Development of the SoloSTAR^® insulin pen device: design verification and validation

Abstract

Background: SoloSTAR^® (SOL; sanofi-aventis, Deutschland, GmbH) is a new, disposable insulin injection pen device for use by people with type 1 or type 2 diabetes to administer long- or short-acting insulin. Objectives: To discuss factors that have underlined the design process of the SOL device. In addition, to highlight the studies that shaped the direction of its development, such as addressing the unmet needs of people with diabetes, which included a need for better differentiation features and a lower injection force compared with existing prefilled disposable pen devices. Results: The development of the SOL pen device was an iterative process involving both patients and the design team, which has lead to a manufacturable, tailor-made pen device. Patients' needs have been taken into account in the pen design; there are numerous differentiators on the device, which avoids confusion between insulin types. Furthermore, the SOL device has a lower injection force compared with other marketed pen devices. Finally, studies have shown that the SOL device is more accurate, easier to use and is preferred by patients over other pens on the market. Conclusions: The SOL device has undergone rigorous user and laboratory testing, which has captured evolving improvements to better meet the needs of people with diabetes.

Keywords::

• design
• development
• device validation
• device verification
• diabetes mellitus
• engineering
• insulin pen device
• long-acting insulin
• short-acting insulin

Acknowledgments

The author thanks Roger Caillon (Global Metabolism Franchise, sanofi-aventis, Paris, France) for providing helpful discussion and critical input. Editorial support for this manuscript was provided by the Global Publications group of sanofi-aventis.

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