Updated EU MDR regulatory matrix wanted

Watchcat

Trusted Information Resource
#11
As far as the general public is concerned, EUDAMED 1.0 worked/works well. Technologically, it mostly met it's upfront defined goals. It was never meant for the general public use. If it "failed", it was more a matter of general EU (cross-Member-State) policy/conduct.
Yes, I gather it was something like that. At one point I was going to post a query here, about what was the problem. Maybe I did and don't remember. Everyone I knew who had any basis for an opinion seem to think there was one, but I had no direct experience with it myself. The comment I got most often was on the order of "Oh, it works fine. There just isn't much in it."

All I know is that, whenever it came to mind (which wasn't often) I would think it was kind of ironic, all of these people searching all these safety databases all over the world for data to include in an EU CER, except for the EU safety database.
 
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Watchcat

Trusted Information Resource
#12
slowly but surely you drive independent consultants out of the market and eventually you'll be left with only a handful of big expensive RA firms that won't even be interested in your SME business because they'll have plenty of work and income from your multinational competitors.
Less slowly, lately, I'm afraid. I'm pretty connected with the device RA community. The last year or two, there has definitely been an increase in independents throwing in the towel. Most them are older (and therefore the most experienced, a loss to the sector). In the US, if they qualify for Medicare and are able to take social security, why not. Many of the slightly younger ones are counting the days to Medicare.

Corrigendum 2 was a blow to many independents. Lots of smaller "up-classified" companies in a panic...great client base for us...and then suddenly they all rolled over and went back to sleep for another four years. The slow pace of NB designation also didn't help, since many companies concluded that there is no rush to "get ready" for the MDR, if there isn't going to be an NB available to certify them for who knows how long. I think some independents were expecting last year to be a banner year, and therefore that much more discouraged by dashed expectations.

This is what happens to an industry in consolidation. The larger companies are getting bigger, there are fewer of them, and those that remain are more and more in control, pushing smaller competitors out. Larger companies have always hired the big firms for serious RA consulting, and used placement agencies to hire temps for the RA grunt work. Meanwhile, the smaller companies are feeling the pressure, and trying to cut costs even more. Even if they hire consultants, often they've cut costs so much, it's a frustrating environment to work in...and this frustration is shared by the employees as much as the consultants.
 

Ronen E

Problem Solver
Staff member
Moderator
#13
Yes, I gather it was something like that. At one point I was going to post a query here, about what was the problem. Maybe I did and don't remember.
Yes, you did.
I already wrote about it, along similar lines, several times in Elsmar.
"Oh, it works fine. There just isn't much in it."
Define "much".
There surely isn't much in it for the general public.
For its intended users, it wasn't intended to hold "much", compared with the "much" that's planned to be held in EUDAMED 2.0. Compared with what WAS intended to be there - sure, there could be more (that's the policy/conduct issue I mentioned), but even as it is I think that there's enough there to say that the original goals were met. At least as far as I can tell.
All I know is that, whenever it came to mind (which wasn't often) I would think it was kind of ironic, all of these people searching all these safety databases all over the world for data to include in an EU CER, except for the EU safety database.
That's why they instigated EUDAMED 2.0...?
 
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Ed Panek

QA RA Small Med Dev Company
Trusted Information Resource
#14
Yes, because people like you respond to the questions. You also assume that I haven't asked our consultants the same question.

Perhaps I misread your meaning. Are you suggesting that asking a question on this forum is bad for small QARA consulting business and should be avoided?
 
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Watchcat

Trusted Information Resource
#15
I much preferred the question that arrived in my inbox to the one that I assume you edited it to be, so I'm going to answer that one instead:
Are you for or against people asking questions on this forum?
I'm decidedly in favor of questions like these. I think I've commented elsewhere that these types of forums are always labeled "Discussions," but there is usually very little discussing going on, mostly just Q&A. Where there is discussion, it tends to be limited to the relative merit of the As, not infrequently leading to something a bit warmer than a "discussion."

As for this forum, what I like is mostly moot, because this is not a forum where you are likely to get a lot of thought questions. Sometimes discussions do break out, and I like that. I have further found that discussions are more likely to break out in a forum after I start discussing things, instead of just answering questions. Forums are what you help make of them, and like attracts like. (One thing I think might make the Cove's medical device forums stronger is if they were moderated exclusively by people in medical devices, but that's a topic for another day.)

That said, I am not on a mission to turn Q&A forums into discussion forums. I find some of the Q&A to be of interest and value to me. That is why I'm here. If I post discussions instead of answers, that's just me being me. If it encourages others to do a bit more discussing than just Q'ing and A'ing, for me that's a good thing, but it's not a goal of mine.

There are types of questions I like better than others. Those that I don't like, it's less the question than the fount from which it sprang, as well as where it is likely to lead.

The classic is someone who has never been active in the forums and shows up with a question. Actually, lots of questions, but you have to start somewhere. The quickly approaching MDR date has brought them out in record numbers. In addition, if you are experienced in medical device RA, it is painfully easy to tell who is clueless. These are people who work with either clueless startups (typically, an unholy union of academics and VCs) or very marginal established device companies that have never had any RA anything. Often no QA anything, for that matter.

The clueless startup may have hired someone (employee or consultant) they thought was RA, but a RAC does not an RA expert make. (Nor does prior experience auditing anything, nor a does a JD, nor does previous employment by a regulator.) The painful irony here is that no one needs serious RA more than a startup. But most of them will not get it. Most of them will also fail, almost always slowly, rather than fast, taking a lot of other people's money with them, which was really the point, not actually starting anything. Certainly not developing a "break-through, life-saving, innovative, market-disrupting" medical device that will "improve patients' lives!"

Usually the established companies are marketing Class I devices that are, in the US, 510(k) exempt, and in the EU, self-certified. Not infrequently, marketing their products over the internet. They have no RA because they are essentially unregulated, so what would you need RA for? Nothing...until you get "up-classified." These companies could probably hire at least a reasonably competent RA professional if they wanted to, but they don't. That's why there were selling essentially unregulated product in the first place. to avoid all things RA. At most, they have people engaged in "product registration," who think they "doing RA," but at that level, they are truly "just paperwork" professionals that often get confused with RA professionals. Oh, and there are those that think they are "in RA" because they work in regulated industry. Sigh.

[Just for some comic relief, I get a kick out of reading these kinds of ads on Amazon: "FDA Lipstick: Our Lip Gloss all have FDA test. Materials are Warranted and Trusted." Many of the most marginal device companies in the world also sell cosmetics, no surprise there. I don't think this crowd is likely to be asking questions on Elsmar, because I don't think they could find their way here with a map and flashlight.]

So that's where these questions come from. Where they are leading is also discouraging.

There is the person who bought a job ticket from RAPS, snagged a job with a clueless startup, and is now in the process of wasting some part of their lives thinking they are "in RA," when they are not, and therefore no glorious RA career is going to unfold in front of them. They are not in RA, and may well never be in RA. It's a mindset, not a body of knowledge, not a certificate. If you don't have it, the sooner you realize that and find a career that is a good fit for the mindset you do have, the better for you, the better for the world in general.

As for where it leads in terms of the companies they work for...if it's an academic startup, probably to a slow death, but, on the bright side, it "created jobs!" Not very good ones, mostly, and not for very long, but, hey, it's a myopic world we live in. If it's a marginal device company, these days it is often the small business owner asking, or some poor schmuck they tasked with sorting out the MDR. What they really want to know is whether to pull their devices from the EU, whether they can go 510(k) exempt in the US, and not infrequently, whether maybe it's time to close up shop entirely and move on to something else. If they tasked it out, they didn't tell the poor schmuck this, so the more motivated, the more clueless questions they earnestly ask, not understanding where the answers are likely to lead them.

And then there is the whole question of value of regulatory advice (or any other kind, for that matter) given freely, but even more so, freely over the internet by someone you don't even know. If nothing else, it's pretty awkward (and I have seen it happen) when the boss asks a junior staffer how they know that something is "required," and the junior staffer is suddenly struck by the realization that "somebody on the internet named yodarocks told me so" is not an answer they want to give the boss. Nor an intelligent answer, no matter who they might be giving it to.

I think I'm just going to stop here. Much more I could say, but probably more than enough already.
 
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Watchcat

Trusted Information Resource
#16
Yes, that's the question, isn't it?

There surely isn't much in it for the general public.
I'm pretty sure that was not their perspective. These were people in industry, who, if they cared at all about what was available to the general public, would have been more likely to say that any information at all was too much. I myself am opposed to making information on adverse events accessible to the general public.

For its intended users, it wasn't intended to hold "much"
I think it was voluntary reporting, or perhaps mandatory with no way to enforce and/or no practical way to know what was available to report had been reported? If I had to guess, "not much" meant "only a small percentage of what was intended to be reported." But that's just a guess.

the original goals were met. At least as far as I can tell.
Was there a way to tell?
 

Ronen E

Problem Solver
Staff member
Moderator
#17
Yes, because people like you respond to the questions. You also assume that I haven't asked our consultants the same question.

Perhaps I misread your meaning. Are you suggesting that asking a question on this forum is bad for small QARA consulting business and should be avoided?
Not all questions asked here are the same. There are certain types of questions that I don't answer, that I'd be happy to see less of. People who answer this type of questions are not "like me", and I don't know why they do it. Maybe they are trying to build up a reputation, maybe it's an ego boost, maybe they're bored; who knows?... I'm talking about questions that should be directed to (and should be able to be answered properly by) the company's own QA/RA staff or its hired consultants. If the latter (both) are unable to properly answer, or just don't exist, the right thing to do would be to find and engage ones that can. If the responses are not of sufficient quality, the right thing to do would be to obtain a qualified second opinion, and as necessary pay for it (exactly like one would do seeking, for example, a personal medical second opinion). Of course, these are only my opinions and they don't count any bit more than anyone else's.

I agree with @Watchcat's analysis that this is likely due to "industry consolidation" (ruthless and ceaseless efficiency improvement quest - that's good, right...?), or in simple words a profit struggle. What I was saying was that this behaviour is myopic, at least for SME.
 
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Ed Panek

QA RA Small Med Dev Company
Trusted Information Resource
#18
My post was a bit of grandstanding; I understand.

I use any resources I can to get answers. I will use Google, talk to former colleagues or use this forum. When I know the exact deliverable I need I will involve consultants. I generally follow the rule of - don't take first-line advice from someone trying to sell you something.
 

Tidge

Trusted Information Resource
#19
I think I've commented elsewhere that these types of forums are always labeled "Discussions," but there is usually very little discussing going on, mostly just Q&A. Where there is discussion, it tends to be limited to the relative merit of the As, not infrequently leading to something a bit warmer than a "discussion."

As for this forum, what I like is mostly moot, because this is not a forum where you are likely to get a lot of thought questions. Sometimes discussions do break out, and I like that. I have further found that discussions are more likely to break out in a forum after I start discussing things, instead of just answering questions. Forums are what you help make of them, and like attracts like. (One thing I think might make the Cove's medical device forums stronger is if they were moderated exclusively by people in medical devices, but that's a topic for another day.)

That said, I am not on a mission to turn Q&A forums into discussion forums. I find some of the Q&A to be of interest and value to me. That is why I'm here. If I post discussions instead of answers, that's just me being me. If it encourages others to do a bit more discussing than just Q'ing and A'ing, for me that's a good thing, but it's not a goal of mine.
I certainly appreciate the discussions, especially those that demonstrate different methods for approaching compliance with the standards and regulations to which we adhere. I'm less impressed when responses are practically indistinguishable from an "appeal to authority" where the authority is the pure text of the standard in question. It can certainly be appropriate to quote the text of a standard, but there is value to be had by peer discussion of particular topics.
 

Ronen E

Problem Solver
Staff member
Moderator
#20
I generally follow the rule of - don't take first-line advice from someone trying to sell you something.
What does that mean?... All consultants are trying to sell something - their services.

Don't worry - this consultant won't try to give/sell you anything anymore. It'd be pointless - you won't take it anyway.
 
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