As of November 30, 2023 T3 Labs is Part of Veranex. Click Here to learn more.
GCMI Design & Development has moved to gcmiatl.org
In this era of consolidation, the dwindling number of preclinical CROs often aren’t interested in developing new models or venturing outside of their well established protocols. Why choose GCMI for your preclinical testing needs? We are collaborative and accountable. We are committed to meeting your needs on your timeline and on your budget. …
As the preclinical CRO industry consolidates, creativity and flexibility suffer. GCMI and our preclinical arm, T3 Labs, works around your needs, around you and your surgeons’ availability, not the other way around. We work beyond the bankers hours because we know time is of the essence, deadlines must be met and your innovation is not…
In the context of GCMI’s phase-gated product development, the “Design and Development” phase (also called “Phase 2” at GCMI) typically follows a Project Planning phase (called “Phase 1” at GCMI). At the completion of project planning, innovators have determined what work is required to take the technology from prototype to product. The Design and Development…
There are approximately 292,000 cases of in-hospital cardiac arrest every year for which the survival rate is less than 24 percent. Resuscitative efforts and supporting technologies are ineffective, slow, fatiguing, traumatic and expensive. As their Fall 2020 Capstone Project, a group of students from the Georgia Tech Schools of Biomedical, Electrical and Mechanical Engineering…
Preclinical evaluations are often the best way to assess a medical product’s performance, and regulatory bodies often require preclinical data in product submissions. But this type of work is also expensive. The most effective product development strategies use preclinical studies wisely. The most expensive preclinical study is the one you have to repeat. How…
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…
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…
GCMI’s Facilities Director Hugh Lambert has spent 11 years ensuring the efficiency of building operations and equipment, maintenance, and facilities management. He uses his 40+ years of experience along with his team to keep our industry leading 31,000 square foot preclinical facility performing at the highest of standards for our medtech and life science customers. …
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…
A significant number of innovative medical technologies fall into FDA’s Class II classification, the vast majority of which require an FDA 510(k) submission. What exactly is a 510(k)? What types of products fall into the Class II, 510(k) category? Grace Powers, principal consultant with Powers Regulatory Consulting, has 20 years of industry experience in…