RIMs "By the Numbers" A Quick Look Guide to Inproving Your Global Submissions

This video provides an in-depth exploration of Regulatory Information Management (RIMs) and strategies for improving global submissions in the life sciences and medical device industries. Alex Butler, a Product Marketing Manager at MasterControl with extensive experience in product development and regulatory submissions, highlights the increasing complexity of navigating international markets and evolving regulations. The presentation emphasizes that timely device registration is crucial for market success and delves into common challenges faced by regulatory professionals, offering strategic approaches to overcome them.

The core of the discussion identifies prevalent issues that impede efficient global submissions. These include the continued reliance on paper-based systems, disparate processes across different teams or regions, inadequate access and control over critical documents, and poor communication channels. Butler presents startling statistics, noting that 70-90% of 510k and PMA submissions to the FDA are rejected at the first review due to clerical and formatting issues, underscoring a systemic problem of overburdened and understaffed regulatory teams. He describes the current regulatory environment as a "perfect storm" due to significant upcoming changes in regions like Canada and Europe (e.g., EU MDR), which demand immediate strategic adaptation.

To address these challenges, the presentation advocates for a holistic, global approach to regulatory success. Key strategies include formalizing procedures and processes across the entire organization, ensuring harmonization of practices with international partners, and establishing a "single source of truth" for all regulatory content. This involves robust metadata management, effective dossier management (treating a body of documents as a single record), and seamless integration with other enterprise solutions like ERP, CRM, and Quality Management Systems (QMS). Butler stresses the importance of project management transparency to accurately track regulatory initiatives, prioritize efforts, and communicate the true cost of delays to executives, who often have unrealistic expectations regarding market clearance timelines.

A critical insight shared is the need for early and continuous engagement of regulatory teams throughout the product lifecycle. Regulatory professionals should not be siloed or brought in only at the submission phase; rather, they must participate from the initial concept and research (lab book) stages through design history file development and post-market surveillance. This proactive involvement ensures that content is created with regulatory requirements in mind, reducing downstream rejections and delays. The presentation concludes by urging organizations to educate executives on the complexities and burdens faced by regulatory departments, emphasizing that regulatory success is an enterprise-wide responsibility that requires robust tools, formalized processes, and cross-functional collaboration.

Key Takeaways:

• Global Regulatory Complexity: The regulatory landscape is increasingly complex due to evolving international markets and regulations, making global submissions a daunting but critical task for life sciences companies. Changes in regions like Canada and Europe (e.g., EU MDR) are creating a "perfect storm" that demands proactive strategies.
• Common Submission Pain Points: Regulatory professionals frequently encounter issues such as paper-based systems, disparate processes across teams, lack of controlled access to documents, and poor communication, all of which contribute to significant delays and rejections.
• High FDA Rejection Rates: A staggering 70-90% of 510k and PMA submissions to the FDA are rejected at the first review, primarily due to clerical and formatting errors, indicating a fundamental breakdown in submission preparation and quality.
• Underestimated Costs of Delays: Executive expectations for product clearance timelines (e.g., 90 days for 510k) often do not align with reality. Delays in market clearance lead to substantial financial losses and missed market share opportunities, which are often not adequately captured or reported.
• Regulatory Team Understaffing: The industry's regulatory teams are generally understaffed, with regulatory staffing often around 1% of the organization, leading to overburdened individuals managing three to five complex projects simultaneously, making errors and slippages almost inevitable.
• Holistic Global Submissions Approach: Companies need to adopt a global strategy that includes formalized internal procedures, harmonized practices with external partners (affiliates, distributors), and robust document and change control mechanisms across all markets.
• Single Source of Truth: Establishing a centralized, digital "single source of truth" for all regulatory information is paramount. This includes effective metadata management, dossier management (treating a body of documents as a single record), and secure access controls.
• QMS as a RIMs Foundation: Organizations should leverage and optimize their existing Quality Management Systems (QMS) to function as a Regulatory Information Management (RIMs) solution, rather than investing in separate, disparate systems. This requires thoughtful configuration and integration.
• Project Management Transparency: Formalizing project management for regulatory initiatives is crucial. This enables clear communication of project status, bottlenecks, and potential slippages to all stakeholders, including executives, and helps prioritize competing initiatives based on impact and resources.
• Early Regulatory Engagement: Regulatory teams must be engaged much earlier in the product development lifecycle, ideally from the concept and research (lab book) stages, rather than just at the design history file or submission phase. This proactive involvement helps guide testing, design, and content creation to meet regulatory requirements from the outset.
• Regulatory's Unique Role: Regulatory professionals have a unique and challenging role, often reporting slippages to executives while not being the authors of 90% of the content required for submissions. This necessitates strong cross-functional communication and collaboration.
• Executive Education is Key: Executives often lack a full understanding of the burdens and complexities faced by regulatory departments. Educating leadership on regulatory needs, timelines, and the impact of non-compliance is essential for securing necessary resources and support.
• Adaptation to Change: The constant flux in global regulations requires organizations to continuously monitor changes (e.g., EU MDR, MDSAP) and adapt their processes and strategies to minimize damage and ensure ongoing compliance.

Key Concepts:

• Regulatory Information Management (RIMs): Solutions or systems designed to manage and track all regulatory information, submissions, and activities throughout the product lifecycle.
• Dossier Management: The process of organizing, managing, and controlling access to a collection of related documents (a dossier) that support a regulatory submission or product registration.
• Quality Management System (QMS): A formalized system that documents processes, procedures, and responsibilities for achieving quality policies and objectives, often used in regulated industries.
• Design History File (DHF): A compilation of records that describes the design history of a finished medical device, as required by FDA 21 CFR Part 820.30.
• Lab Book: Refers to the early-stage research and development documentation, often containing proprietary information and initial concepts.
• FDA Refusal to Accept Policy: An FDA policy outlining the criteria for refusing to accept a submission for review if it is incomplete or contains clerical/formatting errors.
• EU Medical Device Regulation (EU MDR): A comprehensive regulation governing the production and distribution of medical devices in the European Union, replacing the Medical Device Directive (MDD).
• Medical Device Single Audit Program (MDSAP): An international program allowing a single audit of a medical device manufacturer's quality management system to satisfy the requirements of multiple regulatory authorities.

Tools/Resources Mentioned:

• Microsoft Project: A project management software used for planning, tracking, and managing projects.
• Agile: A project management methodology that emphasizes iterative development, collaboration, and flexibility.
• MasterControl: The company hosting the webinar, providing cloud-based quality and compliance software for life sciences and other regulated industries.

Examples/Case Studies:

• FDA Submission Statistics: 70-90% of 510k and PMA submissions are rejected at first review due to clerical/formatting issues (from MD UFA quarterly report, Sept 2018).
• Cost of Slippage: Data from the America Group and LNS reports illustrate the significant financial impact and loss of market share over 10 years for products that are not first or second to market.
• Regulatory Staffing: Industry data suggests regulatory staffing is often around 1% of an organization, while 25% might be needed for new product development alone, highlighting a severe understaffing issue.
• Customer Examples: Two customer examples were shared regarding QMS configuration for RIMs: one large company needed less than 20 configuration changes, while a mid-level company needed over 300, emphasizing the importance of a "less is more" approach to metadata.