One of the more interesting aspects of medical device manufacturer’s view of the label industry is their belief that our raw material suppliers, the folks that produce the label stock that we convert, actually care about the time it takes for device manufacturers to qualify a new material. The unvarnished truth is that they just don’t. The entire label stock usage for the entire medical device industry is a gnat on the elephant’s backside of total pressure sensitive material volume. What that means is that if there is a new face stock or adhesive out there that performs better at less cost, PS label stock coaters are going to implement the new product and dump the other one. The typical timing of this process from when we label printers hear about the material change to the date the old stock is laid to rest is typically about three months.
We recently received a communication from one of our customers asking us to reaffirm that we agreed not to change or discontinue any part or component of any part that we supply to them for 18 months. After wiping the tears of laughter from my eyes, I politely explained the typical three month window along with our vendors almost complete lack of sympathy for their plight. It was like they didn’t even hear my response. Like the ugly American that speaks slower and talks louder to a non- English speaker, our customer reiterated that 18 months was the requirement. At this point we were in a house Republicans v Obama-like standoff. I will keep the readers informed of how this impasse plays out. One disturbing point that I made was even if the customer authorized us to purchase 18 months worth of inventory, the shelf life on most paper label stocks is one year. Beware of Catch 22, this will be interesting.
In the past couple of years, the number of materials changing due to performance issues or component shortages has almost doubled. Some changes are more major than others but three very different short case studies will illustrate some of the angst. In the first a very familiar trade name of a long lived 60# cast coated high gloss sheet, Kromekote, was discontinued. Had the description on the label drawings / prints been generic, 60# cast coated high gloss, everyone would have been fine. Instead of Gold medal flour they could have simply switched to Pillsbury’s Best, pretty much the same stuff with a different brand name. Unfortunately all the prints said Kromekote, and since we need to issue certificates of conformance saying that the product we produced was indeed Kromekote, the ECR/ECO process swung into high gear. Panic ensued and after much frantic qualification, validation, fines, and suspensions, justifications were put into place to allow the change.
Case study number two involves a .002 vinyl face stock that was discontinued with virtually zero notice due to a supply chain issue. How vinyl was approved in the first place for a device application given its health concerns, toxic environmental waste, and plasticizer migration issues is beyond me. In this case the .002 vinyl was replaced with .002 PET, a face stock in common usage in the device industry, especially in autoclave applications. All the companies affected by this material change use PET and have extensive test data on its performance. In addition, the topcoating for TTR printing is the same, the adhesive is the same, and the liner is identical as well. We are still in mid chaos on this one as well with no resolution as of yet.
Lastly we have the case of the changing adhesive. One of our vendors has discovered that the shear properties of one of their adhesives has been decreasing, pretty much from lot to lot. They contacted their adhesive supplier who told them that the issue could not be improved. The decision was made, after pretty extensive testing, to replace the adhesive with a newer, higher performing product. This change is far more serious and has greater impact than the first two cases because the adhesive is the key component, the element that provides the long term chemical bond between the label face stock and the substrate labelled. In this case the window was three months but we have the ability to order as much as we need before it’s discontinued. Inexplicably, even though this information was sent out in mid-November to the affected device companies, no additional material was ordered to tide them over during the testing process of the new adhesive .
I will resist my natural surly and curmudgeonly opinions on the above three case studies and attempt to offer a few things that can be done, both to prevent the problem and help solve it when it does pop up. The first thing to do, a trick that I’ve written about on this blog before, is to avoid trade names of label stock like I avoid clichés; like the plague! You don’t want Kromekote, Scanrite, or Transtherm II or any of that junk on a print. Ever! All it does is box you in and create more issues. A generic description with liberal use of the nominal symbol such as 60# (nominal) cast coated high gloss or perhaps .0035” (nominal) thermal transfer receptive paper will avoid chaos when the paper mill switches to LustraGloss, ScanPerfect, or Transtherm III. Another good idea is to have a reasonable protocol for testing a label material with a minimal component change like occurred in case #2, a sort of 510(K) for label stock. In case #2 the new construction is more than Substantially Equivalent to the nasty vinyl that it’s replacing plus there are reams of test data on the performance of PET on terminally sterilized device packaging. Finally, order enough label inventory so your package engineering and regulatory people have some time to do what they need to do. Shelf life for paper is typically one year and films are two years so order enough to make the qual time frame comfortable.
Healthpack is in two weeks in beautiful Norfolk, VA. I don’t know about any of you but I plan on touring the USS Wisconsin, named after my home state, as well as attend the sessions. You can debate and/or ask me how these case studies turned out as we enjoy the hospitality that is Healthpack. I will also be in Vegas the end of March for the AAOS convention and we will be sponsoring a happy hour along with several other MDRG members. At both events I will be accompanied with my partner in crime, Blake Insteness. I hope to see you at one of these fine events in the near future.