Challenges in assembly of delivery devices

Bengaluru Pharma Summit 2025 had some really informative sessions that offered actionable insights critical for the pharma industry. One of them was the session on ‘Challenges in assembly of delivery devices’ that gave an overview on the evolving landscape of drug delivery systems, with a focus on pen and autoinjector devices. Loganathan S, Associate VP, Onesource Biopharma, the speaker, began by highlighting the expertise and infrastructure of their specialty pharma CDMO, OneSource. This set the context for a detailed overview of how complex devices are assembled and the kinds of challenges that manufacturers encounter. 

Loganathan explained that the assembly of pen devices is a multi-step process involving three core device components along with a filled cartridge. He pointed out how key aspects such as stopper depth, plunger position, and assembly force as parameters that directly affect both process efficiency and product safety. 

A major part of the session revolved around the challenges faced during assembly. High rejection rates, lower operational efficiency, limited flexibility in changeovers, and difficulties in scaling up were identified as recurring issues. The speaker also highlighted high development costs, qualification delays due to weak technology transfer, and regulatory complications when pilot and commercial processes differ. Each of these issues can lead to significant project delays and cost escalations. 

The session also explored how such problems can be mitigated through strategies such as modular equipment design, strong ownership of validation, and closer collaboration between development teams, operations, and equipment manufacturers.

In conclusion, Loganathan made a strong case for treating device assembly as a critical enabler of speed, quality, and regulatory success.