TL;DR

• Early design failures come from missing conversations, not engineering ability.
• Early stakeholder input reshapes assumptions more than teams expect.
• Honest assessment of your true development stage prevents expensive rework.
• Regulatory clarity and business model alignment drive better design decisions.
• The risks nobody wants to mention are usually the ones that matter most.

After years of working with founders and technical teams, I have learned that early design missteps rarely come from engineering flaws. More often than not, they come from missing conversations. Not the obvious ones everyone expects, but the ones teams assume they can have later, postpone, or sort out once the business picture feels clearer.

Those overlooked conversations influence design decisions more than any CAD model or concept sketch and typically in many of the programs I have observed, the signals were present early. They simply never made it onto the table at the right moment.

These are the conversations that consistently shape whether a device moves forward smoothly or gets bogged down in avoidable rework.

The conversation about what you think you know

Teams often begin confident that they understand the user, the workflow, or the unmet need. Early conversations with clinicians or technicians almost always reveal gaps.

I once watched a thirty-minute discussion with a frontline nurse overturn months of assumptions about how a device would be handled in practice. That single exchange prevented a major pivot later and helped the team reframe their entire approach.

The real point is not validation. It is discovery. And discovery needs to happen well before a design starts to harden.

The conversation about where you actually are in development

This is the area where teams misjudge themselves most often. Someone believes the device is nearly ready for verification when key risks still lack evidence. Someone else is pushing toward a design freeze before demonstrating feasibility.

I have seen teams move ahead because they want momentum, only to face significant delays months later. The root cause was simple. No one asked the direct question:
“Are we truly ready for the next stage, or are we just tired of the current one?”

Clear staging is not bureaucracy. It is the mechanism that keeps development honest and prevents expensive reversals.

The conversation about the regulatory truth, not the optimistic version

Regulatory strategy is architecture. It defines evidence requirements, testing plans, claim language, and ultimately your timeline to market.

The most difficult situations I have seen came from early assumptions about classification that turned out to be wrong. Months of effort had to be reoriented once the actual pathway came into focus.

This is why regulatory conversations belong at the beginning, not as a final checkpoint before submission.

The conversation about whether the business model and the design agree

Teams often treat business strategy as something parallel to design. In reality, it runs through it. Reimbursement, adoption pathways, clinical economics, and purchasing behavior are not commercial concerns. They are design constraints.

I have watched technically strong devices stall because the business model did not support the design choices already locked in. By the time the misalignment surfaced, reversing it meant time, cost, and frustration that could have been avoided.

A device succeeds when its technical strategy and commercial strategy reinforce each other.

The conversation about the risks no one wants to bring up

Every team has a list of known risks. That is rarely the issue. The real challenges are the unspoken risks, the ones that feel inconvenient, politically sensitive, or outside the technical comfort zone.

Supply chain fragility, human misuse, workflow disruption, or failure modes that are hard to model. These risks do not slow progress when raised early. They slow progress when discovered late.

Healthy development culture makes room for uncomfortable conversations before those risks become embedded in the design.

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