Lynde Kintner, design researcher, shares her reactions to a recent presentation on the recently released Human Factors Standard HE 75.

Michelle Wu reflects upon whether Design Reviews are a Moral Hazard in the first part of a two part series.

Meredith DeZutter reports on a recent visit to an FDA workshop on Home Medical Devices.

A year ago I was told that I needed to read and understand 13 (out of 67) company “Standard Operating Procedures” (SOPs).  Until that time, I had no comprehension of what an SOP was, and after I read through the towering stack, I still couldn’t figure out what they were, or why it was so important that I become familiar with them.  Let me rephrase this: it took me 3 valuable hours to read materials that I didn’t understand, but that were in theory supposed to help me do a better job as Director of Design Research.  As I began speaking to my colleagues across the company – those in Design, Manufacturing and Quality, for example, I learned that they too found them difficult to understand and follow.   Clearly, something had to change.

So you think you are ready to manufacture a device?  As the numerous near life-size cut-outs illustrate, a number of questions must be answered and worked on by various areas of expertise at Ximedica before our clients are ready to ship physical product out the door.  There is definitely more work than just assembling the parts of the device together!