Class II Medical Device Contract Manufacturing Success Story

Hemedex Logo

Medical Device Development and Contract Manufacturing Case Study

Hemedex, Inc., a Cambridge, MA-based medical device company, was founded in 2000 to commercialize a proprietary platform technology conceived at the Massachusetts Institute of Technology (MIT) to quantify tissue perfusion (i.e., blood flow at the capillary level). This technology addresses the need for real-time, prognostic data in complex medical and surgical procedures. These complex procedures often involve compromised vasculature and other serious pathophysiology, resulting in high rates of morbidity, delayed recuperation, poor patient outcome and higher overall costs. Hemedex developed and commercialized the Bowman Perfusion Monitor.

Cogmedix Role

Cogmedix, a wholly owned subsidiary of Coghlin Companies Inc, focuses on the production of Class I and Class II medical and clinical devices, and offers full logistics and fulfillment services. Cogmedix collaborates with innovative companies bringing new medical and clinical products to the market. Cogmedix aligns itself with companies seeking a compliant, conscientious, cost effective, domestic manufacturing and fulfillment resource to assist them with volume turnkey manufacturing.

Hemedex Partnership with Coghlin Companies

When Hemedex needed a reliable medical equipment contract manufacturer to produce its leading-edge technology, Hemedex contacted Coghlin Companies. Since its inception, Hemedex has been a close customer of Cogmedix. “Our work with the Coghlin family, Columbia Tech, and Cogmedix has been much more than vendor-customer. We feel like we’re part of the family and look forward to a long future working together with the Coghlin family, the company, and its people,” says Fred Bowman, CEOand founder of Hemedex.

Hemedex Leverages Cogmedix FDA Compliant, High Quality,
Flexible Manufacturing

Hemedex relies on Cogmedix to manufacture the Bowman Perfusion Monitor, a Class II medical device that quantifies blood flow at the capillary level during complex medical and surgical conditions where real-time continuous knowledge of perfusion provides early warning of compromised flow and allows state of the art patient management. Says Lisa Coffey, Managing Director, “Knowing we are in great hands with Cogmedix for FDA compliant, high quality, flexible manufacturing, we are able to dedicate more time and energy on technology development and worldwide marketing of our products and services.”

hemedexThe Bowman Perfusion Monitor is a densely integrated combination of electronics, PCB‘s, an LCD, a thermal printer, sheet metal, plastics, and software. Cogmedix provides a full range of cGMP compliant manufacturing services for Hemedex, including supply chain and inventory management, flexible manufacturing to dynamic forecasts, and implementing product changes through very well defined and documented New Product Introduction, Engineering Change, and Validation processes. As part of the finished device manufacturing process, an extensive test of the system parameters are executed prior to final packaging, (DHR) completion, and shipment. Rigorous adherence to revision controlled assembly, test, and quality documentation is required in the FDAcompliant environment and culture at Cogmedix and helps Hemedex to continue trusting their outsourcing requirements to Cogmedix.