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Crimson’s Research Memo Details Total Cost of Device Documentation

By Omar Ford

Medical Device Daily – October 21, 2011

Fifteen years ago, Crimson Life Sciences’ (San Francisco) founder and CEO Marc Miller was at a conference when one of the speakers mentioned the futility of med-tech companies focusing on markets outside the U.S.

“I was sitting at a Regulatory Affairs Professionals Society [RAPS] conference about 15 years ago and one of the panelists was saying ‘don’t worry about the overseas market, focus on the U.S. The U.S. is where the money is, and the overseas market’s regulatory and operations overhead
just don’t justify the revenue’,” Miller told Medical Device Daily. “Of course not everyone was thinking that way, but the fact that you would get a panelist at a RAPS conference saying something like that was a little stunning to me. It definitely indicates the mind set at that time.”

Fast forward to today, and the picture of the medical device space looks completely different, as some med-tech companies derive at least 50% of their revenue from outside the U.S. market.

“In the last 10 years, U.S. manufacturers have seen the handwriting on the wall and have been moving toward overseas market,” Miller said.

This has created a tremendous opportunity for Miller and his firm Crimson Life Sciences, a company that translates the language of the literature and documents surrounding a medical device to match a potential region. Crimson Life Sciences was acquired by TransPerfect Translations (New York), a privately held language services company, six years ago.

Crimson most recently released a research memo, which details the total cost associated with creating, approving, updating, maintaining, translating, and formatting content into different languages in the key areas of regulatory, marketing, and training. The memo shows that these costs amount to about 1% of revenue, or $1 billion per year. Based on implementation of content and translation management strategies and technologies, Crimson estimates potential savings of up to 40% of this total ($400 million).

The company took the time that people, who have a hand in content creation, review and management along with their salaries and total time the staffers spent with their overall duties to come up with the figures represented in the memo.

The genesis of the memo came from discussions Crimson had with its clients throughout the past nine months. Specifically, the conversations pointed out that clients were interested in how much it costs to produce training, regulatory and marketing material along with other content associated with the device.

“There has been a shift in the last couple of years, in the volume of content that’s being produced by different departments,” Miller said. “There has been an increase in marketing content and the addition of a training department that adds to the amount of content as well.”

This has caused an unwelcome side effect of an increased volume of content necessary to make, register, train, and market devices worldwide. In fact, by some measures, the company estimates that the content complexity has increased by 300%-400% in the last decade. For most manufacturers, increased complexity means significantly increased cost to create, update, maintain, translate, and format device-related content across a variety of formats.

“Many manufacturers have been living with this issue for some time,” he said. “However, current economic conditions have pushed them to the realization that potential savings and increased profitability justifies the required effort.” He added, “when I started out 20 years ago, a six to
eight language project was typical, now we’re looking at 26 language projects. The markets outside the U.S. have exploded.”

The planning and migration effort required to capture these content management savings is not trivial, Miller said. He advises manufacturers to begin with translation process automation.

“The systems and approaches that device companies are using are actually pretty manual and often very antiquated,” he said.

He suggested that a solution could be in the form of the implementation of the firm’s component content management systems Astoria Software.

“A system like Astoria can help manufacturers dramatically reduce costs and turnaround — that’s why it is important to remain dedicated to the implementation effort. The exercise is not easy, but it is definitely worthwhile.”