A materials scientist and six GT students take aim at Civil War technology still ubiquitous in clinical care and its implication in 30,000 deaths every year. The technology that has become Hub Hygiene’s easySCRUB started as a challenge issued to material scientist Jud Ready, PhD, in 2015 by a friend’s spouse, a North Carolina…
In the realm of medical devices quality is systemic, mandatory, codified and highly regulated because lives are literally at stake. It considers a device’s complexity, but it never, ever exempts it from safety standards and good manufacturing practices.
Due to a high number of ecosystem colleagues who have asked us directly, we are compelled to again share the following:
Veranex did not acquire GCMI. They acquired the preclinical testing arm, T3 Labs, only. GCMI has not been “taken private.”
Three key considerations and solutions related to the challenges of manufacturing at scale; but the Golden Rule here is design for manufacturability from day one.
A webinar with GCMI and the Georgia Manufacturing Extension Partnership, June 25, 2024 at 10:30 a.m. EDST When – at long last – it comes time to build your new medical device, be that for verification and validation testing, show and tell or educational examples, clinical trials or “full scale,” you will always wish you…
By: Marty Jacobson with Paul Snyder Because clinicians have such an intimate knowledge of unmet clinical needs, hospitals are fertile ground for medtech innovations that improve value and outcomes. But bringing a technology or device to bear in clinical use, especially at any scale, works in much different, much more rigorous ways and paths…
Prologue – Eliminating a Surgical Never Event that Should not Exist Surgical instruments that emit high-intensity light coupled with human error are a leading cause of intraoperative fires and patient burns. The healthcare system refers to incidents like these as “never events” so they should never happen, right? But, survey results published in the Joint…
First, the news. “On January 31, 2024, the FDA issued a final rule amending the device current good manufacturing practice (CGMP) requirements of the Quality System (QS) Regulation under 21 CFR 820 to align more closely with the international consensus standard for Quality Management Systems for medical devices used by many other regulatory authorities…
By: Emily Blum, MD, Medical Director, GCMI The Challenge: Innovation Roadblocks in Pediatric Care Hospitals are brimming with brilliant ideas from healthcare providers who have a deep understanding of patient challenges. Innovation directly addressing unmet clinical needs provides a superior foundation for new technologies, increasing the likelihood of improved patient care, positive outcomes, and…
GCMI recently welcomed Georgia Tech President Angel Cabrera for an inside look at our work and its impact. Almost immediately after Angel Cabrera was named President of Georgia Tech in 2019, he led “more than 5,700 members of the Georgia Tech community [who] contributed to a new 10-year strategic plan that launched in November 2020.…