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


OBJECTIVE
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.
Bode
Andreas
A
Device Design & Development, sanofi -aventis Deutschland GmbH, Frankfurt, Germany. andreas.bode@sanofi -aventis.com
D003922:Diabetes Mellitus, Type 1 / Q000188:drug therapy*; D003924:Diabetes Mellitus, Type 2 / Q000188:drug therapy*; D004209:Disposable Equipment; D016503:Drug Delivery Systems / Q000295:instrumentation; D004867:Equipment Design; D006801:Humans; D007004:Hypoglycemic Agents / Q000008:administration & dosage*; D007328:Insulin / Q000008:administration & dosage*; D017060:Patient Satisfaction / Q000706:statistics & numerical data; D054928:Validation Studies as Topic
D007004:Hypoglycemic Agents; D007328:Insulin