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New medical technologies or devices cannot enter stages of research or clinical trials in humans without certain authorizations required by regulatory agencies responsible for safety and efficacy. As far as those regulatory bodies are concerned, the path to clinical trials in humans is the same whether it’s research or commercial driven. Failing to walk that…
Since the first quarter of 2020 the demand for virtual bioskills training and education programs for medical technologies has skyrocketed . Teams leaned on virtual engagement technologies, dedicated lab staff, and proctors onsite, to deliver the training and education required to learn how to safely employ new technologies, products and techniques. At the importance of…
According to the American Red Cross, every two seconds someone in the United States needs a blood transfusion. That fails to take into account injuries sustained by troops in war zones or others needing the precious resource in corners of the world that can take days or weeks to reach. Yet currently, whole blood…
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…
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…
The Fluid Fighters Capstone team needed to test their prototype for draining rates and tissue adherence or occlusion avoidance. GCMI’s preclinical testing and bioskills training arm T3 Labs provided the facility and resources the team needed to complete the task.
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.
“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.”
“We needed to validate whether or not our device could create the appropriate pressures needed to restore esophageal function in tissue that closely mimics live human tissue… in a safe environment for live tissue where sanitation would not be a concern. The GCMI and T3 Labs team helped prepare the space, tools, and specimen we needed for the validation testing event.”
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…