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...
by Steve Donnigan | Feb 12, 2026 | Uncategorized
Designing a medical device that performs beautifully isn’t enough. It also has to meet the world’s toughest regulatory and safety standards. In 2026, compliance is more than just a checkbox, but, rather, a competitive advantage. Teams that integrate regulation...
by Steve Donnigan | Feb 6, 2026 | Uncategorized
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 | Uncategorized
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 | Jan 21, 2026 | Uncategorized
Outsourcing Engineering Is a Strategic Business Decision Medical device startups rarely fail because of insufficient engineering effort, they fail because scarce resources such as capital, time, and attention are misallocated. Outsourcing engineering is often...
