Georgia Tech researchers partner with GCMI to move their innovative IV Sensor closer to clinical trials

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…

Demand, Logistics, Technologies and Lifecycle Services: The State of Bioskills Training and Education

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…

GCMI Capstone Support Spotlight: The Hemogoblins: Extending the Shelf Life of Cold Stored Whole Blood

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…

Faculty Researchers and Innovators: Medtech Innovation does not work like any other form of innovation. What you need to know about IRBs and the medtech innovation process; a GCMI webinar.

Join us as we walk through the required steps of medtech innovation and, more importantly, why they’re required for academic researchers and innovators with ideas or technologies that could improve healthcare provision, save or improve lives.

Wearable pediatric stethoscope wins inaugural GCMI Baby SharQ Tank competition.

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…

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

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

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…

StrideLink Walks Quickly Into the Future of Physical Therapy Through CREATE-X and GCMI

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.…

Design History File Generation For New Medical Technologies and Devices

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…