Chapter 35: On-Market Prefilled Syringe and Autoinjector Studies

Launching a new or improvement to a combination product can bring the patient satisfaction and confirmation but also the potential for an unexpected surprise as they may not be familiar with the combination product or changes made to the on-market product. In addition to planned changes, normal variation in combination product constituent parts may be perceived as a difference to the user and impact their experience with the product. These types of use experiences come back in the form of customer appreciation, complaints, and/or testimonies, through direct access via company product support channels, social media, as well as health care givers. In this chapter, lessons learned from the launch and sustaining engineering of the Humira Autoinjector will be discussed, including examples of design/process improvements based on an understanding of the key functional attributes of the design and constituent parts required to deliver robust autoinjector performance.