AI for medical device teams that work under regulatory rules.
Patient outreach, reporting, and workflows across disconnected systems, with copy written to your regulatory rules and a person approving everything before it reaches a patient.
We connect what already exists and make it think.
Your company already produces the signal: commercial conversations, quality records, regulatory correspondence, R&D decisions. It lives in separate systems that do not talk to each other. We build the intelligence layer that connects them, custom, for your company, inside a regulated industry.
What we are not: Not a CRM. Not a dashboard. Not a marketing agency. Not a body shop. We do not sell more of anything. We connect what you already have.
What the operating system does
- More intelligence, not more people. The system compounds what your team already knows. Headcount stays small. Judgment gets sharper.
- Know what to build and when to build it. Commercial signal, quality data, and regulatory reality read together, so the roadmap is a decision, not a debate.
- Collapse the time to milestone. Clearance, first cases, first revenue: the milestones that decide your company arrive sooner when nothing waits in a silo.
- Replace the expectation gap with shared truth. Founders, boards, and teams work from the same picture of where the company actually is.
Built for a regulated industry from the first line of code.
Compliance is the design constraint, not a late review. The system is built to work inside your quality and regulatory reality, not around it.
- A person reviews every regulated decision. Claims, submissions, and communications stay with your team.
- HIPAA-aligned handling for anything patient-adjacent.
- Visible logic and logged decisions, so what the system did and why is always answerable.
We are documenting this build. Three partner spots. One is filled.
We are building this operating system with a small set of medical device companies and documenting the work as a public case-study series. The first spot is taken: an early-stage company with FDA-cleared robotic-assisted technology. Two spots remain.
- Early-stage, FDA-cleared (Filled): Robotic-assisted technology moving from clearance toward commercial scale. Build underway.
- Pre-commercial, raising capital (Open): You need milestones, evidence, and a credible path to market before the next round. The operating system becomes part of the story you raise on.
- Global Traction. U.S. Market Entry. (Open): You've proven the opportunity abroad. We help you build a lean U.S. operation where commercial, quality, and regulatory move together from day one.
Case-study partners get the build documented, the system installed, and a seat at the table while the playbook is written.
How the engagement runs
- Assess: Map your commercial, quality, regulatory, and R&D systems. Pick the first job, the data boundaries, and the measure that proves it.
- Pilot: Build the first connection in production conditions, with review gates and logging from day one.
- Ship: Deploy into the systems your team already uses, with named ownership and a weekly review rhythm.
- Enable: Your team runs it. The next connections sequence from evidence, and the system compounds.
Tell us the workflow you want to improve.
We will tell you if AI is the right fit and what a first pilot could look like under your regulatory rules.