describe the image

Patton Medical Devices

 

 I-Port Injection Port

 

The I-Port is a low-profile injection port through which insulin can be injected subcutaneously from a standard syringe and needle. The I-Port reduces multiple daily injections and increases user compliance.

Fallbrook Engineering was contacted by Patton Medical Devices in 2004 with their unique injection port concept. Patton Medical needed design and development support to bring their concept to market.

The product requirements were identified and documented to define project goals and objectives and to provide the criteria necessary for developing a safe and efficacious product.

Fallbrook Engineering began by generating several design iterations for review and testing with the goal of selecting the best configuration for high volume manufacturing.

Fallbrook created 3D solid models, prototype components and assemblies for market evaluation, component testing and design optimization. In parallel vendors were sourced, evaluated and selected for the purchased components, molded components and product assembly.

Fallbrook Engineering developed the test protocols and performed all the appropriate tests for submission to the FDA.

We also provided the regulatory support for preparing the 510k submission to the FDA.

The I-Port is now available by prescription in most markets throughout the U.S.

 PattonMD Logo

 www.pattonmd.com 

 

 

© 2012 Fallbrook Engineering, Inc.

Home | About | Services | Portfolio | Contact | Links | Blog