A Scalable, Customized Solution to an Unmet Clinical Need Long in Need of Innovation

How GCMI supported Georgia Tech Spring 2022 Capstone Team UCOLLECT’s Need for Verification Testing on the pathway to commercialization.   “More than 6 in every 10 women will, at some point in their life, be unable to toilet. For these women, the best options include the Foley catheter, a device that is inserted up the…

What high value preclinical support looks like when re-expressing pacemaking cells for cardiac arrhythmia in pediatrics

“Our confidence in data generated by our in vivo studies with T3 Labs cannot be greater.” – Dr. Hee Cheol Cho   The Preclinical Challenge Dr. Hee Cheol Cho and his team needed sufficient feasibility data from physiologically appropriate preclinical studies to pursue public funding opportunities to complete their translational research for a life changing…

Medtech Innovators and Investors: Are You Wasting Cash In Design & Development?

Watch, listen and learn. Our 2020 AdvanSE session can help you know, and fix, the ways medtech innovators burn cash unnecessarily.    Too many promising medtech innovations and early stage companies fail unnecessarily because they run out of funding before achieving milestones required for next-round investments.    It is possible to know earlier in the…

ALung Technologies granted Emergency Use Authorization by the FDA for their Hemolung® Respiratory Assist System for the Treatment of COVID-19

A long-time customer of GCMI and T3 Labs, ALung Technologies, has recently announced that they have received FDA Emergency Use Authorization (EUA) for their Hemolung® Respiratory Assist System (RAS), the world’s first fully-integrated respiratory dialysis system. This system removes carbon dioxide directly from the blood, allowing the patient’s lungs to rest and heal while avoiding…

Free webcast: Importance of gross pathology and histopathology in a preclinical study

Gross and histopathology are very important aspects of preclinical research. They can be crucial endpoints for safety and toxicity studies. Oftentimes, they help determine whether adverse events were device related. Laboratory veterinarians that write preclinical veterinary reports rely on pathologists to help explain some in-life clinical observations. Regulatory guidance documents also require that preclinical protocols…

What is verification and validation in medical product development?

Medical product design verification and validation activities (called “Phase 3” and “Phase 4” at GCMI) typically come after a design phase (called “Phase 2” at GCMI). At the completion of the design phase, a product will have well-defined design inputs, plus fully described design features and manufacturing methods. Design verification and validation then takes this…

Proudly collaborating with Georgia Tech, Emory faculty and staff to support frontline healthcare workers in a time of crisis.

In one week, a team of students in a joint biotech medical lab with Georgia Tech and Emory students started making and distributing face shields to help save lives.   “The goal is to meet the needs locally to actually supply the Georgia Department of Public Health and when they have enough to actually supply…

Delta Flight Products begins manufacturing process of GCMI-designed PPE

From the Delta News Hub: April 2, 2020: Delta Flight Products, the airline’s wholly owned subsidiary, is collaborating with Global Center for Medical Innovation (GCMI), a non-profit affiliate of the Georgia Institute of Technology, to manufacture face shields to protect hospital workers during the COVID-19 pandemic. Using materials and designs provided by GCMI, Delta Flight…

Webinar: The most important things to know before you start a GLP preclinical study

Curious about the most important things to know BEFORE starting a GLP preclinical study? Now would be the perfect time to attend a webinar! The team at GCMI is excited to announce that we will be hosting a series of webinars starting next week.    Our first webinar focuses on good laboratory practice (GLP) preclinical…