as injection moulding tooling and automated assembly machines need to be serviced and accounted for, along with all associated software, hardware, and ancillary equipment, with effective, appropriate spare parts policy management.

Consistent product quality and supply are critical when it comes to drug delivery devices. That's why effective supplier management should be a priority, with defined roles and responsibilities, regular meetings, agreed triggers and escalation procedures, and clear governance. Metrology and test teams need to be involved in supplier selection for medical devices. Ongoing management is required to ensure suppliers consistently deliver to the required standard. Regular auditing and working closely with suppliers make it possible to check that all the relevant systems, equipment, methods and skill sets are in place to measure, test and deliver to the agreed level of quality. It also means ways of working can be aligned. This helps avoid unwanted variations in components, measurements, processes and settings.

At Owen Mumford Pharmaceutical Services, we launched a review of our supply chain vulnerability in the wake of Brexit and the pandemic, to ensure potential risks to continuity of supply are addressed. We have also created the concept of 'virtual factory management' to improve partnerships with strategic suppliers, with key KPIs shared and reviewed so that issues with supplier performance, capability or strategies can be identified at an early stage.

Creating centres of excellence can be a useful way of bringing together key engineering expertise focused on a particular area of operations such as moulding, assembly or automation, improving efficiency and performance by encouraging the development and implementation of best practices. Knowledge sharing among people from multiple backgrounds with different levels of experience is extremely valuable.

Centres of excellence have many practical uses too. They can help maintain order fulfilment commitments and provide a rapid response to resolve unforeseen technical issues during production. They can provide key skill and competency coverage in times of planned or unplanned leave. And they can also lead to improved planning and awareness of potential issues – helping to formulate appropriate risk strategies across a wide range of projects and products. 

A proactive approach is the crucial ingredient in all the operational strategies mentioned here – constantly looking to the future while keeping an eye on optimisation of existing processes. As manufacturing operations expand, they are likely to need significantly more space, for example, and facilities need to be flexible enough to accommodate the latest innovations. Robust operational planning is therefore vital for growth, as well as managing risk and maintaining supply.

Learn more about Owen Mumford Pharmaceutical Services here.

John Swift is Head of Supply Chain at Owen Mumford Ltd. He is an experienced operations program manager with a successful track record working throughout the supply chain, covering procurement, supplier management, invention, development and manufacture, as well as promotion, sales and distribution. He is experienced in applying and adapting skills across both large corporations – such as Abbott, Abbvie and Tyco – and SMEs, and has worked in multiple industries, including medical device, aerospace and defence, rail, chemical, automotive, and printing.