Client Profile:
An early-stage AI health startup developing a deep learning algorithm for automated optic nerve assessment in primary care and low-resource settings.

Challenge:
The company needed to demonstrate clinical validity and model transparency for a novel Software as a Medical Device (SaMD), but faced significant constraints in data access, regulatory familiarity, and timeline.

Our Approach:
We led the full clinical strategy lifecycle—from shaping inclusion criteria and defining sensitivity/specificity targets to preparing a modular Clinical Evaluation Plan aligned with FDA expectations. Our team also authored a model explainability and risk mitigation report tailored to AI/ML-specific guidance (e.g., IMDRF, FDA SaMD Action Plan).

Impact:
We reduced expected regulatory preparation time by over 6 months and positioned the client for a successful Pre-Sub meeting with the FDA. Their AI screener is now undergoing pivotal validation with alignment on post-market performance monitoring.

Client Profile:
A digital therapeutics company launching a CE-marked wearable for sleep and circadian rhythm disorders, aiming to enter EU markets with payer-backed support.

Challenge:
The client faced tight timelines for EU MDR technical documentation submission and lacked a comprehensive reimbursement and health economics strategy.

Our Approach:
We provided end-to-end EU MDR readiness support: preparing the Clinical Evaluation Report (CER), technical file guidance, and risk-benefit justification tailored to real-world evidence sources. Simultaneously, our market access team conducted a rapid landscape review across 6 EU countries to identify digital reimbursement pathways and clinical coding gaps.

Impact:
The company submitted its EU MDR dossier within 45 days and secured early-stage pilot funding discussions with two national payers based on the value proposition and outcomes framework we developed.