by Steve Donnigan | Oct 28, 2026 | Design & Development, Engineering Leadership & Outsourcing, Medical Device
Almost any reasonable computer-aided design (CAD) structure can get a development team through its first prototype. However, the real test comes later. Requirements change. Suppliers introduce new components. Interfaces move. Product variants appear. Meanwhile, more...
by Steve Donnigan | Oct 21, 2026 | Design & Development, Engineering Leadership & Outsourcing, Medical Device
Mechanical architecture decisions are usually driven by familiar priorities: performance, packaging, cost, manufacturability, assembly, reliability, and interfaces. Verification comes later, once the design is mature enough for teams to define detailed protocols and...
by Steve Donnigan | Oct 13, 2026 | Design & Development, Engineering Leadership & Outsourcing, Medical Device
One of the biggest differences between early-career engineers and experienced product developers has very little to do with technical ability. It comes down to expectations. Young engineers naturally expect parts to look like the CAD model. Experienced engineers...
by Steve Donnigan | Sep 18, 2026 | Design & Development, Engineering Leadership & Outsourcing, Medical Device
Some development programs encounter expensive tooling changes, failed verification testing, supplier problems, regulatory delays, or manufacturing inefficiencies right when they’re almost at the finish line.. Many of the conditions that create those costs were...
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...
by Steve Donnigan | Apr 24, 2026 | Engineering Leadership & Outsourcing
Outsourcing is often presented as a straightforward way to move faster. If a program needs more speed, add external resources. If specialized expertise is missing, bring in a partner. If timelines are tight, increase capacity. Sometimes this works exactly as intended....
