Human factors and design researchers at a newly-opened Battelle laboratory at the firm’s Columbus, Ohio headquarters will observe and evaluate how patients and clinicians use medical devices.
The nonprofit research and development organization said it opened the 4,500-square-foot user research lab Monday, located close to the firm’s medical device development building.
“The FDA continues to increase its focus on incorporating human factors studies prior to clearing or approving a medical device,” said Reade Harpham, manager of Battelle’s human centric design team. “It is critical to get as much feedback from the patient or clinician as you can, as early as you can. This enables teams to evaluate behaviors in a real-world setting and to design safe and effective devices.”
He added Battelle has previously conducted human factors studies under registered medical device quality systems.
The new lab has five rooms for testing hardware, software and interiors for home healthcare settings and an additional 5,000 square feet for converting into different types of environments.
Battelle installed several high-definition cameras in every room for streaming live video feeds to clients worldwide to watch how their devices are used.
The HCD team will conduct usability studies for the medical and pharmaceutical communities.