Medical device company reduces organizational risk through robust data-driven compliance program

Client background

An established multinational medical device company headquartered in the U.S. that has experienced significant growth since its inception.

The business challenge

The company had three compliance employees striving to ensure that a culture of compliance was prioritized in company decision-making. Although the company knew it could improve its analytics capabilities, it did not know how to do so or where to begin. Its team also did not have the bandwidth or the technical capabilities to build a reliable solution to drive a risk-based, data- driven compliance program. Furthermore, the company’s IT team did not prioritize compliance initiatives and did not have the compliance expertise to create analytics that supported the company’s compliance needs. After a third-party risk assessment identified analytics as an area of focus as well as the on-going focus by the U.S. Department of Justice’s (DOJ) guidance regarding risk-based, data-driven compliance programs, the company decided it should address this challenge.

Baker Tilly’s solution-driven approach

Baker Tilly’s interdisciplinary team of life sciences compliance and data analytics specialists worked together to provide the medical device company with custom analytics and reporting to improve visibility into its compliance policy effectiveness and key risk areas. The project began by assessing the company’s current state and needs in addition to understanding its risk profile. Better understanding the company’s risk profile helped Baker Tilly identify existing data sources and create a plan to design and build a compliance analytics platform for the organization that utilized available data along with prioritized risks at the company. Baker Tilly also provided outsourced advisory work related to management of the tool and dashboards.

The accomplished results

By building a robust data-driven compliance program, the medical device company was able to eliminate the uncertainty and doubt of not knowing where to focus its compliance resources. Being more analytically enabled gave the company the ability to factor compliance performance into employee compensation and bonuses as well as promotion decisions. The company was also able to identify and address additional compliance risks as the compliance dashboards were being built, which caused a significant drop in compliance infractions. Enabling the compliance department to quickly identify and remediate issues when employees – unknowingly or not – have broken a policy or made an error has allowed the company to continue its mission of instilling a culture of compliance throughout the entire organization.