Alternate Paths to CE Marking and Regional Approvals
10 min read
In today’s marketplace, it’s imperative to make sure that your content cuts through the noise, draws attention, and maintains impact. That’s where a content strategist comes into play. Content strategists create content that resonates with an existing client base while drawing in new, underserved, or overlooked consumers. We asked Dan Koenig, a content strategist whose experience spans the transition from light tables and IBM Selectric typewriters to modern CAT systems, to provide a little more insight into the profession.
Dan Koenig: I spent 15 years creating a localization program at a global medical device company that began with post-it notes stuck to my computer screen as “translation requests” and ultimately became an enterprise level effort that included two content management systems. One was for large IFU content and the other was for chemistry sheets and box labels, and they moved through a centralized translation management system and process and fed content directly to reagent fill lines around the world and to the corporate website. In my current role at Argos, I’ve been able to elevate the effort to include better terminology management and higher quality that points the way to AI and machine translation. I view this as the most important next step for the life sciences industry to keep up with the growing demand for faster delivery of vaccines, therapeutics, and medical devices.
DK: I wrote an article for International Clinical Trials magazine called “The Pillars of Centralization” that detailed the steps needed to create a centralized content strategy that includes terminology management and elevated language quality assurance. The next logical step once those elements are in place is to use that verified data to train a machine translation engine so that the output is closely aligned with verified terminology and prior linguistic quality assurance efforts. We are about to record a webcast series based on these concepts as well.
I also engage directly with client queries regarding the best approach to overcome issues they encounter, such as dealing with certain elements of the new EU MDR/IVDR requirements. We have a lot of life sciences clients and are seeing the demand for faster turnaround for their products and for the support services (such as localization) that enable their release. Machine translation has matured to the point where it can be implemented in tandem with human post-edit and ongoing LQA to accelerate time-to-market with equal or even better quality. I am going to be pushing this to the forefront of client discussions whenever appropriate, because I strongly believe it is the way forward for the industry to meet these growing demands.
DK: I’ve seen a lot of change in technical communication over the last four decades or so. There have been dramatic improvements in technology for content management, publishing engines, translation management tools, and so on. Headless CMS programs now allow for rapid content repurposing for print, web, and mobile apps as never before. Despite this incredible tech evolution, the core need has never changed. It is still fundamental for organizations to get their experts together and decide what to call things, lock those down, then translate them accurately and put processes in place that ensure they don’t change unless evolving language usage or product design updates dictate that they do.
Obviously, the need for consistency and accuracy is stricter in the life sciences space than it is in marketing or industrial design, but I would argue that excellent customer experience is still largely dependent on consistency of terminology and the conveyance of that information into multiple languages in the same consistent manner. Any differences beyond this point are generally based in “voice” and content style, which should still be agreed on in advance of creation and maintained through the appropriate content channels.
DK: I have found it useful to seek out support in executive suites through ongoing presentations on what we intend to do and why it is beneficial, with follow up meetings to show progress and the need for ongoing support to meet new challenges. Ultimately, this approach is useful to establish the centralized content strategy (including localization) as a legitimate activity and discipline within the organization. I encourage anyone starting up a centralized content or localization program to keep track of core metrics such as quality, cost, and delivery right out of the gate. This will become the baseline to report the progress and growing maturity of the program. It will also allow for course correction as needed and will tell your executive sponsors why it needs to be done.
When presenting to execs, I have consciously begun by framing centralized content and localization as a bottom-line cost savings program – because it truly is – but I have also made sure to include data on terminology management and quality and why that’s so important. In other words, I have “played to the room” and still managed to convey the larger message that quality pays for itself over time. It certainly has and will continue to do so.
DK: Without question. I think the need to accelerate time-to-market is clearer than ever from the rapid assay, therapeutics, and vaccine development efforts that are going to ultimately get us out of this crisis. Now that we know what is possible, those same processes are certainly going to be applied across the life sciences industry to bring new therapeutics, tests, and medical devices to market more quickly to fight cancer, HIV, and the next pandemic that may arise. This is both a medical imperative for the benefit of patients around the world and a competitive advantage from a practical business perspective.
As I said earlier, machine translation is going to be a core solution to keep up with translating documentation for accelerated clinical trials, product registrations and releases, and the web content and labeling that will be required. But the fundamentals must be in place to access the benefits – stringent language quality assurance and terminology management to create a verified data pool for training the machine translation engine and the human post editors in each language required. This is the “tough love” part of the message – do the heavy lifting now (we’ll be happy to help) and the benefits will come down the road in short order. The time to begin is now!
Dan Koenig has been a thought leader in technical communications for, as he puts it, “more years than I’d care to admit.” Before joining Argos Multilingual, Dan spent over fifteen years designing and managing human and technology-based translation processes and systems for Beckman Coulter, Inc., a global medical device manufacturer and longtime client of Argos. When time allows, Dan is a popular speaker at LocWorld, a leading international business, translation, localization, and global website management conference.
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