Medical Device Design: From Concept to Production
Fast, Risk-Reduced, Ready for FDA Review
13+ Years of Experience | Trusted by 100+ Product Teams | FDA Compliant
Trusted by innovators at:
Life-Saving Devices Built with Speed, Usability, and Compliance in Mind.
We create life-saving medical device solutions that prioritize patient safety, usability, and manufacturability.
We can help if you’re looking to:
- Reduce development risks and accelerate timelines
- Validate a medical device idea with benchtop prototyping
- Navigate FDA requirements
- Move from concept to DFM without wasting capital
Our proven development process translates complex medical needs into market-ready solutions designed to enhance patient care and improve outcomes.
The Root3 Labs Proven Process
How We Turn Your Idea Into a Real-World Medical Device
Not Sure Where to Start?
Download our Free Product Development Guide to understand how to reduce risk, avoid costly reworks, and prototype a medical device the right way the first time.
See What Our Clients Have to Say!
“We wanted to thank Root3 Labs for their time and expertise on our project. They consistently meet our complex challenges with practical solutions and are always available for conversations. Their communication is exceptional and we look forward to continuing our work with this team.”
-Darryl DuBre, Director of Operations & CTO, MarinsMed
“The team at Root3 Labs found the answers to the many difficult engineering demands we placed on them, enabling us to realize our dream design. We are forever thankful.”
-Brian LaGette, CEO, Ammortal Inc
Explore Our Successful 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.
Schedule Your Free Consult
Ready to Talk?
Schedule a free 1 hour project consult. You’ll talk directly with an expert engineer – no pressure, just expert feedback.
Why Root3 Labs?
- Experts in early-stage medical device prototyping
- Trusted by 100+ medical device teams
- Experienced at navigating FDA regulation
- In-house prototyping workshop
- 13+ years of medical device design experience
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