by Steve Donnigan | Mar 11, 2026 | Design & Development
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 | Feb 6, 2026 | Design & Development
Cutting prototyping to save time or expense is one of the most reliable ways to lengthen a medical device development program. When prototyping is undervalued and treated as an optional expense rather than a requirement, cost and schedule risk almost always increase...
by Steve Donnigan | Jan 28, 2026 | Design & Development
Medical device organizations today are operating in a tighter, more complex environment than ever before. Regulatory scrutiny continues to rise, technology stacks are converging, development timelines are compressing, and cost pressure is unrelenting. In this context,...
by Steve Donnigan | Dec 12, 2025 | Design & Development
How to Get Them Right Designing a successful medical device is a disciplined process rooted in systemized product development and advanced regulatory compliance, not luck or guesswork. Every life saving product on the market today has passed through FDA-mandated...
