The Regulatory Watchcat
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.
Never attribute to malice that which can be accounted for by stupidity.
Hanlon's Razor, Robert Hanlon
No matter how cynical I get, I can't keep up.
Lily Tomlin
All organizations come to the same bad end...serving themselves instead of their mission.
Julie Omohundro
Those who seek happiness, believe. Those who seek the truth, inquire.
Friedrich Nietsche
Question EVERYTHING.
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
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
Do or do not. There is no try.
Yoda
All men are ignorant, just on different subjects.
Mark Twain
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.