Documentation, Medical Devices, and the FDA

This month the implementation date for MDD directive (2007/47/EC) comes due. There are a number of issues that require action by manufacturers (changes to the Essential Requirements, clearer requirements for clinical evaluation, changes to the QA of third parties) and the Notified Bodies ( higher requirements for auditing Technical Files).

After seeing how well positioned Medtronic is, we started wondering how well the other device manufacturers were doing. Interestingly enough, none of them have really started the discussion about the benefits of dynamic information delivery in their business.

I might have expected it. The first step is always: let’s meet the requirements and be done with it. But when translation costs are $50/page when they could be less than $5/page, it makes me wonder when the life sciences companies are going to really join the discussion.

We had a customer in the manufacturing space — not life sciences — and their translation vendor offered them a steep discount if they got out of FrameMaker. Their translation costs went from $20,000 to $6,000.  Just getting out of proprietary systems and into a standard XML publishing system got their costs down by 2/3.  (Reuse is the second driver of cost reduction.)

Is there something about this I’m missing?

Medical Devices have a huge margin, why wouldn’t any medical device manufacturer want to maximize it as much as they could while improving their odds against failing an FDA audit due to product information development processes?

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Author: Liz Fraley

Liz Fraley https://www.linkedin.com/in/elizabethfraley/