When developing a new product, or launching the updated version of a legacy product, there are two scenarios in which proactive terminology management can help your organization to mitigate inconsistency problems that have a profound effect on the overall success of your product launch.
In the first scenario, an organization is looking to leverage existing content for a product whose functionality is similar to—if not exactly the same as—previously manufactured versions. In this scenario, with the use of a terminology management system, you can ensure that the nomenclature espoused by previous versions of the product is used consistently within any updated or supplementary product literature, including user documentation, product specifications, online help, printed marketing material, and legal documentation, etc. As mentioned previously, it’s not uncommon for organizations to leverage previously written content, especially when dealing with bulky, content-thick user manuals and regulatory documentation. In this instance, systematic terminology management is really the only practical solution to guarantee that multiple authors creating additional content are using pre-approved terms for key product functions.
In the second scenario, an organization is looking to leverage existing content for a product whose functionality has been redefined, or is vastly different in certain aspects of functionality, from previously manufactured versions. Herein lies a largely unexplored objective of terminology management, to wit: terminology management is not only aimed at ensuring the use of pre-approved terms, but is also aimed at preventing the use of out-dated or deprecated terms.
Let’s return to the blood-analyzing device example given in the previous section of this article. For the purposes of this example, say that the Life Sciences organization in question has manufactured blood analyzers before, but previous versions of the product were referred to as “Blood Samplers,” hence the use of the term sample being used in product literature to refer to the analysis function of the device. Although previous versions of the device sold fairly well, the company’s marketing team realized that the use of the word sampler in reference to the product was neither technical nor specific enough. Because of this, their product was largely positioned for a more layman’s market and, as such, was massively overlooked by professionals in the medical industry. This revealed an enormous source of untapped revenue for the company. In order to make the new device more palatable to a broader, decidedly more expert audience, the marketing team decides that the product needs to be strategically redefined as a “Blood Analyzer.”
This is a common scenario in business today, and in order to ensure that the change in product name occasions the most substantial gains possible in terms of both visibility and customer experience, then all functional groups who are contributing to product-related written communication need to go back and revise all relevant legacy content. In this case, sample is now a deprecated term, and the term analyze is now the approved or preferred synonym. Because of this, the word analyze needs to be applied to all applicable aspects of the product’s written communications, including software GUI strings, labeling, training documents, online help, regulatory documentation, explanatory materials and, of course, marketing collateral.
Without a terminology management strategy in place, there is no efficient, foolproof method of ensuring terminological consistency between product deliverables. With the terms analyze, sample, run analysis,and sample run allrunning amok (pardon the pun) across the various forms of this product’s written communication, when the manufacturer’s regulatory department files samples of the product’s user manual, operator’s guide, service manuals, training material and marketing collateral with the FDA, it’s a safe bet that they will flag the device in question based on sweeping terminological inconsistency. And when the FDA questions the consistency of a medical device, they will more likely than not reject the product’s application and return the documentation back to the manufacturer, demanding that they address and resolve any discrepancies present before resubmission. This will severely delay the launch of the device (by at least two to three months) even if the manufacturer is able to clear up the matter in a timely fashion.
Product delays are a resoundingly best-case scenario. In a worst-case scenario, the FDA does not initially notice any terminological discrepancies, and clears the release of your product. However, if after distribution a user gets injured as a result of unclear or inconsistent instructions, then this will result in an FDA investigation, which is decidedly more painful than delayed clearance.
The typical response to an FDA investigation involves an immediate stop shipment and possible product recall. From there, an organization must change their labeling and possibly reprint all non-compliant material. Rather than updating all offending documentation, which can cost millions, many companies in the Life Sciences opt to send a letter to all users, detailing every single inconsistency for which their organization is responsible. Even hitherto satisfied consumers can quickly lose confidence in the quality of the product they’re using, and also in the overall reliability of the brand name that’s printed across every page of the written mea culpa.