In the recent film Lost in Translation, what's lost is meaning, specifically the meaning of some key human relationships. But in the medical technology and healthcare fields, a whole variety of things can be lost in translation: the meaning of words and phrases themselves, the understanding of the technology or drug described, the proper understanding of medical technologies and pharmaceuticals in particular cultural contexts or all of the above. More importantly, perhaps, translation errors can produce a loss of confidence in your company and potentially large amounts of money. Addressing the need for correct, appropriate and quick turn-around of translation projects is TransPerfect (New York), specializing in translations of materials for a broad range of companies and, increasingly, organizations in the medical device, med-tech, pharmaceutical and healthcare sectors generally.

"Basically, anything in a foreign language that a company needs, we do," says Liz Elting, co-founder, president and chief executive officer of TransPerfect. A language student in college, then living abroad and working for a translation firm, she saw "big companies out there with a need for top-of-the-line service, the best-quality translation with quick turnaround," she told The BBI Newsletter. So with a partner, she founded TransPerfect 11 years ago. Because wrong or unclear meaning in healthcare puts people at risk, the exactness of translation for a medical product in another country is perhaps more crucially important than any other industry, according to Elting. "One word being wrong can be a major problem," she says.

"Definitely, everything needs to be accurate [in translation]: no typos, no missing text, no spelling mistakes, the right terms." Additionally, she says that good translations will be pitched to the level of language of those using the device or technology and suited to the particular cultural context. She calls this "style accuracy," a talent especially sought in the translators that the company chooses for its work.

TransPerfect currently has 21 offices, 15 in the U.S., the rest in Europe and Asia, with a full-time staff of 160 and resources of "outside linguists." Elting reports the company having done translations in at least 100 languages Yapese, Zulu, Truk and Tigrinya being just some of the more abstruse examples but usually providing translations from English to 30 of what she calls the "big business" languages of other countries. TransPerfect's list of clients in the healthcare and medical technology sectors is imposing, including (to name only a few), Abbott Laboratories, Becton Dickinson, Boston Scientific, Edwards Lifescience, Ethicon, Interpore Cross, Johnson & Johnson, Medtronic, Siemens, St. Jude and Smith & Nephew.

Not incidentally, some extra work is likely soon to come TransPerfect's way with the May 1 expansion of the European Union, which will grow from 11 to 20 countries. Of these, 19 of these countries' languages are required in the context of the EU's Medical Device Directives Malta being the exception, accepting instructions for use in English. The range of the work required, of course, is extensive: packaging and labeling, advertising and marketing materials, product use manuals, clinical research documentation, informed consent and conference interpreting even the audio for interactive voice response systems.

Ron Tan, director of business development and a medical device specialist for the company, says that a key feature of TransPerfect's service is the speed with which it works. "That's a big issue getting the translation out there in a timely manner can make a big difference in terms of the money you make," Elting says, a concept totally familiar to device firms. And having to redo another company's poor translation is a significant source of unnecessary expenditures. She also emphasizes that providing enough time for translation of materials is something that companies need to think about early on. "You have to provide enough time so that quality translation can be produced," she says. "It's hard to do hundreds of pages in a couple days and ensure perfection."

Elting notes that TransPerfect is ISO-certified, which she described as "an especially relevant credentialing ... because we have so many clients in the medical device industry."

Study may push Charite disc as 1st to market

Results of a recent study may help get the first artificial disc to market in the U.S. within the next year and offer patients an alternative to spinal fusion, the traditional standard of care for degenerative disc disease. Data from a two-year clinical study of patients implanted with the Charite Artificial Disc, developed by DePuy Spine (Raynham, Massachusetts), a Johnson & Johnson (New Brunswick, New Jersey) company, indicate these patients experienced earlier pain reduction in comparison with spinal fusion patients, and they improved or maintained their range of motion.

The findings of the study, sponsored by DePuy Spine, were presented at the annual meeting of the American Association of Neurological Surgeons (Rolling Meadows, Illinois)/Congress of Neurological Surgeons (Schaumburg, Illinois) section on disorders of the spine and peripheral nerves, held in San Diego, California. The randomized prospective clinical trial supports a premarket approval application (PMA) the company submitted to the FDA in hopes of becoming the first firm in the U.S. to have an artificial disc on the market. That PMA received "expedited review" status.

If approved by the FDA, the Charite would provide doctors and patients an alternative to lumbar spinal fusion surgery, which may reduce or block back pain but limits a patient's range of motion and may unnaturally stress adjacent anatomy. Lumbar spinal fusion surgery is performed on more than 200,000 people each year in the U.S.

The Charite is comprised of two components: a pair of endplates made of cobalt chromium, inserted in the space between the vertebrae and fixed in place via tiny teeth; then, after seating, a polyethylene material is inserted between the plates to create a disc providing both vertebral separation and flexibility. The procedure is done with an open surgical approach through a small abdominal incision to reach the spine. The particular approval sought is for degenerative disc disease at a single level.

In the study, both the patients implanted with the Charite and those receiving spinal fusion experienced improvement in pain and functional test scores compared with their pre-operative status. However, the study found that patients implanted with the Charite improved more quickly, and their pain and functional test scores were statistically superior to those of the fusion patients at all points through 12 months, and numerically superior at 24 months. Additionally, on average, patients implanted with the artificial disc were discharged from the hospital a half-day sooner than fusion patients.

Patients were evaluated immediately following surgery, again at six weeks, and at three, six, 12 and 24 months. The company noted that more than 90% of patients were seen at key follow-up time points, an important measure for this type of study. "We had a very high rate of patient follow-up," said Bill Christianson, vice president of clinical and regulatory affairs for DePuy Spine. He told BBI that this response rate reflected the hard work of the clinicians who participated in the study. And he noted the importance of the follow-up data "because FDA likes to see high rates of follow-up."

Two-thirds of the 304 patients enrolled in the pivotal study received the Charite, the remainder receiving traditional spinal fusion surgery with an FDA-approved interbody fusion device. Both devices were implanted using the anterior surgical technique to minimize surgical variables. At 24 months, 88% of patients implanted with the Charite expressed satisfaction with the procedure, compared with 81% of fusion patients. The disc has been used to treat more than 6,500 patients internationally since 1987, originally as the flagship product of Link Spine Group (Bradford, Connecticut). DePuy acquired Link and the Charite product last year for $325 million, plus milestone payments based on the device's regulatory progress. Christianson predicted that FDA clearance might come in early 2005, possibly as early as late 2004.

A number of other companies are in the race to bring this technology to the U.S. market. They include Medtronic Sofamor Danek (Memphis, Tennessee); Raymedica (Minneapolis, Minnesota); Replication Medical (New Brunswick, New Jersey); Spinal Dynamics (Mercer Island, Washington), a company purchased by Medtronic (Minneapolis, Minnesota) in June 2002; Spine Solutions (New York), which was purchased by Synthes-Stratec (Oberdorf, Switzerland) last year and SpineCore (Summit, New Jersey).

FDA cites 'downward trend' in innovation

In a report issued last month, the FDA said it intends to work with medical device, drug and biologics stakeholders to create a new generation of performance standards and predictive tools aimed at providing better and quicker results about the safety and effectiveness of investigational products. The agency said that despite advances in innovative fields such as genomics, proteomics and nanotechnology, "there has been a downward trend in recent years in the number of innovative medical product applications to the FDA and its counterpart agencies throughout the world." Indeed, even though the number of new product applications and approvals was somewhat higher in 2003, most new scientific fields have not had a fundamental impact on patient care, a statement from the agency said.

In an era in which the price of overall healthcare, including the costs of new medical technologies and drugs, is increasing, lawmakers have charged that the industry fails to spend research and development money on breakthrough technologies or therapies. Meanwhile, the industry complains that it is bogged down in regulatory matters and must invest in products that are more likely to guarantee a financial return for shareholders.

Then-FDA Commissioner Mark McClellan and Deputy Commissioner Lester Crawford requested the report, prepared under the leadership of Janet Woodcock, director of the Cross Center Initiatives Taskforce. The Senate last month confirmed McClellan's nomination as administrator of the Centers for Medicare & Medicaid Services (Baltimore, Maryland). Crawford has been tapped to temporarily run the FDA. Under the leadership of Crawford, the agency said it would hold a series of public workshops and meetings to generate a list of priorities to identify areas that would benefit the most from a modernized path of medical product testing and manufacture.