Mauro Usability Science Announces 3 New Advanced Human Factors Research and Usability Testing Methodologies for Medical Products

 NEW YORK, Oct. 19, 2022 /PRNewswire/ -- Founded in 1975, MUS is a leading provider of human factors research and usability testing services for medical products requiring FDA submission.

A core problem with medical product development is identification of feature sets that improve clinical outcomes and drive user acceptance. Our validated methodology employs psychophysical data capture, including micro-facial expression analysis, high-performance eye-tracking, and cognitive workload analysis, along with high-fidelity simulations of proposed feature sets. This produces a roadmap for medical products that have emotional resonance and robust human factors benefits for designated medical professionals. More

Large molecule drugs offer unprecedented clinical advantages. However, these drugs have surprisingly high viscosity. This presents critical usability problems for patients and/or HCPs. MUS has developed and validated a force measurement system that captures Newtonian forces, user physiological data, and 3D spatial tracking of needle and device excursion, during injection sequences. This human factors platform provides robust engineering specifications for the design and/or purchase of PFS devices that meet the needs of the proper statistical range of users. More

MUS has executed hundreds of FDA summative studies for major corporations. Our experience reveals that a surprising number of medical products arrive at summative testing with serious usability problems. When this happens, it causes major cost and FDA submission problems. To address this problem, MUS has developed and validated an advanced method for minimizing cost overages and submission delays. This methodology is focused on rapid identification of usability problems, error patterns, and error root causes, presented in the form of a detailed daily summary. When errors reach a critical threshold, we suggest pausing the study. We then employ proprietary rapid response redesign of instructions for use (IFU) to mitigate critical error patterns. Before relaunching the summative study, we execute a specialized pilot study to validate all IFU changes before relaunch of the summative testing. Upon relaunching summative testing, we strive to maintain sample size to minimize schedule impact. We have saved clients hundreds of thousands of dollars and reduced delays for critical FDA submissions with this methodology. More

Director of Research Chris Morley
[email protected]

SOURCE MAURO Usability Science