IVD, diagnostics, MedTech: FDA pathway, study design, EDC build, data through submission
I build the clinical evidence behind IVD and MedTech submissions. Most delays come from study design and data problems that were fixable six months earlier.
PhD immunologist, seven years running clinical studies for in vitro diagnostics and point-of-care devices. EUA, De Novo and 510(k) submissions. I design the studies, build and validate the EDC, manage the data through submission, and build the automation and QC tooling that runs alongside it. I've also run a CLIA lab, so I know what a protocol does to the people executing it.
Worth booking me for: which FDA pathway fits your device, how large your clinical study needs to be and what it will cost, specimen and site strategy, whether a CRO or lab proposal you've been handed is reasonable, and how to set up data capture so review doesn't stall on a data problem.
I work in IVD and point-of-care diagnostics. I don't work on therapeutics, companion diagnostics, or EU pathways.
Book me to discuss the right path!
Introductory call to scope potential collaborations
Ninety minutes on the decisions that set your study up: which FDA pathway fits your device, how large the study needs to be and what it will cost, and specimen and site strategy. Send your intended use and where you are in development beforehand and we'll work from that. You'll leave with a pathway recommendation, a sizing range, and the things that need deciding before the protocol is written.
Written review of a document you're about to commit to: a study protocol, a statistical analysis plan, a CRO or lab proposal, or a data management plan. You get a marked-up document and a written summary of what will cause problems later, what's missing, and what to renegotiate. Three business days.