In product development, it is tempting to focus solely on solving the technical problem in front of you. A specification, a block diagram, a functional requirement — these are critical artifacts, but they are not the whole story. In fact, they can be dangerously misleading when stripped of the broader environment in which a product must live and evolve.
Over my career developing regulated medical devices and complex systems, I’ve learned that true engineering excellence does not lie in elegant circuitry or clever code alone. It lies in the relentless pursuit of context — understanding the “why,” not just the “what” or the “how.”
Beyond the Spec: Engineering as Translation
Every engineering engagement is an act of translation. Stakeholders express a need, usually in business terms or end-user language. That need is translated through layers of product management, regulatory requirements, user expectations, and technological limitations. What arrives in an engineer’s inbox may be technically precise but contextually impoverished.
A good engineer meets the spec. A great engineer interrogates it: “Why is this feature prioritized? Who will use it? Under what conditions? What trade-offs were already made upstream? Are there assumptions hidden inside this requirement?”
Context Enables Judgment
The core value an engineer brings to product development is not just implementation — it is judgment. But judgment requires perspective. If you know only your layer of the stack or your subsystem, you risk making decisions that optimize locally but damage the system as a whole.
For example, when designing surgical navigation systems, we encountered situations where interface latency could technically be within tolerance — but if the end user is a neurosurgeon navigating millimeter-scale anatomy, even acceptable lag undermines confidence. The system might pass verification but fail in practice. Context closes the gap between compliance and usability.
Regulation is a Stakeholder Too
In regulated industries, the context includes more than just users and customers. The FDA, for instance, is not merely a checkpoint at the end. It is a stakeholder with expectations, constraints, and its own interpretation of “quality.” Designing with regulatory context in mind early reduces late-stage churn and enables a smoother path to market. In one of my first medical device roles, we had to address an FDA 483 finding tied to undocumented calculations. The code worked, but the context — namely, verifiability and traceability — was absent. We weren’t wrong technically. We were incomplete contextually.
Partnerships Thrive on Context
Product development partners are often handed specs and asked to “execute.” But success requires challenge and inquiry. True collaboration begins when the partner internalizes the customer’s mission and constraints as their own. That’s why at Boston Engineering, we insist on contextual immersion.
We want to know: What market dynamics shaped this roadmap? What does success look like beyond feature completion? What happens to the product after delivery — in manufacturing, in servicing, in the hands of customers?
Design Debt and Contextual Blind Spots
Many forms of design or technical debt stem not from incompetence but from contextual blind spots. A tradeoff made to meet a deadline becomes a liability when misunderstood by the next team. Decisions that make sense in isolation become fragile under new conditions. Understanding the surrounding system helps avoid these pitfalls and build architectures that can gracefully evolve.
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Final Thoughts
Context is not a luxury; it is a prerequisite. The most impactful engineers I’ve worked with are not only technical experts — they are curious, empathetic, and attuned to the full landscape in which their work lives. They seek first to understand, then to design.
Whether you’re developing a life-critical medical device or an internal tool, remember: context is king. Without it, you’re building in the dark.
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For three decades, Boston Engineering has designed, developed, and optimized devices and technologies the medical community relies on to save lives, enrich quality of life, and reduce costs to the healthcare system. We provide solutions to the challenges in the adoption of surgical robotics.
Our expertise includes industrial design and product redesign, sensors and control systems, robotics technical innovation, and digital software solutions.
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