by Steve Donnigan | Sep 10, 2026 | Design & Development, Medical Device
Drawings Alone Do Not Create Alignment Geometric Dimensioning and Tolerancing (GD&T) is often introduced as a drafting standard tied to manufacturing drawings. In many organizations, GD&T enters the conversation late in development, when drawings are nearing...
by Steve Donnigan | May 26, 2026 | Regulatory & Risk Management
The “Green Program” That Wasn’t Three months before formal verification, the program review looked exactly as leadership would hope. Every major workstream was green. Milestones were holding. No critical issues were open. The dashboard signaled control. The first full...
by Steve Donnigan | May 22, 2026 | Manufacturing & Quality
The Common Approach Design for Manufacturing is often introduced as a cost reduction activity. It shows up when margins tighten, when sourcing changes, or when a program is already under pressure. At that point, teams look for ways to make the product cheaper to...
by Steve Donnigan | May 8, 2026 | Verification & Testing
When Treated as a Phase, Verification Is Undervalued Most development teams treat verification as something that happens near the end of a program. It is planned, scheduled, and executed as a step to confirm that the design meets requirements. In that model,...
by Steve Donnigan | May 1, 2026 | Verification & Testing
Verification failures are rarely surprises. When a test fails late in development, teams often treat it as an execution issue. Attention shifts to the method, the setup, or the result itself. In most cases, the underlying problem was introduced much earlier. Many...
