Luminary is an integrated MedTech development partner. We connect early feasibility strategy, clinical insight, engineering, regulatory, medical affairs and executive marketing — so a device is engineered around the patient, the clinician, the pathway, the evidence and the market at the same time, not in sequence.
Where clinical insight, engineering expertise and industry experience drive innovation. From an idea or prototype through development, validation, clearance, launch and commercialization.
Ideas into commercialization
The model
Most device programs ask these one after another, each by a different team, each after the last one has locked its decisions. That sequence is where redesign, regulatory delay and poor adoption come from. We ask all six from the first week.
Early feasibility & development
Is the idea fruitful, and how do we actualize it?
Intended use, clinical use case, technical and clinical feasibility, early evidence and reimbursement considerations, development roadmap.
Engineering
Can we build it?
Concept development, prototype refinement, design strategy, requirements, V&V strategy, usability and technical testing.
Regulatory
Can we clear it?
Pathway assessment, FDA strategy, 510(k), De Novo, IDE, pre-submissions, documentation and interaction strategy.
Clinical
Can we demonstrate that it works?
Clinical strategy, protocol development, feasibility and pivotal studies, endpoints, operations and data interpretation.
Medical affairs
Will clinicians understand, trust and support it?
KOL development, advisory boards, clinician feedback, clinical education and evidence communication.
Marketing & commercial
How do we position it, launch it — and will someone actually buy and use it?
Market assessment, positioning, segmentation, go-to-market, launch planning, adoption and commercialization.
Engineering a device is not the same as engineering a product. The product has to work for the patient, the clinician, the reviewer, the payer and the buyer — and those answers have to agree with each other.
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
Medical device companies run in functional silos. Each discipline may be excellent on its own, but late integration creates avoidable risk, cost and rework. Engineering develops technology independently of clinical workflow. Regulatory strategy is introduced after the design is frozen. Clinical and medical affairs are engaged once the major product decisions are already made. Marketing arrives last of all. The result is redesign, regulatory delay, misaligned evidence, difficult adoption — and products that do not quite answer the clinical need they were built for.
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 firms staff one side of that table. We were built from both, and we put both on your program from the first week — including before formal development begins, when the decisions are cheapest to change.
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.
Practice areas
Fill a single capability gap or hand us the whole program. Either way you get senior people doing the work rather than selling it, one document trail, and one person accountable for the date you are trying to hit.
Engage before formal development begins. Idea and prototype assessment, intended-use and clinical-use-case definition, technical and clinical feasibility, early regulatory, evidence, market and reimbursement considerations, risk identification, KOL and user feedback, and the roadmap that turns a concept into a structured development program. We would rather tell you the concept needs reshaping than bill you for eighteen months of building the wrong one.
Concept development, prototype refinement and design strategy through design freeze, with design controls and risk management built in from the first drawing rather than reconstructed before filing. Product requirements, design verification and validation strategy, usability, technical testing and engineering advisory — including the human factors work that accounts for the largest share of first-cycle deficiencies.
Classification and pathway assessment before anything is built, then the submission itself. We draft and assemble the package, build the substantial equivalence argument, run the Q-Submission, and manage correspondence with the review division through to decision — including the response when an Additional Information request lands. Then the same file, adapted, for markets outside the US.
Clinical strategy and protocol development by people who have run the procedures and published the trials. Feasibility and pivotal studies, endpoint development, clinical operations strategy, execution and data interpretation — plus site and investigator selection from inside the networks that actually enroll.
The discipline that decides whether clinicians understand, trust and support your device. KOL development, clinical advisory boards, structured clinician feedback, medical strategy, clinical education and evidence communication — and the integration of real-world clinical practice back into product development while it can still change the design.
Executive-level marketing capability without hiring a marketing executive. Market assessment, product and brand positioning, value proposition and messaging, customer and clinician segmentation, competitive analysis, go-to-market and launch planning, adoption strategy and commercialization support — brought in early enough to shape the product rather than describe it.
Build a quality system from zero, or find out what is wrong with the one you have before an auditor does. Our gap analyses map each finding to the clause it fails, the risk it carries and the work it takes to close — then we do the closing. Cybersecurity, advanced engineering and specialized R&D testing are brought in where the program calls for them.
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
Startup executive leadership across nine device categories — spinal implants, orthopedics, cardiovascular, biologics, vascular access, capital equipment and AI software. A significant number of FDA clearances to her name, and deep experience leading and developing medical AI solutions from concept through clearance, launch and revenue.
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Co-founder & Chief Medical and Strategy 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 across multiple MedTech startups, holding R&D, quality and regulatory under one roof. A named inventor on 40 issued US patents, a significant number of FDA clearances, and three separate startups taken through ISO 13485 and MDSAP certification.
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.
Without that, a company sources a VP of Regulatory, a VP of Clinical, a Chief Medical Officer, a VP of Medical Affairs, engineering consultants, executive marketing leadership, clinical research resources and a KOL network — separately, and hopes they agree with each other. We provide coordinated access to all of it through one organization.
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.
Who we work with
Our clients range from an innovator with an idea that needs a feasibility read, to an established manufacturer that needs one senior capability it does not want to hire for.
Idea- and prototype-stage innovators
“We have an idea or a prototype — what now?” Early feasibility assessment, development strategy, expert input, and a clear roadmap from concept into full development.
Early-stage MedTech startups
Experienced development leadership and an integrated roadmap, without the cost of building a full internal executive and functional team.
Funded growth-stage companies
Specialized clinical, regulatory, engineering, evidence, medical affairs or commercialization support to reach the next development or commercial milestone.
Established manufacturers
Targeted expertise for new technologies, new indications, a different regulatory pathway, a validation program or market expansion.
Investors, private equity and strategic partners
Technical, clinical, regulatory and commercialization diligence to evaluate opportunities, de-risk an investment or strengthen a portfolio company.
Pre-market and commercialization-stage companies
Moving from clinical evidence and FDA strategy into launch readiness, positioning, adoption, clinical integration and commercialization.
Engagement
Companies arrive with different funding, internal capability and timelines, so we do not run a single consulting model. We will tell you which structure is cheaper for your situation before you sign anything — including when the answer is that you do not need us yet.
Ongoing strategic, clinical, regulatory, engineering, medical affairs or commercial support. Continuity, and fast access to the team as needs change.
A defined scope with agreed deliverables, milestones and fees — a feasibility assessment, a development roadmap, a submission, a protocol, a launch plan.
Targeted support, document review, meetings, troubleshooting or specialized expertise where a broader engagement is not warranted.
Senior MedTech leadership — clinical, medical affairs, regulatory, development or marketing — without the fixed cost of a full-time executive hire.
Built around an outcome rather than hours: feasibility to development-ready, clinical and regulatory strategy through FDA submission, or evidence through market launch.
Combinations of retainer, project fees, milestone work and hourly support, restructured as the program moves through its stages.
Contact
A founder reads every inquiry. Tell us where the program is and what is in front of you — an idea that needs a feasibility read, a design that needs a quality system, a submission on hold, or a cleared device that needs a launch. We will tell you on the first call whether we are the right team.