How technology can simplify medical device regulatory compliance | Veeva Systems

This video provides an in-depth exploration of how technology can significantly simplify and enhance regulatory compliance within the medical device and diagnostics industry, particularly in light of evolving regulations like the EU MDR. Annemien Pullen, Director of Strategy for Vault Medical Devices & Diagnostics at Veeva Systems, outlines a strategic approach for companies to transition from reactive compliance management to a proactive, sustainable model enabled by robust technological solutions.

The discussion begins by highlighting common regulatory challenges faced by medical device companies, such as fragmented data across organizations, inconsistencies in information, and a reliance on short-term workarounds. Dr. Pullen emphasizes that addressing these foundational issues through structural changes in regulatory operations, rather than temporary fixes, is crucial for long-term organizational sustainability. She underscores that despite external pressures like the COVID-19 pandemic and budget constraints, global regulatory changes, such as the EU MDR, are inevitable and require a strategic investment in a resilient regulatory operating model.

Dr. Pullen elaborates on how technology acts as a powerful enabler, not an end goal, for optimizing the entire regulatory process. A single, global tool can harmonize business processes across different geographies and business units, providing leadership with real-time insights for informed decision-making. This approach significantly boosts efficiency by eliminating time wasted searching for data or the latest document versions. Critically, an effective Regulatory Information Management (RIM) system can track and trend health authority correspondence, allowing companies to anticipate questions, improve the quality of submission documents, and ultimately reduce time to market. This proactive stance also frees highly skilled regulatory professionals to focus on strategic intelligence and value-adding tasks rather than administrative burdens.

The conversation concludes with essential considerations for selecting and implementing appropriate technology. Key factors include the system's security, its ability to facilitate secure internal and external collaboration (e.g., with economic operators and notified bodies for remote audits with granular access controls), and its overall usability. An intuitive user interface is paramount for high user adoption, ensuring the technology delivers its intended value. Furthermore, the chosen system must support the entire end-to-end regulatory process, functioning as more than just a data repository by enabling joint drafting, submission planning, product registration linking, and comprehensive correspondence tracking.

Key Takeaways:

• Prioritize Structural Regulatory Change: Medical device companies should focus on solving fundamental regulatory challenges like data sprawl and inconsistency through structural changes to their regulatory operating model, rather than relying on short-term workarounds.
• Invest in Organizational Sustainability: View structural changes in regulatory operations as a critical investment in long-term organizational sustainability, especially given the continuous evolution of global regulations like the EU MDR.
• Leverage Technology as an Enabler: Technology is not an end in itself but a powerful enabler for optimizing the end-to-end regulatory process, allowing for harmonization across business units and geographies.
• Shift to Proactive Compliance: Implement technology to move from a reactive approach (responding to audits and non-conformities) to a proactive one, continuously monitoring the regulatory environment and maintaining compliance 24/7.
• Gain Real-time Insights and Efficiency: A global regulatory tool provides leadership with real-time insights for better decision-making and increases efficiency by reducing time spent searching for data or managing disparate systems.
• Improve Submission Quality and Time to Market: Utilize a robust RIM system to track and trend health authority correspondence. This intelligence allows companies to anticipate potential questions, improve the quality of initial submissions, and thereby reduce time to market.
• Empower Regulatory Professionals: By automating administrative tasks and streamlining processes, technology enables highly skilled regulatory teams to focus on strategic activities, regulatory intelligence, and other value-adding tasks.
• Reduce Non-Compliance Issues: An appropriate technology solution can significantly decrease non-compliance issues caused by human error or a lack of insight, contributing to a more robust compliance posture.
• Ensure High System Security: When selecting a regulatory system, prioritize a high level of security, as it will serve as the single source of truth for sensitive regulatory documentation and process data.
• Facilitate Secure External Collaboration: The system must support secure collaboration with external stakeholders, such as economic operators and notified bodies, by providing appropriate access rights and permissions for specific documents during remote audits.
• Emphasize Usability and Intuitive Design: A user-friendly and intuitive interface is crucial for high user adoption. A modern system that is difficult to navigate will not deliver its full value, regardless of its features.
• Support End-to-End Regulatory Processes: The chosen technology should be more than just a document repository; it must support the entire regulatory lifecycle, including joint drafting of submission documents, planning submissions, relating product registrations, and tracking health authority correspondence.

Key Concepts:

• EU MDR (European Medical Device Regulation) & IVDR (In Vitro Diagnostic Regulation): Key European regulations governing medical devices and in vitro diagnostic medical devices, driving significant changes in compliance requirements.
• Regulatory Operating Model: The framework and processes an organization uses to manage its regulatory activities and ensure compliance.
• RIM System (Regulatory Information Management System): A comprehensive software solution designed to manage all aspects of regulatory information, submissions, and compliance throughout the product lifecycle.
• Economic Operator Obligations: Requirements placed on various entities in the supply chain (manufacturers, authorized representatives, importers, distributors) under regulations like the EU MDR.
• Notified Body: An independent third-party organization designated by an EU member state to assess the conformity of certain products before they are placed on the market.
• Remote Audits: Audits conducted remotely, often leveraging technology to provide auditors with access to necessary documentation and data without requiring physical presence.

Tools/Resources Mentioned:

• Veeva Systems: The speaker is from Veeva Systems, and the discussion implicitly refers to their suite of solutions, particularly Veeva Vault RIM, which addresses regulatory information management for the life sciences industry.