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EXPERTISE

Experience that comes with stories and scars.

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We’ve shipped products the hard way… across labs, launches, and late-night pivots. Now we build smarter: deeply embedded, tech-forward, and faster than ever before.

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DISCOVER

Frame the problem. Understand the users. Align Stakeholders. AI-driven deep research. Clear purpose. No guesswork.

ARCHITECT

Generate actionable requirements. Map Risks. Shape Strategy. Define the System. Design to Scale.

PROTOTYPE

Build fast, test hard. Use AI to iterate without wasted cycles. Rinse. Repeat. Refine.

PROVE IT

Bench it. Stress it. Break it. Put it in the hands of real users. Push on reliability, usability, performance. Make it earn it’s keep.

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VERIFY + VALIDATE

No Surprises - by design. Generate gorgeous data. Clinicals run clean. Investors lean in. Everyone’s watching.

SCALE

Stand up supply chains. Audit Ready. Make handoff a non-event. Launch.

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Your on-demand Swiss-army knife for medical device
co-development.

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Senior engineers and scientists, battle-tested operators, highly vetted partners, and proprietary AI workflows all ready to push your device from napkin sketch to that next big raise.

We plug in where you need us most, close the gaps you didn’t know you had, and leave your team stronger than we found it.

Build.
Iterate.

Rapid CAD, firmware, and cloud pipelines. AI-drafted requirements, risk controls, and DHF entries cut paperwork loops, so you can pour cycles into bench data, not formatting docs. Fail fast, learn faster, ship.

Scale.
Supply.

We stand up right-sized QMS, lock in reliable manufacturers, and prep you for the audits that matter — ISO 13485, 21 CFR 820, IEC 62304. Supply chains, device history, and field support — all built to expand with you.

Tech Stack.
Balance.

Pinpoint high-impact AI plays, upskill your team in a day, and let us spin up custom LLM pipelines — always under senior oversight and built for regulated compliance.

Embed.
Uplevel.

Senior leads drop into your sprints, guide the build, and transfer playbooks on the fly. Your crew learns by doing — no bloated slide decks, no junior consultants. When we roll off, your team keeps climbing.

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Our Philosophy

Our experience is hard-earned through decades of successes and failures. Through these experiences, we've learned three fundamental truths that guide how we share our expertise with you.

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People
First

Tech follows humans, not the reverse. We start with real users, real teams, and real impact. Then build the products to match.

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Proof over
Hype

From AI-drafted risk management to clinical read-outs, we chase clean evidence and relentless transparency. Because guesswork never summits.

AI helps us move fast, but data and experience keeps us honest. Every decision earns its place in the lab and in the DHF.

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Teach
as We Build

We embed, we carry the heady load, walking beside you. Then we transfer playbooks and step back. Your crew climbs higher next time, without needing us on the rope.

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Entrepreneurs and innovators have great stories to share

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Learn about some entrepreneurs and innovators we have partnered with and the impact we have created together.

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