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Patient getting a shot in the arm.

Studying Safety for Devices Under Stressful Conditions

Challenge

A 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). They wanted to determine how well users were able to use the devices when under extreme stress and develop risk/safety profiles for each of the devices.

Solution

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 as markedly better for use under the stressful conditions. The study results also (1) 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; and, (2) 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

Ultimately the client delayed ramping up an expensive development program targeted for one of the devices until further risk reduction activities were able to be investigated.