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
human factors
What 4 things should app developers, traditional medical device and pharmaceutical companies, and regulators do to accelerate the growth of mHealth?Check out Nicholas Araujo's proposals, featured on Med Device Online's website. 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. Read more
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." Read more
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). Read more
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? Read more
Is the awakening over? Has the medical industry finally come to embrace the benefits of human factors engineering…? In a word, the answer is “yes.” In more than a word, the answer is “not entirely.” In an article in INNOVATION’s summer 2014 issue, Michael Wiklund (of Wiklund Research & Design) and Stephen Wilcox, FIDSA, argue that human factors is a tool not only for evaluating a product’s. Read more
The landscape of the medical device industry is transforming. As the tide of technological change reshapes how people interact with their devices, human factors engineers face the task of evolving with the industry. Read more
What does a user do if his medication is child-proofed, but his illness causes him to have the dexterity of a child? Read more
Design Science is so very happy to officially announce the opening of our San Francisco Bay Area office—and we have just retrieved the keys! Read more