When conducting usability testing, moderators rely heavily upon observations and interviews in order to evaluate medical devices. However, as Data & Systems Analyst Mahajabin Rahman points out in Design Science’s most recent article for MedDeviceOnline, the use of eye-tracking software can support these methods with objective, real-time data. Read more
In Design Science’s most recent guest column for MedDeviceOnline, Analyst Bryon Calawa examines the challenges that researchers face when evaluating auto-injectors in usability studies. Read more
Designing usability studies that are “representative” is not only necessary for valid data, it’s also an FDA requirement. Chad Uy shares some methods for maintaining realism to ensure representative usability studies in his recent article for Med Device Online.
Understanding the ramifications of less-than-perfect validation testing results can be complex. In his recent article for Med Device Online, Peter Sneeringer presents 6 questions to help companies decide if errors seen during testing indicate a likelihood that the FDA will reject their submission.
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What 4 things should app developers, traditional medical device and pharmaceutical companies, and regulators do to accelerate the growth of mHealth? Read more