I&#x27;ve thought about this a lot. I&#x27;ve had private conversations with the CEO which lead me to believe that their apathy is a, if not the, primary driver in this situation, at least within the company. Ultimately, they are the single individual who can force these changes in the departments. As things stand today, as far as I can tell, the CEO and the rest of the executive team got theirs and that&#x27;s that. Anything extra is just that, extra.<p>We&#x27;ve been close to undergoing &quot;major&quot; scrutiny (as it was sold to me, it was A Big Deal) from the FDA before. I, personally, just a lowly and underpaid engineer, have saved executive staff from having to sign their names on that noose. I had a manager once who seemed to want to push it that far, to stand idle-by while the walls fell down around us. I, unknowingly at the time, prevented it from happening because I was trying to help our customers. I don&#x27;t regret that decision, actual patients shouldn&#x27;t have to suffer because of a management teams ineptitude. I do think about it often, though. I understand this is nebulous, and I&#x27;m sorry for that. This is a reality, though.<p>I guess that&#x27;s the thing that really gets me, the FDA. We sell FDA approved devices. Where the fuck is the FDA? We send them paperwork and they are happy. I can only form the opinion that they, the FDA, are ill prepared to handle this situation; The actual situation, the &quot;the medical devices industry is a fucking train wreck waiting to happen&quot; situation, and especially so they are ill prepared to handle it at scale. Audits are cursory and almost as a rule non-technical. I suppose it&#x27;ll take a Toyota-level incident to bring change about.