Your Vision,
Our Expertise.
From Concept to Clearance
Strategic Medical Device Development for Clients of All Sizes
Our Services
For Entrepreneurs
Have a great idea but not sure where to begin? We can help develop and execute the plan to bring your medical device idea from the earliest stages to launch.
For
Startups
Need to ramp up design, development, and product testing fast? We are seasoned startup professionals comfortable navigating innovative technology within aggressive timelines.
For Established Companies
We integrate seamlessly with your team for additional design, development, documentation or remediation support and can scale according to your needs.
A prototype is just the beginning…
Ontogen Medtech is your trusted partner to go beyond where other firms stop short. We provide holistic, end-to-end product development and realization services, all under one roof.
What Our Clients Are Saying…
“When an employee left, the Ontogen team stepped in and helped wrap up our verification bench testing and supported our clinical validation testing. They've been invaluable to keeping our project moving quickly toward FDA clearance.”
– Alyssa Bailey, Director R&D
Innoblative
“Ontogen has led our product development activities every step of the way, from concept through to 510(k) clearance and commercial launch. They are a core part of our team and we couldn't do it without them.”
– Casey Qadir, CEO
Hubly Surgical
“Ontogen goes above and beyond product design and development and are a pleasure to work with! Their team helped us secure our initial SBIR grant, which funded our first prototype and led to a major strategic investment in our company. Tyler and his team have been instrumental to our entire R&D journey.”
– Jennifer Fried, CEO
Flow Medical
Strategic insights for best-in-class product development.
Our team boasts extensive expertise in device design and development, spanning an unrivaled breadth of device types and healthcare sectors.
Class III Implants
Cardiovascular
Minimally Invasive Catheters
Neurosurgery
In-Vitro Diagnostics
Women’s Health
Drug Preparation & Infusion
Airway Management
Sensor-driven “Smart” Devices
Pediatrics & Neonatal Tech
& more!