Medical device firm managers trust physicians to screen out defects in lieu of recalls, a study conducted by Indianapolis-based Indiana University and Minneapolis-based University of Minnesota business professors found.
Researchers conducted a behavioral experiment with 167 managers from a Fortune 500 medical device firm and a replication study with 614 subjects from Amazon Mechanical Turk. The study was published in the Journal of Operations Management.
Here are three key insights:
1. If a physician is able to detect a defect before using the product, medical device managers are less likely to issue a recall. This occurs because managers have a perception of increased patient safety when defects can be detected, lead author George Ball told Science Daily.
2. Managers are also less likely to issue a recall if they don't understand the root cause of the defect.
3. The FDA expressed interest in improving oversight of medical device quality based on the study findings.
"The decision to recall a product can significantly affect an operations manager's career, the credibility and financial performance of the firm, and the safety of customers," study authors concluded. "Surprisingly, the FDA does not clearly specify how a manager should integrate the multiple, and potentially conflicting, criteria influencing whether or not to recall a product. Consequently, managers use individual judgment in arriving at recall decisions."