Accelerating Innovation: Effective Design Controls and Risk Management in MedTech

This video provides an in-depth exploration of effective design controls and risk management within the MedTech industry, emphasizing how these practices accelerate innovation while ensuring regulatory compliance. The webinar, presented by Rook Quality Systems and QuickVault by Veeva Systems, features industry experts Kyle Rose (RookQS), Axel Strombergsson (Veeva), and Jeff Hau (Veeva). The session begins by outlining FDA and ISO guidelines for design controls, stressing the critical importance of early planning and robust documentation, particularly for software-driven medical devices.

The discussion progresses from the foundational principles of design control, such as defining user needs and translating them into measurable design inputs, to the practical aspects of implementation. Axel Strombergsson frames design controls as a specialized form of project management, highlighting the need for upfront planning, meticulous execution, and continuous review to minimize setbacks and achieve faster market entry. He underscores the regulatory imperative that "if it's not documented, it never happened," emphasizing the role of comprehensive documentation throughout the design and development lifecycle. The speakers delve into the interconnectedness of design inputs, outputs, verification, validation, and risk assessment, illustrating how these elements form a traceable matrix crucial for regulatory submissions and post-market compliance.

A significant portion of the webinar is dedicated to showcasing QuickVault, Veeva's cloud-based EQMS solution tailored for smaller MedTech companies. Jeff Hau provides a live demonstration of QuickVault's capabilities, illustrating how the platform automates and streamlines the management of design controls and risk. This includes creating and linking user needs, design inputs, and risks, conducting integrated design and risk reviews with electronic signatures, and automatically generating regulatory-ready documents like the Design Development File (DDF) and Medical Device File (MDF). The demo highlights QuickVault's user-friendly interface and its ability to simplify complex regulatory processes, thereby reducing the need for extensive prior experience in quality management and accelerating product development. The speakers also touch upon the nuances of software device development, including agile methodologies, cybersecurity considerations, and the management of design changes.

Key Takeaways:

• Early Implementation of Design Controls is Crucial: Starting the design control process early, even at the conceptual "back of a napkin" stage, helps identify testing requirements and market pathways sooner, preventing costly delays and rework later in development.
• Design Controls as Regulated Project Management: Design controls can be viewed as project management with a regulatory twist, requiring robust upfront planning, diligent execution, and formal documentation to achieve project success, faster market entry, and high submission success rates.
• The "If It's Not Documented, It Never Happened" Principle: Regulatory bodies like the FDA emphasize that undocumented activities or poorly recorded data are considered non-existent. Meticulous documentation throughout the design and development process is paramount for compliance and successful submissions.
• Foundational Planning Elements: Successful design control hinges on three foundational elements: a comprehensive Design and Development Plan (project plan), clearly defined Design Inputs (measurable specifications based on user needs), and an early, thorough Risk Assessment.
• Traceability is Key for Compliance: ISO 13485 and FDA regulations mandate traceability between user needs, design inputs, design outputs, verification, validation, and risk assessments. Modern software solutions like QuickVault automate this traceability, simplifying management and ensuring compliance.
• Automation Enhances Efficiency and Reduces Expertise Dependency: Leveraging modern EQMS software like QuickVault automates many regulatory processes, increasing efficiency, reducing the need for extensive prior experience in quality management, and organizing documents for regulatory submissions and audits.
• Formal Design and Risk Reviews are Mandatory: Design reviews must be conducted at specific project milestones, documented with meeting minutes, and include an independent reviewer (as per ISO 13485) to ensure objectivity. QuickVault integrates these reviews directly into the workflow.
• Distinction Between Verification and Validation: Design verification confirms that design outputs meet design inputs (e.g., bench testing, electrical testing), while design validation ensures the product meets user needs and intended use (e.g., usability studies, clinical trials). Both require formal, approved protocols and defined acceptance criteria.
• Risk-Based Approach to Sample Size Justification: When determining sample sizes for verification and validation testing, a risk-based approach should be employed. Higher-risk components or failure modes that could cause harm to end-users necessitate larger sample sizes.
• Specific Considerations for Software Devices: Software development, while potentially faster and more iterative (e.g., agile sprints), still requires defined processes for requirements, architecture, testing (unit, functional, regression), and maintenance. Cybersecurity is a critical concern for medical device software, requiring dedicated planning and testing.
• Rigorous Design Change Management: Any design change, whether during development or post-market, must undergo a thorough review and risk analysis to determine its impact on regulatory status, performance, safety, effectiveness, and the need for re-verification, re-validation, or new regulatory submissions.
• Understanding Regulatory Classification: Products are classified (e.g., FDA Class I, II, III) based on risk, which dictates the level of design control, testing, and regulatory submission required. Early identification of the regulatory path is crucial for design planning.
• QuickVault's Value Proposition: QuickVault offers a "day one ready" EQMS, continuous software improvement with frequent releases, compliance with industry standards, free industry best practice documentation, and flexible month-to-month subscription models, making it accessible for smaller MedTech startups.
• Integrated Regulatory Document Generation: QuickVault automatically generates regulatory-ready files such as the Design Development File (DDF) and Medical Device File (MDF) by indexing and categorizing all related documents, significantly reducing the manual effort involved in preparing submissions.

Tools/Resources Mentioned:

• QuickVault by Veeva Systems: An EQMS (Electronic Quality Management System) specifically built for smaller MedTech companies, offering automated design controls, risk management, quality events, training, and supplier management.
• Rook Quality Systems: A consulting firm specializing in quality and regulatory support for MedTech companies, offering services in design control, risk management, product development, validation, and audit support.
• Project Management Institute (PMI): Mentioned as a leading organization for establishing best practices in project management.
• FDA Website: Recommended for understanding design control regulations.

Key Concepts:

• Design Controls: A set of quality practices and procedures to ensure that medical devices meet user needs, intended use, and specified requirements throughout their development.
• Risk Management: The systematic application of management policies, procedures, and practices to the tasks of analyzing, evaluating, controlling, and monitoring risk.
• User Needs: High-level requirements describing what the user wants the device to do.
• Design Inputs: Detailed, measurable specifications derived from user needs, against which the device will be designed and tested.
• Design Outputs: The results of the design process, including drawings, material specifications, software code, instructions for use, and labeling.
• Design Verification: Testing to confirm that design outputs meet design inputs ("Did we build the product right?").
• Design Validation: Testing to confirm that the finished device meets user needs and intended use ("Did we build the right product?").
• Design Review: Formal, documented meetings at various stages of development to evaluate the design and ensure it meets requirements.
• Design History File (DHF) / Design Development File (DDF): A compilation of records that describes the design history of a finished medical device. The term DDF is evolving with the QMR.
• Medical Device File (MDF): A compilation of records that contains the device master record (DMR) and other essential information for a medical device.
• EQMS (Electronic Quality Management System): Software solutions that manage and automate quality processes, documentation, and compliance for regulated industries.
• QSR (Quality System Regulation): FDA regulations (21 CFR Part 820) governing quality systems for medical devices.
• ISO 13485: An international standard for quality management systems specific to medical devices.
• QMR (Quality Management Regulation): The upcoming merged regulation combining FDA QSR and ISO 13485.
• Preliminary Hazard Analysis: An early-stage risk assessment technique used to identify potential hazards and hazardous situations.
• Risk Acceptability Matrix: A tool used to evaluate and classify risks based on their severity and probability.
• Agile Software Development: An iterative approach to software development that emphasizes continuous delivery, collaboration, and adaptability to change.
• LDT (Laboratory Developed Tests): Diagnostic tests that are designed, manufactured, and used within a single laboratory.
• Combination Products: Products that combine a drug, device, and/or biological product.

Examples/Case Studies:

• A fictional example of designing "medical gloves" was used to demonstrate the design control and risk management features within QuickVault, including defining user needs (protection, comfort, durability), design inputs (resistance to liquids, low permeability, comfort for 8 hours), and associated risks (contamination, discomfort).