LTR Monthly Webinar: May 2024
“When risks manifest, they can have a huge impact, including a huge financial impact.”
Eric Maas emphasizes this point as he reviews the Fidelis lead recall in 2007, that led to a significant drop in Medtronic’s stock price and market valuation.
The Fidelis lead was designed and tested using a testing approach similar to an earlier version. The critical difference was that, unlike the previous version, Fidelis was a much thinner lead.
A compliance based testing approach that worked for the previous lead, failed to expose some of the potential failure modes in the Fidelis lead due to the thickness difference. In this Let’s Talk Risk! conversation, Eric explains how he was able to demonstrate that these failures could have been predicted by using probabilistic models to quantify the effect of noise factors related to use conditions.
That is why we need to use probabilistic models during design and development, and not rely on compliance testing, to ensure high quality and reliability.
Watch the full episode (approximately 60 minutes) or jump to the topic of interest using the timestamps below:
Chapters
0:00:57 Introduction
0:03:23 Early success at Motorola with probability and statistics
0:07:12 Next stop: Medtronic; designing-in quality using probability and statistics
0:12:10 Case study introduction: Fidelis lead recall
0:15:47 Why compliance is not enough - the Case for Quality program
0:17:50 Analysis of common elements in past recalls at Medtronic
0:19:48 Why worst cast testing does not address inherent uncertainty due to variation
0:21:44 Medtronic stock takes a hit due to Fidelis lead failures
0:25:42 Using a predictive modeling approach to simulate Fidelis lead failures
0:28:25 How compliance-based testing of Fidelis leads missed the failure opportunity
0:33:25 P-diagram approach to designing robust products
0:35:17 Understanding variation due to noise/use conditions
0:36:50 Breaking down barriers for collaboration R&D, Quality and Manufacturing
0:41:10 How a shared goal of a flawless launch promotes collaboration
0:46:30 Focusing on the patient in flawless launch
0:50:35 Communicating effectively with executive leaders
0:54:50 Career trajectory, lessons learned for career success
0:58:05 Closing comments
Suggested links:
Fracture prediction of cardiac lead medical devices using Bayesian networks
Applying design for six sigma to software and hardware systems
About Eric Maas
Eric Maass currently serves as an adjunct professor at the Arizona State University. He was one of the original founders of the Six Sigma program at Motorola where he served in different roles for nearly 30 years. Most recently, he was at Medtronic as the senior director of design, reliability and manufacturing (DRM), a technical fellow and master black belt. He retired from Medtronic in 2020 and now provides training, coaching and consulting services in product/process development and optimization.
Disclaimer
Information and insights presented in this podcast are for educational purposes only. Views expressed by all speakers are their own and do not reflect those of their respective organizations.
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