Evaluative Methods for Medical Product Development

Performance based usability testing and comparative evaluations provide quantitative rigor for making decisions during the medical product development lifecycle. Our testing capabilities includes formal, lab-based testing of concepts, prototypes and existing medical devices. We have relationships with research facilities across the United States and abroad for recruiting and conducting studies for medical product development on an on-demand basis.

Medical device usability testing can measure many aspects of user-medical device interaction, including:

• Task performance accuracy, duration and speed

• Error rates and type

• Ergonomic fit and problems

These quantitative metrics can be combined with qualitative measures to assist with medical product development including:

• Perceived comfort and control

• Interface learn ability and ease-of-use

• Aesthetic preferences and feedback

The integration of objective and subjective inputs provides a valuable combination of inputs to drive medical product development and design decisions. For example, in a comparative study, two prototype medical instruments may have equivalent ergonomic fit, but different significantly in perceived comfort due to more subtle issues such as the center of gravity or even the visual appearance of the handle.

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