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Content Audit, Review & Consulting for Medical Device Makers
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Something Fishy About Device Marketing Translation

Tue, 01/29/2013 - 16:16

Today’s New York Times has a short, well-written piece about the challenges of literary translation which, in many ways, mirrors the challenges of translating marketing material for medical device manufacturers:

http://opinionator.blogs.nytimes.com/2013/01/28/the-treachery-of-translators/

The author despairs of adequately translating metaphor or humor when he sees his use of the classic Groucho Marx joke “you’re only as old as the woman you feel” rendered into French as “A man is only as old as the woman he can feel inside of him trying to express herself.” Regarding the ability of translation to render fluent literary text, he closes his essay with, “you can’t get it right, so the only thing you can do is make it better.” If only it were that easy!

Translating marketing material is very close to literary translation – only when it comes to medical device content, it’s even harder. Medical device marketing material must not only be technically accurate, but it must also capture the panache of the English original. So, faced with a difficult-to-impossible task, many translators may simply follow the English – which often yields a stiff, non-fluent result in the target language. And, even in those moments when the translator makes an honest attempt to capture the spirit of the original, an in-country reviewer may have an altogether different turn of phrase in mind.

Of course, the way to manage this situation is to use translators who are able to re-create the essense of the English original in the target language (“transcreation” is a word – awkward and contrived, in my opinion - that’s sometimes used in the industry) AND to get input from trusted, native-speaking, in-country resources.  To reduce risk and cost, the best way to get this input by using technology. Crimson’s sister division, Translations.com, offers a cutting edge “Translation & Review Portal” that enables reviewers to track assignments, make updates and even see a formatted preview of the file – all in a simple, online format.

To paraphrase the Times article, marketing translation for medical device makers may be difficult to do right, but with good resources, process and advanced technology, you can definitely make it better!


eLabeling Arrives (finally)

Thu, 01/17/2013 - 17:23

For those of us who’ve been in the medical device industry for a few years (or 20), it has sometimes seemed that eLabeling would never arrive. Well, here we are! In March of this year, eLabeling will be available for some professional use devices – the text of the EU Commission Regulation is here:

http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2012:072:0028:01:EN:HTML

Also, the MHRA has a very nice explication of the new Regulation here (and in English, too!):

http://www.mhra.gov.uk/Howweregulate/Devices/Devicesregulatorynews/CON222581

Everyone should note that a risk assessment is required (of course!) before implementation.

Happy eLabeling!

 


5 Medical Device Industry Resolutions for 2013

Thu, 12/27/2012 - 15:21

A recent article in MedCity News caught my attention today: Top 5 New Year’s Resolutions for the Medical Device Industry for 2013 and Beyond – you can read the entire article here.

Many interesting points to consider inculding:

1. Comparative Effectiveness: much like the famous Dr. Strangelove title, device companies need to “stop worrying and learn to love the law”.

2. Be more aggressive about international markets: in my experience, over the past 20 years, the device industry has made remarkable progress in international markets. However, there’s still much more work to be done – MedCity estimates that the device industry is 10 years behind pharma. With the impending device tax, overseas revenue is suddenly more valuable than ever before.

3. Innovate for local markets: successful product mixes will vary based on geography

4. Hire medical economists: see #1 (above)

5. Engage patients for better products: as more devices move into the home use environment, human factors design input becomes increasingly important.

2013 promises to be a year of change for the entire healthcare industry. As the old saying goes, “the best way to predict the future is to create it”.

 


Risk Management is Home for the Holidays

Fri, 12/21/2012 - 19:23

FDA Releases Its New Draft Guidance on Design of Medical Devices for Home Use  …Just in Time for Christmas!

Only four days until Christmas! Chestnuts roasting on an open fire…but, hey! Those things could explode!…or pop out and singe the rug.  Of course, it’s a well-known fact that home is where you’re most likely to have an accident.

Home and holidays have long been filled with all kinds of risk. That’s why I found it appropriate that FDA just released their draft guidance on design considerations for home use devices. You can read it here. Not surprisingly, risk management is prominently featured.

When it comes to high-risk home-use devices, that labeling is often considered higher-risk than labeling for professional use devices. This is because the home-user doesn’t have the same level of training or professional experience that would let him/her over-ride faulty instructions in labeling.

With cost as a primary driver, medical device treatments, more and more, are moving into the home environment. Manufacturers of many riskier devices are now learning what manufacturers of, say, glucose devices have long known: poor quality labeling and user instructions are a significant use hazard.

And it is even more hazardous in the case of translated labeling, where the manufacturer is at the mercy of a service provider delivering a final product that is difficult to accurately evaluate. Importantly, translated labeling carries the same risk as the English original…except it applies to your patients all over the world.

The FDA guidance speaks to risk management. In translation, effective risk management is imperative since the risk of error can never be fully eliminated. That is why Crimson developed the first-ever translation risk mangement system – patented and registered to ISO 14791. For home use device makers, this is the best defense against labeling quality issues that could potentially cause patient harm.


Update: French Decree No. 2012-743, No. 2012-744 (Loi Bertrand)

Wed, 12/19/2012 - 18:03

As a result of the Mediator drug and PIP breast implant scandals, the French government is implementing a number of new controls on medical device advertising (see previous post and press release) – the new law comes into force on Jan 1, 2013. If you haven’t assessed your advertising materials for compliance, you should do so right away.

Some updates for your information below:

Affected advertising items
Brochures, print advertising, press releases, white papers, scientific articles, conference booth materials, PowerPoint presentations, letters, emails, etc. – guidance on websites is forthcoming.

Regulations
In addition to common-sense requirements (no deceptive advertising), there are a number of other requirements:
- Information in the ad must be up-to-date, correct, verifiable, legible and complete to enable assessement of the claims of the product
- Ads must be in French. English can be used for articles or white papers, but must also have compliance info in French attached
- Recommendations by scientists or HCPs is NOT permitted.
- Quotations must be reliable and the source attributed and must be legible.
- Non-compliant websites must NOT be advertised (e.g. reference to website removed from email signature)
- All digital advertising material must include the information below

Compliance information that must accompany all advertising
Registered name of product
Intended use
Manufacturer name
Device class
Notified Body
Invitation to attentively read instructions on notice for use
Statement to carefully read IFU
Reimbursement info
Date of publication
Internal reference number (high-risk device ads must be pre-approved by ANSM)

ANSM provides statement for booth graphics that refers to compliant, printed materials

ANSM text for smaller advertising pieces
Dispositif médical ou, CE (n° notified body), consultez la notice / consultez la l’étiquetage pour plus d’informations

For materials that reference a number of products
Dispositifs médicaux, consultez les notices/ consultez les étiquetages spécifiques à chacun pour plus d’information

If you want to learn more about the French Decree please send email to info@crimsonlanguage.com


The Road to Damascus

Sat, 12/08/2012 - 13:56

For most of us, “the road to Damascus” has certain connotations. Common among them is St. Paul’s miraculous vision and conversion on that very road. It’s written that Paul’s experience had such a profound effect, that he was unable to see, eat, or drink for three days.

Today, Damascus has another too-common meaning: the suffering of millions of innocent civilians in the Syrian conflict. Crimson has been active here – providing pro bono translations for medical devices, soliciting in-kind donations from device manfacturers, and organizing private donations – you can see and read more here: http://www.crimsonlanguage.com/Syria-support.cfm

Now, a new type of media has emerged to cover the Syrian conflict: SyriaDeeply.org (http://beta.syriadeeply.org/). Started by noted Armenian journalist Lara Setrakian, SyriaDeeply.org is a single site that presents editorial, video, interactive maps, twitter feeds, headlines, and back-story as a way to completely inform about the Syrian crisis. In a recent NPR interview with the founder, she describes the content template, or model, that they have developed to manage and organize fast-moving content and provide a complete perspective on events. The content management structure at SyriaDeeply will be used as the basis of other temporary sites covering specific current issues and events.

In terms of relative importance, the events in Syria can only be compared with other large-scale humanitarian crises brought on by war. However, as I listened to Ms. Setrakian describe the structure and approach of the SyriaDeeply site, I was struck by similarities between their attempt to integrate diverse content into a comprehensive whole and our own recently-introduced EnCompass content management solutions for device makers. EnCompass addresses the various content needs of a global device manufacturer by encompassing all of the device-specific technologies and services available through Crimson Life Sciences, sister divisions Astoria Software and Translations.com, and parent company TransPerfect Translations.

The DITA OASIS standard, XML publishing and Astoria Software are important parts of the EnCompass solution. In fact, the first time I saw the publishing efficiencies that are possible with this approach, it was a complete revelation for me – a real “road to Damascus” experience. The effect was that I recently co-presented a webinar, sponsored by the OASIS DITA Technical Committee and the Center for Information-Development Management, outlining the importance of DITA and XML publishing for medical device makers.  You can watch the recording here: http://www.crimsonlanguage.com/resources.cfm

So, in my opinion, if you want to see the future of media coverage get over to SyriaDeeply.org. If you’re moved by what you see, please consider a donation to the Syria American Medical Society (http://www.crimsonlanguage.com/Syria-support.cfm) – either in-kind (if you’re a manufacturer) or monetary.

If you want to see the future of medical device content, our EnCompass approach will be a revelation for you.


Shhhhh! Your Secret French Website

Thu, 12/06/2012 - 16:35

Those of you who sell in France are likely aware of French Decree No. 2012-743 – the upcoming law that requires device makers to add nine points of information to all advertising, to register ads with the French government for approval, and cease ALL direct-to-consumer advertising.

We put out a press release on this issue way back in early October – you can read it here.

Some updates on this evolving situation:

  1. Guidance for websites is still pending – but you can’t put a web address on French advertising…I guess they think it’s going to be a secret?
  2. No testimonials from physicians or patients will be allowed in advertising
  3. In public meetings, French authorities have specified 10-pt type for the “nine points of information”  – though pharma companies are allowed to use 8 (?)

If you would like to discuss this Decree in more detail or need help with translation or compliance of your French advertising, feel free to contact us at info@crimsonlanguage.com

 


IRS Issues Final Medical Device Tax Guidance – 26 CFR Part 48

Wed, 12/05/2012 - 11:56

Today, the IRS issued their final guidance to medical device companies who are subject to the upcoming “Device Tax” (26 CFR Part 48) - the guidance document can be downloaded here. According to the summary:

This document contains final regulations that provide guidance on the excise tax imposed on the sale of certain medical devices, enacted by the Health Care and Education Reconciliation Act of 2010 in conjunction with the Patient Protection an Affordable Care Act. The final regulations affect manufacturers, importers, and producers of taxable medical devices.

This document contains final regulations that provide guidance on the excise tax imposed on the sale of certain medical devices under section 4191 (the medical devic excise tax) of the Internal Revenue Code (Code), enacted by section 1405 of the Health Care and Education Reconciliation Act of 2010, Public Law 111-152 (124 Stat. 1029 (2010)), in conjunction with the Patient Protection and Affordable Care Act, Public Law 111-148 (124 Stat. 119 (2010)) (jointly, the ACA).


The $400 Million “Gray Swan”

Sat, 12/01/2012 - 12:13

On Thursday, I presented with JoAnn Hackos from Comtech Services on DITA/XML for the medical device industry. A very interesting topic, indeed, and definitely the future of publishing for the medical device industry. DITA/XML is also quite relevant in today’s economic climate – it’s estimated that device companies could see a potential $400 Million savings by implementing this Oasis standard industry-wide. However, to realize these savings, device manufacturers must first move to single-source publishing systems and processes.

One critical point underscored during the presentation was this: single-source publishing systems create single-point failure risks – in the case of labeling content, this means errors that might affect patient safety or compliance (labeling errors are the #1 cause of recall). Not only that, but single source content is *leveraged*, meaning errors at the single source can be multiplied out many times.

In 2007, The Black Swan by Nassim Taleb hit the NY Times bestseller list. A Black Swan is an event with an economically large impact…very much like a leverage single-point failure event. However, a true Black Swan is also unexpected – which is definitely not the case here. In fact, the risk to device makers is quite predictable. So, we might actually call this a “Gray Swan”. Not only that, but in the case of single-source systems, we can also do something about it. That something is called “Quality at the Source”.

In the case of DITA/XML tagged content, Quality at the Source means well-written, global English/original source as well as expertly translated and QA’d derviative source – including tested, high quality resources and “state of the art” risk management processes. And, with millions of dollars in savings available from single-source system improvements, these upgrades in quality are not only possible, they are required.

At Crimson, we are extremely quality systems and risk management-minded. Which is the reason we are the first translation company registered to ISO 13485 and ISO 14971. It’s also the reason we hold the only patent for translation risk managment (for medical device labeling). I am an active supporter of the DITA/XML standard in the medical device industry because I believe, properly implemented, DITA/XML provides a roadmap for elevating not only the quality and effectiveness of device labeling in particular, but also medical devices in general.


“Audit-Proof” Your Labeling

Tue, 11/20/2012 - 15:49

Labeling and labeling translation processes are getting more and more attention these days. In fact, most auditors don’t actually examine the translated labeling itself (though some might) – rather, following the “process model” they will look at your translation process and the basis of approval for your translation suppliers.

On more than one occasion, clients have contacted us to request copies of our ISO certificates for an in-process audit. In these situations, we typically send our ISO 9001, ISO 13485, ISO 14971 certificates along with our Notified Body endorsements and, more recently, a copy of the cover page for our labeling translation risk management patent (U.S. Pat No. 8,140,322 B2).

Did that provide the proof that the auditor was looking for? You bet!


Chinese IP Theft at Nortel: A Cautionary Tale

Tue, 02/14/2012 - 10:53

Another story of Chinese IP theft - this time at Nortel Networks and lasting a decade. Advanced medical device technology is a well-known target of Chinese IP theft (both industry-based and government-based) and manufacturers should pay attention to several key areas:

- Network intrusions (hacking)

- Supplier integrity (transfer of sensitive information)

You maynot have considered it, but translation services are emerging as a significant source of IP risk. Sensitive information that is translated by China-based services is “as good as gone”. Other suppliers, too, can be a security risk for sensitive information.


New Online Service Provides Consumer Access to FDA’s Recall Database

Tue, 01/31/2012 - 10:08

Today, the Wall Street Journal reported on two new websites that provide consumer access to FDA’s drug (AERS) and device (Maude) adverse event reporting databases. The story is here.

The site that reports on device events is Clarimed. According to Clarimed’s founder, Nora Iluri, the site’s purpose is to empower consumers and promote quality-based competition among manufacturers.

Although this information is interesting, I have my doubts about it’s ultimate usefulness in the device arena. Unlike drugs, physicians often have the ultimate say-so about which device they are using…my hip replacement is a Stryker because that’s what my doctor uses and was trained on…consumer preference is a secondary consideration. Will consumers start educating themselves about scalpels and IV pumps? Even if they did, would they be able to influence what gets used? That decision is largely in the hands of the hospital purchasing department. While some device decisions may be open to consumer input (e.g. hip, heart valve, pacemaker), the large majority are going to be beyond the patient’s immediate control. However, the launch of websites like Clarimed are interesting because they illustrate the democratization of information on the web…and a growing consumer awareness of the risks associated with medicines and medical devices.


Medical Device Technology Targeted by China for IP Theft

Mon, 12/19/2011 - 17:06

In my last post, I cautioned device makers to think “long and hard” before sending their advanced IP to China. Now, it appears that China may be coming to you.

On 12/15/2011, it was reported by Bloomberg that 760 companies were hit by Chinese-based hackers, including device maker Boston Scientific. No surprise here, since I have been writing about the dangers of Chinese IP theft for the past 3 years . According to Representative Mike Rogers, chairman of the Permanent Select Committee on Intelligence, “They are stealing everything that isn’t bolted down, and it’s getting exponentially worse.” Adds Scott Borg, an economist and director of the US Cyber Consequences Unit, “We’re talking about stealing entire industries. This may be the biggest transfer of wealth in a short period of time that the world has ever seen.”

China’s most recent 5-year economic plan (approved by the National People’s Congress in March) prioritizes a number of key industries. According to KPMG International (the auditing firm), the 5-year plan focuses on clean energy, information technology…and medical devices.

Time to bolt down your IP…that is, if you haven’t already handed it over by submitting to SFDA testing protocols.


US Government Accuses China of IP Theft…What Took So Long?

Fri, 11/04/2011 - 17:06

I originally wrote about the dangers of Chinese IP theft in a June, 2008, edition of Medical Products Outsourcing. Since then, I’ve followed up with cautionary tales from the various industries. Now, the US government has added it’s voice to the chorus – calling The Chinese the world’s “most active and persistent” perpetrators of economic spying (see Wall Street Journal article).

Given this latest indictment, US device makers should think long and hard before sending their advanced IP to China.


China’s SFDA Sidesteps IP Question at RAPS Annual Conference

Tue, 10/25/2011 - 11:28

Representatives of China’s SFDA were on hand at the 2011 RAPS Annual Conference to provide an update on regulatory developments in that country. However, what the delegations didn’t say in response to an audience question, was perhaps most interesting.

“On the one hand, SFDA has extensive requirements for product testing and technical file review. On the other hand, there are state-sponsored programs, such as the so-called ’863 Program’ that are devoted to the acquisition of certain high-tech IP for the benefit of the domestic Chinese industry. Can you briefly describe the firewalls that exist between SFDA and the other state agencies to protect medical device IP?”

After a long, pregnant pause, the delegation merely referred to the Chinese office for intellectual property rights – saying that SFDA had no hand in addressing device IP. Of course, this is ridiculous – SFDA is in the busines of accumulating a vast amount of information for every device that enters the country. They are the conduit for US IP and their silence on the safeguards for that IP speaks volumes.

See my previous posts on Chinese Super-Competitors and IP theft.


Jet Planes and Medical Devices: A Cautionary Tale

Fri, 09/30/2011 - 11:09

From time to time, I’ve written and spoken about the connection between the aerospace and medical device industries. Historically, there has been a significant amount of congress between the two industries in terms of engineering and management talent. Both have a strong safety mandate because catatstrophic product failure has dire consequences for users. In fact, this is why we adopted and modified a standard from the aerospace industry (SAE J2450) as the basis for our resource testing, audit and QA activities. Today, it still stands as the only metric to recieve an official Notified Body endorsement.

I’ve also written in this blog about the dangers to the device industry of Chinese IP theft. Now, an avionics joint venture between GE and a Chinese firm is raising many of the same  questions for US avionics/aerospace technology…and it also highlights concerns for US medical device technology. If aerospace joint venture technology, with all it’s required firewalls, is potentially at risk, how much more device technology? Especially when SFDA technical file examination + scrutiny from 3 seperate Chinese testing houses is taken into consideration. This may be a the reason why GE recently transferred their entire imaging business to China…a simple acknowledgment of an impending reality.


Greek Tragedy: Sovereign Debt Harms Patients

Sun, 09/25/2011 - 10:36

There were quite a few pieces of bad news this week - several of which directly affect the device industry and the patients it serves:

To begin, Citi analysts cut their 2012/2013 sales estimates for Smith & Nephew. While this alone is not particularly earth-shattering, what came next in the downgrade report was: Citi’s view is that Hip & Knee markets won’t recover in the short term and emerging markets aren’t expected to grow until 2014. 

Don’t expect much from developed markets, either. A recent Financial Times article documents how the Greek government has fallen dramatically behind in payments to device companies. According to the article, Roche has cut staff and is operating on a cash-only basis…BD and Covidien have shuttered their Greek operations and transferred them to local distributors. Many haven’t been paid in over a year.

With device payments grinding to a halt, device deliveries aren’t far behind…and this is now having a direct affect on patients. One retired school teacher who was interviewed for the FT article reported, “My consultant sent me to colleagues at three different hospitals to try to arrange the [hip replacement] operation but I haven’t managed to get a place on the list for surgery”. No need to look further for a cause behind the lack of growth in the hip market.

Let’s hope the Europeans can get their act together soon. Most large device manufacturers have well over 50% of their sales overseas – with a large portion coming from Europe. Another financial crisis – driven by sovereign debt issues in Greece, Portugal, Italy, or Spain will not have a sanguine affect on device industry growth prospects – despite the ageing of worldwide markets. Doubtless, the result would be the pervasive under-serving of an at-risk, at-need, growing poplulation of elderly people. Tragedy, indeed.


A Rose is Not a Rose: All ISO 13485 Certifications Are Not Equal

Fri, 09/09/2011 - 17:13

The FDA just delivered a scathing 483 to device maker Pharmaceutical Innovations of New Jersey, citing, among other blatant violations:

Lack of calibration or maintenance of in-house sterilizers, lack of validated processes, lack of sterilization verification testing, no DMR/DHF, lack of sterilization batch information, and openly destroying legally required production records rather then permit FDA review (!) – the full text 483 is here.

The situation that set up the for-cause FDA inspection was particularly alarming. As stated in the letter, several infants in a neonate ICU (NICU) cultured positive for Pseudomonas (potentially lethal for immuno-compromised individuals, like premature infants!). The hospital’s investigation led to culturing the company’s ultrasound 8 oz bottles and 5 liter gel which tested positive for the Pseudomonas organism. You can see a company video touting their latest product, designed for (you guessed it)  infants is here.

Apart from the seeming lack of quality system rigor that seriously jeopardized some of the most vulnerable patients imaginable – it was especially alarming to see that this company was registered to ISO 13485…by Orion Registrar.

In fact, I’ve written before about the importance of ensuring that your suppliers are certified by a reputable registrar (e.g. DEKRA, BSI, etc) – and doing your own audit verification. For translation suppliers, this means examining Management Reports, CAPA records, project records, and other systems documentation to ensure that hazards are identified and mitigated.

Either that, or risk having a company like Pharmaceutical Innovations on your Approved Supplier List.


Wicked Good Words: Lighthearted Linguistics

Fri, 08/12/2011 - 11:36

Just to lift your mood after this week’s wild economic ride: lighthearted linguistics

Having lived in Boston for some 29 years, I feel a certain affinity to the place – though not a native, Boston feels like home in many respects. One of the things that I’ve always liked about Boston are the distinct neighborhoods. As if, when immigrants disembarked their ships in the 1700′s and 1800′s, they kept a hope of return and established ethnic enclaves to remind themselves of home.

A unifying aspect to the varied and successive waves of English, Scots, Irish, Italians, Portuguese, Greeks is the distinctive Boston Accent. Often illustrated by a pithy suggestion to “Pahk the Cah in Hahvad Yahd”, a Boston accent (in my opinion), is best when peppered with New England regionalisms – wicked pissah, right? My undergraduate work in Celtic Studies and graduate studies in Scotland gave me with a real appreciation for regional accents and dialect. Robert Burns, the national poet of Scotland, wrote in a broad, lowland Scots dialect – and regionalisms represent some of the richest areas to mine for linguistic curiosities and unexpected connections to history.

I always enjoy hosting clients in our Boston offices because I get to play tourguide to the many interesting and historically significant places. For everyone who visits us in the future – I plan to use this book and web article as background for the rich and curious dialect, too.


Device Manufacturers Risk Creating “Super-Competitors” in China

Thu, 08/11/2011 - 19:13

If risk is defined as “probability of occurence x severity of harm” China is looking riskier and riskier for US medical device manufacturers. The reason behind this risk is, paradoxically, current success.

According to industry resource MassDevice, Medtronic plans to double the number of employees in China over the next 4 years – already China is the leading market for Medtronic overseas sales and is growing at 20% per year. Likewise, Boston Scientific announced plans to invest $150 million in the Chinese market over the next 5 years and GE Healthcare took the unusual step of moving its entire x-ray business to China. Together, these substantial industry growth iniatives are laying the groundwork for short-term financial returns, but also long-term problems on a massive scale.

I’ve written before about the long-term threat to US device manufacturers posed by China: including reverse engineered products, government-sponsored IP theft, lessons learned by Cisco and concerns from the US automotive industry. Given the current rate of Chinese investment by US manufactuers, it’s not hard to see that while the short term rewards are tantilizing, the long-term risks of creating Chinese super-competitors are immense.


 

 

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