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Not saying it doesn't happen, but the situation in medical devices is more complicated.

• iancmceachern 3y ago
  It's not really more complicated, just different. It's funny, the F in FDA stands for food, so you still need to deal with the FDA and its regulations, just different ones. Its really more of a paperwork/comiance thing than anything. I.e. genaric drugs. Source- I've designed medical devices and food processing equipment for 20 years.
  • ska 3y ago
    I shouldn't have been so terse. I didn't mean to suggest that the regulatory side didn't exist in commercial food equipment, obviously it does. OP seemed to suggest that medical devices was rife with situations parallel to McDonalds/Taylor, and that just doesn't seem to be the case; partially because the landscape is more complex in terms of who pays, how liability is distributed, and how the maintenance work is done, etc. Which isn't to say device industry doesn't have lots of its own problems, they just look different.
    • iancmceachern 3y ago
      I am OP, and the parent commenter to this comment both. I was making exactly the opposit point you are. I have actually worked directly with the manufacturer of the pumps in those machines (Watson marlow), and also designed and saw through to clinical release many similar complex medical devices with the same exact pumps. The situation is nearly identical between these two examples, it's just the names of the forms you need to fill out are different, and the division of the company that supplies your components is different, but it's all the same thing just a different name.
      • ska 3y ago
        Ok, I confused myself somehow about who I was replying to, my apologies. The OP is jmsflknr though, no? However, my point was not meant to be about the pump design nor the regulatory bodies involved, so I think we are just miscommunicating. My fault for quick replies. I was responding to "There are so many of these situations in medical devices." by which I took you to mean that there are many parallel situations the the McDonalds/Taylor issue in the linked article and the franchises inability to keep them in service, or accept 3rd party help in doing it; I read this as the core point of the article. When I said "things are more complicated" I meant the relationship between the various entities and how systems get deployed, managed, maintained, etc. doesn't look the same. So is that what you meant? It's possible you just mean there are similar technical issues in the pumps, something I'm happy to accept you have direct experience in; in that case I just misread you. If you had said there are similar (identical) pumps in some medical devices I would have understood it that way. It read to me like you were making a far broader claim.
        • jt2190 3y ago
          Not the OP, but I think the mistake many people make is that they assume that the goal is to get the machine pumping out ice cream, without considering that the ice cream might make people sick because the machine wasn’t properly sanitized as well. Hence the regulations and paperwork.
          • ska 3y ago
            This isn't about the regulations (which must exist and do have some parallels) but about systemic differences in how the industries work which mean that it wouldn't play out the same way it has in fast food franchises, is all.
        • iancmceachern 3y ago
          I'm replying here because I cant reply to your comment below. I'm still saying the opposite, I'm saying that those 2 industries (food equipment and med devices) are actually very similar in the way they operate. Having direct experience in both. Good manufacturing practices, maintenance, etc. Are all the same no matter the application. Things are remarkably similar if you look past the surface level.