EG-GILERO Enhances Human Factors & Clean Room Capabilities

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EG-GILERO, a provider of comprehensive product design & development and contract manufacturing services to leading medical device and pharmaceutical companies, announced additions to its design & development service offerings.

Human Factors Usability/Observation Room

Expanding our human factors team & offering onsite cleanroom manufacturing and assembly was an easy decision and natural extension to our core competencies

Human Factors and product testing research capabilities have been enhanced through upgraded processes and the completion of a new usability/observation room. This addition will help meet the increased industry demand for Human Factors Evaluations with the goal of ensuring medical devices and drug delivery devices/combination products are safe and easy to use when released to the market, ultimately improving patient outcomes.

“The new observation room allows for sophisticated video recording, streaming, and in-person viewing within a controlled environment to discover avoidable mistakes throughout the product development lifecycle. The creation and adoption of formalized processes on how to plan, conduct, analyze and report human research studies is now part of our rigorous QMS,” says Jay Zignego, Director of Human Factors & Design.

Additionally, a 1,300 sq/ft ISO Class 8 clean room has opened for small scale assembly & packaging of complex medical devices and drug delivery devices/combination products. Located within the Design & Development Center in RTP, NC, provides the benefit of bringing designs directly from napkin sketch to production under one roof.

Locating a flexible production environment directly within the same space as the designers and quality personnel means we can accelerate the manufacturing development process, quickly produce clinical trial materials , design verification and validation parts and simplify the transition to our full-production environments in our other locations across the globe,” said Andrew Corson, Director of Commercialization.

“Our customers see us as an extension of their business,” said Tim Hopper, EG-GILERO’s Chief Marketing Officer. “We put ourselves in their shoes and realized the transition from design & development into production was a pain point for them—we listened and now have the ability to ease that transition point. We are constantly looking for ways to increase the investment in our infrastructure and people.”

“We have always invested in our clients unique and demanding needs to offer comprehensive solutions that ensure their success. Our talented team of design & development engineers know complex devices and work routinely with the FDA. Expanding our human factors team & offering onsite cleanroom manufacturing and assembly was an easy decision and natural extension to our core competencies,” said Ted Mosler, Chief Technical Officer and Co-founder.

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