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…
In 2014, a Children’s Healthcare of Atlanta nurse, Lynn Pogue, approached an engineer, Leanne West from Georgia Tech, to discuss the burden of IV monitoring. This is when Sherry Farrugia, the current Chief Executive Officer of GCMI, stepped in to help assemble the team that would begin the investigation into a new device capable 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…
A team of mechanical, electrical and computing engineers, supported by the Director of Cardiac Intensive Care for Children’s Healthcare of Atlanta, has been named winner of the inaugural GCMI Baby SharQ Tank Pitch Competition for their novel, low cost, wearable pediatric stethoscope. The interdisciplinary team, including engineers (Dr. Hong Yeo, Dr. Yun-Soung Kim, and…
How we walk is a key indicator of any injury, recovery pathway and overall health. Clinicians’ analysis for assessment of gait is still done in a highly subjective way with the naked eye. As such, physical therapists struggle to track patients’ recovery and therapeutic process without a technical, objective yet visual solution for gait assessment.…
Once a new medical technology or device is ready to go from prototype to product, following a defined process and generating appropriate documentation is crucial. Regulatory bodies require specific documentation as evidence to determine the safety and efficacy of the product. These documents range from design input requirements to outputs like design specifications, manufacturing processes…
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.
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.