4 months ago
December 16, 2020
Medtech Localization Buyers on Tech, Regulations, and Translation Demand
Slator welcomed senior localization buyers from two world-leading medtech companies — Varian Medical Systems and Medtronic — to the medtech localization panel at SlatorCon Remote. Aurélie Baechelen (Varian) and Bibiana Magalhães (Medtronic) joined Slator’s Esther Bond to discuss the role of language services in the medtech sector.
Magalhães, who has spent 13 years at Medtronic, focuses on cross-functional programs, processes, and technology efficiencies in her role as Linguistic Services Manager, Strategic Programs, for one of the largest medical devices companies in the world. Medtronic covers a plethora of disciplines and develops everything from heart valves to surgical robotics and diabetes management systems.
As to where language services are in the equation, Magalhães said, “We want to expand the access of our products to more patients and physicians across the world, and localization is a requirement for companies that want to reach global markets.”
Baechelen, who has a background in scientific translation and documentation and has a passion for medical devices, works as Localization Manager at oncology specialist Varian. Her role involves managing the localization of technical documentation such as user assistance, customer documentation (including the physical labels that are printed on radiation therapy machines), and sales materials, among others.
Major Impact of EU MDR
The panel first tackled the matter of regulation in medtech and how it factors into medtech localization. Baechelen outlined its role in daily business, highlighting that regulations “define how we can reach out to external vendors,” for example. Regulation touches on almost every aspect of the day-to-day, governing how medtech companies buy services, how they qualify suppliers and how they set up and document processes, she explained.
Magalhães also discussed a recent change in the European regulatory environment for medtech — the EU Medical Devices Regulation (EU MDR) — which, she said, “brings major requirements for pre-market and post-market clinical evidence, for R&D, quality and labeling.”
“Soon the rubber will hit the road and we will have an increase in demand in the medical translation space” — Bibiana Magalhães, Linguistic Services Manager, Strategic Programs, Medtronic
There are big implications for translation demand and “soon the rubber will hit the road and we will have an increase in demand in the medical translation space,” Magalhães said. “On one hand, we will have to update multiple manuals to add new symbols, additional verbiage around hazardous substances, warnings and precautions and, on the other hand, we will have new documents such as the Summary of Safety and Clinical Performance [SSCP] which will be translated into the applicable EU languages where the device is sold and made publicly available in the EUDAMED Database,” she added.
MT in Medtech
The discussion turned to the use of machine translation (MT) within medtech localization workflows. MT is “something that we are investigating,” Medtronic’s Magalhães said. However, “We are not applying it to patient- and physician-facing materials — there we apply a controlled human-based process — but we are exploring its usage in the post-market surveillance and corporate communications space.”
Post-market surveillance is a logical candidate for MT use because translation deadlines are tight due to the requirement to report issues to authorities in a timely manner. And, in the case of corporate communications, time or budget (or both) may be tight, and the risks are relatively low compared to other content types.
Baechelen concurred with Magalhães’ observation about the conservative approach to MT among medtech companies. Medical device companies and medtech in general are very cautious when it comes to the adoption of new technologies, Baechelen said, adding “We tend to be quite conservative and because of all of the regulations we have to adhere to.”
Although Baechelen acknowledged that, as a sector, “we’re also a bit behind with the adoption of MT,” she said she believes the opportunity for implementing MT exists in her company because “our development teams are becoming fully focused on AI and on digital transformation, and it makes people a lot more receptive to the topic of MT.”
A major question remains, as Baechelen pointed out: “How do you fit MT into the regulatory frameworks you have in medtech? For example, how do you document the process, and how does the post-editing fit into the [ISO] certification for medical devices?”
The full medtech discussion — procurement models, vendor strategies, risk management, translation management systems (TMS), and more — and the entire SlatorCon Remote recording are available to watch on Vimeo.