It's no secret that 90% of in-country reviews are a waste of time. Yet many medical device manufacturers (for a variety of reasons) continue to conduct these validation steps.
A number of ways exist to streamline reviews. Despite the organizational challenges that often exist, some device manufacturers are actively working to improve review process. And several of our clients are working to minimize the number of reviews that are done.
The approach this getting the most "traction", however, is to outsource in-country reviews.
Clients who outsource in-country reviews (to ForeignExchange or to other specialized providers) generally realize four important benefits:
- Accountability - By outsourcing, somebody proactively manages reviewers. This results in guaranteed availability, known costs, and the existence of backup reviewers. Records are kept, and clients can pinpoint what changes were made when by what reviewers. Most importantly, though, it affords clients the opportunity to change reviewers in case of quality or turnaround issues.
- Faster turnaround time — In-country reviews completed with employees of the device client usually take a long time. Weeks and even months are not uncommon. Reviewers often miss the review deadlines, eventually forcing clients to proceed without reviews. By relying on an independent review organization, clients can dramatically cut review times - to days instead of weeks or months. Clients are also assured that translations get reviewed, every time.
- Quality — Thanks to ForeignExchange's robust methodology for seeking, qualifying, and approving reviewers, the reviewers selected by clients are "known quantities". In contrast to some company-internal reviewers, it will be clear what educational, professional, and linguist background the reviewers have. This results in review comments that are more consistent and more meaningful.
- Efficiency — Many device companies (incorrectly) believe that reviews are needed for regulatory reasons. By outsourcing this "safety net", clients make optimal use of available resources. It will free up company employees and resources while maximizing the efficiencies that specialist providers like ForeignExchange have achieved in providing this service.
Well managed reviews can be an efficient and effective part of a device company's multilingual publishing cycle. To make sure of that, know why you are reviewing, communicate early, often, and widely - and consider outsourcing your in-country reviews.
For a much more in-depth look at the topic of in-country reviews, attend the upcoming audio conference Best Practices for Managing In-Country Translation Reviews.
ForeignExchange Translations provides outsourced third-party reviews and specialized medical translation services to medical device companies.