Clinical Needs Identification & Market analysis
IP landscape & Freedom to Operate
Prototyping & 3D printing
FMEA analysis & risk mitigation activities
Verification and validation testing
Regulatory submission management
Manufacturing transfer
Rigors increase in intensity based on predicate technologies or devices and the relative invasive nature of their use, adjacent to, in contact with, or invasive within the patient.
Take a look at a few of your GT peers working with GCMI.
More than two decades and hundreds of preclinical studies completed, GCMI remains an industry leader in medtech design, development, preclinical testing and bioskills training programs.
GCMI has dedicated, annual funding for medtech innovation at Georgia Tech, specifically for projects we believe have high potential for successful commercialization.
Scott Hollister, Patsy and Alan Dorris Endowed Chair in Pediatric Technology, Professor, BME
Hollister and his team of biomedical engineers collaborated with the Global Center for Medical Innovation (GCMI) so that GCMI and Children's Healthcare of Atlanta on Georgia's first 3D printed tracheal implant in a pediatric patient.
Omer Inan, Linda J. and Mark C. Smith Chair and Associate Professor, ECE
After an IV needle has been inserted into a vein, there are various factors that can cause it to leak, either just beneath the skin or even deeper, into surrounding tissues. This painful process of unintended leakage is called infiltration.
W. Hong Yeo, Associate Professor, Woodruff Faculty Fellow
Currently available digital stethoscopes are durable but expensive, bulky and heavy for pediatrics, not capable of continuously monitoring sounds and subject to cross contamination. Dr. Yeo'S wireless flexible technology flips the script.
Interest and excellence in subjects like biology and mathematics can be precursors to pre-med study initiation or investigation, but it is far from all that is required to succeed. There are also frequently superseding areas of interest and excellence that influence one’s academic and career path. Franco Zapata, medical device and phase zero research…
With GCMI’s Help, Micron’s Microarray Needle Technology Nearer To Forever Changing the World for the Better Medical device and biotech or medtech innovation doesn’t work like consumer electronics or software. It works more like aerospace. Because lives are literally at stake it needs more than a place for people to work, high speed internet, brilliant…
Opportunities and implications for ISO 9001 certified entities to access the lucrative medical device market through ISO 13485 certification. Researchers estimate the total size of the U.S. medical device market somewhere between $170 billion and $240 billion in 2023. KPMG reports, “The medical device industry is poised for steady growth, with global annual sales…
Insights from a deep dive into medical device innovation and production with GCMI’s Saylan Lukas and GaMEP’s Dean Hettenbach Given the patient safety requirements codified in the United States Code of Federal Regulations overseen and enforced by the Food and Drug Administration, medical device innovation is a challenging enterprise to say the least. …
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…
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…
We've got some funding for promising medical technologies.
GCMI has dedicated, annual funding for medtech innovation at Georgia Tech, specifically for projects we believe have high potential for successful commercialization, follow-on funding and improved patient outcomes. Funded projects are selected by GCMI leadership inclusive of consultation with the board of directors.
You've found a clinical partner. Now what?
New medical technologies are subject to the significant, necessary rigors applied by regulatory bodies and, ultimately, market forces. Those rigors increase in intensity based on predicate technologies or devices and the relative invasive nature of their use, adjacent to, in contact with, or invasive within the patient.
Phase Zero: The place to start for your new medical technology or idea.
Doing the right things early and following a rigorous phase gated process can substantially increase the likelihood of milestone achievement at any point in a technology’s commercialization pathway.
