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Most medtech timelines don’t break during FDA review. They break in protocol design, long before the first patient enrolls.

That makes protocol design an expensive place to get things wrong. Stanford’s study on FDA impact put the cost of taking a lower-risk 510(k) device from concept to market at about $31 million, and a high-risk PMA device at about $94 million. More than three-quarters of that spend goes to regulatory work. A flawed protocol doesn’t cost you a few weeks. It risks the largest line item in your program.

At MedTech World North America 2026, Ascend Clinical Research sponsored and moderated a panel of clinical, regulatory, quality, and insurance experts on one question: what breaks medtech timelines? The panel kept returning to the same cause, a decision made too early and in isolation. Part 1 starts where the breakage starts.

The panel featured Lian Cunningham (VP of Clinical Affairs, Endogenex), Charles Dunham (Partner, Greenberg Traurig), Mark Swanson (medtech quality and ISO 13485 expert), and Lynn Carney (insurance and risk specialist, Medmarc). Joseph Panetta of Ascend Clinical Research moderated. Ascend runs clinical programs across Australia and the wider APAC region.

Where timelines break

Most timelines slip in protocol design, then show up later during enrollment, amendments, or submission. A protocol can read as airtight and still be impossible to run. By the time that surfaces, you have lost months.

The perfect-patient paradox

Lian Cunningham pointed to a common trap. Teams design around an idealized patient and tightly controlled outcomes, and the protocol reads as rigorous. Then enrollment stalls, because that perfect patient barely exists and sites cannot qualify people against criteria this narrow. Timelines start slipping in the first week.

Endpoint overreach makes it worse. When one study tries to answer safety, efficacy, workflow, reimbursement, and future indications at once, you get a protocol too complex to run. Joseph Panetta summed up the thread:

“The perfect patient paradox, the endpoint overreach, complexity versus simplicity, and then plan for the unplannable.”Joseph Panetta, moderator

Quick takeaway

Protocol complexity kills timelines faster than most CEOs expect. A simple, executable protocol beats an ambitious, overloaded one.

Reimbursement comes before the protocol

Charles Dunham moved the conversation upstream. Before you write a protocol, understand how the device gets paid for. Reimbursement requirements drive your endpoints, your patient population, and the evidence you need to generate. Design the protocol first and add reimbursement thinking later, and you can find the mismatch only after you have collected the data.

Quick takeaway Clinical strategy is business strategy. Build the protocol backward from reimbursement, and bring your investors into that conversation early.

Documentation is part of the protocol

Mark Swanson added the operational backbone. A protocol is only as strong as the systems capturing its data. Regulators expect searchable electronic records, a traceable development history, and risk documentation, and you cannot reconstruct any of it after the fact.

“If it’s not documented, it didn’t happen.”

Mark Swanson, quality & ISO 13485 expert

That same documentation pays off later. It feeds device iteration and can surface new indications.

Quick takeaway

Weak documentation creates regulatory problems. Clinical readiness includes operational readiness at every step.

The bigger lesson

A protocol is the blueprint for everything that follows. Disconnect it from reimbursement, build it on optimistic enrollment math, or run it without real documentation systems, and you start behind. Timelines fail late and out of sight, and you end up explaining to your board why a study has to run again.

Key Questions from Article

Why do medtech clinical timelines slip?

Most timelines slip before FDA review, during protocol design. Narrow patient criteria, too many endpoints, and a protocol built without reimbursement strategy create enrollment and regulatory problems that surface months later.

What is the perfect-patient paradox in clinical trials?

It is when a protocol is designed around an idealized, tightly controlled patient. The study reads as rigorous, but the perfect patient barely exists, so sites struggle to enroll and timelines slip from the first week.

Should reimbursement strategy come before or after protocol design?

Before. Reimbursement requirements shape the endpoints and patient populations a study needs, so leaving payer strategy until later forces costly amendments or repeat studies.

How much does it cost to bring a medical device to market?

Stanford research puts it at about $31 million for a lower-risk 510(k) device from concept to market and about $94 million for a high-risk PMA device, with most of that spend going to regulatory work.

This is Part 1 of the five-part series What Breaks MedTech Timelines?, drawn from Ascend Clinical Research’s panel at MedTech World North America 2026.