Category Archives: Uncategorized

Don’t Get Yanukovych’d

Yanukovych_WEB-readyShortly after Yanukovych was ousted as Ukraine’s President, the Ukrainian Parliament repealed a recent law allowing the use of “regional languages” like Russian.  Language has long been been tied up with issues of nationalism and national identity and can often be something of a “land mine” (not to be indelicate in the current, tense, situation).

If you think that these types of language sensitivities don’t apply to the medical device industry, you’re wrong. On one recent client visit, I heard a story of how the company had sent Russian instructions to a location in Estonia…not realizing the reaction that it might provoke (after the Soviet domination of the Baltic States). The result? Even though an exemption could have been written, the client demanded everything in Estonian and at a significant cost. The moral of the story? Know the political implications of your language choices when doing business abroad.

“Milder Than Expected” Device Tax Costs 33,000 Med Device Jobs, Impacts 132,000 Others

Advamed_for-web was a little schizophrenic in reporting the effects of the medical device tax, as outlined in a striking new Advamed report. According to their first post (2/12) the Device Tax’s impact was “milder than expected”…but their later post (2/18) states that 33,000 jobs have been lost in the industry already. So, what gives?

Well, it turns out that 53% of senior-level respondents had predicted “somewhat negative” or “very negative” effects when, after the fact, 45% actually experienced these negative effects. I guess that’s somewhat milder, but not by much.

At first blush, you might be tempted to say “this is an industry-sponsored report and exaggerated” but the scope of the survey suggests otherwise – responses came from 38 companies, accounting for 40% of domestic medical device revenue…45% had revenue below $100 million, the rest were above.

Other notable negative consequences reported by AdvaMed include:

  • 30.6% said they had reduced R&D
  • 10% said they were relocating manufacturing overseas
  • 58% were considering layoffs if tax is not repealed
  • 50% were considering reducing R&D if tax is not repealed

Not a pretty picture.

TransPerfect Doubles Down on XML Publishing for Medical Device

Recent news highlights the growing importance of XML publishing for the medical device industry: Just before the holidays, TransPerfect announced a merger with Vasont Systems – a leader in componet content management systems for the medical device industry. With the addition of Vasont, TransPerfect adds another XML publishing technology – one that is already in place with medical device manufacturers such as Medtronic and J&J – on top of existing XML technology from Astoria Sofware.

Why is TransPerfect doubling-down on XML technology for medical device? Our work with device manufacturers demonstrates a 50% reduction in labeling cost and turnaround with this automated approach to publishing. In some cases, formatting and formatting QC activities can represent as much 70% of translation turnaround time! Given the cost and margin pressures facing manufacturers today, it’s small wonder that interest in XML publishing is at an all-time high. In response, the Vasont merger substantially broadens the XML technology and service offering available to device makers through TransPerfect Medical Device Solutions.

Press Release_Vasont merger

Automated Anesthesiology and Content Lessons for Device Makers

Barak ColonoscopyThe Wall Street Journal just ran a very interesting story on the new Sedasys device from J&J – you can read the article here.

Besides the notable fact that our Crimson Life Sciences division was selected (thanks to a patented risk management processes) to produce the first translated version of Sedasys labeling , this story has important lessons for device companies looking to effectively manage their content. And let’s face it, who isn’t?

The Sedasys system is basically a robotic anesthesiologist for use in low risk colonoscopy procedures (i.e. most of them). The big news here is that, for the majority of colonoscopy procedures, anesthesia costs just encountered a “strategic inflection point” – a 10x change (in this case reduction) in price. First noted by Intel Chairman, Andy Grove, strategic inflection points mean something big just happened. That’s what automating high-cost human processes (in this case, the anesthesiologist) does – it produces significant savings. Though, also in this case, the high cost of the anesthesiologist tips the scale of the effect.

Your translation processes are similar. Though most of your colleagues don’t earn as much as an anesthesiologist, if you can automate labor-intensive human tasks, you can realize some real savings. That’s why EnCompass solutions include GlobalLink translation process automation technology from our division. From project submission and tracking, to web-based, in-context review, to automated xml publishing from our Astoria and Vasont divisions, EnCompass content solutions bring the cost-saving benefits of automation to the translation process.

You might enjoy dealing with translation requirements about as much as, well, a colonoscopy. However, by automating the process with EnCompass technology, you will reduce time, effort, and cost – which should remove some of the sting.

Print is Dead: Device Industry’s March to Digital

If there was any question about the fundamental impact of digital media on print, International Paper answered on Wednesday with the announced closure of their largest papermill – reducing the company’s papermaking capacity by 33% (and displacing 1,100 workers).

This same widespread march to digital content in the medical device industry can be seen from e-IFUs, to e-Learning systems, to, perhaps most importantly, XML content management systems; an important reason EnCompass was created was to harness the digital translation technologies and resources across the entire TransPerfect family of companies and apply them to the medical device industry.

The Perscription for the $500,000,000 Industry Headache

Industry estimates put the total cost of content for the medical device industry at over $1 billion. Sadly, research also tells us that over 40% of this cost is unnecessary, due largely to process inefficiencies and fragmentation:

Because content is the lifeblood of the medical device industry, a fragmented content strategy can create lots of “noise” – disruptions, delays, complaints and cost-overruns in your labeling or documentation processes. This, in turn, contributes an estimated $400 million in excess industry costs every year…doctor, this patient needs your help!

The proven treatment includes best process practices and validated technology for medical device content creation, management, translation, and publication. That’s EnCompass.

Blood Makes Noise: The Theme Song

On the surface, Suzanne Vega’s Blood Makes Noise might seem like an unusual choice as background music for a medical device blog. After all, it describes a panic attack.

However, as anyone will tell you (with 20+ years experience) in medical device content development and content management (including regulatory, labeling,  and marketing) an occasional sense of panic is not-so-very out of the ordinary.  Uncontrolled content has that effect – especially if it prompts a significant recall, derails a key project, jeorpardizes product compliance, or requires destruction of printed materials.

If you’ve ever felt even a little anxious about the cost or complexity of medical device content, you’ll identify with Suzanne’s perspective:

Original version [20-year-old video is dated]: 

Alt version:

House version:

Organized and structured content, supported by best processes and ready for automation, that’s the EnCompass perscription.