Part II of this series proposes that structured expert judgment, when integrated into the current HFE/UE paradigm, can help overcome some of the current limitations of HFE/UE.
This series makes the argument for probability assessments in HFE/UE for medical devices and how to incorporate it into the paradigm.
Aging is not for the faint of heart.
Technology isn’t the only driver in this change; the sociological factor plays a role as well.
Human factor engineering must account for all groups within the Diffusion of Innovation curve. Medical devices must work for the Innovators, and more importantly account for the Majority Adopters and Laggards.
10 factors design engineers must consider when creating stick-to-skin medical devices.
The device should be carefully matched to end users, rather than be an afterthought.
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.