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.
New Product Design & Development Engineer Job Description Individually contribute to new product design and development projects at the Global Center for Medical Innovation (GCMI). Utilize education and industry experience to create and review high quality deliverables for projects from initiation through delivery of new medical devices. This position will interact on a consistent…
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…
On May 8, 2024, Georgia Tech announced promotions for six researchers from the Interdisciplinary Research Institutes and other units reporting to the Vice President of Interdisciplinary Research. We are proud to share that GCMI’s Director of Scientific Affairs Evan Goldberg was one of the six recognized researchers earning promotion. “Growing the careers of…
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…