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.
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.