#378: Who Owns the Design Controls Process?

In this episode of the Global Medical Device Podcast, Etienne Nichols hosts Laura Maher to discuss the critical role of design assurance in medical device development.

They explore the importance of ownership in design and development documentation, delve into the complexities of design controls, and share practical insights on how to ensure compliance and streamline product development.

Laura shares her unique journey from quality control to product development, emphasizing the need for a multidisciplinary approach to create effective and safe medical devices.

Key Timestamps

• [00:00] - Introduction and Sponsor Messages
• [03:10] - Introducing Laura Maher and her background
• [06:45] - Who should own design and development documentation?
• [12:20] - The importance of understanding design controls
• [18:35] - The role of design assurance professionals
• [25:50] - Audience of design and development documentation
• [33:40] - The intersection of quality and product development
• [40:55] - Differences between design reviews and stage reviews
• [47:15] - Collaborative nature of risk management
• [55:30] - Essential skills for a design assurance professional
• [1:02:40] - Closing thoughts and resources

Quotes

• "The value of design assurance professionals lies in their ability to bridge the gap between quality and development." - Laura Maher
• "Understanding the spirit of quality and innovation is as important as knowing the definitions in design controls." - Etienne Nichols
• "A design file is not just for launch; it’s a living document that supports the entire lifecycle of a device." - Laura Maher

Takeaways

Key Insights

1. Multidisciplinary Approach: Combining quality, regulatory, and product development knowledge is crucial for effective design assurance.
2. Documentation Ownership: Assigning clear ownership of design documentation can streamline development and ensure compliance.
3. Design Controls Understanding: A deep understanding of design controls helps in creating documentation that satisfies regulatory requirements and is audit-ready.

Practical Tips

1. Training and Education: Seek out training programs on design controls and quality management to build foundational knowledge.
2. Collaboration: Foster a collaborative environment where engineers, quality assurance, and regulatory teams work together on documentation.
3. Technical Writing: Develop strong technical writing skills to create clear and comprehensive design documentation.

References

• Greenlight Guru - Quality management software tailored for medical devices.
• Rook Quality Systems - Comprehensive compliance services for medical device companies.
• Ultimate Guide to Bringing a Medical Device to Market - A detailed resource for new and experienced MedTech professionals.

MedTech 101

Design Controls: A set of practices and procedures for managing the design of medical devices to ensure they meet user needs and regulatory requirements.

Trace Matrix: A document that maps user needs to design inputs and outputs, ensuring all requirements are met.

Risk Management: The systematic process of identifying, evaluating, and mitigating risks associated with medical devices.

Questions for the Audience

• Poll: Who should own the design and development documentation for medical devices in your organization? (Options: Product Development, Quality Assurance, Regulatory Affairs, Other)
• Discussion Question: How do you see the role of design assurance professionals changing in the next decade with the rise of AI and digital health technologies? Share your thoughts with us at podcast@greenlight.guru.

Feedback

We value your feedback! Please leave us a review on iTunes and share your thoughts on this episode. If you have suggestions for future topics or questions, email us at podcast@greenlight.guru.

Sponsors

Greenlight Guru: Streamline your medical device processes with Greenlight Guru’s quality management and electronic data software. Visit Greenlight Guru to learn more.

Rook Quality Systems: Achieve FDA and ISO compliance effortlessly with Rook Quality Systems. Visit rookqs.com for more information.