Medical Devices
9 articles, newest first.
All AI 33Theory of Constraints 30Strategy 28Small Business 26Healthcare 20Operations 18Practical Tips 16Medical Devices 9Leadership 8Case Studies 4Government 3Workforce 3
- The Same Seven Mistakes, Every Company, Every Decade
· Theory of Constraints, Medical Devices, Operations, 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)
· Theory of Constraints, Medical Devices, 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)
· Theory of Constraints, Medical Devices, 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
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
· Theory of Constraints, Medical Devices, Case Studies, 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
· Theory of Constraints, Medical Devices, 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
· Theory of Constraints, Medical Devices, 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)
· Theory of Constraints, 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
· Theory of Constraints, Medical Devices, Strategy
Why 'Scope Creep' is usually a symptom of a deeper strategic failure—in software, in hardware, and in healthcare.