On July 15, Design Science will welcome Bay Area tech professionals to its office for the “UX Speed Dating” monthly meetup. This event provides web and mobile app designers a chance to gather in-person feedback from actual users. Read more
While Design Science is most well known for its experience in conducting ethnographic research at medical facilities, a growing number of our projects provide opportunities for us to venture outside of the hospital and apply our methodologies to the study of non-medical products. As a field researcher I have had the chance to participate in a number of “unconventional” projects that took me to unexpected places to answer unusual questions. 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
Are you passionate about working collaboratively to make a felt difference in the world? At Design Science we have one mission – fitting products to people.
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.”
Recently at DS, we thought it would be fun for the whole office to take the Myers-Briggs personality assessment (despite one office manager’s insistence that she was far more complex than four letters!).