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By the time a clinical protocol is finalized and regulatory strategy is aligned, many first-time MedTech CEOs assume the hard part is over.

According to our panelists at MedTech World North America 2026, that very assumption is often where timelines begin to unravel.

In Part 3 of What Breaks MedTech Timelines, the discussion shifted toward one of the most persistent operational problems in clinical research: Enrollment.

As a reminder, our expert panel featured:

• Lian Cunningham, VP of Clinical Affairs at Endogenex with more than 20 years leading global device studies

• Lynn Carney, specialist in insurance and operational risk for medtech manufacturers

  
  

And was moderated by Joseph Panetta, Ascend Clinical Research Fractional Chief Marketing Officer.

The message was direct: Sites that say they can enroll are not always the sites that actually deliver.

The Difference Between “Interested” and “Capable”

Moderator Joseph Panetta posed a critical question to Lian Cunningham: What separates sites that say they can enroll from those that actually deliver?

The discussion centered around a reality many startup sponsors discover too late: Enthusiasm does not equal infrastructure.

A respected investigator may genuinely support a study but still lack:

• sufficient patient flow (patient population is foundational)

• coordinator bandwidth (are they overloaded with other trials?)

• operational support (is the overall org set up to support your trial)

• or institutional support to enroll efficiently.

The result is one of the most common patterns in medtech trials: sites opening slowly, enrolling inconsistently, and failing to meet projections.

Panetta reminded the audience: “Enrollment is the number one timeline killer for a clinical trial.” And newish CEOs often overestimate how quickly this process can flow.

Quick takeaway

A well-known site is not automatically a productive site. Enrollment success depends on operational capability, not reputation alone.

“Protocol Ready” Does Not Mean “Trial Ready”

The panel also explored the gap between protocol completion and first patient enrolled (FPI).

Many founders assume this window is short. Experienced operators know otherwise.

When Panetta asked why sponsors consistently underestimate the time between “protocol ready” and “first patient in,” the conversation quickly expanded beyond clinical operations alone.

Insurance requirements, site contracting, startup logistics, and country-specific operational requirements all contribute to delay.

Many of those steps are sequential - meaning the domino effect of one missed requirement that stalls everything behind it.

Quick takeaway

"Protocol complete” is often just the beginning of operational startup. Sites cannot enroll until contracts, insurance, approvals, and logistics are fully aligned.

Insurance: The Timeline Variable Nobody Plans For

One of the more surprising moments in the discussion came from Lynn Carney, who highlighted how insurance itself can become a startup bottleneck. And this is another place where geography can come into play.

Different countries may require:

• local admitted coverage

• country-specific policies

• or additional review periods before approval.

Depending on the geo, those processes can take months.

Carney also shared an example of a sponsor dramatically underestimating insurance costs for a pediatric study involving higher-risk procedures. The unexpected expense forced the company to pause and raise additional capital before proceeding.

For many early-stage companies, insurance is treated as paperwork. Operationally, however, it is often a gating item.

Quick takeaway

Insurance is not administrative. It is part of startup strategy. If overlooked early, it can delay enrollment before the first site is ever activated.

Why CEOs Underestimate Startup Timelines

A recurring theme throughout the panel was that first-time founders tend to think about clinical trials linearly:

• finalize protocol

• activate sites

• enroll patients

Real-world execution is far more interconnected.

Enrollment depends on:

• site infrastructure

• startup sequencing

• geography

• contracting

• competent authority approvals

• logistics

• insurance

• and quality systems all functioning together.

As Panetta summarized during the 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.”

The Bigger Lesson

Enrollment problems rarely begin with patients. They usually begin earlier with:

• site selection

• startup planning

• operational sequencing

• feasibility assessment

The companies that stay on timeline are rarely the ones with the most ambitious projections. They are the ones that understand operational reality before enrollment ever begins.