Turn Your Medical Device Idea Into a Viable Product With a Clear Path to Market – Fast
Get Expert Clarity and Risk-Reducing Insights - All In One Free Consultation.
In this one-hour consultation, one of our expert engineers will explore your project concept, constraints, deadlines, and technical goals. You’ll leave with expert feedback, actionable next steps, and a clear understanding of how to move forward – even if that’s not with us.
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13+ Years. Dozens of Devices Developed. One Expert Team at Your Fingertips.
We Don’t Just Build Medical Devices – We Engineer Life-Saving Solutions.
At Root3 Labs, we specialize in translating complex requirements into functional, testable, FDA-compliant, and manufacturable solutions. Our engineering-driven process ensures every device meets rigorous technical standards while delivering under your tight deadline.
From early feasibility and prototyping to design verification, documentation, and regulatory readiness, we support you across the full Product Development lifecycle.
Start With a Technical Deep Dive – No Strings Attached.
Who We Work With
Funded Startups with Vision
You’ve got a small-but-mighty team, customer engagement, funding, and a clear vision – but limited in-house engineering.
Small to Mid-Sized Device Manufacturers
Your internal team could be stretched thin, or a product might be stuck – whatever the challenge, we’ll jump right in to help accelerate your project progress.
Federal Agencies & Research Teams
You’re part of a scientific agency or lab supporting Defense work, looking for outside help to translate basic research into rugged, field-testable prototypes.
Case Studies: Medical Device Projects
Wellness Product Engineering
The Ammortal Chamber is an immersive experience that guides the user through physical, mental, and spiritual rejuvenation. It blends sound, light, vibration, an electrical field, meditation, molecular hydrogen, and breath work.
Coaptive Ultrasound Gastrostomy
We were able to support this project to develop a novel method of CUG that could be performed bedside from the earliest concept phase all the way through to manufacturing and regulatory approval.
Smart Pacifier
We worked with Brainchild Technologies, LLC, to develop a smart pacifier that uses embedded sensors to monitor the suckling behavior of newborn babies. The pacifier communicates intensity and frequency data to a fellow Bluetooth enabled device in real-time.
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