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Human Factors and Accessibility

MEDICAL DEVICE ACCESSIBILITY is the degree of “ability to access” or benefit from the intended uses of devices by end users in diverse environments. Accessibility considers diverse users with functional limitations and assistive technologies. It also focuses on analyses of safety and barriers to the successful use of designs 1.

In the evolving medical landscape, devices must be safe and usable not only in clinical settings, but also in home healthcare settings. Accessibility analyses are especially important for optimizing designs intended for lay users (or users with no formal medical training) operating devices outside of clinical settings (for home healthcare).

Did you know?

More than half of home healthcare device users are operating with some form of functional or environmental limitation. That means the majority of home healthcare users could benefit from accessible design. It is critical for medical device designers and manufacturers to address the growing diversity of users and environments in order to produce safer and more effective user-device interactions. Human Ability Designs can help you apply sound human factors and accessibility methods.

Human Ability Designs will help you better understand the range of abilities and limitations of the potential end users of your device. We will help you determine how user and patient safety can be affected when interacting with your designs due to human factors such as:

According to Molly Follette Story, Human Factors Accessible Medical Technology Specialist, CDRH, FDA, “[addressing device risk is] a shared responsibility among the agency, manufacturers, and medical providers for the health and safety of the patient” (from September 21, 2012 interview with Melissa).

Human Ability Design understands the expectations of FDA related to human factors and accessibility. We also have the expertise and experience to help you produce safe, high quality, usable, and accessible designs for end users with diverse ability levels, operating devices in highly varied healthcare environments. We will help you meet or exceed your human factors and accessibility project goals.