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>Also - if you've worked in the medical industry, you know how vastly overpriced and bureaucratized everything is. Quality guy here,though not in medical devices... Yet. Still trying to get up to speed on all the regulations; but I know enough to be able to vouch for some of the bureaucracy around the industry. The risks in medicine being what they are, when launching into any novel space, there is simply no substitute for A) data and B) audit trail. Your data varies from lot numbers of source material from suppliers (contamination happens), batch numbers of parts (and revision numbers of the process involved in making that batch) from manufacturers, to serial numbers matched up to individual patients in order to be able to implement some form of high-level statistical process control, and rapid intervention when things go wrong in order to figure out why, what you can do about it, and who else may be at risk. No one wants to be the one told "whoops, someone goofed, and that thing we put you on is trying to kill you," anymore than anyone in the chain from treatment inception, to installation wants to hear that they missed something, and even worse, get caught not knowing what to do about it. That means paperwork, signalling mechanisms, and procedures involved with marshalling whatever response is to follow, which is not at all a trivial process to orchestrate, and while all of us wish there wasn't so much bullshit, there are plenty of examples where "falling asleep on the job" has led to catastrophic outcomes. I can't necessarily say I that justifies the overriding though. The markups are ridiculous, but without access to the books, I can't really discount it either. |