Orthopaedic Innovators: Do Not Underestimate the Importance of Process in “Medtech Innovation: From Unmet Clinical Needs to Clinical Solutions”

Bio-skills and medical device training, Blog, Events, GCMI, News, orthopedic, Preclinical CRO Excellence, spine, T3

Join GCMI’s Dr. Emily Blum, Evan Goldberg, PhD and John Tipton for an ORS Innovation Network Webinar August 31, 2022   “For over 60 years, the Orthopedic Research Society (ORS) has been the leading research society supporting engineers, orthopaedic surgeons, biologists, veterinarians, and clinicians in pursuit of a world without musculoskeletal limitations.”   GCMI and…

Rooted in Cardiology: Let’s talk preclinical and cardio innovation at TCT 2022

Blog, Cardiology & Cardiothoracic, Conferences, Design & Development, Event, Events, GCMI, News, Physician Innovators, Preclinical CRO Excellence, T3

Founded by Cardiologists In the late 1990s, Dr. Robert Matheny, Chief Scientific Officer of CorMatrix Cardiovascular Inc., was looking for accessible resources, including preclinical support, needed to support innovation in care for cardiovascular physicians and their patients.   In 1999, his collaboration with other Atlanta area interventional cardiologists and cardiothoracic surgeons resulted in the development…

High Demand, Regulatory Support and Importance of Advance Planning Highlight the 2022 State of the Preclinical Ecosystem

Bio-skills and medical device training, Blog, Cardiology & Cardiothoracic, Design & Development, GCMI, GI, neurology, News, orthopedic, Pediatric, Physician Innovators, Preclinical CRO Excellence, Regenerative Medicine, spine, T3

As industries of all shapes and sizes continue to evolve embracing remote work models and various levels of return to travel for business, medical technology innovation and critical supporting service providers are not only working through pent up demand for delayed projects from 2020 and 2021, but also striving to advance technologies that reduce cost…

A Scalable, Customized Solution to an Unmet Clinical Need Long in Need of Innovation

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

“The failure of existing products on the market to successfully accomplish the needs of patients and clinicians made this a problem we addressed with enthusiasm and with the support and encouragement of Dr. Emily Blum and Dr. Jenelle Foote.”

Phase Zero and Phase One Services Accelerating Wearable Pediatric Stethoscope Path to Commercialization

Blog, Cardiology & Cardiothoracic, Design & Development, GCMI, How GCMI Supports Georgia Tech Innovators, Researchers, PIs and Students, News, Pediatric

“I can say with confidence our journey toward commercialization of our new [wearable pediatric stethoscope] medical technology would have taken years longer without GCMI’s Phase Zero and Phase One services.”   As the winner of the 2021 GCMI Baby Sharq Tank competition for their innovative wearable pediatric stethoscope, the interdisciplinary team of Dr. Hong Yeo,…

When clinical relevance calls for on-the-fly preclinical protocol deviation

Blog, Cardiology & Cardiothoracic, GCMI, News, Physician Innovators, Preclinical CRO Excellence, T3

How GCMI and T3 Labs is supporting Dr. Lindon Young’s novel therapy to significantly reduce cardiovascular reperfusion injuries.    During events such as myocardial infarction (heart attack) and surgical procedures involving angioplasty, bypass surgery, or heart transplantation, reactive oxygen species (ROS) can be generated, which cause organ and blood vessel damage. ROS is generated from…

Recording & Insights: An Introduction to the U.S. FDA’s Investigational Device Exemption (IDE)

Blog, Cardiology & Cardiothoracic, Design & Development, GCMI, GI, neurology, News, orthopedic, Physician Innovators, Preclinical CRO Excellence, Regenerative Medicine, spine, T3, Webinar

Investigational Device Exemptions are required by the U.S. FDA for devices or technologies that require clinical use before regulatory approval or general market release. Examples of devices that may require an IDE study are first in human devices, devices that require Class III premarket approvals, some Class II devices, or a de novo device or…

GCMI’s Sherry Farrugia and Mike Fisher share in the Presidents’ Award of Distinction from CTSA for translational research

Blog, Design & Development, GCMI, News, Preclinical CRO Excellence

Congratulations are in order! GCMI Chief Executive Officer, Sherry Farrugia, and Director for Product Development Mike Fisher, were among those recently awarded the Presidents’ Award of Distinction for Team Science from the Georgia Clinical and Translational Science Alliance (Georgia CTSA).   In collaboration with an interdisciplinary research team led by Omer Inan, associate professor in…

Are you a life science innovator seeking funding in the next 12 months? Applications are open for PitchRounds at AdvanSE 2022.

Accelerator, Blog, Cardiology & Cardiothoracic, Conferences, Design & Development, Digital Health, Events, GCMI, GI, neurology, News, orthopedic, Physician Innovators, Preclinical CRO Excellence, Regenerative Medicine, spine, T3

Our colleagues at Southeast Life Sciences are now accepting applications for Pitchrounds at AdvanSE 2022.   They’re seeking the southeast’s most promising life science innovators across multiple life science categories including biopharma, medtech, diagnostic, digital health and agriculture biotechnology technologies.   Along with Southeast Life Sciences, we encourage those seeking early rounds of six figures…

An Introduction to the U.S. FDA’s Investigational Device Exemption (IDE): A GCMI Webinar

Accelerator, Blog, Cardiology & Cardiothoracic, Design & Development, Events, GCMI, GI, neurology, News, orthopedic, Physician Innovators, Preclinical CRO Excellence, Regenerative Medicine, spine, Webinar

Learn from our experience to streamline your regulatory pathway and set your new medical device or technology up for commercialization success.   Investigational Device Exemptions are required by the U.S. FDA for devices or technologies that require clinical use before regulatory approval or general market release. Examples of devices that may require an IDE study…