Market Entry

Project conducted by: Randy

Client: A digital pathology startup

Objective: Provide an SaMD client (AI biomarker prediction → precision therapy) a clear reimbursement strategy and detailed implementation plan.

Randy evaluated critical decision points that can lead to a delay to market, as related to FDA (pre-)submission, CLIA lab buy-borrow-build, pursuance of ADLT status, and AMA CPT coding. 

Other Deliverables:

• In-depth HCP (oncologist/pathologist/Lab Director/COO) interviews 

• Advised on CLIA/no-CLIA reimbursement strategy after engaging the key government regulator

• Financial modelling for purchase incentivization of hospital central labs

Outcome: Client pursued the recommendations to (1) raise additional VC funds, (2) build a 2-year go-to-market plan, (3) tailor their sales strategy, and (4) pursue a hospital billing pathway.