Medical Contract Manufacturing Success Story

BioBehavioral Logo

Medical Device Development and Contract Manufacturing Case Study

BioBehavioral Diagnostics, a Westford, MA-based medical device company founded in 2006, is focused on developing a tool that aids in the objective and accurate assessment of ADHD symptoms. The objective of their Quotient® ADHD System is to provide physicians, parents and patients with high–value information to guide personalized strategies and to enhance quality of life for patients with ADHD. Their vision is to provide accurate tools for the diagnosis and management of neurological and psychiatric conditions, leading to a transformation of behavioral medicine.

BioBehavioral Diagnostics Leverages High Quality, FDA Compliant, Medical Contract Manufacturing Services at Cogmedix

BioBehavioral’s Quotient® ADHD System, manufactured by Cogmedix, captures and reports objective, accurate data on hyperactivity, impulsivity, and inattention. Through a Motion Tracking System, reflectors, an LCD screen, and a keyboard combined with information from other assessment tools and clinical evaluations, the clinician is provided with a guide to treatment decisions.

Cogmedix provides FDA Quality System Regulation, 21 CFR Part 820 compliant medical contract manufacturing services including finished device assembly, test, and inspection. In addition, Cogmedix provides BioBehavioral with supplier management and fulfillment of the complete bill of materials, system packaging and storage in a cGMP compliant facility, and order fulfillment services. Part of the Cogmedix value is the ability to leverage Coghlin Companies’ aggregate buying power and search and recommend alternate vendors to help contain costs while maintaining superior quality.

“Cogmedix has been very helpful in seeking out alternate vendors to hold costs without sacrificing quality in any way whatsoever,” said Ken Hoadley, VP of Product Development and Operations at BioBehavioral. “It’s comforting to know that we can always rely on Cogmedix for everything from handling and inspecting the large thermoformed components of the console to testing our motion tracking systems and delivering a fully integrated, tested, and packaged finished device in a compliant manner.”

BioBehavioral Diagnostics Partnership with Cogmedix and the Coghlin Companies

quotientSince BioBehavioral contacted Cogmedix to produce its innovative technology, the two companies have grown together and have maintained flexibility in meeting each other’s commitments and expectations along the way. “Cogmedix continues to be very responsive and flexible with respect to our constantly changing needs as a small start–up. The quality of the products delivered to our customers is excellent,” said Hoadley.

The ability to meet the requirements of BioBehavioral as well as maintaining an ISO 13485 certified and FDA QSR compliant quality system has positioned the two companies for a bright future together.