Regulation, Process and Profit: A Look at Localization in Life Sciences

Regulation, Process and Profit: A Look at Localization in Life Sciences
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March 15, 2017
Renato and Michael with Jeff Gerhardt
What if the translation of a word had to deal with life and death? Join us as we talk with someone who handled that very responsibility every single day.
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Renato Hi, I am Renato Beninatto.
Michael And I am Michael Stevens.
Michael Localization of Life Sciences is a hot topic. One that I haven’t had a lot of exposure to but hear about often. In the last couple months we’ve seen that companies in this space have been acquired at high premiums.
Renato Well that’s true. Welocalize bought Global Language Solutions in California, and RWS acquired Corporate Translations in 2016, and Luz, now in 2017, for something like 11 times profit or 3 times revenue. Which is unheard of in the language services space.
Michael These are impressive numbers indeed.
Renato Well, keeping that in mind, we recently sat down with Jeff Gerhardt for a very enlightening conversation about the challenges in localizing life science-related products like medical devices.
Michael So Jeff Gerhardt, he was a director of global labelling at Edwards Life Sciences. They are a global leader in the science of heart valves and hemodynamic monitoring. I’m guessing that has something to do with blood. And now he is the CEO of Centix Life Technologies, a management consulting firm in this space.
Renato So let’s hear from him.
Michael Sounds good.
Jeff I’m Jeff Gerhardt. I’m the Founder and Principal at Centix Life Technologies. I’ve been working in the life science space for nearly 20 years, now. I’ve had the fortune of having great experiences, being responsible for IT overseas, in Europe, the Middle East and Africa, and all the way coming back to working with companies that are highly innovative that and supporting them across their needs for quality, engineering, regulatory, IT, HR, all sorts of needs.
Renato And you are in the life sciences space and in this space everything is regulated. So, what are the implications of regulations in translation?
Jeff It really makes for a minefield. From a regulatory perspective, there’s no greater risk than mislabeling a product, or misrepresenting a product, and translations are really where all the mines and the minefield are at because it’s so simple for a non-medical translator to do their best to try to take a very complex concept, phrase or medical term and try to get that moved into that language. And in the localization process completely misrepresent that you’re not talking about salad dressing, you’re talking about a medical dressing.

And those types of issues and phrases and such have to be comprehended, and it requires a specialty that you really rely on your translation partners to house and not just bodyshop anybody that can take your source language to a local language but really have a level of medical expertise and the linguistic expertise.

So, I can tell you that the people that are in regulatory or marketing in a life science company are like a cat on a hot tin roof on these subjects because when they pop up they have the ability to call recalls which can bring your business to a halt in a region or country; or in an innovation-focused company they can halt your launches and the timeframe for those launches.

So, significant pressure to get it right, not only to get it right but get it done fast; so, technology, process, strong process, are just real key to making sure that you’re going to be able to not have a product have a false start or have a pull-back in the field.
Renato People love – and I hate to do this but that’s the reality – people love horror stories. Tell us one.
Michael Yeah, you guys are dealing in both high fines and life and death, and are you aware of any…that something has gone on there?
Renato Hopefully with a competitor!
Jeff Yes, that’s the thing. I really couldn’t share something too deep but maybe I could mix a few stories together and say this story is based on facts that really happened.
Renato “On true facts”.
Jeff On true facts, right. But does not imply any of my clients or partners. There are all sorts of things where localization, for instance, I can tell you I’m familiar with cases where localization caused issues on labels and in-country there is Typex or White-out being used to correct labels, which is a regulatory person’s nightmare because it creates issues. There are numerous stories where the information inside of instructions for use got all the way to the field, and they told someone to put the product in the wrong body cavity…
Renato Oh my God!
Jeff Yes. You realize that humans are at the end of these things and why it makes everyone so nervous. And anyone who’s responsible for the content on a global scale is filled with pressure because speed is of issue but quality can never, ever be suffered or you will suffer a much more dire consequence than having to go back to your executive and saying “I’m sorry, we’re not going to be able to hit this timeline that you’re asking for”

So, the horror stories are common, and the fear is real on a regular basis. I can tell you as being responsible for content at a major medical device company your worst emails are the ones that call out “we found a problem” because you know, at the least, you’re going to spend some time trying to peel back the onion on “how did this happen in the first place?” To, at worst, the recall and you’re going to be inside of a CAPA that could land you in front of a regulator. You’re going to be asked and answering all sorts of very uncomfortable questions.
Michael What is a CAPA, Jeff?
Jeff Oh yes, sure. Absolutely. So, this is a corrective action or preventative action. And so this is a root-cause tool that’s used in our industry to not only find the root cause but make sure that it never happens again.
Michael As someone who is not quite as familiar with life sciences, it is assuring to hear that there are standards in place to help both prevent problems but then, also, there’s the reality of “hey, you’re going to have some errors that enter the system; our standards are going to help us be able to go back and identify how they…” basically course correct. “Let’s make sure that doesn’t happen again”, and it sounds like what you’re describing.
Jeff Absolutely. It’s really a culture that has to be embedded into the company but, especially the organization that’s responsible for the content that says that “we have processes that we rinse and repeat every day; we don’t deviate from those and when we have issues we’re able to pinpoint how did this happen so we can make the adjustments” and be in a continuously improving organization, not staying static so that it can stay ahead of the issues.

Hopefully, you create the systems downstream that can catch these problems so they don’t get outside of the doors of your company. A problem found internally is a score, actually, it’s a win. Being able to find those problems downstream, even up until the point of just before shipping, if there is some way to be able to use your systems and processes, to be screening at that level, too, and you can catch it, it’s going to keep the problem inside your walls, but it’s also going to be a win because you’re going to have found out “oops, we had this problem; we didn’t know it existed; and now we’re able to really stay in front of this on an ongoing basis and keep getting better.”
Renato One of the things that I understand from the regulatory perspective is that content is part of the device.
Jeff That’s right.
Renato So, if you have a defective part in the device you have a process to replace, repair, you have training documentation on how to maintain the device, etc., but the documentation is an integral part of the medical device. So, I might be exaggerating, but I was told that sometimes if you figure out that there is a comma that is wrong in a document, you have to go through a very detailed correction process that goes back to the regulatory agency, that you have to explain why you are changing that comma and things like that, is it that detailed?
Jeff It can be very… well, yes, absolutely. That’s not an exaggeration. Of course, first, you have to perform a risk analysis to understand “hey, did this problem really create an issue for the patient or the doctor in the use of the healthcare professional?” And you roll that back and you have to then, after that risk analysis potentially, you’re going to have to notify the regulatory agency that has this on record; you may have to go through a set of hands, through engineering and marketing and regulatory internally. And it can only stand to potentially delay business but, most importantly, you probably are keeping a life-saving and/or life sustaining device from being able to get out to the field. So, humans, again, being on the other side of this, you’ve got to get it right.
Renato Michael, one of the interesting things about this is that for the translation company, for the LSP, there is always this interest “oh, I’m going to be a life sciences translation company” because you can charge a lot more for life sciences than you can charge for a regular translation. But, there is this risk/reward element that’s part of that.
Michael Right. And some of these standards take some pretty significant investment on the company, on the LSP side. Can you talk about some of the standards that are translation specific?
Jeff Yeah, absolutely. To the point of having a lot of profit potential to go after life science companies, they are demanding as well because if there are problems as described earlier, you’re going to be a part of the root-cause analysis. And if you don’t have a strong quality system inside of your company as an LSP, you are set to be asked a lot of questions that you’re not used to.

Oftentimes life sciences will not even on-board an LSP that doesn’t have a strong quality system, a person who is in charge of quality that sits at the executive level so that there’s enough authority for oversight of quality. So, yes, you have to have that capability internally that really matches the capability of the life science company that you serve so that you can meet them and be proactive with them.

So, there are standards inside of these companies that will require for external testing, and it’s going to require that you have a retained group of translators that have a certain level of medical expertise that need to be demonstrated (and) oftentimes, try to make agreements that lock up those translators in your agreement so that they’re not being moved around a lot because what will happen is not only does the company want a common language about the content that they’re having translated, or common voice about what they’re talking about with the product; they’re also wanting a certain level of understanding about the use and effects of the product.

And that use and effects is what someone has to understand when they’re trying to really realize in the source language “they are saying X; how do I make sure that as I bring it into the local language that I’m not losing something that they really intended, or that they meant to not say?” So, that comes with partnership. It is technical in nature, and it just can’t be treated like a non-regulated product that doesn’t have significant implications.

So, that’s a part of what the LSP really has to be prepared for if they’re going to do business in this space.
Renato So, at Edwards, into how many languages do you localize your products?
Jeff With Edwards they were running at about 35 languages when last I checked. They are, of course growing; and, of course, as each of the countries required ongoing and ramped up requirements…some countries, for instance, would take English on their label and allow it to be imported, but each country, each region seems to continue to step up requirements as they know technology is advancing and allowing for flexibility. So, localization languages and their requirements in life sciences are only growing.
Renato So, here’s my stupid question…you are doing…it’s one of those things…of course, I know that there is a solution but it’s one of those silly questions that has occurred to me occasionally. You do 35 languages. It must be a damned big label to have all those languages on the label?
Jeff Well, there is another big challenge and, actually, this is a smart question. This is not only with life science companies but because the expense of the actual product itself, you need to have efficiency on the labelling. You need to be able to create flexibility on the labelling so that the product is able to be shipped in many regions. If you have a large part of your inventory with Russian on it, and that only represents for that product a point or 2%, perhaps, of your sales, you can get your supply chain completely stopped up with product that can’t be sold.

And so, you think about it, you have to be very strategic, and it connects back to sales; it connects back to demand planning, so that you are really realizing, “okay, the way that we are organizing these labels fits the need of our business and allows us to make sure that we’re going to not have a bunch of extra inventory that is labelled in a specific Indian language that I can’t move somewhere else” for instance.
Renato Does it go with the plugs, because that’s another element of the device, right, you have plugs for Europe, UK, Asia, and the labels must be… I’m assuming, I don’t know, these are the little problems that I never really…
Michael … had a chance to ask. Yes, there’s never a chance to ask someone!
Jeff Well, the French want it in their language, right? And in Europe, of course, where you’ve got all these countries that have many languages in them. There’s another challenge, of course, with Western Europe; there’s just a wonderful opportunity to serve patients there, and having a sophisticated labelling strategy and getting those things into market can be a massive enabler to sales. So, it’s a complication that really requires analysis and, I have to say, when I first started looking at the labelling and the instructions many years ago inside of a product, a medical device product, I thought “that’s just stickers and instruction pamphlets” you know. I get instructions when I buy Monopoly, somebody wrote that, okay, big deal. And somebody throws a sticker on my bottle of ketchup and that’s no big deal.

But, as you start to realize the importance of statements, the importance of the fact that people use those statements and guidance and look at the size and dimensions and use and storage, that can greatly affect a person’s life, and so it’s just it creates a dynamic of challenge and thrill at the same time, if you like that.
Michael Before, I was thinking when we were talking earlier, for the translator who is working in this space, they’re not only helping devices get to market that help save human lives, but by following the standards, by being excellent in their process, they are actually making it more efficient, saving lives, do that efficiency, making sure there are not mistakes the enter into it that create errors. You can directly tie their work to a pretty significant change—that’s people’s lives.
Jeff Yes, you’re absolutely right. In fact, I would go even further just to say that if they’re careful and they’re accurate and they ask questions and they start to interact and not make assumptions or guesses, they are really actually ultimately helping a company and people at the end because we know retranslating or finding problems and going through that wash cycle over and over again only delays things and creates more confusion.

So, accurate translation the first time, by care, just strengthens the ability to get that product out quicker every time that a change comes through.

And so, getting familiar with that, having medical terminology, dictionaries and resources around that make LSPs stronger, especially when you’re working in these fast innovative places because companies like Edwards are making up new terminology all the time to keep up with these new types of things that they’re innovating. So, as they create those new standards, like any type of technology as it evolves, it’s something that has to be managed; you’re going to have to be out there gathering data; listening to podcasts; using sorts of resources that are out there to understand more about who you’re serving, it’s going to make you a better LSP.

End of conversation

Jeff Gerhardt

With nearly 20 years of experience in the Life Sciences space, Jeff Gerhardt is the founder and principal of Centix Life Technologies, and was formerly a director of Global Labeling at Edwards Life Sciences.


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