There is no denying that the market for injectable drug delivery devices is growing rapidly, with forecasts predicting an increase from $39.93 billion in 2022 to $43.54 billion in 2023 at a compound annual growth rate (CAGR) of 9.0%.1 With 60% of drugs in the R&D pipeline designed for injectable delivery,2 there are no signs of this trend slowing in the near future.
However, bringing a new drug delivery device to market is a long and complex process – from defining user requirements and early design concepts, going through building and testing prototypes, human factors testing and finally device verification and validation. To produce a device which can be successfully used for drug delivery by different patient groups, each stage of the industrialisation process must be carefully considered.
In addition, manufacturers must also be able to scale up production of the device in large quantities, while ensuring that quality and performance are consistently and rigorously maintained.
Against this background, this article will explain how to develop an effective operations plan to secure supply resilience alongside product development projects and programmes, to predict and eliminate potential supply chain vulnerabilities.
Planning Ahead: Starting From Lifecycle Management & Design for Manufacture
The importance of lifecycle management has long been acknowledged in the delivery device industry. Strategic planning is key in this fast-paced market, as demand for medical devices typically changes throughout the product’s lifecycle. Manufacturers must be able to adapt rapidly with carefully planned and effectively executed operations strategies that prevent any disruptions to product supply.
Lifecycle planning begins at the design phase, and risk management should be factored into decisions on manufacturing and assembly processes. New products should be designed for both low and high-volume manufacturing, ranging from single cavity moulding and low-volume manual to semiautomated assembly for smaller-scale, low-volume opportunities and high-cavitation moulding with fully automated production for large-scale manufacturing.
Effective lifecycle management also means utilising the manufacturing network effectively, assessing the equipment and resources available at each production facility, as well as related cost implications, to ensure that the most suitable site is used at each stage of the product lifecycle. The ability to dual source – and the consequent reduction in time required to execute alternate sourcing strategies – is another option for reducing supply chain risk. This contributes to establishing supply at the right time and in the right place, in the appropriate volumes for the locations in question.