Posts categorized as“Manufacturing”

When most people think of Lean Manufacturing, they think of large, gleaming, gazillion square foot manufacturing spaces where every surface is clean, meticulously labelled and taped off.  Happy workers reach for their conveniently placed tools on their shadow boards and work on mistake-proof assembly stations. They think of Toyota, or Boeing, or any manner of […]

In a previous medical device company, I worked on a project where First-to-Market (FTM) was a deemed a priority for the company’s survival.  To meet that highly compressed timeline, we decided to skip the phase-gate process and replace it with a FTM production release strategy. FTM product commercialization carries a much higher overall project risk […]

There are lots of stories about FDA recalls where the FDA notes that if the vendor had followed the FDA’s approach, the recall could have been avoided. With that as our inspiration, our blogging team of medical device designers, developers, QA/RA, and manufacturing professionals recently brainstormed 11 medical device development mistakes that have surfaced multiple […]

The New Year brings reflection and desire to improve.  We asked our designers, engineers, manufacturing, supply chain and regulatory experts to consider projects finished in 2017 and think about things they could have done better or wish they had considered. Here is their list of 2018 resolutions and smart things to do that would speed […]