Updated EU MDR regulatory matrix wanted

Ronen E

Problem Solver
Staff member
Moderator
#21
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.
Sadly, in many cases it seems necessary, because the post indicates that the person asking (or one who answers) is not aware of / familiar with the relevant bit of text. And not infrequently that's actually all that's necessary to answer the question.

Sorry we can't impress you more.
 
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Elsmar Forum Sponsor

Watchcat

Trusted Information Resource
#22
What does that mean?... All consultants are trying to sell something - their services
Yeah, that one had me thinking, too. By the time you get a consultant's advice, I would think there's nothing to left sell, assuming you've paid for it.

On the other hand, some device RA consultants start out ("first-line"?) by giving you free advice, i.e., you can claim substantial equivalence to a device under Product Code XYZ. And then they want to sell you their 510(k) submission services. I think this is less common since the direct De novo became a third option.
 

indubioush

Quite Involved in Discussions
#23
You both sound a bit jaded. Isn't the intent of this forum to allow people to obtain free advice? With that said, there are some questions that are best not answered because the question needs a seasoned regulatory professional who can assess the entire situation. In these cases, it is best to provide a friendly response explaining that the OP should obtain professional assistance.

Also, if you ever see me answering someone when the best response is that above, please let me know.
 

Watchcat

Trusted Information Resource
#24
You both sound a bit jaded.
I can assure you that I passed "a bit" several decades back.

Isn't the intent of this forum to allow people to obtain free advice?
I have no reason to think so, and several reasons to think not.

The title is "Quality Forum and Business Standards Discussions." Merriam-Webster has several definitions for "forum," all of which refer to "discussions," and none to "questions," "answers," "asking" or "advice." I think this one clearly describes this type of forum: "a medium (such as a newspaper or online service) of open discussion or expression of ideas." A discussion is "a consideration of a question in open and usually informal debate." This definition starts with a question, but does not end with an answer. If ends with advice only if the question is how/what should I do?

There is a section titled "Purpose" in the TOS subforum, but no purpose is clearly stated. This purpose might be implied:
"The free exchange of scientific and business standards information"

I'm inclined to think this does not mean "free of charge," but "unrestricted," as in "free" press and "free" speech. The existence of the consultants subforums carries the implication that, if you want professional-level advice, there is an expectation that you will pay for it.

But that's just my take. If the purpose of the Cove is to be spelled out, surely it is Marc who should spell it.
_______________________________________________________

I want to add that my own comments are with respect to the medical devices forums only. I take medical devices very seriously. I hold this sector to a much higher standard than other tech sectors, because medical devices are more important to me than other tech products. And I think the consequences of "free advice" about almost anything related to medical devices are potentially far more severe.
 
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Sidney Vianna

Post Responsibly
Staff member
Admin
#25
If the purpose of the Cove is to be spelled out, surely it is Marc who should spell it.
The Elsmar Cove Mission
To be a Free Business Standards Compliance and Business Systems Information Resource to Quality Assurance, Engineering and Management Professionals.
People Helping Each Other since 1996!
 

Watchcat

Trusted Information Resource
#26
Thanks, Sidney! Where did you find it?

I do not equate that mission with "to allow people to obtain free advice." I don't see it as excluding this use of the Cove, but as it's only purpose, not even close.

I will also note that "Regulatory" is not one of the professions cited. See my comments about the medical device sector. The Cove wasn't designed for medical device RA professionals, nor was its mission established to include us, almost certainly without much input from us, especially since device RA was still not that sure of its own purpose in the mid-90s. That's not a complaint, just an observation. I have found that, when things are used for purposes they were never intended to serve, the fit is always going to be a bit ragged.
 

Sidney Vianna

Post Responsibly
Staff member
Admin
#27
Thanks, Sidney! Where did you find it?
Risk Analysis, Quality Assurance, ISO 9001 and Business Standards Information

The way I see it, nobody here is expected to provide professional advice for free. They do it, if they want to. The immense amount of knowledged captured and exchanged here has huge monetary value, in my estimation. Unfortunately, numerous attempts to monetize this knowledge exchange have not been fruitful, in most cases. But professionals can definitely use this space to showcase their knowledge and solutions and demand monetary compensation, in exchange for their services, should they find interested parties.
 

Ed Panek

QA RA Small Med Dev Company
Trusted Information Resource
#28
First-line advice -My point is - If you want to buy a sports car don't drive to the Ford dealer expecting him to say anything about a car he doesn't sell. That's not good first-line advice as a consumer. Go in knowing you want a Ford.

For example, we are undergoing GDPR compliance. I did not just Google GDPR compliance consultant and tell my boss its solved. I did my research to know exactly what our gaps were and tried to understand what our real deliverables were from the consultant. If I went to the GDPR consultant for first line advice I would have been irresponsible and maybe oversold without knowing.

Its also important to obtain multiple quotes. "Is this a good price?" is not knowable without at least 2 quotes.

Anyone poised to make profit off you is not unbiased.
 
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Watchcat

Trusted Information Resource
#29
If you want to buy a sports car
Good advice for buying a sports car, which is a product, not a professional service. So many differences, will not list them all.

So how do you decide you want to buy a Ford? I think most people in the market for a new car will do a bit of homework first, not by going to the car dealers and taking up their time, but first by reading and sometimes also asking their friends and family members. Often this is adequate to decide which car they want, and they head to the dealer, who is going to be compensated for the time he spends with them, by way of a commission.

Alternatively, after doing some homework, they might go to several dealers, to compare prices or models, or whatever. In this situation, only one of those dealers will be compensated directly for the time they spend. Not directly, but this is typically a zero-sum game. These shoppers might not buy a car from a particular dealer, but pretty much everyone who visits a dealer is planning to buy a car, so if this customer doesn't buy from this dealer, someone else who visited multiple dealers will. The time the dealers spend with customers who ultimately bought elsewhere is a legitimate "cost of doing business."

The situation we find with people who are "shopping" for consultants, is that, very often, and more and more lately, they are not shopping for consultants. They are shopping for free advice. In the car analogy, someone who doesn't own a car (because they "can't afford" one) goes to a dealer and says they are interested in buying a car and can I take it for a test drive. Then off they go do to their shopping and appointments, and, when they are done, they return it to the dealer and say, sorry, not what I was looking for. And the next day, they do the same with another dealer, and there are as many or more people "shopping" at the dealerships without any intention of buying a car as there are those who actually want to buy a car. Now imagine how many more would do this if, instead of having to bother to go to the dealership, they could just go online and ask for a test drive and the car would be promptly delivered to their door.

In the early days of automobiles (I'm old), there were people who just liked to go look at new cars, like there are people who go to open houses, some out of curiosity and some to get decorating ideas. And some who will actually go so far as to arrange a private showing with a realtor for the same reason. (These types are known as the "looky-lookies," although the latter practice fell off a good bit when women got "liberated" from sitting at home all day watching soaps.)

I don't think anyone takes the same approach when searching for other professional services. The second opinion in medicine was always largely a myth, always two at the most, and only if you are seriously ill and/or in need of serious treatment. And again, you are going to get treated, not just shopping around to find out what treatment you need and then go home and do it yourself. Very few people meet with lots of accountants before hiring one, and pretty much none of them have any substantive accounting questions, it's more a matter of services offered, rates, and "cultural fit," because they are not talking to an accountant to find how their taxes should be done and then go home and DIY. They might go home and DIY because of cost, but they are usually not interviewing accountants to find out how to do their taxes, and they certainly wouldn't ask the accountants for a copy of their tax software or a sample tax return. In this environment, the "looky-lookies" are the boorish who try to get free medical and investment advice at dinner parties. The latter are usually not seriously interested either, because they don't have a serious medical problem, or a lot of money to invest. If they did, they wouldn't be asking at a dinner party.

I did my research to know exactly what our gaps were and tried to understand what our real deliverables were from the consultant.
So the critical question is, did you then hire a GDPR consultant, or, after doing your homework, did you decide you had learned enough to DIY? Or after getting quotes, did you decide to forget the whole thing, because the company "can't afford" it? The latter is what happens when, after all that, they decide not to pursue that market after all. Moreover, in many cases, when they were asking, they were not planning to pursue that market, for which they would need a consultant; they were just trying to find out how much it would cost, and then they would decide whether they needed a consultant.

"Is this a good price?" is not knowable without at least 2 quotes.
Would you like to guess the percentage of times that all of the independents here at Elsmar have been asked for a quote in, say, the past year, after multiple online exchanges with a potential "client"? I have learned to quote my hourly rate without being asked, and up front, not because I think they are going to consider whether this is an attractive rate, but because that is one way to reduce the amount of time wasted. At least sometimes they promptly go away or cut it short, realizing I'm not planning to give them advice for free.[/QUOTE]

Do you want to guess how many potential clients who are price-shopping and say they are "doing their homework," but have never once even thought about looking for information on pricing of professional services, and would probably say they wouldn't know where to look, even though a simple google search for "hourly rate" and "flat fee" will garner you well over a million hits?

Which brings me back to cars. In an earlier life, I was a freelance scientific/medical writer. My clients were not usually in industry, which meant they did not have a product mindset. They had an expertise mindset. When they asked "how long is it going to take," they invariably meant turnaround time, not billable hours. In industry, they are always shopping for cars. An ISO 13485 audit is a car. They are extremely well-defined, and every AO has an excel spreadsheet or something like it, where they can enter a finite set of variables and come up with a very good estimate of "how long is it going to take?" and "how much is it going to cost?"

Consulting, actual consulting, is not a car. A colleague of mine, who isn't a consultant but a long-time employee at a pharma company, and therefore has used consultants and generally just pays attention, when asked "how long is it going to take," answers "how long is a piece of string?" A writer colleague's husband, also not a consultant, but a long-time employee as a programmer at IBM, used to put it somewhat more colorfully. I think I won't go there.

A lot of the poor quality in industry is a direct result of companies packaging expertise into a box so they can sell it as a product. Because products are easy to sell in industry, where expertise is hard. When clinical research moved from big Pharma (where it was an expertise) to CROs, someone who used to work in pharma dubbed them "the sausage factories," meaning they now simply cranked out products in the form of, usually, clinical study reports. As far as I can tell, clinical research has finally and predictably driven off a cliff, with no one left who has the expertise to do actual clinical research, and the repercussions have been severe for both pharma and medical devices. More so for the latter, because when device companies finally started shopping for clinical trials, they were sold the kind of product the CROs had to sell, which is a pharma trial. It seems that, eventually all chickens actually do come home to roost.

Anyone poised to make profit off you is not unbiased.
Definitely they are not. But with a consultant, they will make a profit (actually, for independents, it's just a living) if you secure consulting services. Almost no one ever ask consultants if they need consulting services. Some will price-shop a bit, and some will go with the $200/hour consultant who will may take 100 hours to do the same job the $250/hour consultant can knock out in 50. And of course, they know perfectly well that they have no way of knowing how long either one of them took, only what it says on their invoice, which makes shopping for "price" in this situation a total myth. Some think a consultant's price is a measure of the quality of the consultant. Sometimes it is, most times it is not, and usually only large disparities ($125 versus $250) that cannot be otherwise explained (e.g. a need to pay overhead).

For this reason (among others), some will go for the warm security of the flat fee, which can be the highest "price" of all, because the consultant knows, even if the client doesn't, that there is no way to predict how long the job is going to take. They have good reason to quote high, in case the project turns out to be a nightmare, which in this business, it does more often than not.

I do not know how typical I am, but the advice I always give for free to potential clients is what kind of consultant they need and how to find that consultant, because few of them have done any homework on this question. ("Asking around" is not homework, but an alternative to it.) The other service for which I do not charge clients is referrals to consultants who I think are a better fit for one reason or another. (I am not as knowledgeable in some therapeutic areas, jurisdictions, some types of submissions, etc, as other colleagues.)

My advice is decidedly biased, by the fact that medical devices are important to me. I want to see them developed and marketed properly and I want anyone who needs a medical device consultant to get one that can seriously help them do that. Not "best," that's a myth, but if I know a consultant who I think is clearly a better fit than I am, I refer, even though I 'can" do the work.

__________________________________________________

Again, I think I will just stop here, and this time, that I will not pick this up again, at least not on this thread, nor another, any time soon.

I want to make clear that this is by no means a rant. It is simply information, much of which I have shared freely many times over the years, often to newbies and aspirings. Sometimes even to clients, if they were cut from the mold of wanting to see things from other people's points of view.

I also don't feel rant-y about it. It is what it is. I'm old enough to have seen a number of industries grow, consolidate, mature, decline, and the consequences thereof. The only good options are to adapt, move on, or retire. Just holding on is not a good option.
 

Ed Panek

QA RA Small Med Dev Company
Trusted Information Resource
#30
We have several consultants. One retainer for on-call services for 12 months as needed for various items at 6 hours per month. A second performing a special 510K since our first one was 5 years ago and our new pharma partners are more curious about it so we feel at our FDA face to face in a month it would be better if it wasn't so old. A third I hired for onsite help with GDPR along with an actual GDPR offsite rep. That's 4. I do bid them out - for example, one person quoted us at 120 hours for our special. The other one 40 hours. This was after we shared our DHF with each.
 
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