Software problems cause 20 medical device recalls a month. 82% of those are classified as software design failures. Dr. Robert Charette has spent five decades documenting why large-scale technology systems fail and why organizations keep repeating the same mistakes.

In this conversation with Shannon Lantzy, Bob brings a perspective rarely heard in medtech: one shaped not by the device industry, but by NASA, the Department of Defense, Fortune 100 companies, and the national rollout of electronic health records. He introduces the distinction between software failures and software blunders, explains why testing is impossible to perfect but impossible to skip, and walks through the risk ecology framework that looks at technical, financial, political, and organizational forces together. He also addresses the Change Healthcare ransomware attack as a case study in systemic interface risk, the red-yellow-green project management inversion, and what AI-generated code means for regulated software.

Timestamps:

[00:00:00] Introduction and the 20 recalls a month statistic

[00:02:44] Why Bob's outsider perspective is the point

[00:03:16] NASA Challenger and the software review panel

[00:08:44] Why you can never test everything but can never stop testing

[00:11:56] Failures vs. blunders: a critical distinction

[00:13:12] What is a risk ecologist?

[00:15:16] When FDA regulation is the only incentive that works

[00:16:08] The case for market-driven standards and tort law

[00:22:24] Bob's role in the EHR meaningful use panel

[00:25:44] Why the national EHR rollout was not well thought through

[00:29:00] Change Healthcare as a systemic interface failure

[00:30:16] How to map interfaces and assume failure

[00:33:36] Efficiency vs. single point of failure

[00:34:44] International regulatory reliance and the turtles all the way down problem

[00:39:24] Designing software to be verified and validated from the start

[00:43:00] Applying V&V to automated insulin delivery systems

[00:48:00] Flipping the risk dashboard: start at red, prove your way to green

[00:51:20] Why no one wants to be the naysayer

[00:53:08] How executives actually tolerate risk

[00:55:04] The Hubble Effect and knowing when to kill a project

[00:56:28] AI and regulated software: the gray beard's take

[01:01:04] AI is perfect for experts and dangerous for everyone else

[01:03:16] Cardinal rule: your system will be evaluated outside the criteria you set

[01:04:12] Rapid fire questions

Follow Shannon and Robert:

Connect with Shannon: 

LinkedIn: https://www.linkedin.com/in/shannonlantzy/

Website: https://www.shannonlantzy.com/

Connect with Robert: 

LinkedIn: https://www.linkedin.com/in/robert-charette-500309/

Website: https://www.ieee.org/