Building a regulated health or life sciences product means navigating a maze of scientific validation, regulatory requirements, and development decisions, often simultaneously and often without a clear roadmap.
The wrong call on biomarker strategy, regulatory pathway, or clinical trial design can cost you twelve months and materially change your fundraising position. These decisions compound early.
We have developed AI-driven biomarkers that achieved CE marking, achieved FDA clearance for an imaging platform, advised on clinical trial design across immunology and fibrosis, and helped companies translate complex science into product strategies that made sense commercially and clinically. We bring that experience directly to your team.
Crafting the scientific narrative that underpins your product, aligning clinical evidence with commercial objectives.
Mapping the route to CE marking, FDA clearance, or other regulatory approvals, including pre-submission strategy and documentation.
Developing and validating biomarker strategies for clinical development, companion diagnostics, and precision medicine applications.
Advising on trial design, endpoint selection, patient enrichment strategies, and KOL engagement.
Advising on the integration of artificial intelligence and machine learning across product development, clinical workflows, and business operations. This includes clinical AI validation for regulated environments, AI-driven diagnostic and biomarker strategy, and the design and implementation of agentic AI workflows that help companies automate and accelerate key processes in their products and operations.
Creating structured development plans with clear milestones, risk registers, and go/no-go decision frameworks.
Artificial intelligence is reshaping how products are built, validated, and brought to market across healthtech, medtech, and diagnostics. We have direct experience on the front line of that shift, having developed and launched eight CE-marked AI-driven biomarkers for oncology and achieved FDA clearance for an AI imaging platform. We hold a US patent for AI-driven biomarker detection.
Beyond clinical AI products, we help companies design and implement agentic AI workflows: systems where AI agents autonomously execute tasks, coordinate processes, and accelerate decision-making across product development, clinical trial execution, drug development pipelines, and business operations.
Whether you are building an AI-driven product, integrating AI into an existing platform, or exploring how agentic systems could transform your internal workflows, we bring both the technical credibility and the commercial judgement to help you do it well.
We work on scientific and product strategy engagements as defined projects or as retained advisors embedded in your team over a period of months. For companies with an active product pipeline, the fractional executive model, fractional CSO or CMO, is often the most effective structure.