Device Recall Regulatory Compliance – A Challenge for Medical Device Manufacturers

Medical device manufacturers may be facing new and emerging regulation on the state and federal levels, but FDA recall rules remains the industry’s most immediate day-to-day compliance challenges. With device recalls, the FDA gives manufacturers some leeway in alerting customers. Companies can use the means of their choice in alerting device users, whether via email or snail mail or mass media. The rule is, however, that at least 80% of the users must be contacted. Fail to reach that threshold, and you have to contact users directly over the phone—meaning your recall gets far more expensive than it already was.

To address the FDA recall rules, most device manufacturers use customer relationship management (CRM) systems. Problems arise, though, when companies use one system for phone interactions, another for online customer contact, and another for snail-mail communication. When customer data is scattered across several systems—and it almost invariably is—accurately tracking contact data across all of the systems becomes difficult-to-impossible. For instance, a customer might have changed her telephone number via a mail-in registration card, but that information never gets reflected in the telephone database. Similarly, a customer might alert a device manufacturer to an address change via the website, but it doesn’t get updated in the postal database. When the company tries to reach their customers of a recall via snail-mail, they might get 20-30% returns due to incorrect addresses, prompting an expensive calling campaign.

No wonder device manufacturers are turning to master data management (MDM) to bolster their compliance efforts. A quality MDM solution can provide manufacturers with consistent, complete and accurate consumer, contact, and communication preference information—even when it is captured and stored in different systems. Companies can use this information to reach customers rapidly and avoid costly and ineffective device recall campaigns. With MDM, if a contact information is changed in the CRM system, that new information will quickly be reflected in the web content management system and other customer-facing systems. This means that any campaign that is using data from the central MDM system would always use the correct preference setting, regardless of the system of origin.