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We need a QMS: file-based templates or software

Ronen E

Problem Solver
Staff member
Super Moderator
#11
To me this is also pretty scary:
We assume we will be bought out by a bigger fish before we have to commercialize the device.
Marc, unfortunately this is a trend now. The big fish actually prefer the little fish very lean, so they are easier to swallow and digest, i.e. so they don't have to assimilate a preexisting sales and logistics system/force. It's actually easier and more convenient for them to erect such a system as an internal division of their own, or just as an add-on to an existing product line. And for the little, dreamy-eyed fish, it's a very sweet dream, because introducing a new device to the market and generating ongoing sales is arguably the hardest task.

Added in edit: Some new devices will be bought by big fish only to bury the competition. To some startup entrepreneurs it wouldn't make a difference - they get the cash anyway.
 
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Ronen E

Problem Solver
Staff member
Super Moderator
#12
We are a pre-revenue medical device, US-based company with about 6 months to go till finishing pivotal clinical study for eventual PMA submission.
We assume we will be bought out by a bigger fish before we have to commercialize the device.

We need a QMS and are struggling with buying Word/Excel file-based templates for < $1K or spending > $2.5K for software/web based system.

Any suggestions from those who may know better than our guessing?

TIA!
This is going to end in tears, in my opinion.

Are you already running the clinical study or just hoping to start and finish it in about 6 months from now?... If the former, I find it strange you have gotten so far without any QMS or anyone on board with meaningful experience or understanding in/about it. Either whoever approved that study was/is careless/reckless, or you are about to be hit with all kinds of related requirements quite soon.

No big fish will look at you without a finalised or close-to-finalised PMA (assuming that PMA is indeed your right path), and I can't see it happening while you have no QMS or just a cover-up one (which - no offence - is what you will get investing that little).

The main thing you need to understand is that a proper QMS is not a fig leaf or a tick in a box. It is what actually sets apart real medical device developers and manufacturers from bogus and wannabes. If you're not willing to invest AT LEAST US$10k in a QMS to support a class III device venture, you're not being serious about yourselves and I'd wager a bet that you'd end up swallowed by oblivion rather than by a big fish.

Sorry to be blunt but I think it's for your best.
 

Marc

Captain Nice
Staff member
Admin
#13
Marc, unfortunately this is a trend now. The big fish actually prefer the little fish very lean, so they are easier to swallow and digest, i.e. so they don't have to assimilate a preexisting sales and logistics system/force. It's actually easier and more convenient for them to erect such a system as an internal division of their own, or just as an add-on to an existing product line. And for the little, dreamy-eyed fish, it's a very sweet dream, because introducing a new device to the market and generating ongoing sales is arguably the hardest task.
It may be the "new normal" to expect to be bought out, but it isn't a bet I'd make. I think for many new startups it may be their bet on a dream, but how many companies with that intent are actually bought out vs. just go bust.

And I realize that these days many times a business buys out another for one reason or another. ATT bought out Direct TV and - What a bust. Facebook bought out Whatsapp (after which I deleted Whatsapp from my iPhone) - Who knows what the gain was to Facebook.

List of mergers and acquisitions by Microsoft - Wikipedia
 
#14
I personally prefer software only because it easier to monitor and make people accountable without digging into the files. However in your context because you are starting out best stick with paper first and then evaluate software later. However stay away from templates, if you already have consultants that assist with the content they should have their own templates to work from and which they can apply it to your organisational context.
 

bob44

Starting to get Involved
#15
Yes; our QMS advisory firm want $35k for their "templates" and some $40-50K more for assisting with revision/content development.
So, seeing how I can get a linked system with templates for $3k, I save $32k on the templates and they can help with the revision/content in a system that allows for tracking of versions, training, etc...not avail on paper-based system. I don't see where this is a bad idea?
 

Tagin

Involved In Discussions
#16
Yes; our QMS advisory firm want $35k for their "templates" and some $40-50K more for assisting with revision/content development.
So, seeing how I can get a linked system with templates for $3k, I save $32k on the templates and they can help with the revision/content in a system that allows for tracking of versions, training, etc...not avail on paper-based system. I don't see where this is a bad idea?
I'd say you need to seriously shop around for another 'QMS advisory firm'.
 

Tagin

Involved In Discussions
#18
Long story; kinda of forced on by uppers.
In that case, I don't see where you have many options, unless you can somehow acquire more in-house QMS expertise. If that's who upper mgmt wants to use, then so be it. Let them sign the checks, and move on.
 

bob44

Starting to get Involved
#19
Thanks all; I appreciate the suggestions.
Once we get it rolling, I'm sure I'll have a question or two that would benefit from the expertise of the forum's members.
 

Ronen E

Problem Solver
Staff member
Super Moderator
#20
Same old story: A company hires a "bad" QA advisor, unhappy with the results they come here for "good" QA advisors to do the job (=provide advice) for free, then still pay the bad one. Makes a lot of sense.
I can get a linked system with templates for $3k, I save $32k on the templates and they can help with the revision/content in a system that allows for tracking of versions, training, etc.
That's an over-simplistic thinking:
1. Good luck with getting "a linked system" that's worth much for $3k.
2. Why do you think your overpriced "QMS advisory firm" will be so happy to work with some random $3k system you found?
3. To get "a system that allows for tracking of versions, training, etc." working well in your own org you will have to input quite a lot of work - these systems hardly ever work as advertised straight out of the box (and then, refer to my item 1 above).
 
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