Main Subject - Business

“Quality is the most important thing.”

“A translation must not sound like a translation – it should sound like an original text.”

“We only ever allow translators to work into their native language.”

It’s time to dig around some translation industry clich?s. For m

According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product

any buyers of translation, the quotations at the top of the page will be very familiar – and in many ways the statements are absolutely right. You would be unhappy to receive a translation that was low quality, that sounded like a translation (and not an original),

; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

Examples of combination products may in

and had been written by a non-native speaker.

Yes and no.

Yes, you would be unhappy if high quality, polished translations by native speakers was what you required.

But the assumption that high quality, polished native speaker translations is the only requirement

lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

is false, and a buyer of translation should be even more unhappy to have been sold an inappropriate service, especially when the service they were sold would have been considerably more expensive than the service that they actually required. Mis-selling is restrict

here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe

d to the world of door-to-door insurance salesmen.

So the question is: when would we use non-native language translators? There are five overlapping factors that will point towards some answers: price, quality, speed, content, and purpose

The “umbrella” reason for

d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

Combination pro

using non-natives is purpose. What is the translation actually for?

If a translation is purely “for information” (for internal use only, just to know what something means), then it doesn’t really matter how beautiful the translated language is. The key to such tra

ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc

nslations is accurate rendition of meaning – and this can (usually) be done absolutely as well by a translator working into a language that is not their mother tongue. In fact (and this now brings in the content reason), the most accurate understanding of any source

easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi

text is likely to be achieved by a native speaker of the source text. So for a highly technical source document, when the translation is only required “for information” maybe we should after all consider using source language native speakers.

Translations “for info

nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically

rmation” might be assumed to be chunky texts, maybe a manual, or a tender document that needs to be understood to prepare a response. A classic cause for non-native “for information” translations is in the field of market research. Imagine you have respondents in 2

and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ

0 different languages to a questionnaire. Many of the answers on the questionnaire will be fixed choice responses but perhaps you have some open-ended questions as well: questions to which the respondent could write anything up to several hundred words. You need to

ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi

now what they are saying, but only so you can incorporate the responses into the overall data for analysis. So you just want to know what has been said, and you don’t even care if the translations have the odd spelling mistake or typo. It simply doesn’t matter (in f

ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a

act the answers of the respondents will probably have spelling mistakes anyway). You may not even want a record of exactly what they wrote – just for the answers to have been categorised to allow for analysis, with the linguists coding the answers against a code fra

dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod

me, created either by you or by the specialist market research translation company. It absolutely makes sense to consider breaking the “rules” about translators only working into their native language. Here you don’t care if the translations sound like translations.

cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin

Natives of the source language will almost always be cheaper than English native speakers, just as good for the purpose, and the accuracy and consistency could be higher, especially if the linguist is coding directly.

Price of course can play a big factor. As ment

tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen

oned above a non-native English speaker will almost always be cheaper than a native English speaker, and dramatically so if the source language is from a region with very low costs e.g. China, India, Eastern Europe.

Supply and demand links into the price, quality,

t?

As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel

and speed reasons for using non-native translators. This is particularly relevant for translations into English from anything other than the major world languages.

Let’s suppose we need to translate a technical manual from Vietnamese into English, and we want to st

ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust

ick to the rule of only using translators working into their native language. How many native English people learn Vietnamese to professional fluency AND decide to be a professional translator AND happen to be available when we need them AND have relevant sector exp

y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products

rtise? Not many, if any, will be the most common answer. And if there is somebody suitable you can be sure they won’t be cheap.

One solution is “translation by committee”. We find a native Vietnamese translator who can provide his best effort at an English translat

.

As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de

ion. An English native (no Vietnamese skills necessary) proofreads and cleans the English text whilst in constant contact with the Vietnamese translator. The result is an accurate, English native quality translation dome at the speed we need it and at a price that r

elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

eflects the supply of Vietnamese translators who have good English skills rather than a price that reflects the almost non-existent supply of native English Vietnamese translators.

Lingo24 Translation Agency London

tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

The more you try to be in control, the less you really are…in life and at work. You just got fired and you think it’s the end of the world. You’re looking at the wrong end.

Are you using your competitors to better serve your clients? If not, this article will be an eye-opener for you.

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Main Subject - Is It Ever Appropriate to Use Non-Native Language Translators?

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