Leadership, in full.

Profile

Caitlyn is a medical device translational scientist. Her career has been spent on the specific problem of moving a device out of the lab and into routine clinical use — the stretch where most good technology dies — and she has done it across an unusually wide span of device types.

Spinal implants at K2M. Orthopedics at Exactech. Cardiovascular and critical care at Edwards Lifesciences. Nerve-repair biologics at Axogen. Vascular access and dialysis at Medical Components. Capital equipment at Motus GI. AI software at Iterative Health. Medtronic and Stryker along the way. Implants, capital equipment, disposables, biologics and software — most regulatory careers cover one of those categories, not five.

That span is the reason Luminary can work on a device it has not seen before. The clinical and regulatory mechanics rhyme across modalities; what changes is the evidence a reviewer will accept, and knowing that difference is the job.

At Iterative Health she was the named submitter on four FDA clearances of the SKOUT system — a Class II AI/ML device under product code QNP, currently the most scrutinized category in front of CDRH. Her role there moved from functional VP to General Manager with commercial ownership of the product, which means she has carried a cleared device through launch and revenue, not just through review.

At K2M she was recruited to direct global clinical outcomes research programs and the global regulatory process for the company's entire product portfolio. It is also where she first worked alongside Todd Wallenstein. Luminary Medical Technologies, which she co-founded in January 2026, is what that bench looks like pointed at other people's devices.

Profile

Dr. Shaukat is the person who tells you whether your evidence will survive contact with a reviewer, a guideline committee and a skeptical clinician — because she has sat on all three sides.

She holds the Robert M. and Mary H. Glickman Professorship of Medicine at NYU Grossman School of Medicine and is Professor of Population Health, Director of Outcomes Research in the Division of Gastroenterology and Hepatology at NYU Langone Health, and co-director of Translational Research Education and Careers at the NYU Clinical and Translational Science Institute. She came to NYU from the University of Minnesota Medical School, where she was Professor of Medicine and Public Health and Section Chief of Gastroenterology at the Minneapolis VA.

For device companies the relevant credential is this: she was principal investigator of the prospective, multicenter randomized registration trial of an AI-enabled detection device, run across five US sites and published in Gastroenterology. Twenty-two board-certified physicians, 1,359 randomized patients, and a primary endpoint chosen to be defensible to a review division rather than merely favorable. That is the template for how a software device earns a clinical claim instead of asserting one.

She also lead-authored a full revision of a national clinical screening guideline. Guidelines are where devices are adopted or quietly ignored, and the evidence bar a guideline committee applies is usually higher than the one that won clearance. If your commercial case depends on guideline placement, she knows what that committee will ask for.

Profile

Todd is the reason Luminary can start before there is anything to submit. He has spent twenty years designing devices, not just documenting them, and he has held R&D, quality and regulatory under one roof — which is unusual, and which is exactly the combination that stops a design decision in month three from becoming a deficiency letter in month thirty.

At Evolution Spine he was VP of R&D, Quality and Regulatory and is the named submitter on FDA clearances including the E3D-A and E3D-C interbody systems, cleared three months apart in 2024. Two clearances inside one product family in one year is what a well-built design history file and a reusable test strategy buy you: the second submission leans on the first rather than starting over.

Those are additively manufactured implants, which raise every hard question a reviewer can ask — material and process validation, porosity and surface characterization, mechanical testing to ASTM standards, and a predicate comparison that has to hold across a manufacturing method the predicate did not use. If your device is made by a process your predicate did not use, this is the specific problem he has already solved.

Before Evolution Spine he was in engineering and innovation leadership at K2M and, after the 2018 Stryker acquisition, at Stryker — progressing from project engineering through senior engineering management. He is a named inventor on issued US patents for spinal implant design, which matters more than it sounds: device IP and regulatory strategy are the same conversation held twice, and both depend on how the design was documented at the time it was made.