Originally Published PMPN December
2004
Roundtable
Breaking the Language Barrier
Medical packagers discuss the challenges of multilanguage label requirements.
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Medical device companies that market their products in the United States and
Europe are faced with a variety of challenges when it comes to packaging requirements.
Perhaps one of the biggest is multilanguage labeling, which has always presented
packagers with unique difficulties.
Those challenges are even greater now that the European Union has added 10 new
countries to its ranks, bringing the total number of member countries to 25.
The new members, Cyprus, the Czech Republic, Estonia, Hungary, Latvia, Lithuania,
Malta, Poland, the Slovak Republic, and Slovenia, joined the EU in May. The
additions represent the EU’s biggest expansion since its inception. They
also represent new labeling and language headaches for medical device packagers.
For example, package space is already at a premium for many products. And, with
additional labeling requirements, that space will likely be even tighter.
Those challenges have given rise to new initiatives from companies seeking to
comply with regulations in Europe. Some companies have begun work on developing
new symbols, since the EU encourages their use. Among those that are commonly
accepted are those addressed in ISO 15223 and EN 980. FDA has also gotten into
the act, issuing a draft guidance last year that addressed the use of symbols
on in vitro devices intended for professional use. The agency has also urged
industry to develop new symbols and include them with labeling submissions.
Elsewhere, companies are faced with the prospect of possibly having to increase
package sizes to accommodate the new languages, an undertaking that would no
doubt force them to incur higher manufacturing and packaging costs.
PMP News senior editor Ben Van Houten spoke with three industry experts about
multilanguage labeling. Barbara Nawrot, manager of packaging and labeling development
at Cordis Corp. (Miami Lakes, FL), Tom Roberts, senior packaging engineer
with the medical division of C. R. Bard Inc. (Covington, GA), and Dave
Olson, vice president of Web Label (Minneapolis) and a member of the
Institute of Packaging Professionals (IoPP) labeling committee, all sat
down to discuss the challenges and some potential solutions to the multilanguage
issue.
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“The
process is basically the same whether you are implementing 12 or 21 languages. It’s a matter of how well you manage that process and how well you can partner with your translation service.” — Barbara Nawrot, manager of packaging and labeling development for J&J affiliate Cordis Corp. |
How are you all involved in the European marketplace?
Nawrot: Cordis is certainly a global manufacturer of medical devices for cardio and vascular disease management. The European marketplace is important to our business, and, in addition, we maintain a manufacturing facility located in Roden, The Netherlands.
Roberts: Our division of Bard does not produce any products in Europe, although we sell products to most of the countries in Europe. C. R. Bard does have a division called Angiomed that produces products in Germany. So we do a lot of work with Europe, and we are also looking to expand our markets in Europe with the products we make at Bard Medical.
Olson: Basically we print labels and packaging, and our labeling winds up in Europe and other multinational locations. Products get shipped into Ireland, France, Holland, Germany, that sort of thing. So we are not directly involved with the European regulatory agencies or anything like that. But our products get printed and sent over there.
As you know, there are 10 new countries in the European Union this year.
What unique challenges does that present?
Nawrot: Over the years, Cordis has been very active in complying with the
growing European language requirements, including languages associated with
emerging markets. In 1997, which was the last major expansion of the EU, we
introduced 12 languages to our product labeling, including Japanese. Currently,
we will be expanding the number of languages on our product labeling from 12
to 21, including the new EU members’ state languages, such as Czech, Hungarian,
Polish, Slavic, Estonian, Latvian, and Lithuanian. We are also going to be adding
Korean and Chinese.
In order to meet the challenge associated with available space, we are also
looking at creative solutions such as symbols to replace multilingual copy.
While many of these symbols have been approved by European regulatory authorities
(EN 980 and ISO 15223), other symbols are created in-house at Cordis. For clarity,
these customized symbols will be illustrated and explained in our instructions
for use (IFU). Other creative solutions include the use of e-labeling, using
either CD media and/or the Internet.
Olson: I think that is a good point that Barbara made. The main problem of course is real estate. If you are making a 4-ft-long steerable catheter, for example, you have plenty of space for the actual label. Also, when we talk about labeling, you have the actual label on the product, but the label also encompasses the IFU or the leaflet. So symbols are something that we have been working with, too. I chair a labeling task group within the IoPP medical device technical committee. That is one of the things we have been working on. As far as we know, you can, as Barbara said, create your own symbols other than the ones that are approved under EN 980.
Nawrot: That’s right. Recommended documents surrounding symbols include EN 980, ISO 15223, and the Medical Devices Directives.
Olson: As long as you explain them in your IFU. There are three companies I know of that have some pretty significant pilot studies going right now using e-labels. That will not only get rid of the space constraint but will also make it easier to change things. If you go to an on-line setup, you can change things a lot quicker than going through the whole printing/proofing process, which as a printer I don’t like that much. But it is definitely the way it is going to work. It is about the only way you are going to pull off all of that verbiage in there.
Nawrot: Cordis was the first J&J company to introduce Internet labeling, back in April of 2003, with the launch of our Cypher stent. Since then, we have created a Web site specifically for labeling content (www.cordislabeling.com). Although the new site is restricted to products that are sold in the United States, since Internet-based labeling for medical devices is not approved in Europe, we see www.cordislabeling.com as a platform for the future.
Olson: Also, in the European regulation I think in vitro products you can e-label but…
Nawrot: In vitro diagnostics (IVD).
Olson: Yes. But I think they are just around the corner from coming out with a broader e-labeling directive.
Roberts: We have actually looked into doing that also, and one of the things we have discovered is a lot of our customers in Europe and other countries don’t really have access to that. With most of our customers it would work, but there still are the ones that don’t have that capability.
Nawrot: That goes to the digital divide, where you are selling your
products, and what type of technology they have available at the hospital. It
also depends on your customers. At Cordis, we are not dealing with consumer-based
products. Our primary customers are doctors, nurses, and catheter lab managers
who use the products. So for us, it is much easier. For example, we deliver
one German language on our labeling instead of consumer-based products, which
are faced with multiple German dialects.
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“Frankly,
trying to find a qualified translator in the medical device industry in some of these smaller countries is a very real problem, which means longer lead times.” — Dave Olson, vice president of Web Label and a member of the IoPP labeling committee. |
Olson: Right. One of the components of that whole thing is that a lot
of regulations I looked at say that if you write or call for a printed manual,
the medical device manufacturer has to furnish that to you. And one of the things
that is being integrated with the on-line mode is the on-demand printing setup
where you can request 12 manuals for device 4352, as an example, to be sent
to a certain location. So that is a smaller but fairly important part of the
whole equation.
Roberts: That is the direction we are looking into with our European
distribution center. We are looking at printing our IFUs in English and, in
the distribution center in Europe, having the capability to reprint those in
the language of whatever country that product is being shipped to. The package
labeling would still be very generic, with a brief product description in multiple
languages in the symbology. The IFU is printed on demand.
Nawrot: Associated with our e-labeling efforts, Cordis has printed toll-free
customer contact numbers on our product labeling for those customers who wish
to obtain a hard copy of the IFU. As approval for e-labeling expands outside
of the United States, we envision the growth of our Web site and functionalities
to include enhanced features such as print-on-demand, so that customers visiting
the site can print an IFU in their own language.
Regarding CDs, e-labeling, and other applications: What kinds of challenges do those pose in terms of manufacturing and package design?
Nawrot: When we launched Cypher, the packaging had already been qualified
with a paper insert in the package. Until a second packaging validation could
be completed, we were packaging a dummy paper insert. Looking back, the solution
was not ideal, but it is what we had to do at the time. Therefore, in introducing
e-labeling, companies must examine their current processes and infrastructure
including packaging validations, software compliance and validation requirements,
logistics, inventory, and customer-related issues such as call centers.
Then there is the liability issue. Companies must engage their legal departments
in order to establish clear policies on the issue. In summary, e-labeling opens
up new opportunities, and with that, a host of issues and challenges.
Olson: The one big cost in this deal is translation. If you look at translating a word into all the EU member state languages, at $5 a word for a 5000-word document, which is basically your average 12-, 15-, or 18-page IFU, it is $25,000 for the translations. In some of the countries, some of the new terminology does not exist in certain languages. Frankly, with this going on, trying to find a qualified translator in the medical device industry in some of these smaller countries is a very real problem, which means longer lead times. You are not getting your information as quickly as you need to. It is a problem in a lot of places.
Roberts: That is what we are finding also. Labeling issues alone can actually delay product launches.
Olson: Absolutely.
Roberts: And when you finally do get the translation back, you find errors. You have to change them, or maybe someone in marketing wants to rewrite a section. Then you have to go through the whole process again. It costs a lot of money and it takes a lot of time.
Nawrot: The process is basically the same whether you are implementing 12 or 21 languages. It’s a matter of how well you manage that process and how well you can partner with your translation service. Companies should try using the technology to their benefit. There are programs out there that actually store language memory and can certainly reduce your cost. To further reduce costs, it is important for companies to engage their strategic sourcing group. At Cordis, we found that e-sourcing provided an excellent opportunity to go out there and see what other translation companies were offering and what they could do for us. In the end, we had our existing translation service, which confirmed my belief that we had achieved a successful partnership in terms of cost, quality, and speed.
As far as package sizes getting bigger, is that something that is going to be happening? Is this a move that is already happening in your companies?
Olson: We’ve actually seen packages becoming smaller just due to the whole green movement, which in Europe is very strong. A smaller package with less material entering into the waste stream is a goal over there. So it is definitely kind of a six of one, half-dozen of the other, situation where we need the information on there, but yet we don’t want to contribute to the waste stream. That’s an issue that I have heard addressed a number of times, but no one has really come up with a great answer.
Roberts: We have several products that are sold in the United States only in very small packages. So right now the labeling is not an issue. As these products get CE marked, the package size definitely is not big enough to accommodate all the new labeling information we have to add. So we’ll be increasingly challenged to find a way to make it fit or to unfortunately increase package size just for our label.
Olson: Exactly. That is why I think your product is key. For example, some of the new pacemaker and defibrillator packages I have seen are basically the size of a CD case that would hold 15 or 20 CDs. Again, that is why symbols, and creating new symbols and reusing the ones that are there is crucial. Basically, the vital information on the outside of the package is obviously the company name and the logo, the model, the manufactured date, and the sterilization information. Those are the items that have to be on there in order to make it a functional package. I think a lot of people are getting rid of as much of the extraneous stuff as they can.
Nawrot: That’s right. Companies are taking a second look at their packaging graphics and getting regulatory and QA departments involved to see what can be improved.
Roberts: Since the early days with the fairly generic device label—black and white and maybe a couple of extra colors—we are actually seeing more color being used. Marketing departments have definitely had their influence on the shelf in the hospital. So in a lot of cases there is less hard information on the package, but it is presented in a better graphic design element.
You’ve all talked about the cost associated with translation and the extra time that it is going to take. What can companies do to deal with that challenge and potential headache?
Roberts: As Barbara said, if you can partner with a translation house
it will definitely help, which we have done. We get translations pretty fast,
though it still takes time. It is better than it used to be. Changes to the
label come in after you get translations and you have to go through the process
again. That is where a lot of the extra time comes in.
Olson: Part of it is the validation process, too. The new countries may
not have a relationship with an independent validator that is familiar with
medical device regulations. The markets in these countries are typically not
going to be huge, but they are part of the EU and they are there. So if you
are going to be selling stuff over there it is something you absolutely have
to do.
Nawrot: The Internet certainly makes it possible for us to have access to translators there that we wouldn’t have had access to 10 years ago. Back then, it was common to have a staff of translators sitting in an office in New York, San Francisco, or Utah. Partnering with your translation service and giving them a heads-up on what language issues you are going to be adding is key. But you still have unforeseen glitches. For example, new fonts had to be purchased and installed at Cordis recently. Needless to say, we ran into some difficulty and conflict when loading them onto the operating system and that caused a few headaches. Don’t forget, the fonts you purchase must also be available at your translation service and your printer.
Olson: Barbara really hit the nail on the head with that one because being a printer you pretty much have to have a format that can be turned into a printing plate. For example, Greek has always been a problematic font. Most printers that have to make a printing plate need Macintosh-based things. Usually it is not an issue, but the conversion programs just aren’t readily available for certain European languages. There is additional work being done to get PC-based text into Mac software but it is not cut and dried. I personally don’t see how anybody who is in the process of validating this thing is going to figure it out easily. I don’t know if Barbara and Tom had the same issues crop up.
Nawrot: We only send PDF files to our suppliers now. I think that eliminates most problems on their end.
Roberts: We do the same thing. But there is the initial step of when you first bring in the fonts and you print out a new booklet for review. The proofreading becomes important, making sure every letter is correct and has the right marks over the top of it because in some of these languages, an asterisk or something in the wrong direction changes the meaning of the word.
Olson: We will generally proof the PDF the first time through. But the final, final proof is going to be a film proof from the same piece of film that the printing plate is made from. That is kind of the fail safe. Image setters have a tendency to reflow type and, as Tom said, if it decides that an accent mark is going to disappear or be in a different place, bad things happen.
As far as the symbols, where does FDA stand on the issue?
Roberts: From what I have seen, FDA still likes to see everything in English on the package.
Nawrot: Wherever the symbols appear, you need to have the English text next to it, such as on the carton or pouch. Currently, we list both the English and Japanese text next to the symbol. Then, on the IFU, the symbol appears again, and next to it, translations in all 21 languages. This explanation is especially important if the symbol is customized or pending approval.
Olson: The standard ones in EN 980 we typically see as stand-alones.
Obviously the lot number is the word LOT in capitals with a box around it. That’s
pretty self-explanatory.
Single-use is the number 2 with a circle around it and a line through it. So
that type of stuff we see as stand-alone.
Roberts: We need more of those graphics.
Olson: Right.
Do companies typically come up with those symbols?
Olson: A lot of companies have their own corporate symbol files, as opposed to the EN 980 file. I’ve seen tons of examples of those. Again, if you take the time to explain it in your IFU or on your CD-ROM and have the “Refer to Instructions for Use” on there, from everything that I have seen, I think you are good to go.
Nawrot: I would agree with that.
As far as other regulatory issues in Europe, what are some other hot-button issues right now besides the multilanguage issue?
Nawrot: We touched on this earlier, but the approval of electronic labeling is a very hot issue right now in Europe. Currently, the regulations read that an insert must accompany the product. But what if that happens to be a CD? Is that acceptable? That’s the challenge. For Cordis, being able to include a CD will greatly resolve a lot of the issues we have talked about here. We did a market study in 2004 that basically said 97% of our customers would be able to accommodate CD-based e-labeling.
Roberts: Another issue we deal with is the green dot, which is mainly for package shipment to Germany. Also, getting PVCs and chlorides out of our packaging. That is a totally different issue.
Olson: You kind of get the feeling that the EU is close to coming up with an e-labeling directive of some sort.
Roberts: It will happen.
Olson: Yes, similar to what they have right now with the IBD 1.
Roberts: That is probably going to happen in the near future.
Nawrot: And this is not just Europe. China and South Korea have come out with their own sets of regulations requiring their languages. So my advice to companies that embark on this effort would be to look and see how they can use this as an opportunity not only to become compliant with the regulations, but really as an opportunity to offer some added benefit to their product labeling. For Cordis, the issue of additional languages has really changed the way we view labeling and the processes that govern it.
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