Watchcat Wisdom

Incessant Quotes

Friends, family and close colleagues will tell you that I repeat these quotes incessantly, and I will tell you that I repeat them to myself far more often than to others.

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Never attribute to malice that which can be accounted for by stupidity.
Hanlon's Razor, Robert Hanlon

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No matter how cynical I get, I can't keep up.
Lily Tomlin

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All organizations come to the same bad end...serving themselves instead of their mission.

Julie Omohundro

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Those who seek happiness, believe.  Those who seek the truth, inquire.
Friedrich Nietsche

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In politics, it isn't just that everything is a lie, but that, with astonishing regularity, it's the opposite of what they are telling you.
Free Spirit

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It isn't what you don't know that gets you into trouble; it's what you think you know that you don't know.
Variously attributed

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Do or do not. There is no try.

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All men are ignorant, just on different subjects.
Mark Twain

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A conclusion is simply where you stopped thinking.
Martin H. Fischer

The Way I See It

I've given a lot of thought to many topics, including some relevant to a Regulatory Watchcat. I plan to share some of these thoughts here.

What Is It with Medical Devices, Anyway?

Over the years, this question has been put to me, not a lot, but often enough that I have usually had an answer ready.  However, that answer has evolved over time.  I'm going to recount that history and muse about where I stand on this question now.

On Science

Science can be defined on multiple levels. Much confusion arises as a result.  I'm going to take a shot at unraveling that confusion, as well as my thoughts on how science should be applied to medical devices.

On Regulatory

My profession has always suffered from a perpetual identity crisis.

Within the industry, Regulatory is often confused with Compliance, which is a Quality function, not a Regulatory function.  For reasons that remain a mystery to me, many Compliance professionals are not satisfied to be Quality professionals, and instead insist they are Regulatory professionals.  I'm going to take a shot at resolving that crisis. (How's that for going big or going home?)

How the 510(k) Destroyed...

When I first thought I might write something under a title that began with these words, I thought it would end "...innovation in the medical device industry."  Later, I thought maybe with"...the medical device industry."  Now, on a bad day, I think maybe "...the world as we know it," or maybe "Western civilization."  To be fair, I can't really connect those dots, so that is less on the order of a prediction than a measure of my discouragement with the whole thing. I think this is one of those things that I won't know what it's about until I finish writing it.  Hope you can stand the suspense.