by Steve Donnigan | May 26, 2026 | Medical Device
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 | Medical Device
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 | Medical Device
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 | Medical Device
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 | Medical Device
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....
by Steve Donnigan | Apr 17, 2026 | Medical Device
The Risk Analysis Paradox In regulated product development, risk analysis is one of the most formalized engineering activities. Hazard analyses are created, risk matrices are populated, and mitigation tables are carefully maintained. Yet many design problems...
by Steve Donnigan | Apr 6, 2026 | Medical Device
Strong engineering teams still miss milestones. Many medical device companies have excellent engineers, experienced quality groups, and significant investment in development programs. Yet milestones still slip. This pattern appears across organizations of every size....
by Steve Donnigan | Mar 19, 2026 | Medical Device
Medical device development is a coordinated system of distinct domains operating under regulatory constraint. When that system performs well, progress feels disciplined and predictable. When it struggles, the issue is often not capability but structure. Sustained...
by Steve Donnigan | Mar 11, 2026 | Medical Device
Most development teams believe they understand their users. Human factors activities are completed, documented, and validated. Yet use-related problems still emerge once devices enter real clinical environments. These failures are rarely random. They typically stem...
by Steve Donnigan | Mar 5, 2026 | Medical Device
Believing in DfM Is Not the Same as Doing It Most development leaders agree that Design for Manufacturing belongs in early product development. The logic is clear. Cost, quality, and scalability are shaped long before design transfer. Yet many organizations that...
