The medical device industry is going global on a scale unheard of just ten years ago. As new markets open, device manufacturers are no longer content to let others "test the waters" before jumping in. Companies now make efforts to launch products globally, with packaging and labeling that work seamlessly across borders.
For executives who must manage this process, the pressure is getting worse. For every additional market, there are additional language, regulatory, and logistical issues that must be negotiated. Budgets and schedules are tight; and upper-level management often doesn't understand or appreciate the complexity of the issues involved.
Labeling professionals are on the forefront of this challenge: how to fit multiple languages on products, particularly small ones.
To compound the problem, most languages use 30% more space than English. The typical medical device company supports between 5 and 25 languages on the package labels.
And as package labels get denser, their clarity suffers, making necessary information harder to find for the customer. Unwilling to increase the size of label stock used (and with it, packaging costs), this shortage of label real estate is convincing companies to adapt new labeling strategies.
Some of the other approaches that are becoming more common include:
- Single-language or regional labeling, i.e., grouping languages by geographic area, depending on the supporting distribution network.
- "Boilerplating" by preprinting some common text on boxes and pouches. This approach frees up much-needed space on the label itself.
- "Pack-to-demand," meaning that a generic label is affixed at the manufacturing facility and that additional more specific labeling and documentation are added at the shipment/distribution point.
- Labeling at the distributor level may or may not be a feasible alternative for certain overseas offices. While there are strong incentives for this approach (handing off part or all translation management, cleaner cost accounting, etc.), there are also significant drawbacks. Affiliate offices may lack the infrastructure, resources, or skills to take on this additional responsibility.
ForeignExchange Translations provides specialized medical translations for medical device IFUs, operating manuals, and product labels.