News & Insights

Over the course of this five-part series from MedTech World North America 2026, one message surfaced repeatedly from our panelists: Most clinical delays are not caused by one catastrophic mistake. They are caused by a series of disconnected decisions:

• protocols designed in isolation

• regulatory pathways considered too late

• unrealistic enrollment assumptions

• weak operational systems

• execution plans built around optimism instead of predictability

MedTech World brought together our panel to provide lived experience from leaders across clinical affairs, regulatory law, insurance, and quality systems to discuss the operational realities of medical device development; what they have seen work and (importantly) where they have seen failure.

Our speakers included:

• Lian Cunningham, VP of Clinical Affairs at Endogenex

• Charles Dunham, Partner at Greenberg Traurig

• Mark Swanson, medtech quality and ISO expert

• Lynn Carney, insurance and risk specialist for medtech manufacturers

• moderated by Joseph Panetta, Fractional Chief Marketing Officer at Ascend Clinical Research

By the end of the discussion, the panel arrived at one final debate: What matters more for startups: speed or predictability?

Almost every panelist chose: Predictability.

Why Predictability Wins

For early-stage medtech companies, speed feels critical. And in many ways, it is.

But experienced operators understand something many first-time CEOs do not: fast timelines are meaningless if they produce:

• unusable data

• protocol amendments

• delayed submissions

• operational dead ends

Predictability protects:

• investor confidence

• cash runway

• operational planning

• regulatory momentum

Joseph Panetta summarized during the discussion:

“Speed can make them hit a brick wall. Predictability can help them see it in advance and go around it.”

Quick takeaway

Fast is only valuable if it is repeatable and defensible. Predictable execution compounds over time.

The “Day Zero” Decision

The panel closed with one final question: If you could advise a first-time MedTech CEO before their first trial, what is the one decision they need to get right on Day 0 to avoid losing a year?

The answers varied slightly by discipline, but all pointed toward the same conclusion: Plan earlier. Think holistically. Connect systems sooner.

Mark Swanson emphasized the importance of writing things down, building plans early, and integrating quality, regulatory, and operational systems from the beginning.

Lynn Carney pointed to operational realities like insurance planning and budgeting - issues many founders underestimate until they become startup blockers.

Charles Dunham emphasized aligning reimbursement, regulatory, and IP strategy from the outset rather than treating them as separate workstreams later in development.

And throughout the session, Lian Cunningham repeatedly reinforced the importance of operational realism:

• executable protocols

• realistic enrollment assumptions

• understanding the difference between theoretical timelines and actual site performance.

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Quick takeaway

Clinical timelines rarely break because companies move too slowly. They break because companies move without alignment.

The Bigger Lesson From this Series

Across all five discussions, several themes consistently emerged:

• Protocols must be designed for execution - not perfection.

• Regulatory strategy must begin before the first study.

• Enrollment success depends on operational reality, not optimism.

• Quality systems are operational infrastructure, not paperwork.

• Clinical, regulatory, reimbursement, quality, and execution are interconnected systems.

The companies that stay on timeline are rarely the companies with the biggest claims or the most aggressive projections. They are usually the companies that:

• plan holistically

• build operationally

• choose partners who understand how all the pieces fit together.

Final Thought

Toward the end of the panel, Panetta offered perhaps the clearest summary of the entire discussion:

“It is not about a single study. It’s about what do you ultimately want to achieve and reverse engineer all of the elements to get you there.”

That may ultimately be the real lesson behind what breaks medtech timelines.

Not speed. Not regulation. Not enrollment alone.

But whether a company understands and defines - early enough - that successful clinical development is not built study-by-study but by a cross-disciplinary program built to be flexible.