Regulatory Team Development in Post-Merger Integration: A Survey of Views from Medical Product Companies

Mergers and acquisitions (M&A) frequently occur in the medical product industry to achieve a variety of business objectives. However, the success record is variable. The degree of success appears to be influenced by how well companies can manage the integration process for the merging companies. Historically, companies have approached the reorganization of the regulatory functions following an M&A transaction with varying levels of care. The challenges are particularly great for companies in the medical product industry, where differences can exist between the regulatory competencies and approaches of the two companies with respect to activities as varied as the oversight of premarket product development, regulatory agency interactions and other activities that have regulatory compliance implications. However, little systematic research has been directed at the industry practices associated with managing post-merger integration applicable to the highly specialized function of regulatory affairs. Using a survey tool and a modified implementation framework adapted from Hirsch (2019), this study probes how companies have put into place their new leadership structures and subordinate regulatory teams and closely examines the many influencing factors that affect the post-merger integration of teams. Shortcomings of the integration process have been identified and many of these appear not just due to poor strategy, but also to flawed execution and bias toward a specific organizational model. The insights gleaned from this study illuminate how the culture and characteristics of the work environment shape a climate that influence organizational change and its ability to endure.