Elvis Pointing to Me – Now That’s Quality!

Quality is King – but many medical device companies are heading for the bloating, dangerous stage for quality systems. Research shows it does not have to be that way.

I wrote a blog post recently that is on the new blog site “Manufacturing Geek” and I’m just delighted

  1. to be on there, since I am totally a manufacturing geek
  2. that they chose The King as the photo (thanks Eric!!!)

The post pulls from the MESA Metrics research special report using the medical device industry data, Redefining Performance Goals to Unlock Business Improvements: A New  Focus for Medical Device Manufacturers.
This research shows that most medical device companies have not made significant improvements in non-compliance events.

How can that be, since so many companies spend plenty of time and effort on quality systems?  My perspective is that, much like the diet that made Elvis fat and eventually unhealthy, the focus was on the wrong thing.  He focused on sugar and fat (fried food and marshmallow fluff) that felt good in his mouth, but did not make him feel so well afterward.  If you focus on compliance and systems to correct problems, then you probably don’t have time for prevention and making the changes that will help you in the future.

The medical industry is famous for putting employees on shifts that are not good for their health – but the medical device industry can make better choices and improve the health of its quality systems.  Make the shift to focus on the PA part of CAPA, so you have less CA to do.  Quality at the source is a completely different way of thinking and working, but the regulators are providing encouragement for QbD, TPLC, and quality that will not only have better outcomes, but cost you less.

Pressure on device pricing will only grow in markets worldwide, so lowering the cost of quality can really matter.  As the King sings “It’s now or never…”


Redefining Performance Goals to Unlock Business Improvements, copyright 2012 MESA International and Cambashi Inc.

Manufacturing Geek is sponsored by Camstar, who was my first client as an independent analyst after leaving software marketing at Baan.

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