Your Vision,
Our Expertise.

Concept | Clearance | Commercial Traction
No hand-waving, just hands-on. The one-stop medtech partner built on strategy and efficiency.

One partner, hands-on from feasibility to execution.

Product Development

Design, Prototyping, Engineering

Testing & Validation

Comprehensive in-house testing

Contract Manufacturing

ISO 13485 Certified Production

Regulatory Support

Guidance & Compliance Expertise

Trusted by 
innovators worldwide

"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

"Ontogen seamlessly integrated design and manufacturing solutions for our business that were otherwise impossible. Their team quickly brought structure to our commercialization process, aligned all stakeholders, and was critical to turning what had been a stalled project into a smooth, coordinated effort. Clear communication, actionable deliverables, and consistently high quality effort kept everything moving on schedule."

Hank Stiehl, CEO

Stiehl Tech

"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 of 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

Transforming challenges into electro-mechanical devices.

Transforming challenges into reusable devices.

Transforming challenges into surgical devices.

Transforming challenges into single-use devices.

Transforming challenges into diagnostic devices.

See More Case Studies

The numbers that define our clients' success

$16.6 M+

Grant Dollars

awarded to clients

132+

Patents

granted to our clients

$2.2 M+

Prizes

awarded in pitch competitions

1000's

Devices

Shipped and utilized nationwide.

Take the next step to success

Medical device development can be daunting-- we are here to help.

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