Project Case Studies

Iota Biosciences
Class III implantable neuromodulation

Led bladder wall neurostimulator system from functional prototype through full GLP study and FDA IDE approval in under 2 years.

Openwater
Laser based interrogation of brain hemodynamics and noninvasive ultrasound

Wearable to diagnose blood flow issues from 1st to 2nd human study in 1 year w/improved miniaturization, usability, and performance.

Equalize Health
Neonatal Respiratory (CPAP)

Led the neonatal CPAP from early need finding through commercial licensing with Dräger. Served as RA owning FDA presubmission and Usability role owning the formative study.

Stryker Endoscopy
Surgical instrumentation

Drove a novel ergonomic laparoscopic instrument from initial concept through 510(k) clearance and commercial launch, executing regulatory and DHF strategies and supporting surgeon usability evaluations.

Common Questions

What types of companies do you typically support?

I work with early stage medtech and digital health teams that have strong science or engineering but need senior product and program leadership to reach critical milestones. Most are pre-IDE, pre-510k, or preparing evidence packages for early adoption. They bring me in when they need experience but are not ready for a full time hire.

Can you help us with regulatory strategy even if you are not our regulatory consultant?

Yes - I do not replace your RA consultant, but I can bring in the best and can make their work easier and more effective by ensuring product strategy, intended use, early claims, design inputs, and evidence plans are aligned. This reduces surprises from FDA feedback and prevents "redos" from having to change intended use / indications down the line that comes from misaligned product direction.

Are you open to working full time or coming on board as a W2 Employee?

It depends on the opportunity and the timeline, but I think "try before you buy" is mutually beneficial to make sure it's a long term fit.

What does working with you actually look like day to day?

I create the execution structure your team is missing: clear plans, requirements, risk registers, dependencies, and decision points. I join your standups or leadership syncs, drive cross-functional alignment, and make sure progress is predictable. For longer engagements, I mentor PMs or early product hires so capability remains inside the company after I transition out.

What types of arrangements do you support?

Engagements range from short-term advisory sprints to multi-month fractional roles embedded with the team.