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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On April 15th, the Food and Drug Administration will begin accepting applicants through its new Expedited Access Premarket Approval Application for Unmet Medical Needs for Life Threatening or Irreversibly Debilitating Diseases or Conditions (“Expedited Access PMA” or “EAP”). Read more
What 4 things should app developers, traditional medical device and pharmaceutical companies, and regulators do to accelerate the growth of mHealth? Read more
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A new guidance for medical-device field research has just been released: the Technical Information Report, AAMI TIR51:2014, “Human factors engineering – Guidance for contextual inquiry.”
Last week, 15 Syrian children died after receiving measles vaccines. In what appears to have been a medication error, a muscle relaxant was used as the diluent to reconstitute the powder form of the measles vaccine, instead of the normal diluent (probably saline).
Sitting cross-legged on the floor and staring at the textless Ikea instructions in my hands, I wonder how I’m supposed to assemble this entire desk using only an Allen key. I’m no carpenter–how can I possibly be doing this right?