by Steve Donnigan | Apr 17, 2026 | Uncategorized
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 | Uncategorized
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 | Uncategorized
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 | Uncategorized
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 | Uncategorized
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...
by Steve Donnigan | Feb 25, 2026 | Uncategorized
Cost, Quality, and Predictability Design for Manufacturing is often discussed as a downstream optimization activity that is addressed after the design is complete and the focus shifts to scale-up and production. In medical device development, that framing is...
