A selection of engagements illustrating our approach to MedTech strategy — from AI commercialization and regulatory navigation to hospital partnerships and market entry.
A Boston-based AI company had developed a deep learning platform for automated polyp detection in capsule endoscopy. Despite strong clinical validation data, the company lacked a coherent commercialization strategy — unclear on target customer segments, reimbursement pathways, and the competitive positioning required to differentiate from incumbent GI diagnostic platforms.
We conducted a comprehensive market assessment covering the US GI diagnostics landscape, competitive analysis of existing capsule endoscopy platforms, and a detailed reimbursement pathway analysis. We developed a tiered commercialization strategy targeting academic GI centers as reference sites, followed by community gastroenterology practices. A health economic model was built to support payer conversations, and a pilot program framework was designed for the first 10 hospital accounts.
A digital health startup had built a clinically validated remote patient monitoring platform for chronic disease management but was operating under a direct-to-consumer model that was generating high churn and unsustainable unit economics. The founding team needed to pivot to a B2B health system model but lacked the commercial architecture to do so.
We redesigned the commercial model from DTC to B2B, developing a health system value proposition centered on readmission reduction and chronic care management reimbursement. A new pricing architecture was built around per-member-per-month contracts with outcome-based components. We identified and prioritized 15 target health system accounts and developed a pilot program framework with defined success metrics and expansion criteria.
A California-based surgical robotics company was preparing for a Series B raise and needed a rigorous, investor-grade market analysis to support its valuation narrative. The company also needed to determine the optimal geographic expansion sequence for its laparoscopic robotic platform — balancing regulatory complexity, market size, and competitive dynamics across three regions.
We developed a comprehensive market analysis covering the global surgical robotics landscape, with deep dives into the US, Indian, and Southeast Asian markets. The analysis included competitive positioning against incumbent platforms, hospital adoption modeling, regulatory pathway comparison across jurisdictions, and a prioritized market entry sequence with investment requirements and expected timelines.
A wound care AI company had developed a smartphone-based platform for automated wound measurement and healing trajectory prediction. With no clear predicate device for FDA clearance, the company faced a De Novo pathway that its internal team had limited experience navigating — creating significant uncertainty around timeline and capital requirements.
We led the regulatory strategy development, including device classification analysis, De Novo request structuring, and clinical evidence planning. A pre-submission meeting strategy was developed to engage FDA early and align on performance criteria. We also developed the clinical study protocol for the pivotal validation study, designed to meet the evidentiary standards for De Novo authorization.
A Singapore-based digital health platform had secured Series B funding and was tasked by its board with establishing anchor hospital partnerships across three Southeast Asian markets within 18 months. The company had strong technology but lacked the institutional relationships, value proposition frameworks, and partnership structures required to engage health systems at scale.
We designed a comprehensive hospital partnership strategy covering stakeholder mapping, value proposition development, and partnership agreement frameworks for Singapore, Malaysia, and Thailand. A tiered engagement model was developed — from pilot agreements to enterprise contracts — with defined success metrics at each stage. We also facilitated introductions to senior clinical and administrative stakeholders at 8 target hospital systems.