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…

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

Blog, Design & Development, Digital Health, GCMI, How GCMI Supports Georgia Tech Innovators, Researchers, PIs and Students, News

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

Blog, Design & Development

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…

Why GCMI for your medtech design & development needs? We have established a proven, capital-efficient pathway and process.

Blog, Design & Development, GCMI, Physician Innovators

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.

Family ties to clinical care professionals drive the Fluid Fighters’ to help solve a painful problem for paracentesis.

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

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.

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.