From Capstone through CREATE-X and on to the precipice of commercialization: Ethos Medical’s medtech journey for its novel spinal guidance system

Blog, GCMI, How GCMI Supports Georgia Tech Innovators, Researchers, PIs and Students, News, Preclinical CRO Excellence, spine, T3

In 2018, GCMI chronicled one Georgia Tech Capstone team’s effort to end complications from epidural misplacement.   Fast forward more than three years and the promising product dubbed Neuraline has evolved to become a new medtech startup: Ethos Medical. The Ethos team leveraged the supporting elements and mentors within the Georgia Tech CREATE-X program—with assistance…

The State of Preclinical Studies: A Q&A with GCMI’s Director of Scientific Affairs Evan Goldberg

Blog, Cardiology & Cardiothoracic, GCMI, GI, neurology, News, orthopedic, Physician Innovators, Preclinical CRO Excellence, Regenerative Medicine, spine, T3

Our lives, personal and professional, bear little resemblance to those we led at the beginning of 2020. Remarkably, in February 2021, U.S. FDA announced the agency “approved, cleared, or authorized a record high of 132 novel medical devices in 2020, surpassing the 40-year high mark we set in 2018 and capping off 10 years of…

Fast tracking a fix for intraoperative alignment in surgery to correct severe scoliosis: Meet Spring 2021 Capstone Design Team ScolAlign

Blog, Design & Development, GCMI, How GCMI Supports Georgia Tech Innovators, Researchers, PIs and Students, Preclinical CRO Excellence, spine

Yoel Alperin, Parth Gami, Sindhu Kannappan and Kelly Qiu comprise the Georgia Tech Spring 2021 Capstone Design Team ScolAlign. Their technology seeks to objectively improve the standard of care for intraoperative spinal alignment during scoliosis correction surgery.

Increasing Availability of Lateral Access Spinal Surgery Training: GT Spring ’21 Capstone “Vertebros”

Blog, Design & Development, GCMI, How GCMI Supports Georgia Tech Innovators, Researchers, PIs and Students, orthopedic, Preclinical CRO Excellence, spine

“Our validation work would not have been possible without GCMI’s support and T3 Labs’ facility and equipment. Being ‘radio-opaque’ is a critical design input for this tool. That type of feedback is impossible without a proper operating room environment.”

Why GCMI for preclinical testing and bioskills training? Commitment to value.

Bio-skills and medical device training, Blog, Cardiology & Cardiothoracic, GCMI, GI, neurology, orthopedic, Physician Innovators, Preclinical CRO Excellence, Regenerative Medicine, spine, T3

We know preclinical testing is a substantial commitment of time and treasure for medtech and life science innovators. We also know the most expensive study is the one you have to do twice.   Our response to your request for preclinical work may not be the lowest bottom line price. But please know this: all…

Why GCMI for preclinical testing and bioskills training? Our scientific acumen.

Blog, Cardiology & Cardiothoracic, GCMI, GI, neurology, orthopedic, Physician Innovators, Preclinical CRO Excellence, Regenerative Medicine, spine, T3

At GCMI and our preclinical testing arm T3 Labs, we take great pride in our scientific acumen. After all, the organization was conceived and designed by translational researchers for medical product developers. Thirst for science: it’s in our DNA.    We won’t turn your project away because it’s too hard, or because we haven’t done…

Why GCMI for preclinical testing and bioskills training? Quality, compliance and accreditation.

Cardiology & Cardiothoracic, GCMI, GI, neurology, orthopedic, Physician Innovators, Preclinical CRO Excellence, Regenerative Medicine, spine, T3

At GCMI, we strive to provide the highest quality data for our preclinical sponsors and customers.   GCMI is committed to working with innovators to test medical technologies and therapeutics that consistently meet customer needs and regulatory requirements. We maintain Quality Management Systems to ensure compliance and ongoing quality of our deliverables, products and services.…

Why GCMI for preclinical or bioskills training? Collaborative accountability.

Cardiology & Cardiothoracic, GI, neurology, orthopedic, Physician Innovators, Preclinical CRO Excellence, Regenerative Medicine, spine, T3

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.  …

Why GCMI for your preclinical or bioskills programs? Flexibility.

Cardiology & Cardiothoracic, GI, neurology, orthopedic, Physician Innovators, Preclinical CRO Excellence, Regenerative Medicine, spine, T3

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…

Preclinical testing’s role in the medical device design and development phase

Blog, Cardiology & Cardiothoracic, Design & Development, GCMI, GI, neurology, New, orthopedic, Physician Innovators, Preclinical CRO Excellence, Regenerative Medicine, spine

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…