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:  
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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.  
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“The manual nature of spreadsheets and desktop authoring tools is no longer sustainable with all the different regulations and the global operating model that most companies have where you're trying to quickly get submissions out to different markets and then have to keep track of where your products are registered and where there are renewals, and where there are expiration dates. Having that information in informal spreadsheets and SharePoint sites is really not sustainable and creates a lot of compliance risks." - Brian Williams, KPMG‍

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The RIM Maturity Model: A Framework for Transformation Progress

Our panel also explored the new RIM Maturity Model framework from Rimsys, which was built to help MedTech teams modernize their processes no matter where they are in their transformation journey.

“MedTech teams want to modernize their processes but don't know where to start from a business or data collection standpoint. They don't have a framework that takes their current processes into account." - James Gianoutsos, Rimsys

The RIM Maturity Model 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.  

“If you're considering a RIM adoption or are already going through one, make sure you understand your own expectations. You can't get to a spacecraft without without getting into a horse and buggy, Data collection and harmonization is milestone-driven and progression-based. You're not going to get to an optimized state on Day 1. But as long as you keep continuing to make well-informed decisions with your data and aligning internally on key terms in that data digitization processes, you will… get there." - James Gianoutsos, Rimsys

"As you're progressing, you need to be really thoughtful about the cost benefit of any initiatives that you're undertaking, Make sure that you have clear objectives that can be measured and that you can report value against and really just make sure that you create recognition with your management teams and with your operational teams that this is going to be a phased journey. You're not going to get there overnight and set expectations appropriately, but try to make measurable steps along the way. And as you do that, you start to build confidence, you build awareness and you build trust that you're delivering on the kind of the objectives that you set out to deliver. It's really a journey.” - Brian Williams, KPMG

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Case Study: RIM Maturity Lessons from Boston Scientific

Adrienne 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.

“The added benefit of a MedTech solution is also that with these external partners, we can understand what is industry standard and that can help us with our change management.” -Adrienne Bishop, Boston Scientific

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.  

"The solution we picked works for other people, so we can make it work for us. We also realized that what we were doing before maybe wasn't wrong, but it was definitely inefficient. We now have different inputs and different regulations. And now we need to change to get there." - Adrienne Bishop, Boston Scientific

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.  

“There's a lot of anxiety about really what AI will deliver. But I think a lot of people that have been working with it, they see it as the virtual assistant or assisting. So it's more augmentation because there's a lot of concern.” - Steve Gens, Gens and Associates

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

“There are some benefits you can definitely achieve with AI. But first and foremost data is going to be the most challenging yet the most effective way to get to that holy grail that I think everybody wants out of a regulatory information management system.” - James Gianoutsos, Rimsys

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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!