Toolbox Medical Innovations services

Toolbox performs usability testing and human factors engineering on medical devices and point-of-care products to ensure they go to market with complete confidence in their performance.

As a full contract research organization (CRO), Toolbox provides the fastest path to FDA clearance for your IVD diagnostic device study.  Our team has achieved multiple dual and straight 510(k) and CLIA Waiver submission clearances and we can do the same for your medical device.

Blister pack technology allows onboard delivery of diagnostic reagents into a receiving well on a microfluidic chip where they can be dispersed through channels. The process of incorporating blisters onto a microfluidic cartridge may seem simple. However, designing and manufacturing reagent blisters for long-term stability and reproducible volume delivery while minimizing introduction of air to the fluidic channels is quite challenging. Our team has more than 20 years of experience with reagent blister packaging for diagnostic Point of Care (POC) microfluidic applications and can design a solution for your project.