90% of in-country reviews are a waste of time
Written by Andres Heuberger on Thursday, January 29, 2009
Device companies usually conduct in-country reviews for one of two reasons:
- Compliance requirements (validate translations)
- Marketing requirements (obtain buy-in from local offices)
The problem is that in 90% of the cases that I see, these aren't the case. Much more common is:
- Lack of information sharing (e.g., no reference materials)
- Lack of understanding regarding brand
- Review schedules that are "black holes"
- Clarity of review changes is lacking (ever try reading a French doctor's handwriting?)
- Mechanics fail (file exchanges don't work, changes are entered inconsistently)
- Quality of review changes (linguistic, technical errors are introduced)
So how do you fix in-country reviews? If you cannot scrap reviews altogether (as many device manufacturers have done), focus on these five elements:
- Know why you are reviewing
- Consider outsourcing the reviews
- Communicate early, often, and widely
- Document your processes and track review metrics
- Put in place a continuous improvement process specifically for in-country reviews
- Improve your in-country reviews - by having somebody else do them
- How to streamline in-country reviews
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Categories: medical devices, quality
1 Comment:
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- Xiedong Lei said...
June 12, 2009 11:43 PMAgree!
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