#422: ISO 14971 and the Road to Risk Management with Edwin Bills

This episode takes an unexpected journey with Edwin Bills, a lead expert in medical device risk management and a key contributor to the development of ISO 14971. Edwin shares stories from his diverse career, beginning with his time as a submariner and electronics technician in the Navy, where he worked on early GPS technology and helped build missile subs from the ground up. This unique hands-on experience taught him the importance of knowing every component of a system.

From there, Edwin transitioned into manufacturing, where he applied his skills in teaching electronics and later, quality management. He was trained by renowned quality gurus like Joseph Juran and learned about concepts like Six Sigma and Kaizen from companies like Motorola and Toyota. These experiences, which focused on process improvement, cost of quality, and efficiency, laid a critical foundation for his future work.

Edwin connects these seemingly disparate experiences to his pivotal role in medical device risk management. He explains how issues in manufacturing—such as supplier quality, process capability, and yield—directly impact patient safety and a company's financial bottom line. This holistic view, blending technical expertise, quality principles, and a deep understanding of manufacturing processes, ultimately led him to the committee that developed the ISO 14971 standard.

Key Timestamps

• 01:52 - Edwin's military background as a submariner and electronics technician, and how he helped build a missile sub from scratch.
• 04:27 - The transition from military to a career in manufacturing and quality management, including his training under Joseph Juran.
• 10:59 - Edwin’s role in supplier quality and his lessons learned from working with a wide range of suppliers.
• 15:48 - The impact of Kaizen projects and other modern manufacturing techniques on efficiency and quality.
• 18:18 - An incredible story of a supplier with an ownership mindset that maintained delivery schedules after a factory fire.
• 18:59 - Connecting manufacturing experience and quality principles to the fundamentals of risk management.
• 20:46 - The crucial link between quality, patient safety, and a company’s financial success.
• 25:28 - How to apply statistical and manufacturing improvement tools in the medical device industry.
• 27:20 - The value of hands-on experience and a holistic understanding of a product's lifecycle.
• 30:09 - How Edwin’s diverse experiences ultimately led him to a key role in developing ISO 14971.

Quotes

• "If you want to think about cost of quality, it, you know, what is the cost to the company of this? You've got to have safe and effective medical devices." - Edwin Bills
• "When you get a statistician to help you improve your manufacturing processes, you want an industrial statistician... When you get to the clinical trials, that person's not the right person to have. You want a research statistician." - Edwin Bills

Takeaways

• Manufacturing Quality is Risk Management: The principles of quality improvement, process control, and supplier management—learned in high-volume manufacturing—are directly applicable to mitigating risks in medical devices. A high-quality, reliable process inherently reduces the likelihood of product failures that could harm patients.
• Prioritize Quality Over Price: As Edwin's experience with the electric motor supplier shows, prioritizing the lowest cost can lead to significant issues, non-conformances, and a higher overall cost of poor quality. A supplier focused on quality and delivery will ultimately save a company money and protect its reputation.
• Seek Hands-On Experience: Knowing a product "down to the nuts and bolts" provides invaluable insight. This can be achieved through cross-functional training, allowing engineers and managers to understand the practical challenges of manufacturing and assembly, leading to more robust and safer designs.
• Right Tool, Right Time: The medical device industry can improve by adopting modern statistical and process improvement tools like Kaizen and Six Sigma. However, it's crucial to select the right kind of expert for the specific task at hand, whether it's process improvement or clinical trial design.
• Holistic Approach to Risk: Effective risk management goes beyond just patient safety. It must consider the full spectrum of risks, including financial and reputational damage, which are often the direct result of a failure to manage quality and safety risks effectively.

References

• Joseph M. Juran: A 20th-century quality management pioneer. His work on the "Juran Trilogy" (quality planning, quality control, quality improvement) and the concept of the "cost of quality" were foundational to modern quality systems.
• Six Sigma: A set of techniques and tools for process improvement, originally developed by Motorola. It aims to reduce defects and variation to near-perfect levels.
• Kaizen: A Japanese term for "change for the better" or "continuous improvement." It is a business philosophy focused on improving all functions and involving all employees.
• ASQ (American Society for Quality): A global organization dedicated to quality management and improvement.
• Link to Etienne Nichols' LinkedIn: https://www.linkedin.com/in/etienne-nichols-pmp-csm-a1851b14/

MedTech 101

• CPK (Process Capability Index): CPK is a statistical measure that tells you how well a manufacturing process is performing relative to its design specifications. A higher CPK value means the process is more reliable and consistently produces parts that meet requirements. A CPK of 1.0 means the process is just barely capable of meeting the specs, while a CPK of 2.0 (associated with Six Sigma) means it’s highly capable and produces very few defects.
• Kaizen: Think of Kaizen like a never-ending team effort to make small, smart improvements. Instead of waiting for a big problem to fix, everyone from the CEO to the factory floor worker looks for tiny ways to make things a little bit better, a little bit faster, or a little bit safer every single day.

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Sponsors

This episode is brought to you by Greenlight Guru, the only medical device success platform designed specifically for MedTech companies. Their flagship QMS and EDC solutions are helping MedTech professionals get products to market faster, and with less risk. To learn more about how Greenlight Guru's solutions can streamline your quality and data processes, visit www.greenlight.guru.