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QMS requirements for legal manufacturer when outsourcing manufacturing process

#21
I don't think most device companies do much of anything anything directly related to patients. Development should include establishing both user requirements and design specifications. (I think of specification development as a narrow activity; medical device/product development as a much broader one, of which spec development is just one piece.) If "voice of the customer" is practiced, the customer tends to be taken literally...whoever is going to buy the product from the manufacturer, which is usually not patients. For many startups, the real customer is investors, and the focus is often as much or more on convincing investors that users require what the startup is developing, rather than on finding out what users actually require. It's possible the companies that sell directly to patients on Amazon do better at assessing patient needs, but I rather doubt it.

Anyway, cyclical or not, I'm at the point of diminished returns. Any further, and I'll have gone well past my current understanding. As it is, you've pushed me to the limits, which is a good thing.
 

Ronen E

Problem Solver
Staff member
Super Moderator
#22
Anyway, cyclical or not, I'm at the point of diminished returns. Any further, and I'll have gone well past my current understanding. As it is, you've pushed me to the limits, which is a good thing.
Let me push you a little further...
To me this discussion is not about winning a point, it's more about sharing opinions and highlighting issues. I'm happy to keep going as long as it's interesting, but if you're exhausted we can definitely call it a day...
I don't think most device companies do much of anything anything directly related to patients. Development should include establishing both user requirements and design specifications.
a. I wrote "patients and users", not just "patients", and a device may have many users that are not patients or even carers (e.g. the biomedical technician in the hospital). Maybe some "device companies" (not sure what exactly you include in this term; I'll assume medical device developers and manufacturers) don't do anything directly related to patients and users, but I think it's a bad practice, and I don't think that it's true for the majority of such companies. My visits to hospital wards, operating theatres etc. were arguably the most fruitful part of my activity in medical devices development and improvement.

b. Of course "development" includes collecting inputs from usesrs, that's why I wrote you didn't mention it explicitly. It's not being petty; it's important because we were discussing "core" vs. "non-core", and I'd think that core activities should never be implied from something else. They should be called out loud and clear. I think that interacting with patients and users for the purpose of creating better medical devices is the single most important activity a spec developer can take, so a "core" activity for them in my view.
For many startups, the real customer is investors, and the focus is often as much or more on convincing investors that users require what the startup is developing, rather than on finding out what users actually require.
This is a rather cynical view, but sadly I have to admit I've seen it from up close more than once. I believe that such short-sighted strategy may lead to some personal success (as in a successful exit for the founders), but it's not a good predictor of long-term viability for the company (other than as an minute division in a large multinational).
It's possible the companies that sell directly to patients on Amazon do better at assessing patient needs, but I rather doubt it.
If they don't do a fair job at it, they'll be out of business quite quickly. It may not look so glamorous because these are usually OTC / low-risk devices, but the companies that succeed are probably getting it right.
 
#23
Let me push you a little further...
To me this discussion is not about winning a point, it's more about sharing opinions and highlighting issues.
Absolutely. I don't even know that I always agree with me, but I will post something that sounds ballparky for people to comment on anyway, as the comments help inform and refine my perspective. I also find the process of articulating a perspective (whether I agree with it or not) is also informative, as this pushes me to think it through.

I'm happy to keep going as long as it's interesting, but if you're exhausted we can definitely call it a day...
Well, just exhausted, I can always get a good night's sleep for that. More like mentally overloaded and need to think a lot more about these things before I can absorb any more. So, done (in) for now, but probably something I'll pick up again another day. Plus I've come out the other side of a lot of things and have other things I'm eager to pick up now.

This is a rather cynical view, but sadly I have to admit I've seen it from up close more than once. I believe that such short-sighted strategy may lead to some personal success (as in a successful exit for the founders), but it's not a good predictor of long-term viability for the company (other than as an minute division in a large multinational).
Indeed, I am unapologetic cynic. But this isn't really cynical, it's just the way these things go, IMO.

And this is one of the things I want to pick up, although it's not at the top of my queue. I want to look at what actually happens with startups, as opposed to all the hype and spin. (Starting with X% of medical device startups fail, like there is a database of startups out there that one can use as the denominator for that percentage.)

I would call it financial success, which I tend to think is not personal success. Money is pretty impersonal.
 
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