Marc Miller, Division President, TransPerfect Medical Device Solutions01.06.20
Predicting the future is a tricky business. Wrong assumptions, weak projections, the “unknown unknown”—often, it’s best to start by reviewing prior forecasts to see how they panned out. As 2019 has ended and 2020 has just begun, there is plenty of uncertainty about the future and how things will pan out in the medical device industry—largely driven by regulatory and political changes in Europe and trading relationships with Asia. In times like these, it feels especially appropriate to assess past predictions to see what lessons can be learned to help navigate tomorrow’s challenges.
Fourteen years ago, I wrote an article for MPO that described three different types of language service provider—how they compared and contrasted with one another and their relative odds of future success. Given the seismic changes taking place within the medical device industry, the accuracy of these predictions is relevant for manufacturers—especially as they provide guidance for improved supplier selection.
“Well, how did I get here?”—The Talking Heads
In Growing Deep: Vertical Specialization in the Translation Industry, I discussed three types of language services provider, each with a specific business origin:
Although each type brings a particular perspective and approach to their work, TransPerfect (entrepreneurial) first specialized its operations according to vertical customer markets. And, as a result of its extensive work with the life sciences sector (including medical device), TransPerfect was also the first enterprise-scale supplier to implement quality systems in production as a standard part of its operations. In fact, TransPerfect Medical Device Solutions was the first language services supplier certified to ISO 13485 and ISO 14971.
In 2006, I predicted the combination of entrepreneurial customer focus and vertical specialization, supported by quality systems experience, would prove to be a winning strategy. In fact, by 2017, TransPerfect had grown to be the largest language services provider in the world—fueled, in part, through sales of its process automation technology suite, GlobalLink. As a division president, it was remarkable to see an $80 million “family of companies” grow to over $705 million: a testament to the value added by an entrepreneurial culture that stresses customer service, innovation, collaborative problem-solving, and measured risk-taking.
“We had to destroy the village to save it.”—U.S. Commander in Vietnam (attributed)
Now comes MDR. Although originally designed to enhance patient safety, this new European regulation may actually increase risk through its “piecemeal implementation” and dramatic increase of regulatory requirements. Evidence of this can be seen in the large number of devices expected to be pulled from the European market (20-30 percent) by manufacturers who are unable to foot the cost of compliance across large numbers of device types. It can also be seen in change-management issues rippling through functional operations (e.g. Post-Market Surveillance and Labeling) as manufacturers struggle to implement numerous new requirements in a regulated, controlled environment. In a dangerously ironic twist, a regulation meant to protect EU patients from high-profile, high-risk device failures of the recent past (PIP breast implants, metal-on-metal hips, etc.), may actually expose them to an entirely different set of troubling risks due to poor implementation by regulators.
Beyond implementation difficulties, there is no doubt the EU MDR (and IVDR) will have a profound, long-term impact on medical device manufacturers’ operations. In this environment, consider the compliance requirements of today, along with solutions that address the permanent changes that come as part of a future under MDR and IVDR.
“Partnership is not a posture but a process—a continuous process that grows stronger each year we devote ourselves to common tasks.”—John F. Kennedy
So, what can all this tell us about selecting suppliers to support MDR requirements now and in the future? In the case of language services and content management, the same characteristics and assets that accurately predicted TransPerfect’s ultimate success 14 years ago are precisely what device makers need to address for MDR (and IVDR) requirements now:
Vertical specialization—The time remaining for MDR compliance is short and experienced suppliers with veteran resources can provide informed guidance and, with the right resources, valuable solutions. For instance, TransPerfect MDS has been exclusively dedicated the device industry for over 27 years. Substantial experience, when combined with specialized resources, enables suppliers to make best practice recommendations for specific MDR challenges.
Quality systems-based production—Medical device-specific quality systems, developed over years of successful operation, provide the most effective hedge against the operational risks of MDR and IVDR. For example, TransPerfect MDS was the first translation supplier to register to ISO 13485 and ISO 14971 and holds the only patent for labeling translation risk management.
Supplier scale—The 2006 MPO article noted Peter Drucker’s observation that larger organizations, thanks to resources and qualified staff, are in the best position to succeed. This is especially true of current MDR labeling initiatives where hundreds of thousands (if not millions) of discrete documents require translation and updating. The larger the supplier, the more qualified resources can be brought to bear in a short amount of time to effectively address the increased need. In this particular case, bigger is better.
Advanced automation—Many manufacturers are scrambling to simply meet initial MDR compliance deadlines. However, increased regulatory requirements will continue after May 2020. Expert opinion from regulatory consultant Qserve notes manufacturers will see a permanent increase in the volume of content that needs to be created, managed, and translated, as well as an increase in the velocity at which this process occurs. The result is device makers must automate their labeling and content management processes as quickly as possible to reduce cost, risk, and maintain MDR compliance—automation should be employed in every area subject to the MDR’s “volume and velocity” effect. For instance, manufacturers should favor suppliers who can provide XML technologies for single-source content management and automated publishing, AI for automated PMS decision support, eTMF systems for clinical trials, and proxy-based solutions for automated website translation.
Innovative, entrepreneurial focus—As noted in the original MPO article, entrepreneurial companies are characterized by intense customer focus. Because of this, they are also characterized by innovative solutions to customer problems. In response to the increased content requirements facing device makers because of MDR and IVDR, some suppliers now offer automation solutions that leverage content management and process automation (e.g., TransPerfect’s EnCompass system) or advanced AI (e.g. GlobalLink AI Portal for PMS). These validated technologies are already in use and providing substantial relief for MDR content requirements.
Because the requirements of MDR and IVDR will continue to evolve, manufacturers will have an ongoing need to improve processes, develop best practices, and implement automation technologies. This will require engagement and exchange beyond the typical arms-length “supplier” relationship. Because the common task is overall operational efficiency, a well-equipped partner is also a device maker’s best supplier.
“History doesn’t repeat itself, but it often rhymes.”—Mark Twain (attributed)
Amid the drastic MDR-related changes currently working through the medical device industry, it’s comforting to note some basic principles remain the same. For MDR language services and content technology suppliers, device makers should look for the same characteristics that accurately predicted industry success over 14 years ago; vertical specialization, quality systems-based production, supplier scale, advanced automation solutions, and entrepreneurial focus are a winning combination in a supplier/partner—then, now, and for the future.
Marc Miller is the division president of TransPerfect Medical Device Solutions. For over 28 years, he has assisted all sizes and types of device manufacturers with translation and process automation for labeling, marketing, e-learning, software, and other product-related content. Marc founded the first translation company certified to ISO 13485 and ISO 14971 and is the co-author of the industry's only translation risk management patent. He also led the development of the first content automation system specifically designed to meet MDR and IVDR content requirements. Marc earned his bachelor of arts degree from Harvard University and his MBA from Stirling University in Scotland.
Fourteen years ago, I wrote an article for MPO that described three different types of language service provider—how they compared and contrasted with one another and their relative odds of future success. Given the seismic changes taking place within the medical device industry, the accuracy of these predictions is relevant for manufacturers—especially as they provide guidance for improved supplier selection.
“Well, how did I get here?”—The Talking Heads
In Growing Deep: Vertical Specialization in the Translation Industry, I discussed three types of language services provider, each with a specific business origin:
- Technology-first suppliers who began operations by servicing software clients—SDL is the largest of this type
- Wall Street or VC-funded, MBA-staffed, language industry “ventures”—Lionbridge is the largest of this type
- Boot-strapped entrepreneurial start-ups—TransPerfect is the largest of this type
Although each type brings a particular perspective and approach to their work, TransPerfect (entrepreneurial) first specialized its operations according to vertical customer markets. And, as a result of its extensive work with the life sciences sector (including medical device), TransPerfect was also the first enterprise-scale supplier to implement quality systems in production as a standard part of its operations. In fact, TransPerfect Medical Device Solutions was the first language services supplier certified to ISO 13485 and ISO 14971.
In 2006, I predicted the combination of entrepreneurial customer focus and vertical specialization, supported by quality systems experience, would prove to be a winning strategy. In fact, by 2017, TransPerfect had grown to be the largest language services provider in the world—fueled, in part, through sales of its process automation technology suite, GlobalLink. As a division president, it was remarkable to see an $80 million “family of companies” grow to over $705 million: a testament to the value added by an entrepreneurial culture that stresses customer service, innovation, collaborative problem-solving, and measured risk-taking.
“We had to destroy the village to save it.”—U.S. Commander in Vietnam (attributed)
Now comes MDR. Although originally designed to enhance patient safety, this new European regulation may actually increase risk through its “piecemeal implementation” and dramatic increase of regulatory requirements. Evidence of this can be seen in the large number of devices expected to be pulled from the European market (20-30 percent) by manufacturers who are unable to foot the cost of compliance across large numbers of device types. It can also be seen in change-management issues rippling through functional operations (e.g. Post-Market Surveillance and Labeling) as manufacturers struggle to implement numerous new requirements in a regulated, controlled environment. In a dangerously ironic twist, a regulation meant to protect EU patients from high-profile, high-risk device failures of the recent past (PIP breast implants, metal-on-metal hips, etc.), may actually expose them to an entirely different set of troubling risks due to poor implementation by regulators.
Beyond implementation difficulties, there is no doubt the EU MDR (and IVDR) will have a profound, long-term impact on medical device manufacturers’ operations. In this environment, consider the compliance requirements of today, along with solutions that address the permanent changes that come as part of a future under MDR and IVDR.
“Partnership is not a posture but a process—a continuous process that grows stronger each year we devote ourselves to common tasks.”—John F. Kennedy
So, what can all this tell us about selecting suppliers to support MDR requirements now and in the future? In the case of language services and content management, the same characteristics and assets that accurately predicted TransPerfect’s ultimate success 14 years ago are precisely what device makers need to address for MDR (and IVDR) requirements now:
Vertical specialization—The time remaining for MDR compliance is short and experienced suppliers with veteran resources can provide informed guidance and, with the right resources, valuable solutions. For instance, TransPerfect MDS has been exclusively dedicated the device industry for over 27 years. Substantial experience, when combined with specialized resources, enables suppliers to make best practice recommendations for specific MDR challenges.
Quality systems-based production—Medical device-specific quality systems, developed over years of successful operation, provide the most effective hedge against the operational risks of MDR and IVDR. For example, TransPerfect MDS was the first translation supplier to register to ISO 13485 and ISO 14971 and holds the only patent for labeling translation risk management.
Supplier scale—The 2006 MPO article noted Peter Drucker’s observation that larger organizations, thanks to resources and qualified staff, are in the best position to succeed. This is especially true of current MDR labeling initiatives where hundreds of thousands (if not millions) of discrete documents require translation and updating. The larger the supplier, the more qualified resources can be brought to bear in a short amount of time to effectively address the increased need. In this particular case, bigger is better.
Advanced automation—Many manufacturers are scrambling to simply meet initial MDR compliance deadlines. However, increased regulatory requirements will continue after May 2020. Expert opinion from regulatory consultant Qserve notes manufacturers will see a permanent increase in the volume of content that needs to be created, managed, and translated, as well as an increase in the velocity at which this process occurs. The result is device makers must automate their labeling and content management processes as quickly as possible to reduce cost, risk, and maintain MDR compliance—automation should be employed in every area subject to the MDR’s “volume and velocity” effect. For instance, manufacturers should favor suppliers who can provide XML technologies for single-source content management and automated publishing, AI for automated PMS decision support, eTMF systems for clinical trials, and proxy-based solutions for automated website translation.
Innovative, entrepreneurial focus—As noted in the original MPO article, entrepreneurial companies are characterized by intense customer focus. Because of this, they are also characterized by innovative solutions to customer problems. In response to the increased content requirements facing device makers because of MDR and IVDR, some suppliers now offer automation solutions that leverage content management and process automation (e.g., TransPerfect’s EnCompass system) or advanced AI (e.g. GlobalLink AI Portal for PMS). These validated technologies are already in use and providing substantial relief for MDR content requirements.
Because the requirements of MDR and IVDR will continue to evolve, manufacturers will have an ongoing need to improve processes, develop best practices, and implement automation technologies. This will require engagement and exchange beyond the typical arms-length “supplier” relationship. Because the common task is overall operational efficiency, a well-equipped partner is also a device maker’s best supplier.
“History doesn’t repeat itself, but it often rhymes.”—Mark Twain (attributed)
Amid the drastic MDR-related changes currently working through the medical device industry, it’s comforting to note some basic principles remain the same. For MDR language services and content technology suppliers, device makers should look for the same characteristics that accurately predicted industry success over 14 years ago; vertical specialization, quality systems-based production, supplier scale, advanced automation solutions, and entrepreneurial focus are a winning combination in a supplier/partner—then, now, and for the future.
Marc Miller is the division president of TransPerfect Medical Device Solutions. For over 28 years, he has assisted all sizes and types of device manufacturers with translation and process automation for labeling, marketing, e-learning, software, and other product-related content. Marc founded the first translation company certified to ISO 13485 and ISO 14971 and is the co-author of the industry's only translation risk management patent. He also led the development of the first content automation system specifically designed to meet MDR and IVDR content requirements. Marc earned his bachelor of arts degree from Harvard University and his MBA from Stirling University in Scotland.
