Gilead wanted confidence the product in development would be safely and effectively used by CF patients, and to understand any patient concerns surrounding the product.
We designed and fielded formative human factors studies. Deep-dive one-on-one interviews with cystic fibrosis patients enabled us to understand and define user needs. We created a new package system, and validated it directly with patients. All in record time.


Translating Human Factors research into Package Innovation

Cystic Fibrosis patients have unique needs. They spend up to two hours each day simply taking their medications via complex nebulizers and inhalation devices.

The client was developing a new device that would deliver one of the CF patient’s medications in 5 minutes instead of the 45 minutes typically required. However, the device could potentially be complex to handle: it involved an inhaler, medication that had to be loaded, and a sequence which had to be strictly followed in its use. All of this could be fairly cumbersome to manage, considering the plethora of other medications the patient was often required to take. Also, the US regulatory agencies had recently released new guidelines for medical device development, Gilead wanted to do things right.

CharlesGroup first designed several approaches in which the package served to facilitate and make simpler the device/drug use and overall system manage- ment. We then designed and fielded a national study with CF patients in which we reviewed the concepts, obtained their input, and even generated some new ideas real time (A bonus afforded by having moderators who are also product designers).

This integration of concept generation, iteration and validation, is a delicate process. It’s easy to bias the subjects, or contaminate the findings. If done properly, however, an excellent product and validation data can result.