Orthogonal·Concept Consulting

Who We Are

Orthogonal·Concept is a consulting and lab-service group that specializes in simulated use studies and the interactions between medical devices and pharmaceuticals, including insulin.

Our staff have a history of success in:

Pharmaceutical Science
Combination Device Design Optimization for Drug Compatibility
Simulated Use Drug - Device Compatibility Studies
CMC Chemistry Submissions
Technical Interactions with Pharma and the FDA (CDRH, CDER, CBER).
Non-Clinical Study Device Analysis and Troubleshooting, Root Cause Analysis.
Analysis of Returned Clinical Devices
Grant Applications

What We Do

Orthogonal·Concept will support your pursuit of feasibility data, design optimization, grant applications, and regulatory approval.

We have substantial drug-device compatibility testing and troubleshooting capability. This includes on-site simulated use and in-house analysis of most pharmaceutical and mechanical samples. We are also able to inspect, document and test certain biohazard clinical returns.

Orthogonal·Concept has helped several engineering startups to build submission packages, design and perform feasibility studies, and vet materials changes. We are an experienced liaison for device startups in their interaction with the FDA and/or big Pharma.

Bridge the Drug - Device Divide

The Orthogonal Team knows how to bridge the gap between competing drug stability and device performance requirements. We understand the different perspectives of both CDRH and CBER. We can help your development program meet the requirements of both agencies to bring a safe and effective product to market.

ORTHOGONAL·CONCEPT

ORTHOGONAL·CONCEPT

Who We Are

What We Do

Bridge the Drug - Device Divide