Evidence is easy. Understanding it is hard.  The world is overrun with people who want to use evidence, and short on those who want to understand it.  Much evidence is collected, analyzed, and reported by those who understand neither evidence nor their subject matter. No doubt many don't want to.  Others want to, but can't, leaving their good intentions to pave the way.

In the industry, a lot of evidence is collected to show something, e.g., substantial equivalence, safety and effectiveness, compliance. In law, evidence is collected to make a case. In marketing, to persuade.  This leads to talk of whether evidence is "fit for purpose."

Thus, the world is drowning in evidence and starved for understanding.  For this project, the Regulatory Watchcat aims to stay focused on evidence presented as contributing to an understanding medical device regulation, but that simply spreads misunderstanding instead.

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FDA Impact on U.S. Medical Technology Innovation:  A Survey of Over 200 Medical Technology Companies. Josh Makower, MD (Stanford University), Aabed Meer MD-MBA (Stanford University),  Lyn Denend (Stanford University).  With support from MDMA, NVCA, and multiple state medical industry organizations. Independent data analysis and verification by PWC. November 2010.

This is the evidence that started it all.  The first time I came across it, something in me crossed over. And eventually a Regulatory Watchcat emerged out the other side.

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The publication is one of legions of such publications, which report, not very well, the results of a survey based on marketing, rather than scientific, methodology.  All three authors have MBAs, which probably explains it. A couple also have MDs, but that's irrelevant, since this is not a publication about the practice of medicine. It's not a publication about business, either.

It has taken a long time for me to review this publication. For a long time, I simply couldn't get through it.  Each effort ended in an unpleasant combination of dismay and nausea. At the time, I wasn't ready to roll out The Regulatory Watchcat, so nothing was to be gained by perseverance.  Instead, I asked around about the history of the publication. Some day I might try to track down documentation of that history.  Like all products, this one is the result of the process that led to its creation.

To me the single most remarkable thing about this publication is that it pretty much says out loud that many "innovative" medical device startups wouldn't spend a dime to assure the safety and effectiveness of their devices if FDA didn't make them do it. It's not at all remarkable to encounter this mindset among the "innovators," but until I saw this publication, I was under the impression they thought it prudent to avoid admitting it in public, much less in print.

Otherwise, It take it as a textbook example of what happens when amateurs try to develop medical devices, including the amount of other people's money wasted in the effort. It's my impression that, when it was published, some players in the industry were genuinely stunned to discover what was going on during the 510(k) feeding frenzy, while others were "shocked to hear."  There seems to have been some scrambling to do damage control, including some initiatives to improve matters.  Whether matters have improved appreciably, color me skeptical.  Perhaps the only really substantive improvement was that word got around in startup land not to say stuff like this in public.

Click on the icons above to read the report and my review, which is still an early work in progress.

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Modernizing the FDA's 510(k) Program: Request for Comments

Click on the icons below to read FDA's request for comments, the Regulatory Watchcat's comments, and my summary of all the other comments posted to regulations.gov.

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Regulatory Watchcat's Summary of Comment

I posted this one under Evidence because I don't have a project titled No Evidence and don't especially want one, although I recognize the potential.

Comparison of rates of safety issues and reporting of trial outcomes for medical devices approved in the European Union and United States: cohort study.  Thomas J Hwang (Harvard University), Elisaveta Sokolov (King's College London), Jessica M Franklin (Harvard Medical School) & Aaron S Kesselheim (Harvard Medical School. BMJ 2016;353:i3323 

Reviewers: Alan Fraser (University Hospital of Wales, University of Leuven, Wales Heart Research Institute Cardiff University), Art Sedrakyan, MD, PhD (Weill Cornell Medical College), Diane Zuckerman (National Center for Health Research)

This article fails, as so many bad research articles do, first and foremost on its authorship.  Second, on its reviewership, and finally, on its editorship.  

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It attempts to report a study that attempted to compare US and EU medical device regulatory frameworks.  As best I can tell, none of the authors, reviewers, or editorial board members ever worked for a medical device company with products on the US or EU markets, much less had responsibility for getting a device through either CDRH or an EU notified body.  

The result is pretty much what you would expect, made worse by poor writing.

I first came across the article when it was published in 2016. 

I posted some preliminary comments to the BMJ website at the time.  I have continued to review it on and off since then.  There is so much that is wrong and bad about the article, I may be at it for years to come.  When I'm done, I will have looked, not only at the article, but also at the authors, reviewers, and editorial board members, all of whom I would like to see prohibited from touching anything involving the regulation of medical devices, ever again.

In the interim, you can read the article by clicking on the icon above.  The other two icons are currently inactive.

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KHN Article on "Hidden" FDA Reports

I have a long-standing, deep animosity toward the media.  I think it is by far the single most destructive force in our society.  I avoid it like cats avoid water.  However, I owed a friend a favor, so when they asked my opinion of an article they had read recently in Kaiser Health News, I acquiesced. I read the article and gave her my unfiltered opinion. Astonishingly, she is still speaking to me.

Then I spent the next two weeks walking around, the house, telling myself to "just let it go, just let it go."  Eventually it became clear that that I could not let it go.  Instead, an exorcism was needed.

Click on the icons below to read the original article and my Watchcat rant.

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