Tag Archives: medical device manufacturers

Benefits beyond the “have to”

Nearly everyone has “have to” or “should in their vocabulary, and feels there are things that fall into those mandatory categories. For individuals that might be spending time with difficult family members, getting regular exercise, and paying taxes. For manufacturing companies, much of that is regulatory or customer compliance. We often feel these as major […]

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UDI: Medical Device Profits at Risk – Unnecessarily

How many companies’ profit margins will plummet because of the FDA’s Unique Device Identifier (UDI) requirements? Quite a few, I imagine. Don’t get me wrong. I am not opposed to the regulation. I think it makes sense, and that companies will comply. The question is: at what cost? I believe it is possible to comply […]

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Elvis Pointing to Me – Now That’s Quality!

I wrote a blog post recently that is on the new blog site “Manufacturing Geek” and I’m just delighted to be on there, since I am totally a manufacturing geek 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 […]

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It’s time for Medical Device companies to Grow Up!

The purpose of a business is to make money – and in manufacturers’ case, they do that by making things.  Seems pretty obvious, but when you wade into the heavily regulated world of medical device manufacturing, confusion reigns on that point.  Because these companies spend so much time worried (with some cause) about regulators and […]

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Portfolio

We love to share what we know.  Julie Fraser writes and presents regularly, and has done so for many years. Often she works with associates who also write and present.  In hopes that some of this material might be useful for you in your work and/or your life, we are making some papers, research reports, […]

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