This research involves feasibility testing of design concepts to support device development of an electric breast pump. The purpose is to evaluate a prototype device for feasibility purposes and not health outcomes.
This engineering evaluation involves the voluntary participation of healthy adult lactating women for feasibility testing of breast shield designs. Participants will be asked to rate the breast shield design for fit, comfort, and the ease of use. In addition, participants will be asked to rate a comparison of the device relative to their experiences with their current commercial breast pump and breastfeeding their baby.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Enrollment
48
Prototypes of breast shield and Freedom Double Electric Breast Pump.
Blur Product Development
Cary, North Carolina, United States
Breast shield comfort
Rate comfort of device by Questionnaire
Time frame: 1 day (Single timepoint)
Breast shield fit
Rate fit of device by Questionnaire
Time frame: 1 day (Single timepoint)
Breast shield ease of use
Rate ease of use of device by Questionnaire
Time frame: 1 day (Single timepoint)
Volume of milk expressed
Rate volume of milk expressed with device by Questionnaire
Time frame: 1 day (Single Timepoint)
Participant comparison of device to current commercial breast pump
Rate comparison of device to current breast pump experience by Questionnaire
Time frame: 1 day (single timepoint)
Participant comparison of device to breastfeeding
Rate comparison of device to breastfeeding experience by Questionnaire
Time frame: 1 day (single visit)
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