Our Expertise
Our Expertise
Our Expertise
We work with digital health founders running their first
FDA-regulated clinical trial.
Specifically: SaMD and medical device companies pursuing 510(k) or De Novo clearance.
We work with digital health founders running their first FDA-regulated clinical trial.
Specifically: SaMD and medical device companies pursuing 510(k) or De Novo clearance.
We work with digital health founders running their first FDA-regulated clinical trial.
Our Works
Our Works
Our Works
Our Success Stories
Discover how we’ve helped businesses and organizations achieve remarkable results.
Specifically: SaMD and medical device companies pursuing 510(k) or De Novo clearance.
Trial Rescue & Restructuring
Well-Funded Startup
From Disaster to FDA Clearance in Under a Year
A digital health startup was 14 months into their clinical trial with
a mid-sized CRO. Enrollment was at 40% of target. Budget had blown past the original plan.
Their investors were losing patience.
We audited the trial in week 1, restructured everything in month 1-2, and got them FDA cleared in 10 months. Next funding round closed two months after clearance.
From Disaster to FDA Clearance in Under a Year
A digital health startup was 14 months into their clinical trial with
a mid-sized CRO. Enrollment was at 40% of target. Budget had blown past the original plan.
Their investors were losing patience.
We audited the trial in week 1, restructured everything in month 1-2, and got them FDA cleared in 10 months. Next funding round closed two months after clearance.
From Disaster to FDA Clearance in Under a Year
A digital health startup was 14 months into their clinical trial with
a mid-sized CRO. Enrollment was at 40% of target. Budget had blown past the original plan.
Their investors were losing patience.
We audited the trial in week 1, restructured everything in month 1-2, and got them FDA cleared in 10 months. Next funding round closed two months after clearance.
Protocol Review + FDA Pre-Sub Prep
Funded, Pre-Trial
They Almost Wasted $1.8M on a Protocol That Would Have Failed FDA Review
A digital health startup was weeks from signing a $1.8M CRO contract.
The protocol looked professional. It had five fatal flaws that would have led to FDA rejection.
We caught them before they started. Fixed the protocol in 8 weeks.
Got FDA's written confirmation. Saved them 12+ months and significant cost.
They Almost Wasted $1.8M on a Protocol That Would Have Failed FDA Review
A digital health startup was weeks from signing a $1.8M CRO contract.
The protocol looked professional. It had five fatal flaws that would have led to FDA rejection.
We caught them before they started. Fixed the protocol in 8 weeks.
Got FDA's written confirmation. Saved them 12+ months and significant cost.
They Almost Wasted $1.8M on a Protocol That Would Have Failed FDA Review
A digital health startup was weeks from signing a $1.8M CRO contract.
The protocol looked professional. It had five fatal flaws that would have led to FDA rejection.
We caught them before they started. Fixed the protocol in 8 weeks.
Got FDA's written confirmation. Saved them 12+ months and significant cost.
FDA Submission Strategy & Management
Post-Trial, Pre-Submission
Their Trial Data Was Good. Their Submission Strategy Was a Mess. We Got Them Cleared in 5 Months.
A digital health company finished their clinical trial with strong data. But they had no idea how to package it for FDA. Their internal team was all engineers—no regulatory experience.We stepped in, prepped the 510(k) submission, anticipated FDA's questions, and got them cleared in 5 months with minimal back-and-forth.
Their Trial Data Was Good. Their Submission Strategy Was a Mess. We Got Them Cleared in 5 Months.
A digital health company finished their clinical trial with strong data. But they had no idea how to package it for FDA. Their internal team was all engineers—no regulatory experience.We stepped in, prepped the 510(k) submission, anticipated FDA's questions, and got them cleared in 5 months with minimal back-and-forth.
Their Trial Data Was Good. Their Submission Strategy Was a Mess. We Got Them Cleared in 5 Months.
A digital health company finished their clinical trial with strong data. But they had no idea how to package it for FDA. Their internal team was all engineers—no regulatory experience.We stepped in, prepped the 510(k) submission, anticipated FDA's questions, and got them cleared in 5 months with minimal back-and-forth.
Reserve Your Strategy Session
We’ll pinpoint opportunities to accelerate execution, improve efficiency, and ensure your study stays on track.
Let’s Accelerate Your Study
Reserve Your Strategy Session
We’ll pinpoint opportunities to accelerate execution, improve efficiency, and ensure your study stays on track.
Let’s Accelerate Your Study
Reserve Your Strategy Session
We’ll pinpoint opportunities to accelerate execution, improve efficiency, and ensure your study stays on track.
Let’s Accelerate Your Study