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…
Earlier this month, Georgia Bio announced the winners of its 2024 Golden Helix Awards. The GCMI team proudly shares that our own Emily Blum, MD, pediatric urologist and GCMI Medical Director will be presented a 2024 Golden Helix Community Award at the Georgia Life Sciences Summit in October. The Community Award is presented “to…
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…
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…
New medical technologies for pediatric care face difficult hurdles to commercialization, especially industry investment, due to relatively small market size and the quickly shifting nature of pediatric anatomy. In many cases, compassionate or “expanded use” regulatory pathways are needed to make new technologies available for clinical use in pediatric patients. In December, GCMI Research…
If you’ve been following our funding series for innovators seeking to spin out new medical technologies from higher ed “environments” like Georgia Tech, you’ll have seen: The Top 5 Medtech and Life Science Funding Resources for GT Faculty, Researchers and Investigators – at Phase Zero, THE Place to Start, and Follow-On, for University Sourced…
Innovation in pediatric technologies that address unmet clinical needs lags behind innovation for adult populations in large part due to its relatively small market size and ROI (return on investment) prospects for industry, continuously changing anatomies of children, and limited populations for testing and clinical trials. Activity sequence and process matters a great deal…
Funding varies in specific levels from fiscal year to fiscal year, specifically supports projects with high potential for successful commercialization, follow on funding and improved patient outcomes. Projects are selected by GCMI leadership in consultation with the board of directors. These funds are not for staff / salary or lab support.
You’re a researcher or engineer who has found a clinician with a strong unmet clinical need your technology might solve. Outstanding! Too many technologies go looking for problems to solve instead of finding the clinically stated problem first and fitting your technology to meet it in a way that truly works in the clinical…