The FDA enforced the requirement for dose indicators on inhalers for sale in the US; the challenge for Bespak was to develop a dose counter capable of satisfying US regulatory guidance while distinguishing ourselves in a competitive market where several other technologies existed.
We took a strong IP position which provided us the freedom to operate. Research and development was focused on creating a displacement-based counter that was highly reliable. The product needed to be functional and user-friendly, thus extensive human factor testing was conducted to confirm performance, ease of use and robustness in the field.
Successful trials led to a final product that is a highly reliable dose counter. During the project we installed a substantial Class 8 cleanroom and invested in commercial scale tooling and fully automated printing and assembly capabilities.
The first nasal variant dose counter launch took place in 2012