AAMI News October 2018

Medical Device Firms Trust Physicians to Detect Defects, Study Finds

Managers in medical device firms rely on physicians to detect product defects, in lieu of issuing a voluntary recall, according to a behavioral investigation of the factors that influence the decision to recall a defective product.

“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,” the authors wrote in their abstract. The research—conducted by George Ball of the Indiana Kelley School of Business and Rachna Shah and Karen Donahue of the University of Minnesota’s Carlson School of Management—was published online in the Journal of Operations Management in August.

For their study, the authors interviewed regulators and industry professionals to identify factors that influence recall decisions, then tested the effect of these factors in an experiment with managers from a Fortune 500 medical device firm.

“We find that a physician’s ability to detect a defect prior to product use decreases the likelihood to recall, while a manager’s understanding of the root cause of the defect increases the likelihood to recall,” because information, rather than intuition, shapes their decisions, the authors wrote.

Medical device industry managers “appear to trust physicians to screen out defects on behalf of the firm, meaning that when the defect is detectable to the physician, managers are less likely to recall,” Ball told ScienceDaily for a release about the research. “This is because of a perception of increased patient safety when defects are detectable.”

“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,” the authors wrote in their abstract. “Consequently, managers use individual judgment in arriving at recall decisions. … By uncovering behavioral factors and their mechanisms in the recall decision, this study offers important insights to both industry and regulators.”

ScienceDaily characterized this behavioral investigation of actual industry managers as “an important new field of study considering the prevalence and customer safety impact of product recalls across multiple industries.”


Ball GP, Shah R, Donahue K. The decision to recall: A behavioral investigation in the medical device industry. Journal of Operations Management. doi.org/10.1016/j.jom.2018.07.003. Accessed Sept. 11, 2018.

ScienceDaily. Medical Device Managers Rely on Physicians to Screen Out Defects Rather Than Issue Recalls. www.sciencedaily.com/releases/2018/08/180822082440.htm. Accessed Sept. 11, 2018.