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…
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…
A medtech or life science project’s success is dependent on the careful consideration of several intersecting components: technological, clinical, commercial and legal. GCMI follows a structured, phase-gated process that allows for a disciplined, capital efficient medical device design and product development approach.
When it comes to medtech innovation, our client’s success is always our top priority. We help find the right people for the task at any point on the commercialization pathway.
“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.”
Congratulations to GCMI’s very own: Dr. Emily Blum on her recent advancement within Emory University from Adjunct Clinical Instructor to Adjunct Assistant Professor. The advancement is a testament to Dr. Blum’s commitment to education and clinical research. Emily is instrumental in advancing med tech innovation for GCMI. She works tirelessly to promote GCMI in successfully…
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…
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…
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.…