Traditionally, medical device industry translations are considered exceptional compared with the best practices of industries such as IT, and for good reason. This is a highly regulated industry, and the quality of translation is not just a matter of customer satisfaction.
However, these differences are starting to blur for two reasons. First, the world of medical devices is going digital. Content related to medical devices is appearing online, such as instructions for use (IFUs), support content, user-generated content or even instructional and promo videos. Medical devices also include complementary mobile apps or standalone software, or may themselves be medical apps. In addition, reporting of postmarket medical device adverse events such as medical device reports is more common, as are electronic ways to register new medical devices with regulators.
The second reason is that high-tech companies have discovered health care as a market with high growth potential. Using skills in IT, user experience and “go-to-market,” startups and tech leaders alike are launching products from simple wearable devices to sophisticated mobile apps that complement or even substitute for medical devices.
Google, for instance, broke new ground and struck the first alliance between big technology and pharmaceutical companies by joining forces with Novartis to develop “smart” contact lenses. The prototype lenses, embedded with electronics thinner than a human hair, measure glucose levels in tears and communicate the data to a mobile device, a strategy that the company hopes could help with diabetes management (Figure 1).
While the joint Google-Novartis project may take five years to commercialize, other high-tech giants have ventures that will hit the market much faster. Apple announced at the 2014 Worldwide Developers Conference the rollout of their own HealthKit as part of iOS8, with the aim to store, retrieve and present the personal health and fitness data of its Apple iOS users coming from a variety of apps and devices and even medical records. Apple was also granted a US patent on a means to embed a heartbeat sensor into its devices, as a way of replacing passwords with biometric methods, in this case an ECG, to authenticate users.
Likewise, Samsung announced that it would invest $50 million in the Samsung Digital Health Challenge, designed to accelerate the development of advanced sensors, algorithms and data collection and analysis in the health tech space.
Digital health is a ripe field for smaller companies, too. The mobile health (or m-health) industry is exploding, with companies producing apps and wearable devices that monitor the wearer’s physical fitness, as well as apps and devices that link patients with a specific medical condition to a health care system. Such technologies are used as much by health care professionals as their patients.
Hence, a shift is underway from traditional cures as delivered by medical devices to data-driven prevention of health issues and ongoing management of chronic diseases. In fact, according to the market research company research2guidance, 500 million smartphone users worldwide will be using a health care application by 2015, and by 2018, 50% of the more than 3.4 billion smartphone and tablet users will have downloaded mobile health applications. These users include health care professionals, consumers and patients, so no wonder high-tech startups and giants alike are moving into position to capture digital health.
Regulating new technology
While the technological developments in health care are exciting, there are a few major issues at hand. One is privacy — the storage and access to highly personal health data and records that get collected. The other is cyber security, and prevention of hacking of medical devices. If you’re caught up on Homeland Season 2, you’ll appreciate the threat of hackable devices implanted in bodies. To date, there are no known instances of medical devices like pacemakers misused this way, but these dangers clearly exist.
Regulatory agencies in the United States and Europe are playing catch-up on these issues and trying to assess how well newly developed medical devices address them. Patient safety and data security lead regulatory reforms that aim to keep government abreast of health technology developments. Regulators are actively redefining and reclassifying medical devices that overlap with high-level technology, especially when it comes to medical apps and medical software (Figures 2 and 3).
Once an app, software or device is classified as medical, it must comply with existing regulations, which includes requirements for CE marking approval in the European Union (EU) or clearance by the FDA, and of course also with the requirements for translations.
In the EU, the language and translation requirements for medical devices are driven by three council directives on active implantable medical devices (AIMDD), medical devices (MDD) and in vitro diagnostic medical devices (IVDD). All of these were drafted in the 1990s, and although they have been amended several times since then, they are approaching the end of their shelf life. Not surprisingly, they contain few provisions that would clearly and directly apply to the new generation of digital medical apps and devices and the risks that come with them.
As things stand, all three current directives provide member states with the option of having medical device labeling in the official languages of their states. And although optional, 22 of the current 28 EU member states have enacted legislation that requires medical device labeling in their official languages, whether that content is for laypersons or professionals. The remaining countries — Ireland, the United Kingdom, Cyprus, Luxembourg, Malta and Poland — will accept medical device labeling in English if the device is for professional use only.
It’s worth noting that medical device content is called labeling in the industry. So medical device labeling includes affixed labels but may also cover packaging, IFU, software, display screens, marketing collateral, patient information, and safety and technical information.
This means that a typical medical device marketed in the EU may need to include labeling in 20+ languages, which is more than the usual number of languages apps and devices targeted in nonregulated industries.
From directives to regulations
Will the new European legislation for medical devices mean a radical change? While the legislation process is still in place, it seems certain the current three directives will be reduced to two regulations — one on in vitro diagnostic medical devices and another on all other medical devices. This change is significant: while EU directives normally leave member states with a certain amount of leeway as to the exact rules on topics like translation requirements, EU regulations are immediately enforceable as law in all member states, all at once.
The new regulations are still a work in progress, and they focus on changing the way medical devices in the EU are regulated and classified, but so far there is little detail on any new translation requirements. Specifically, the draft regulations propose that:
For technical documentation, the manufacturer needs to supply a complete set of the label(s) on the device and on its packaging, as well as the IFUs and a list of the language variants for the member states where the device will be marketed.
Manufacturers shall ensure that the device is accompanied by the required information in an official EU language that is easily understood by the intended user (or patient, for medical devices). The language(s) of the information to be supplied by the manufacturer may be determined by the law of the member state where the device is made available to the user or patient.
The proposed reforms will likely be adopted in 2014 and 2015 and gradually come into effect from 2015 to 2019, so while they’re hardly final, there are presently no discussions about radically changing the parts related to translations.
One critique of the current proposed regulations is that they continue to focus on regulating “traditional” medical devices rather than addressing new technological developments. Among other things, the proposals do not cover hot-button high-tech issues such as compatibility, interfacing standards or security.
Medical software or not?
Since medical apps represent one of the fastest growing segments, they’re the focal point of recent guidelines issued by regulatory agencies. As recently as 2011 we saw the world’s recall of an m-health mobile app: Pfizer’s “Rheumatology Calculator.” Apple iPhone and Google Android users were alerted that the app had to be removed from the respective app stores for incorrect calculations, since an error in the application caused it to give 10-50% higher or lower disease scores than was accurate. Withdrawing faulty apps from app stores is an everyday occurrence, but as a medical app, Pfizer was obliged to issue an official withdrawal letter to doctors, advising them to delete the app from their devices.
The EU provides guidance on medical device standalone software, including apps. Software applications are medical devices when they have a medical purpose and are standalone, or in other words are not embedded in a physical medical device, and they are therefore regulated as medical devices on their own. If so, they must undergo a conformity assessment by notified bodies. These apps may include decision support or decision-making software that carries out calculations, so that, for example, clinicians do not need to review raw data. They may include apps acting as accessories to medical devices, such as in the measurement of temperature, heart rate, blood pressure and blood sugars. Or they may include software that monitors a patient and collects information if the output affects an individual’s treatment.
Meanwhile, the FDA issued its “Guidance on Mobile Medical Applications” to claim its role in reviewing and enforcing medical claims in the mobile app space. This guidance defines a subset of mobile apps under the FDA’s oversight based on their potential risks. With other apps, the FDA intends to exercise “enforcement discretion.” The guidance also makes it clear that app store operators (Google, Apple, Microsoft) are not considered mobile medical app manufacturers.
In the FDA’s case, mobile apps are regarded as medical devices when they:
Connect to an existing device for purposes of controlling its operation, function or energy source.
Transform a mobile platform into a regulated medical device.
Display, transfer, store or convert patient-specific medical device data from a connected device.
If such software is classified as a regular medical device, then it is subject to labeling requirements, premarket submission for approval or clearance (unless exempt) and the subsequent requirements for medical device reporting.
Beyond the extra time required for regulatory approval once the device is classified as medical, the obvious concern is the cost. A typical premarket application may cost some $258,000, whereas a Premarket Notification 510(k) will cost you $5,000. Plus, how do you know if an app update requires a new regulatory application? In the words of the FDA, it would not for “minor, iterative product changes,” but such a definition is subject to interpretations.
It’s worth mentioning that mobile apps intended for use as a digital version of medical device labeling or IFUs are not considered medical devices on their own and therefore are not considered mobile medical apps. Instead, they are considered part of the medical device labeling and are subject to the regulatory labeling requirements relevant to that particular product.
But how different is it really to translate or localize the new wave of medical devices that come in the form of apps or other software? On the one hand, some of the core elements of a typical translation process in life sciences are the same, with the same focus on quality, accuracy and terminology adherence, and with well-defined quality assurance steps. But there are more technical steps in the process, including software and app testing, which are functional as well as linguistic, and in-context review. Translators also need to take into account the aspects of usability and end-user experience. This is where high-tech companies excel, and where traditional medical device manufacturers are catching up.
At the same time, the process is much more streamlined compared with localization of embedded medical device systems, which until recently comprised practically all medical software. These have been characterized by relatively low levels of internationalization built in, and often featured a wide range of custom user interfaces. As a result, their localization and testing have been unnecessarily complicated and time-consuming. In comparison, medical apps running on any current platform — iOS, Android or Windows Phone — can enjoy highly advanced internationalization support and sophisticated tools and environments for localization, making the process much more effective.
Electronic labeling is on the rise
Digitizing medical devices is not just the trend pursued by IT companies. The medical device industry has enacted legislation that allows providing labeling in electronic form instead of in paper form. EU Commission Regulation No. 207/2012 established rules regarding electronic or e-labeling that apply to medical devices and accessories intended only for use by professionals. This means that e-labeling, as a replacement of printed IFUs, is allowed for devices where use by lay people is not reasonably foreseeable by the manufacturer of the device.
Electronic provision of IFUs means that they are displayed in electronic form by the device, contained in portable electronic storage media supplied by the manufacturer together with the device, or that IFUs are available through a website, which is the most practical option because it easily allows for IFU updates. Since this is an EU regulation in force since March 1, 2013, it is directly applicable in member states law and doesn’t need to be transposed into domestic medical devices regulations to take effect.
The good news is that the new European medical device regulation, in its current draft wording, does not change this provision. IFUs may continue to be shared with users in electronic form to the extent and under the conditions set out in the Commission Regulation 207/2012.
In practice, this regulation, which applies also to standalone software, requires manufacturers to conduct a specific risk assessment related to the provision of IFUs electronically, and to clearly identify which parts of the customer information are considered to be part of the IFUs, or in other words, which information is required for its safe and proper use.
The manufacturer needs to have a system in place to provide IFUs in printed paper form at no additional cost to users within seven calendar days of request — a tall order since it means printing and delivering the printed version of IFUs to any user across the European Union in this short window. The regulation also calls for any website distribution of e-labeling to designate the languages in which it is available.
Trying to anticipate the wording of forthcoming regulations always brings Niels Bohr’s famous quote to mind: “Prediction is very difficult, especially about the future.” But it is safe to assume we’ll see a wave of medical devices and their accessories arriving in the shape of apps, software and wearables, as health care companies turn digital and IT and consumer companies focus on health care. We may expect a certain clash of approaches, under or outside the regulatory framework for medical devices. But the ultimate beneficiaries will be us — consumers, patients and users — along with our health.