The Need for Better Regulatory Information Management in Medical Device Manufacturing

This presentation explores the critical need for robust Regulatory Information Management (RIM) systems within the medical device and diagnostics manufacturing sectors, emphasizing the challenges posed by relentless global change and fragmented data sources. The speaker establishes that the regulatory landscape is constantly shifting—driven by changes in regulations, business environments, politics, and technology—necessitating that regulatory professionals maintain synchronization, transparency, and registration of product data across all global stakeholders. The core argument centers on the necessity of moving beyond siloed operations where regulatory data is treated separately from product data, stressing that "data is data" and must be shared across the enterprise to effectively communicate product acceptability and compliance worldwide.

A significant portion of the discussion focuses on the complexity of managing product data throughout its lifecycle, particularly within the "sustaining organization" responsible for products already on the market. The speaker highlights that regulatory data is fundamentally product data, used to "tell the story" of why a product meets requirements. This integration is complicated by global variations, using Unique Device Identification (UDI) as a prime example. While countries worldwide adopt UDI, their specific data requirements often differ, forcing manufacturers to account for diverse global needs in their sustaining operations. The speaker notes that these sustaining teams, though crucial, are often overlooked until an issue arises, underscoring the lack of internal recognition for proactive compliance management.

The speaker provides a compelling personal anecdote illustrating the stark contrast in RIM maturity across the industry. They recount moving from a large medical device company that utilized a Product Lifecycle Management (PLM) system and an existing, though outdated, RIM system, to a diagnostics company that operates primarily on paper-based processes. This shift revealed a common, problematic theme within the diagnostics world: reliance on decentralized, manual tools like individual Excel files and scattered SharePoint sites for managing critical worldwide registrations. This reliance creates severe operational risks, making it nearly impossible to accurately track the status, quantity, associated revenue, or required updates for registrations when regulations change. The presentation concludes by polling the audience to gauge the prevalence of these challenges across different industry sectors (med device, combo products, etc.), underscoring the widespread nature of the "hill to climb" in digital transformation for regulatory affairs.

Key Takeaways: • The Imperative for Synchronization: Regulatory teams must actively work to keep product registrations, compliance data, and internal business processes synchronized with constant changes in global regulations, political environments, and emerging technology standards. • Eliminating Data Silos: The traditional view that regulatory data is separate from core product data must be abandoned; data should be treated as a unified asset, requiring shared, transparent access across all internal stakeholders (e.g., R&D, manufacturing, commercial, and regulatory). • Master Sources of Information are Critical: To ensure consistency and accuracy, organizations must establish and maintain master sources of product and regulatory information, moving away from fragmented systems like local Excel files and SharePoint sites. • Sustaining Operations Complexity: The sustaining organization, which manages products post-launch, faces immense pressure to maintain global compliance, often without adequate systemic support or recognition, making them highly vulnerable to regulatory gaps. • Global UDI Fragmentation: Although UDI standards are globally adopted, the specific data requirements associated with UDI often vary significantly by country, demanding complex, localized data management strategies from manufacturers. • The Diagnostics Industry Lag: A prevalent challenge, particularly noted in the diagnostics sector, is the reliance on outdated, paper-based systems for managing critical worldwide registrations, which dramatically increases risk and operational inefficiency. • Risk of Decentralized Tracking: Managing worldwide product registrations using manual, decentralized tools (like personal Excel files) makes it impossible to answer fundamental business questions, such as the total number of registrations managed, associated revenue, or the impact of regulatory changes. • Assessing the Regulatory Burden: Companies must be able to quickly assess the size of their regulatory burden—how many registrations are active, which markets they cover, and what revenue is tied to them—to prioritize resources and manage risk effectively. • Impact of Regulatory Change: Without a structured RIM system, regulatory changes often necessitate starting the registration process over, rather than allowing for efficient updates, leading to significant time and cost overruns. • Digital Transformation Necessity: The industry must recognize that the shift from paper-based and manual systems to integrated digital platforms is not optional but essential for competing globally and maintaining timely compliance in complex markets.

Key Concepts:

• Regulatory Information Management (RIM): The systems and processes used to manage, track, and submit regulatory data and documentation throughout the product lifecycle.
• Sustaining Organization: The internal teams responsible for maintaining product quality, compliance, and market presence after the initial launch, often handling post-market changes and regulatory updates.
• Unique Device Identification (UDI): A system used globally to mark and identify medical devices through distribution and use, though its specific data requirements vary by jurisdiction.
• Data Silos: The isolation of data within specific departments (e.g., regulatory, R&D) preventing enterprise-wide transparency and efficient use of information.