Human factors addresses not only the obvious or physical, but also digs deep.
FDA releases achievements of its Combination Product Review Program, along with next steps for the near term.
Severity of harm is what ultimately matters most in terms of protecting patients from the consequences of use errors.
To truly understand device use scenario, one must observe with intention.
Why this sentiment can cause more harm than good.
Manufacturers can rely upon internal human factors engineers and/or external consultants to apply HFE effectively during device development.
Human factors engineering and the tools companies can leverage will get way more sophisticated.
Why you can’t afford to overlook this important part of product development.
This video demonstrates how ECRI Institute tests medical devices.
The agency calls out specific devices that should include human factors data in premarket submissions, along with recommendations for combination products.