When Use Environment Counts: Studying Safety for Devices Under Stressful Conditions

Challenge 

Our client needed a comparative formative study of two different devices for administration of glucagon in rescue situations (i.e., diabetic severely hypoglycemic and going into shock). It was critical to determine how well users were able to use the devices when under extreme stress and develop risk/safety profiles for each device. 

Solution

To meet this challenge, Battelle designed and executed a study using novel stress-induction methodologies and scenarios that stimulated realistic emotional conditions in study participants. Study findings revealed one candidate device as markedly better for use under the stressful conditions. 

The study results also:

• Revealed valuable contextual information about the intended users' expectations and the rescue situation itself that led to a re-examination of the risk/safety profiles of the candidate devices
• Emphasized the importance of simple-to-use device design in products that may be used infrequently (i.e., only on an "as needed" basis)

Outcome 

By conducting this early formative study, our client gained valuable product and business insight into the risk and safety associated with their device designs. Based on the study outcomes, our client chose to delay ramping up an expensive development program targeted for one of the devices until further risk reduction activities were able to be performed.