Implementing a new RIM system is a complex journey, often fraught with challenges and resistance among regulatory team members. At the recent U.S. Veeva MedTech Summit, Ann Sturgill, director of regulatory affairs operations at Cook Medical, shared how her team navigated through the “messy middle” of their global Veeva RIM rollout when change management can be the most difficult.
Sturgill explained that the driving force behind Cook’s move to a new RIM system was the ever-changing regulatory landscape. Like many medtech companies, they struggled with siloed groups, disparate systems, and disjointed data, which made it difficult to maintain compliance and efficiency across multiple teams and global manufacturers. They needed a standardized system to keep pace with evolving regulations.
Cook selected Veeva RIM and took a phased, “crawl, walk, run” approach to the global rollout. They started with registration tracking and submission archives, which allowed them to first standardize existing data into a single, unified format. By beginning with smaller teams to learn and refine their processes, they could then apply those lessons as they expanded the rollout to larger, more complex groups.
To begin their phased implementation, Cook assembled a core team to evaluate use cases and prioritize key functionalities. This team also identified early adopters within the organization – those who were process-oriented and adaptable to change. These early adopters become change champions, playing a vital role in driving adoption and providing valuable feedback.
Sturgill shared that they made a point to recognize and reward the efforts of their change champions as a way to boost morale and foster a positive environment throughout the implementation process. “Often in regulatory we’re focused on milestones and getting to the end line,” explained Sturgill, “but it’s important to empower your people and remind them of the incredible value they bring to the table”.
As Sturgill described, the messy middle is the uncomfortable phase of a rollout project when unforeseen obstacles can hinder progress. Resistance is inevitable, as regulatory professionals often rely on familiar tools like Excel spreadsheets and established processes as their safety blanket. Overcoming this opposition requires a multifaceted approach:
While Sturgill acknowledged that “data can be the hardest thing” in a RIM implementation, she also framed it as a foundational opportunity. The process of standardizing information from previously siloed groups is the first step toward building a powerful single source of truth. One critical aspect is aligning product data with regulatory information. Sturgill emphasized that while this effort requires dedicated focus, it successfully creates the core master data for RIM, providing a stable and reliable base for all future regulatory activities and and unlocking new efficiencies for the entire organization.
This journey also inspires a crucial mindset shift, moving from static spreadsheets to a dynamic, living asset. Sturgill explained that data management is an ongoing process of improvement, not a one-time migration. “It’s not like you add your data in and you’re done,” she noted, viewing this evolution as a positive. As teams use the system more, they find new ways to optimize it for emerging needs like MDR. This continuous improvement is what transforms data into a strategic tool, ultimately empowering regulatory professionals to accelerate submissions and focus on their most impactful work.
While the RIM implementation journey may be challenging, Sturgill shared that the long-term benefits are significant. A well-implemented RIM system can help medtech organizations:
It is important to recognize that RIM implementation is not a one-time project but an ongoing process of continuous improvement. Regular evaluation, feedback, and system updates are necessary to ensure that the solution meets the evolving needs of both the organization and the regulatory landscape. To learn more about how leading medtechs prepare for implementation success, read about the five steps for planning a cloud-based project.