Rimsys recently hosted a webinar, Assessing RIM Maturity for Your Regulatory Management Strategy, to help RA teams put together a practical RIM transformation plan for their MedTech company. Featuring industry leaders, Adrian Bishop of Boston Scientific, Brian Williams of KPMG, Steve Gens of Gens Associates, and James Gianoutsos of Rimsys, the discussion centered on the evolving MedTech regulatory information management (RIM) landscape, using the RIM Maturity Model Framework to guide your regulatory information management strategy, a RIM maturity case study, and AI’s role in regulatory information management. Here's a quick recap of the insights we discussed:  
‍‍

The Growing Need for MedTech RIM Modernization

The session underscored the increasing complexity of global regulatory requirements in the MedTech sector. From EU MDR to the adoption of EUDAMED, the shifting regulatory environment is pushing companies to modernize their RIM processes to ensure compliance and avoid operational inefficiencies. Steve Gens shared key insights from his 2024 World Class RIM Study research that by 2024, 52% of life sciences companies had fully adopted global RIM programs, a significant leap from 32% in 2022. However, many MedTech organizations remain in the early stages of RIM maturity, reflecting the need for process harmonization and robust digital solutions.  
‍‍

The RIM Maturity Model: A Framework for Transformation Progress

Our panel also explored the new RIM Maturity Model framework from Rimsys, which categorizes organizations into six levels based on their current regulatory information management processes:

• Level 0 - Unaware
• Level 1 – Aware
• Level 2 – Reactive
• Level 3 – Proactive
• Level 4 – Well Managed
• Level 5 – Optimized
  ‍

Most MedTech teams fall between Levels 0 and 2, relying on siloed data and manual processes and reactive regulatory information management. Progressing toward higher maturity levels involves:  

• Data Harmonization: Establishing consistent definitions and processes across business units.  ‍
• Process Transformation: Moving beyond "firefighting" modes to proactive regulatory planning.  ‍
• Technology Adoption: Implementing a RIM system that centralizes data, automates tasks, and facilitates cross-functional alignment. This is a critical step to reaching fully optimized regulatory information management.  
  

Case Study: RIM Maturity Lessons from Boston Scientific

Adrian Bishop from Boston Scientific shared her company’s journey toward RIM maturity. After previous attempts to implement global systems, the team learned to prioritize readiness, secure buy-in from stakeholders, and leverage external expertise. Key lessons they learned include:   ‍

• Start with Data: Define data fields clearly and cross-check sources to ensure accuracy.
• ‍Limit Customization: Avoid over-customizing solutions that can hinder transformation; instead, adopt proven industry-standard processes.  ‍
• Invest in Change Management: Equip teams with the skills and mindset to embrace transformation.  

‍
Boston Scientific’s phased approach—beginning with foundational product registration data and expanding capabilities over time—demonstrates the importance of incremental progress. Boston Scientific, for example, has made strides in adopting a RIM system by focusing on transformation rather than harmonization alone, emphasizing the importance of cross-department collaboration and clear data governance.  
‍

AI and Automation in RIM

The panel distinguished the key differences between automation and AI, noting that while automation focuses on rule-based processes, AI serves as a good starting point for handling complex, abstract tasks. While AI can reduce time spent on tasks, it’s important for RA teams to verify the source information and the outputs for accuracy.  

Both automation and AI are important to regulatory modernization. Specific use cases include:  
‍

• Automation: Streamlining data ingestion, workflows, and compliance monitoring.  ‍
• AI: Mining historical regulatory data, collecting regulatory research, and enhancing regulatory intelligence.  

‍
Despite the attention around AI, the panel emphasized that its effectiveness hinges on high-quality, harmonized data. Poor data foundations can render even the most advanced AI tools ineffective, highlighting the need for a phased, data-first approach to digital transformation.

Looking Ahead: The Future of RIM As the MedTech industry advances

Achieving higher levels of RIM maturity will require strategic investment in technology, data, and talent. Organizations must treat RIM modernization as a holistic transformation, integrating robust processes and aligning cross-functional teams.  With automation poised to play an increasingly significant role, companies that prioritize data governance and process maturity today will be well-positioned to leverage advanced technologies like AI tomorrow.  

RIM modernization is not just a compliance imperative but a competitive advantage. By adopting a structured maturity model, focusing on data quality, and embracing RIM solutions like Rimsys, MedTech organizations can streamline regulatory processes, reduce risk, and drive innovation.  If your organization is considering RIM modernization, now is the time to assess where you stand and take the first steps toward a holistic transformation.

For more insights, listen to the webinar recording here!