Quality Myths & Lessons Learned Part II

February 22, 2024


In this episode of the Global Medical Device Podcast, host Etienne Nichols delves into the world of medical device quality and reliability with expert guest Kevin Becker.

They explore the nuanced challenges of ethical decision-making in the MedTech industry, the complexities of accelerated testing, and the continuous quest for quality improvement. Becker, author of "Quality Myths and Lessons Learned," shares his insights from the second edition of his book, emphasizing the importance of ethics, the intricacies of statistical models, and the practical aspects of quality management in medical devices.

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  1. Latest MedTech Trends: The episode underscores the critical role of ethics in the rapidly evolving MedTech industry, where technological advancements and moral responsibilities intersect.
  2. Practical Tips: Listeners gain practical insights into the importance of rigorous testing, continuous learning, and ethical decision-making in ensuring the quality and reliability of medical devices.
  3. Future Predictions: The discussion hints at the increasing significance of statistical models and accelerated testing in predicting and enhancing the longevity and efficacy of medical devices.

Key timestamps:

  • [00:05:20] Discussion on the new chapter about ethics in Becker's book
  • [00:10:35] Insights into accelerated testing and its application in medical devices
  • [00:15:50] Kevin Becker's five levels of knowledge and its relevance to MedTech professionals
  • [00:20:45] The significance of standing up for what's right in quality and regulatory matters
  • [00:25:30] Real-life examples of complex problem-solving in medical device engineering
  • [00:30:55] Final thoughts and advice from Kevin Becker for MedTech professionals


Memorable quotes:

  • "The first level of knowledge is you don't have a clue... The third level is you know enough to be effective, which is where we all want to be." - Kevin Becker
  • "All models are wrong; some models are useful." - Quoted by Kevin Becker, highlighting the pragmatic approach in engineering and quality assurance.
  • "Do something, do anything. If it's wrong, we'll learn from it. Just do something." - Kevin Becker's advice to overcome analysis paralysis in product development.


Love this episode? Leave a review on iTunes! Have suggestions or topics you’d like to hear about? Email us at podcast@greenlight.guru.


This episode is brought to you by Greenlight Guru, the only quality management software designed specifically for the medical device industry. Streamline your process and foster innovation with Greenlight Guru’s intuitive platform!

About the Global Medical Device Podcast:

Untitled (8.5 × 3 in)

The Global Medical Device Podcast powered by Greenlight Guru is where today's brightest minds in the medical device industry go to get their most useful and actionable insider knowledge, direct from some of the world's leading medical device experts and companies.

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Etienne Nichols is a Medical Device Guru and Mechanical Engineer who loves learning and teaching how systems work together. He has both manufacturing and product development experience, even aiding in the development of combination drug-delivery devices, from startup to Fortune 500 companies and holds a Project...

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