Posts

Illustration showing user wearing eye tracking headpiece next to visual hierarchy comparison

MDO Article: The Value Of Eye-Tracking Software In Medical Device Usability Testing

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

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MDO Article: Staying Dry: How To Limit Wet Injections In Auto-Injector Design

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

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MDO Article: “Achieving Realism In Human Factors Work: How To Stay Out Of Fantasy Land”

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.

Image: Flowchart

MDO Article: “How To Know You’ve Passed Validation Testing (And What To Do If You Haven’t)”

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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FDA to Accept Applications for Expedited Medical Device Approval

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

MDO Article: “4 Proposals To Accelerate The Growth of mHealth”

What 4 things should app developers, traditional medical device and pharmaceutical companies, and regulators do to accelerate the growth of mHealth? Read more

Now Hiring: Research Associates

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.

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Steve Wilcox Co-Writes AAMI Guidance

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.”

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Serious Medication Error Reminds Us of the Value of Testing

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).

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Feeling Good about Getting Well

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?

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