Updated on 11 December 2012
During the development process a delicate balance exists between providing device design features that fulfil end-user needs and making certain that device design is manufacturable. It is between these two areas that one has to find equilibrium; if they come into conflict with each other, the end-user needs should always have priority over the manufacturing process, so long as it does not affect the safety and effectiveness of the device. Finding a balance is the key. SHL, for example, works closely with customers to develop devices that complement the manufacturing process.
Manufacturing advanced drug delivery devices requires an extensive range of capabilities. Tooling, moulding, automation, assembly and metrology are just a few of the many capabilities that are utilized. While maintaining such capabilities in-house is ideal, in some cases, it is just not practical due to the extensive capital investment that a drug delivery device supplier is required to make. In addition to purchasing and maintaining the required machinery, developing the expertise needed to run this equipment at an optimum level is challenging and takes time. For these reasons, some drug delivery device companies, such as SHL, have followed a staged approach to incorporate key manufacturing capabilities ‘in-house' over several years and many suppliers have been forced to accelerate this expansion in recent years due to an increase in orders and a desire to maintain a sufficient level of capacity.
Tooling and automation are two areas that deserve special attention by biopharmaceutical companies as these capabilities are sometimes outsourced by device suppliers. Tooling is a significant expense in any drug delivery device program and lead times must be planned for carefully. For high volume projects, multiple sets of tooling are needed for production, safety stock and risk mitigation.