Surviving Medical Device Recalls Depends on Automation, Integration, Collaboration

No one wants to deal with a product recall.

But, for those in the medical device and life sciences industries, the challenges are more intense than ever before. Globalization has created elongated supply chains, and that elongation has decreased visibility and complicated communication. Obviously, that's not a desirable combination at all, considering that delays in handling a medical device recall can literally mean the difference between life and death.

Fortunately, many medical device and diagnostic manufacturers are now taking a hard look at their existing processes so that they can improve the way they manage product recalls.

Denise Odenkirk and Tom Kozenski explore these issues in detail in their recent article, How to Handle a Medical Device Recall, at Medical Device and Diagnostic Industry Online.

I was pleased to see that Odenkirk and Kozenski recognize that both automation and integration have become critical components for effective supply chain management. They write:

Factoring in the complexity of procedure kits and the numerous component parts of a medical device, the range of locations of recalled product, the people who need to be notified, and the audit trails required to verify steps have been taken, it becomes clear that automation is the only way to execute a recall quickly and efficiently. Based on the number of such recalls each year, the alternative to automation is strain on personnel, slow execution, and potentially increased liability.

In recognition of this need for automation, many forward-thinking companies have prepared for recalls by setting up integrated business and process controls that extend beyond their internal manufacturing and ERP systems into a supply chain management software system or systems.

Naturally, building strong supplier relationships is also essential. As medical device supplier networks become more and more complicated, it's becoming increasingly important for manufacturers to identify and prioritize supplier relationships using a risk-based approach that focuses on quality, compliance, and security.