Renewed Focus on Medical Device Cybersecurity

Dick Cheney famously turned off the wireless connection to his pacemaker for fear that hackers would attack and disable it – the vulnerability of networked medical devices has been the subject of hacker conference presentations for a number of years now. A recent episode of “Homeland” stirred up this concern, and now a report by Europol has industry talking again – this time about “ransomware” attacks. A recent article in FierceMedicalDevices details concerns about hackers’ ability to disable networked devices in order to extort payments. For sure, the networked “internet of things” has its downside.

Testing and validation is one important component of your overall security strategy – that’s why TransPerfect Medical Device Solutions includes software testing services, to help ensure that your device is operating safely AND securely.

 

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Reports of Death Have Been Greatly Exaggerated

For years, the device industry has lamented declining VC investment, leading to a decrease in new-company formation, innovation and the like. Well, to paraphrase the popular Mark Twain misquote, “reports of the death of medical device venture investment have been greatly exaggerated” According to FierceMedicalDevices:

 “This year, medical device venture fundraising could actually increase for the first time since 2007. That’s driven by the increasingly connected healthcare environment. VCs are going wild for digital health, the promise of convergence between our healthcare systems and all the mobile, cloud, wireless and wearable technologies you could possibly imagine.”

 This convergence of multiple disciplines requires a solutions approach to content management and translations – a key reason that EnCompass was created. Different content types require different treatment in translation, e.g. medical resources for anatomical content, computer/IT resources for software-related content…and testing/verification services for the finished device software.

VC investment in the device industry is focused on digital health – and these new software/hardware/network devices require an integrated approach to content management and linguistic QC that spans a number of technologies and disciplines – not just medical/anatomical. Fortunately, TransPerfect Medical Device Solutions has all the services and technologies that you need to ensure linguistic accuracy and system quality and compliance.

“Scots Wha’ Hae” and Radical Localization for Medical Device Marketing Material

‘Scots, wha hae wi Wallace bled,

Scots, wham Bruce has aften led,

Welcome tae yer gory bed,

Or tae victorie.

As a Celtic Studies major in college and one-time resident of Scotland, I’ve watched with keen interest the impending Scottish independence vote. After 300+ years of union, it’s shocking to think this vote is too close to call (with an incredible 95%+ voter turnout). However, it’s also a very good example of the persistence of regional culture and identity in Europe – and underscores the importance of localizing (not just translating) your marketing content.

Marketing messages designed for the US may not resonate (or even translate) into e.g. French, German, or Turkish markets. That’s why many manufactures are now looking at “radical localization” – a complete rewrite of marketing content for local markets – only “guided” by the English original.

Of course, in these instances, it’s important to have a control in place to ensure that the localized material is acceptable from a Regulatory point of view. This is where technology can help: TransPerfect Medical Device Solutions offers clients  validated technology (Translation Review Portal; TRP) for easy, online review and auditable commenting of translated material – there’s even a preview function so you can see your material in formatted context.

If you *do* need to translate your content into EU target languages, TRP also makes a great platform for your overseas contacts to review and comment on translation quality – there’s even a built-in grading and scoring system so you can track results.

So, whether it’s review of translation accuracy or review of “radical localization” for compliance, technology from TransPerfect Medical Device Solutions can help. And, if Scotland *does* become independent and requires Gaelic for labeling, you’ll be ready!  😉

P.S. Although, romantically, I would love to see an independent Scotland, I know from a practical perspective that continued union is in Scotland’s best interest: No thanks!

Worldwide Medical Costs Declining (in part) Thanks to XML!

OK – maybe the recently reported, substantial drop in worldwide medical costs isn’t entirely due to XML publishing technologies…but it’s one good example. All across the healthcare industries, companies and providers are adopting new methods and technologies that are helping them reduce cost and – finally – contain runaway expenses.

In the medical device industry, content-related costs have been growing rapidly over the past 20 years. But recently, companies like Medtronic, J&J, and Stryker have adopted XML publishing as a powerful way to reduce turnaround, cost, and risk – making their products more price-competitive around the world.

For instance, Medtronic implemented an XML content management system from our Vasont division to cut the time and cost of their translation/localization process by 50% – as one Technical Communications Manager there said recently, “We process ten times more content with the same headcount – this wouldn’t be possible without XML.”

XML is just one of the automation technologies offered by TransPerfect Medical Device Solutions to help manufacturers lower their content cost and risk and increase productivity – or, automate the entire labeling process with our EnCompass system. At TransPerfect, we’re helping to drive down the cost of healthcare – and increase profitability for our clients!

Medical Device Business “Too Hard”…for Google (?!)

Admitting something is “too hard” isn’t common at Google…but if you go to 28:54 of this video, you’ll hear Sergey Brin and Larry Page explain why medical device/healthcare is one of those areas.

Aside from feeling a little self-satisfied that you’re doing something that’s too difficult for Google, there are other points to consider here. Sure, device regulation is complex and difficult – and sometimes a little capricious and illogical. Still, regulation is meant to protect public health from faulty devices and bad actors – not everyone who makes a medical device puts patient safety first (witness the PIP breast implant scandal).

This is a common refrain from new technology companies: regulation is stifling innovation. The battle between taxicabs and Uber is one example. However, part of the cost of a cab comes from liability insurance – you can sue the cab company if you’re injured – a pedestrian can sue the company if they are struck by a cab…who are you going to sue if you’re struck by an Uber?

Technology companies (and some device companies) see regulation as an unnecessary burden, but many of these regulations are what help keep devices safe and effective. In this respect, a “least burdensome” approach to regulation is desirable – as the inscription above the temple of Delphi read: “Nothing in Excess”

 

 

“I am not in the office now. Send any work to translate”…

So reads the Welsh mistranslation for a road sign in Swansea, UK.

Apart from providing an opportunity to utilize my Celtic Studies degree (including Welsh grammar), it also offers a cautionary tale for medical device manufacturers producing mulit-lingual documentation  (see several other, riotous examples of Welsh mistranslations – thanks to Laurel D in our Boston office)

Errors like the one above are not really mistranslations. They are process-related: the result of someone who doesn’t speak the language copy-and-pasting content that they thought was correct. As part of our ISO 13485/ISO 14971-certified QMS, we keep process statistics on errors like this. We know that DTP-related, copy-paste errors are among the most common..and hazardous. In fact, about half of the serious translation errors we find (may result in patient harm) are the result of DTP processes.

This is one big reason why XML publishing is such a benefit for medical device manufacturers. XML publishing with a component content management system (like Vasont or Astoria) is the easiest way to reduce your DTP-related error risk. By virtually eliminating DTP tasks, XML processes not only reduce cost, they also enhance patient safety.

 

 

 

 

 

The Sweet Taste of XML Success

hersheybarTwo weeks ago, I had the pleasure of visiting Hershey, PA for the Vasont User Group conference (Vasont is headquartered in nearby Emigsville, PA). Part of the conference included a tour through the town of Hershey and a recounting of Milton Hershey’s incredible success story: bankrupt 3 times, his aunt’s house (pledged as loan collateral) on the verge of foreclosure, a junior bank officer personally signed on a last-chance loan to fill an order that enabled Hershey to repay his debts and catapulted him on his way to being one of the wealthiest men in America. Perhaps even more remarkable, he used his great wealth to establish a school for underprivileged boys that continues to this day and is backed by a large portion of Hershey corporation stock – you can watch read/see the story here.

Medical device and life sciences customers who attended the conference presented on the cost and time-savings benefits of XML publishing supported by Vasont. And, although XML systems can be notoriously difficult to implement, a quote from Merk summed up the feeling among attendees: “There are no unhappy Vasont customers”  – this is a statement almost as remarkable as the Hershey success story itself.

If you are contemplating XML publishing as a way to cut documentation cost and time or are struggling through a current XML implementation with another vendor, perhaps it’s time to consider Vasont. With deep experience and strong references in the medical device industry, Vasont can provide you with the sweet taste of XML success.