QMS requirements for legal manufacturer when outsourcing manufacturing process

[Ronen E]

Maybe more my startup hat, as they love to do V&V with prototypes that they have no idea how to manufachave for market.

Another example why "V&V" is a bad concept. Verification and Validation are two separate and very different things! There's nothing wrong (engineering-wise and regulatory-wise) with using prototypes for Verification, even if they're not mass-produceable and even if you don't yet know exactly how you'll do it. Validation, on the other hand, MUST be done with units made in the commercial production line or equivalent to ones that would be.

Another terminology comment - what "design requirements" relates to is not always clear, as different orgs / people assign different meanings to it. ISO 13485 speaks of User Needs, Design Input and Design Output.

 

[Watchcat]

Hmmm. No one has a problem with B&B, although a bed and a breakfast are two very different things, or D&D, although dungeons and dragons are two very different things. I do think it gets confusing when you throw software validation into the mix..

Design validation can, and sometimes has been, done with prototypes, and regulators can, and sometimes have, accepted this. But this can be risky, because then any changes made to the design on the way to a validated manufacturing process could render the validation invalid.

 

[Ronen E]

Hmmm. No one has a problem with B&B, although a bed and a breakfast are two very different things, or D&D, although dungeons and dragons are two very different things. I do think it gets confusing when you throw software validation into the mix..

I don't have a problem with the "&" concept in general... The problem in "V&V" is that it leads people to think of it as a single, coherent, activity, while in fact these should be two separate and quite different activities, with the second one not even intended to follow right after the first in a single stroke. There is a lot of wisdom in this intentional gap, and some things that need to happen before the project is truly ready to move on to Validation.

I recently hypothesized that this common mistake was brought over from the software world, and it's now becoming so prevalent because SW is now very common in medical devices, and becoming even more so by the day. In the SW world there is no physical product, so some of the concepts and processes actually become redundant, and maybe it does make more sense in that world to bundle the two Vs together - I wouldn't know because I'm not a SW expert.

Design validation can, and sometimes has been, done with prototypes, and regulators can, and sometimes have, accepted this.

This is (and IMO should be) the exception rather than the rule.
Regulators are not very well known for uncompromising consistency...

 

[Watchcat]

I try to leave software to the software geeks, but now and then I just have to sit down and figure it out. As I recall, these terms not only mean something different in software, but they are either reversed, or the one means the other, and the other means something which has no equivalent in hardware. Or something equally confusing. (I was originally exposed to all four at the same time, with no tech background at all, and it left a scar..)

Back to hardware, I tend to think V&V are related, in that you shouldn't validate until all your verification is done and looking good. I also tend to think of validation as the cherry that sits prettily atop the verification cupcake. As for a gap, my only knowledge of this is as an indicator that something has not gone well in verification, so it's usually a gap filled with design engineers whispering among themselves, hoping they can get it sorted out before the next status report is due, along with silence from me and the product manager, as we hope for the same thing and are restraining ourselves from asking. Otherwise, not a gap so much as a another step, which is (hopefully) a design review.

 

[William55401]

Great thread. Here's an URL related to an FDA warning letter on a spec developer who did not have expected QMS elements in place. This may be useful to understand what QMS elements to focus. I am currently coaching a client in this Spec Developer space and this article helped get them moving in the right direction.

What is needed for FDA QSR compliance as a Specification Developer |

 

[Watchcat]

focusing on core strengths such as marketing

You say that like it's a good thing.

I'm inclined to see "medical device companies" that focus on marketing as more like car dealerships, which I don't think of as "car companies," just retailers. Maybe also something like department stores, where "we just sell 'em."

 

[Ronen E]

Otherwise, not a gap so much as a another step, which is (hopefully) a design review.

This is partly what I meant. A gap in the sense that one doesn't automatically follow the other and therefore combining the two into a single activity is wrong because it forces an assumption that "everything will be all right" (which is seldom the case) and then you end up in situations where people are whispering to each other in terror or embarrassment or both.

The "gap" would many times contain much more than a design review because design verification would be a mix of theoretical analysis and prototype testing, and design (product) validation would require first setting up some sort of commercial production line or an equivalent. This is a point where I can see a big difference between SW and HW and maybe that's one of the sources of this mix up.

 

[Ronen E]

I'm inclined to see "medical device companies" that focus on marketing as more like car dealerships, which I don't think of as "car companies," just retailers. Maybe also something like department stores, where "we just sell 'em."

Sounds like you are confusing distributors with spec developers, and sales with marketing.
Knowing, and really understanding, the patient and the user are many times as important or more important than the engineering.
There is bad marketing and good marketing, just like with engineering. It's a little unfair to paint marketing as "bad" and engineering (or whatever) as honourable.

 

[Watchcat]

It's not marketing vs engineering, it's "core" vs the complete range of strengths needed to support medical device development, manufacture, sales, distribution, etc. Depending on which core, I have different impressions. I don't think of a spec developer as a "medical device company," either. But that's just me.

I always say a good product manager is worth their weight in gold. But most product managers are really just marketing managers, and not always good ones, either. Those that really have the full breadth, those are the ones that bring high value to the company. Whatever kind of company you want to call it, lol.

 

[Ronen E]

It's not marketing vs engineering, it's "core" vs the complete range of strengths needed to support medical device development, manufacture, sales, distribution, etc. Depending on which core, I have different impressions. I don't think of a spec developer as a "medical device company," either. But that's just me.

IMO this is a bit of a cyclic argument. I noted that in your activities list ("development, manufacture, sales, distribution, etc.") you explicitly called out none directly related to the patients and users, so of course spec developers wouldn't be thought of as "medical device companies" - that is (or should be, IMO) their main focus and purpose.

I used Marketing and Engineering as tags, but I think you get the spirit. "Core" is in the eye of the beholder. To me it doesn't matter what a company perceives* as its "core" (what others think of it is less important, though not nil - depending on who they are); the important thing is that they have some fairly-clear perception of having a specific core, and an understanding that they need to focus on that while non-core elements can be, and are sometimes much better, outsourced.

*) When I say "a company perceives" I refer to what its leaders perceive, of course.