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...

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

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