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After hearing about this documentary from a friend of a friend, I wanted to watch it myself since it's one of the few topics I might have a prayer of an informed opinion on given my employment in clinical research. I started hijacking the OPs threads, but fortunately they have comments on a screen process, so I was able to dodge that faux paux and bring my yammerings here.
ETA Credentials: I worked for a contract manufacturer of Class I Medical Devices for 5 years as Quality Control before moving to a contract research organization performing Phase I and early Phase II Clinical Research (in-human trials) in 2016. I transitioned from Quality Control into Quality Assurance in 2018. Both industries are heavily and intimately regulated by multiple bodies, including the FDA and the European Union. Paperwork is my life.
The documentary itself was very much in line with any documentary - skating the edge of sensationalist exploitation of personal tragedies by way of Serious Faces and some text-on-screen data. Near as I can tell, that's what good documentaries do, so fair enough?
I took issue with a couple points, but overall I'm glad I watched it. I learned some interesting and depressing things. I will definitely pay closer attention to any Class III devices being foisted upon me, and I will thoroughly vet my surgeon's qualifications using any devices should that situation come up.
Under the cut is a very extensive breakdown of my take on a few of the movie’s points, including links to FDA websites specific to issues at hand.
( I do go on. )
ETA Credentials: I worked for a contract manufacturer of Class I Medical Devices for 5 years as Quality Control before moving to a contract research organization performing Phase I and early Phase II Clinical Research (in-human trials) in 2016. I transitioned from Quality Control into Quality Assurance in 2018. Both industries are heavily and intimately regulated by multiple bodies, including the FDA and the European Union. Paperwork is my life.
The documentary itself was very much in line with any documentary - skating the edge of sensationalist exploitation of personal tragedies by way of Serious Faces and some text-on-screen data. Near as I can tell, that's what good documentaries do, so fair enough?
I took issue with a couple points, but overall I'm glad I watched it. I learned some interesting and depressing things. I will definitely pay closer attention to any Class III devices being foisted upon me, and I will thoroughly vet my surgeon's qualifications using any devices should that situation come up.
Under the cut is a very extensive breakdown of my take on a few of the movie’s points, including links to FDA websites specific to issues at hand.
( I do go on. )
