Systems Engineering in Medical Device
New product development in medical devices often moves fast, but moving fast without structure can create costly problems later.
In this MedTechMan insight, Justin Bushko explains why systems engineering and upfront design thinking are critical to building devices that truly succeed in the real world.
In many projects, teams begin with a visual goal in mind. They focus on what the product should look like or what features it should include, assuming everything else will fall into place. While this approach may feel intuitive, it often leads to rework because it skips the most important step: defining what the product actually needs to do.
A systems engineering approach starts with requirements, not aesthetics. It asks fundamental questions early—what does the user need to accomplish, what functions must the device perform, and what constraints must it operate within? From there, design decisions are made intentionally, ensuring features are tied directly to user needs and functional requirements. The final product may resemble the original vision, but it will almost certainly evolve as new insights and opportunities emerge.
Testing must be considered just as early as design. If testing is not planned alongside requirements, teams often discover too late that they cannot adequately verify performance. From a systems engineering perspective, inputs, outputs, and testing strategies are interconnected. When testing is planned upfront, teams gain clarity on how success will be measured and avoid scrambling to validate designs after decisions have already been locked in.
Ultimately, systems engineering provides a structured way to navigate complexity. It aligns requirements, design, and testing into a cohesive framework that supports better decisions throughout development. For medical device teams, this upfront discipline is not a delay—it’s a catalyst for smoother execution, stronger products, and fewer surprises down the road.
Justin Bushko
President, Concise Engineering
Next Steps
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