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Beyond Asia: Designing Combitide Starhaler for Western Markets

Bishop DA.

RDD Asia 2014. Volume , 2014: 13-24.

Abstract:

The development of an inhalation device is complex, and the design team must balance the needs of the patients, regulators, and manufacturers, as well as the functional requirements of a drug delivery device. The device designer is responsible for satisfying all of these various (and often conflicting) needs in order to develop a successful drug delivery system. When the drug delivery device is intended for western as well as local markets, the needs and requirements are multiplied manyfold. But a balance can be achieved, so long as the regulatory, performance, and user requirements for the target markets are met, and that the specific device development requirements of the specific jurisdictions are followed. This article discusses the design approach adopted for Combitide Starhaler® which was developed to meet the needs of multiple markets. The approach describes how the design team focused on early “freezing” of key inhaler components, and embraced important concepts including human factors engineering and risk management.