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"Fast action" claim and MDR (Medical Device Regulations)

cam5603

Starting to get Involved
#1
Hello all :bigwave:,
I have a question concerning claims of medical device and regulation. The medical device is a treatment for wax plug and I would like to make sure that we can use “fast action” or “fast-acting” as a claim.

Do you know any requirements for this kind of claims?

An in-vitro study was performed on ear wax and the dissolution of the ear wax was twice faster with our product than with other solutions. Is it enough to use this kind of claim?

:thanx:
 
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FoGia

Involved In Discussions
#3
Does "fast action" of the wax plug relate to a clinical safety or performance aspect? If the answer is yes it needs to be supported in your clinical evaluation report, otherwise not.

Now I see a dissonance between your claim and your data. Your in-vitro study shows that your products dissolves wax faster, not necessarily 'fast'. You could ask a panel of users of what duration they would define as being 'fast'. It could be that even twice as fast isn't fast enough for the users, or that current products are already considered fast and a drop of 50% wouldn't make a difference.

Even if it's not related to clinical performance, make sure that your evidence material is strong in case a competitor would have the idea to sue you for inaccurately claiming that your product dissolves was faster than theirs.
 

Mark Meer

Trusted Information Resource
#4
An in-vitro study was performed on ear wax and the dissolution of the ear wax was twice faster with our product than with other solutions. Is it enough to use this kind of claim?
In my opinion, your approach is fine....but I'm not aware of any authoritative guidance regarding subjective terms like this. If you really want to cover your bases, I suppose you could always use the caveat/asterisk in your labelling. For example:

"Fast-acting* wax removal!
...
*when compared with competing brands"


...You could ask a panel of users of what duration they would define as being 'fast'. It could be that even twice as fast isn't fast enough for the users, or that current products are already considered fast and a drop of 50% wouldn't make a difference....
This is an interesting point of discussion regarding subjective language.
Are we concerned about misleading claims liabilities? If so, I question the utility of having to assemble a panel to define a subjective term.

Consider, for example you take 3 people: one says "fast" means 3s, another says 8s, and the last says 10s. What are you to do with this data? Average it, and conclude that "fast" is 7s? Assuming your sample is representative, and you base your design requirements on this definition of "fast", you'd end up with something that 1/3 of users would not consider "fast".

Don't get me wrong: from a design-input standpoint, this data could still be very useful. But as far as being concerned with being cited for false advertising, I don't know how valuable this kind of undertaking would be...
 

FoGia

Involved In Discussions
#5
This is an interesting point of discussion regarding subjective language.
Are we concerned about misleading claims liabilities? If so, I question the utility of having to assemble a panel to define a subjective term.

Consider, for example you take 3 people: one says "fast" means 3s, another says 8s, and the last says 10s. What are you to do with this data? Average it, and conclude that "fast" is 7s? Assuming your sample is representative, and you base your design requirements on this definition of "fast", you'd end up with something that 1/3 of users would not consider "fast".

Don't get me wrong: from a design-input standpoint, this data could still be very useful. But as far as being concerned with being cited for false advertising, I don't know how valuable this kind of undertaking would be...
It all depends of the context, it may be that if one third don't have an opinion and the rest agrees then it's fine, it's up to you to define the criteria. But if one third of your panel strongly disagrees with the wording 'fast' in my opinion it may be necessary to reconsider the claim. I put that sort of claim in the same category as the product being 'user-friendly','reliable','confident'..., which are also purely subjective by nature. In that kind of situation when there is disagreement on the meaning of subjective words I typically advise against using such language in marketing material for the reason that they're hard to substantiate, they tend to confuse/deceive the target audience and they divert their attention from more important claims. Without going to a court case I've had similar discussions with business partners and notified bodies.
In my opinion, your approach is fine....but I'm not aware of any authoritative guidance regarding subjective terms like this. If you really want to cover your bases, I suppose you could always use the caveat/asterisk in your labelling. For example:

"Fast-acting* wax removal!
...
*when compared with competing brands"
This is fine indeed, because it makes the claim more objective - the claim is now about the product being faster - however competitors may be swift to complain.
 

cam5603

Starting to get Involved
#6
Thanks all for your reply !

I have found a guidance document from UK that could help ("self care medical devices advertising guideline" on PAGB website). Even if we are not selling in UK we might be able to use it as an inspiration.

In this document, it is mentionned " 'Fast' claims
For most therapy areas 'fast' is currently taken to mean 'within 30 minutes'."

But as you said this is not an objective claim and it makes it hard to define...
 

Mark Meer

Trusted Information Resource
#7
...
I put that sort of claim in the same category as the product being 'user-friendly','reliable','confident'..., which are also purely subjective by nature. In that kind of situation when there is disagreement on the meaning of subjective words I typically advise against using such language in marketing material for the reason that they're hard to substantiate, they tend to confuse/deceive the target audience and they divert their attention from more important claims...
Good point of discussion!

In practice, I think there is a risk assessment that needs to be considered. If we are talking about misleading advertising liabilities, there is certainly a risk/benefit call to make.

Consider two companies selling similar products.

Company A advertises "This is the best, top-rated, user-friendly device that does X.", and backs this up through some (tenuous) surveys they carried out themselves.

Company B, worried about potential false advertising, simply advertises "This device does X."

There is no doubt that Company A's marketing is more effective, and they do technically have evidence to back up their claims. They would be considering the probability that (a) a complaint is made, and (b) that their evidence is rejected, and weighing it against the benefits of better marketing.

Company B, on the other hand, recognizes that these are all ultimately subjective terms, so opts to avoid them altogether in their marketing. They eliminate the risk of misleading advertising liability, but do so at the cost of less effective marketing (compared to their competition - Company A).

It seems that you would, in general, advise to take Company B's strategy. However, I think there is a strong case to be made that Company A's strategy makes better business sense...
 

FoGia

Involved In Discussions
#8
This is a discussion I'm sure many people are familiar with, here are a few counterarguments to the use of 'light subjective fluffy claims' ('top-rated', 'best in class', etc):

  • We are all familiar with such claims because they're used commonly for consumer goods in markets that are heavily commoditized (furniture, cars, washing powder, frozen pizzas, etc) where company try to differentiate themselves from others by appealing to customer's perceptions instead of objective value. I recognize that there are numerous examples of medical devices that are in such a position, but overall, we're dealing with medical devices, products that have an impact on health which require more scrutiny. You can't use the same marketing methods for consumer goods and medical devices (or drugs).
  • Other stakeholders(CB, insurances, purchasing organization, clinicians, patients, ...) on the market are more and more in demand for products that have a clear benefit risk profile, to those people light claims are just annoying noise signal and you're not making your life easier
  • The more emphasis you put on such claims in your marketing material the more you give the impression that you try to cover up for weak/inexistent clinical claims
  • Light claims can be perceived to insult the intelligence of your customers if not well formulated, they can backfire
  • And from a broader perspective it depends also how you want your company to be perceived by the market, is your marketing strategy blowing a lot of air, or do you want to build an image of effective clinical solution provider?
I don't say that I'm always against light claims, my first response was not to dismiss the claim of the OP, but I'm going against the perception that "the shinier the marketing material is, the stronger sales will be". In a proper context they can be of value, but don't stand a chance against robust clinical claims.

To be clear, these are in no way commentaries about the product of the original poster, my post is a commentary on the broader topic of subjective claims.
 

Mark Meer

Trusted Information Resource
#9
...
In a proper context they can be of value, but don't stand a chance against robust clinical claims.
...
Agreed. But for the sake of discussion we are assuming that the clinical claims are the same.

I'd like to agree with you regarding the potential to "backfire" with respect to using such terms in marketing. I'd say possibly but not probably...Perhaps medical device consumers are generally more informed or have a particular focus on objective metrics, but at the end of the day they are still consumers and, I suspect, still prone to persuasion when it comes to subjective/emotive language to some degree.

Again, there is a risk/benefit calculation here, and I'd love to see some data to help with the calculation. To what degree do consumers find "top-rated" or "user-friendly" claims to be an insult to their intelligence, or perceive that it is a cover-up for other product deficiencies? To what degree are such terms perceived as "annoying noise signal(s)"? ....I suspect not much...but I'm open to being proven wrong.

Ultimately, I'm for letting the market sort it out in time. To whatever degree use of such terms is prone to backfire, this will reflect in sales and people will adjust their marketing accordingly. It may be the case that such terms are so ubiquitous that we are all numb to them, and it makes no difference either way. Only time will tell, I suppose...
 
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