Subjects - Business

Directives guiding the sale of medical and consumer devices already govern localization in the 25 countries of the European Union.

The European Union’s (EU) Medical Device Directive (93/42/EEC) (MDD) forced a great many medical devi

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

ce manufactures to recognize the fact that there are other languages besides English.

What are the implications from the translation point of view?

For starters, the Directive requires companies to adopt a specific multilingual doc

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

Examples of combination products may in

umentation process. This requirement compels companies to make provisions for translating documents pertaining to their product packaging, end-user instructions, labels and other essential product documentation. These are particularl

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

important when it comes to user instructions since the device’s safety and purported performance could be compromised due to incompetent translation.

While previous directives specify that national languages may be necessary for th

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

is kind of information, most EU member states have now made it clear that this has become an absolute requirement. Specifically the MDD 93/42/EEC Directive Annex I Article 13.1 states that “each device must be accompanied by the info

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

Combination pro

rmation needed to use it safely and to identify the manufacturer, taking account of the training and knowledge of the potential users.” This, along with the directive making the potential user’s “knowledge" mandatory, makes "accurate

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

translation" an imperative.

There are two basic categories into which product information generally falls: (I professional use and II patient use). User information for devices designed for patient (OTC) use is almost invariably tra

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

nslated into all target market languages. This has to do with common sense, regardless of any specific regulations. With regard to devices designed for professional use, safety-related information is also commonly translated. Their h

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

igh-level of complexity often makes it advisable to provide information in the user's native tongue.

It is difficult to predict the outcome of a court case in which a manufacturer is sued as a result of a user error stemming from hi

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

failure to understand instructions provided in a foreign language. However, the damage to the manufacturer's reputation and business would be done in any case, whether he is legally liable or not.

Often manufacturers will use their

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

own distributor or in-house translators to make their products available in different languages. However, this practice while viewed as a viable way to cut costs often results in poor translations. Not only is it in the best interes

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

Following aspects would a

t of the manufacturer to continually monitor all printed material for accuracy and consistency, it is essential to credible business practices. Thus, badly translated instructions are no better than those in a foreign language and ca

dd to the challenges in developing combination products:

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

result in the same legal repercussions as no translation at all. Cutting corners by using this type of translation is clearly not the way to ensure quality.

There is yet another argument in favor of translating medical device mater

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

ial that has little to do with regulatory requirements. As with any product geared for customers in different countries with different mother tongues, it is a matter of user friendliness and a valuable selling point to make it availa

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

ble in the potential clients' native tongues. For example, the German sales force of an MDD manufacturer will find themselves at a serious disadvantage when trying to sell their English-language product if their colleagues from compe

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

itor B offer a similar device in duly localized versions. Thus, translation — whether legally binding for a specific product or not — simply makes good business sense.

As has been clearly emphasized, accuracy in providing translatio

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

Professional from academic institutions, pharmaceutical industries, health care indust

n services is absolutely crucial. Improper translation is not only detrimental to the end user it is a violation of the Directive! Net-Translators provides translation services in over 40 different languages and offers translation se

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

rvices to manufacturers who must comply with these requirements. All of the more than 300 translators at Net-Translators are located in the countries where their native language is spoken, ensuring the most precise translations possi

.

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

le.

Once again, the OneLink:OneSolution™ network is offering solutions to firms in the medical device industry concerning one of the most important matters through one of it’s partners, Net-Translators.

Shy Avni is the Business Dev

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

Companies that provide selfless information through particip

elopment Director of Net-Translators Ltd.

Net-Translators specializes in Translation and Localization services in over 40 languages for the biotechnology industry.

Learn more about Net-translators Bio-Technology Translation Service

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

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Subjects - Translation Shifts From Nice-to-Have to Must-Have

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