Luminary Medical Technologies takes medical devices from early feasibility through commercial strategy — and everything in between. Clinical, regulatory, R&D, medical and clinical affairs under one roof, staffed by practicing clinicians and career industry operators who have done it across orthopedics, spine, trauma, critical care and GI.
AI-enabled devices and software as a medical device through Class III implantables. Global from the start: FDA, EU MDR, ISO 13485 and MDSAP.
Ideas into commercialization
Capabilities
Most consultancies are deep in one modality and one market. Our team's careers span five therapeutic areas, the full device-class range, and the three regulatory systems that matter — which is why we can start on a device we have not seen before.
Approach
Device programs fail at the seams between functions. Feasibility picks a concept the evidence cannot support. Engineering writes a test plan that does not map to a claim. Regulatory writes an indication no clinician would act on. Clinical designs an endpoint that cannot be measured in a real procedure room. Commercial arrives after every one of those decisions is locked. Luminary exists because those seams are where the money and the months go.
How the device actually behaves in the operating room, on a full list, in the hands of someone who did not design it. Which endpoint a reviewer will believe. Which investigators enroll and which ones stall. Why a workflow claim survives contact with a hospital and a usability claim does not.
How to take a concept through design controls to a frozen, manufacturable design. How to build a quality system an auditor will pass, in Rockville or in Brussels. How to pick a predicate that holds. What a review division asks for in a first cycle, and how to answer it inside 180 days.
Most consultancies hire one side of that table. We were built from both, and we put both on your file from day one.
The device that fails is almost never the device that did not work. It is the one that never closed the gap between the bench and the bedside.
Caitlyn Seidl Co-founder and CEO, medical device translational scientist. Twenty years taking implants, instruments, capital equipment and software from first feasibility to clinical use — across orthopedics, spine, trauma, critical care and GI.
Services
Engage a single practice or hand us the whole program. Either way you get one team, one document trail, and one person accountable for the date you are trying to hit.
The decisions that cost nothing now and everything later. Intended use and indications wording, classification and pathway, predicate and competitive landscape, early feasibility study design, and an honest read on whether the claim you want is the claim your evidence can carry. We would rather tell you the concept needs reshaping than bill you for eighteen months of building the wrong one.
Requirements definition, concept development and design engineering through design freeze, with design controls and risk management built in from the first drawing rather than reconstructed before filing. The verification and validation strategy connects every claim on your label to evidence that will hold — including the human factors work that accounts for the largest share of first-cycle deficiencies.
Build a quality system from zero, or find out what is wrong with the one you have before an auditor does. Our gap analyses are written to be actionable — each finding mapped to the clause it fails, the risk it carries and the work it takes to close. Then we do the closing: procedures people will actually follow, document control that survives scale, supplier controls and CAPA.
Protocol and endpoint design by people who have run the procedures and published the trials. IDE and early feasibility strategy, site and investigator selection from inside the networks that actually enroll, monitoring, biostatistics, and the clinical sections of the submission written to the standard a reviewer expects. Clinical evaluation reports and post-market surveillance for EU MDR.
We write the submission, not a memo about writing one. eSTAR assembly, the substantial equivalence argument, test summaries, Q-Submission strategy, and correspondence with the review division managed through to decision — including the response when an Additional Information request lands. Then the same file, adapted, for the markets outside the US.
The part most device companies bolt on too late. Scientific narrative, publication and congress planning, advisory boards, KOL mapping and engagement, and field medical materials that hold up when a clinician pushes back on your data. Then the commercial layer: adoption pathway, payer evidence, launch sequencing and the guideline placement that decides whether a cleared device becomes standard of care.
Leadership
Three principals set the direction and carry accountability for your program — and each of them still does the work: reading your protocol, arguing about your predicate, sitting on the call with the review division. Behind them stands a considerably larger bench, brought in by name when your program calls for it.
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Co-founder & CEO · Medical Device Translational Scientist
Twenty years moving devices out of the lab and into clinical use, across nine device categories — spinal implants, orthopedics, cardiovascular, biologics, vascular access, capital equipment and AI software. Named submitter on four FDA clearances of a Class II AI/ML device, and a contributor to submissions across spine, orthopedics, cardiovascular and vascular access portfolios.
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Co-founder & Chief Science Officer
Dr. Shaukat is an endowed professor at NYU Grossman School of Medicine and Director of Outcomes Research at NYU Langone. Lead author of a national clinical guideline and principal investigator of the multicenter randomized registration trial that carried an AI-enabled device to published pivotal evidence.
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Chief of Engineering & Product Development
Two decades of device engineering, most recently as VP of R&D, Quality and Regulatory at Evolution Spine. Named submitter on multiple FDA clearances and a named inventor on issued US implant patents. Engineering and innovation leadership at K2M and Stryker before that.
Every profile carries the full career record, the cleared submissions, the publications and a link to their professional page. Specialists from the wider bench are introduced by name once we know what your program needs.
The wider bench
Luminary maintains a deep bench of extraordinarily talented individuals across every area we practice in — surgeons and treating physicians, design and test engineers, biostatisticians, notified body and audit specialists, reimbursement and market access advisors, and former agency reviewers.
So when your program needs a particular voice — a spine surgeon who will tell you the instrument handle is wrong, a biostatistician who will defend your endpoint, someone who has sat on the other side of a notified body audit — we bring the person who has already solved that problem, at the point in the timeline where it still changes the outcome. You get the specialist for the question in front of you, not a generalist reading around it.
Questions
The answers we give most often, before anyone gets on a call.
Contact
A founder reads every inquiry. The questions below are the ones we would ask in the first ten minutes anyway — answering them here means the first call starts at the real problem. If there is a live submission or a deficiency letter on the table, say so; those move to the front.