The report also found that medical device companies are taking “huge gambles” in the area of risk management.
This series makes the argument for probability assessments in HFE/UE for medical devices and how to incorporate it into the paradigm.
For reliable systems, we need a different mindset.
In addition, in workforce optimization, retention plays an equally important role as recruitment.
Manufacturers can rely upon internal human factors engineers and/or external consultants to apply HFE effectively during device development.
Why you can’t afford to overlook this important part of product development.
The unpredictability of the process can make it difficult to stay on track throughout every phase.
The agency calls out specific devices that should include human factors data in premarket submissions, along with recommendations for combination products.
A review of how to incorporate complaint handling and risk management into the postmarket surveillance process.
Don’t ignore the changing medtech landscape; it will continue to affect product design and manufacturing. A discussion with Kenneth Fine about design challenges.