As the injectable formulations market continues to see rapid growth and dominate biopharma pipelines, corresponding drug delivery devices like auto injectors and pen injectors have also continued to evolve.

While factors such as usability, ergonomic industrial designs and incorporation of electronics contributes to what defines an innovative device, it is crucial to understand the importance of primary container compatibility & customization; manufacturability; regulatory implications amongst other considerations at the development level.
It is no longer sufficient to just offer an innovative device platform that may meet specifications initially, as it takes a well-established partner with extensive experience, know-how and in-house capabilities to execute a successful delivery device development program.

The ideal program partner should demonstrate an aptitude for:

• Delivering products and services that fully align with global quality standards & regulations.

• Ability to adapt to the changing regulatory landscape.

• Potential changes due to findings from human factor (HF) studies should be anticipated, as user centric designs are core to the success of a device. As HF study outcomes can significantly influence the final device, your selected device partner needs to provide robust engineering capabilities and extensive in-house manufacturing capabilities in order to respond quickly.

• Study outcomes may also affect the configuration of a pre-selected drug container – a supplier should have high flexibility and a broad range of container characteristics, such as different siliconization grades.

Providing a range of delivery platforms and demonstrating a proven track record of success in commercializing products is a must for a device partner. Equally as important is ensuring the freedom to operate with the given platform while making alternative delivery solutions available, such as highly viscous formulations and larger volumes of drug delivery.

Staying innovative and investing in ongoing research and technical improvements is also vital, as this can be of use later on during the life cycle management phase of the drug. An example is the use of cartridges as container solution for auto injection devices, which can further differentiate a given drug product from its competitions.

Crucial manufacturing capabilities such as ramp-up production and willingness to balance slower demand developments are key to a successful program. Another important factor to consider is the final assembly, packaging & labelling of your drug product where best practices regarding glass handling are essential, as container damage during assembly can result in breakage during transportation.