So yes, I have loads of sympathy and admiration for those of you who spend your careers in the trenches of such a highly regulated minefield.

However, that said, even if the choices are limited, there are choices. And looking at some of the naming conventions and design issues from within the same regulatory ecosystem, there is still room for effective, user-centric branding (probably followed by several pages of disclaimers).

The rise of the Purell brand in the post-pandemic world is a topic I’ve been meaning to address on my blog. One of my first clients Paul Webber(www.webbertraining.com) is in the industrial / medical cleaning supplies business as well as being an advocate and trainer in the field of infection control. So perhaps an interview in the new year would be in order. Hmm.

I forgot to mention that the Purell and Soap incident would concern me a bit more if I was an investigator. For instance, while using Purell to “fight” H1N1, the alcohol content might interfere with how a device operates. E.g.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=850566

(BTW this is all public access so put in your favourite brand there and see if any adverse events ever occurred. You would be surprised how misused some products are).

I put “fight” in parentheses because there are non-alcohol based products which do a better job. Purell has a better brand, that’s all. I have even seen “purell” used as a verb

Could “bad branding” just simply be compliance to the regulations?

The FDA does not mince their words when they talk about labeling (yes, yes, everything that you mentioned above and showed are considered labeling not just the stickers and so does every brochure, insert, package, etc that accompany the deemed device). http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/DeviceLabeling/default.htm
If one ever intend to sell any medical device internationally, one will have to check each country for their regulations (or lack thereof) before even sending the first shipment.

Don’t get me wrong. I am all for good branding. However in the Medical Devices industry we cannot choose to leave out some information out just because it looks cluttered or too technical or stretch the truth to sell more. If we do, someone can die. Period. Safety is the main concern.

As for the “I-HAND” story, even if you had handed her something totally wrong, she is trained (hopefully) to check first to know what to administer to your wife. Devices are meant to be used by trained professionals unless specifically having clinical trials to demonstrate home use or other generic usability (e.g. the little diabetes blood level check devices you see sold at the drugstore and which all diabetics can use safely on their own at home).

I work in the Regulatory Affairs department and my role is to ensure that our company claims (usually through Marketing and Sales) are within our claims (those approved by the agencies).

I guess the best example of “off-labeling” in pharma that comes to mind is Pfizer being fined $2.3 billion by the FDA
http://www.safis-solutions.com/resources/IndustryArticles/fda-fines-pfizer.shtml
Thanks to them, we can’t even provide a pen to our next sales event now!!

Interesting approach setting up a “fight bad branding” campaign in the healthcare space. I could easily do the same in my town with a) high tech products & companies, b) government programs, c) not-for-profits, and d) local retail branding.

And it’s all about helping people get access to the stuff they need isn’t it?

But It struck me that the hospital “brandscape” is a fascinating intersection point between blue-collar industrial values, a largely white collar user-base, bureau-centric purchasing chains, and as you point out, engineer-driven product development practices.

Please tell me you’ve actually written the Nymoxlyrum XG-1291x brand manual. If you haven’t, somebody should!