--- title: "Insights: Medical Devices | Common Sense Systems" url: https://common-sense.com/insights/tag/medical-devices/ description: "Articles by John Sambrook tagged Medical Devices, newest first." --- [Insights](https://common-sense.com/insights/) # Medical Devices 9 articles, newest first. [All](https://common-sense.com/insights/) [AI 33](https://common-sense.com/insights/tag/ai/)[Theory of Constraints 30](https://common-sense.com/insights/tag/theory-of-constraints/)[Strategy 28](https://common-sense.com/insights/tag/strategy/)[Small Business 26](https://common-sense.com/insights/tag/small-business/)[Healthcare 20](https://common-sense.com/insights/tag/healthcare/)[Operations 18](https://common-sense.com/insights/tag/operations/)[Practical Tips 16](https://common-sense.com/insights/tag/practical-tips/)[Medical Devices 9](https://common-sense.com/insights/tag/medical-devices/)[Leadership 8](https://common-sense.com/insights/tag/leadership/)[Case Studies 4](https://common-sense.com/insights/tag/case-studies/)[Government 3](https://common-sense.com/insights/tag/government/)[Workforce 3](https://common-sense.com/insights/tag/workforce/) - [The Same Seven Mistakes, Every Company, Every Decade](https://common-sense.com/insights/the-same-seven-mistakes-every-company-every-decade/) July 20, 2026 · [Theory of Constraints](https://common-sense.com/insights/tag/theory-of-constraints/), [Medical Devices](https://common-sense.com/insights/tag/medical-devices/), [Operations](https://common-sense.com/insights/tag/operations/), [Leadership](https://common-sense.com/insights/tag/leadership/) What 500 FDA enforcement actions reveal about how organizations think. The same seven failure patterns appear across medical device companies, decade after decade. The root cause is not poor procedures. It is cognitive biases that evolved for small-group survival but break down in modern industrial settings. - [Why CAPA Systems Rot (And Why Naming Names Does Not Fix It)](https://common-sense.com/insights/why-capa-systems-rot/) July 20, 2026 · [Theory of Constraints](https://common-sense.com/insights/tag/theory-of-constraints/), [Medical Devices](https://common-sense.com/insights/tag/medical-devices/), [Operations](https://common-sense.com/insights/tag/operations/) A deep dive into conflict avoidance as the root cause of FDA quality system failures. Analysis of 500 enforcement actions shows that CAPA failures are not procedural problems. They are cognitive problems that require a different objective function. - [Why Software Defects Kill (And Why Optimism Is the Real Bug)](https://common-sense.com/insights/why-software-defects-kill/) July 20, 2026 · [Theory of Constraints](https://common-sense.com/insights/tag/theory-of-constraints/), [Medical Devices](https://common-sense.com/insights/tag/medical-devices/), [Operations](https://common-sense.com/insights/tag/operations/) Software/firmware defects account for 12 Class I medical device recalls, the most of any category. The root cause is not poor engineering. It is planning fallacy, a cognitive bias that makes every team overestimate their timeline and underestimate their defect rate. - [The Device CLI Was an Organizing Surface, Not Just a Tool](https://common-sense.com/insights/device-cli-organizing-surface/) May 13, 2026 · [AI](https://common-sense.com/insights/tag/ai/), [Medical Devices](https://common-sense.com/insights/tag/medical-devices/) the most important part of the the client work was the protocol boundary. The host CLI, the firmware, the cellphone UI, and the product itself were organized around it. - [From 'Cost Center' to 'Growth Engine': A Theory of Constraints Success Story](https://common-sense.com/insights/cost-center-to-growth-engine-toc-case-study/) March 5, 2026 · [Theory of Constraints](https://common-sense.com/insights/tag/theory-of-constraints/), [Medical Devices](https://common-sense.com/insights/tag/medical-devices/), [Case Studies](https://common-sense.com/insights/tag/case-studies/), [Operations](https://common-sense.com/insights/tag/operations/) How applying the Theory of Constraints 5 Focusing Steps transformed a reactive, email-only support model into a white-glove customer success engine for a high-value ultrasound research systems manufacturer. - [One Tool Was Starving Four Teams](https://common-sense.com/insights/one-tool-was-starving-four-teams/) March 5, 2026 · [Theory of Constraints](https://common-sense.com/insights/tag/theory-of-constraints/), [Medical Devices](https://common-sense.com/insights/tag/medical-devices/), [Case Studies](https://common-sense.com/insights/tag/case-studies/) A clinical ultrasound project was six months behind schedule. The constraint was not the engineering — it was the register map tool that every team depended on and nobody had questioned. - [Two Months Back on an 18-Month Project](https://common-sense.com/insights/two-months-back-on-an-18-month-project/) February 22, 2026 · [Theory of Constraints](https://common-sense.com/insights/tag/theory-of-constraints/), [Medical Devices](https://common-sense.com/insights/tag/medical-devices/), [Case Studies](https://common-sense.com/insights/tag/case-studies/) How standardizing a communication protocol on a smartphone-powered defibrillator project unblocked an entire engineering team and saved two months of development time. - [Why 'Agile' Fails in Hardware (And What Actually Works)](https://common-sense.com/insights/why-agile-fails-in-hardware-and-what-actually-works/) February 17, 2026 · [Theory of Constraints](https://common-sense.com/insights/tag/theory-of-constraints/), [Medical Devices](https://common-sense.com/insights/tag/medical-devices/) You cannot 'sprint' a circuit board design. A systems architect's view on why software methodologies break when applied to physics, and how Critical Chain solves the real constraint. - [The 'Perfect' Product That Killed the Company](https://common-sense.com/insights/perfect-product-killed-company/) February 16, 2026 · [Theory of Constraints](https://common-sense.com/insights/tag/theory-of-constraints/), [Medical Devices](https://common-sense.com/insights/tag/medical-devices/), [Strategy](https://common-sense.com/insights/tag/strategy/) Why 'Scope Creep' is usually a symptom of a deeper strategic failure—in software, in hardware, and in healthcare.