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…
Thursday, Oct 3, 2024 Georgia Tech Advanced Manufacturing Pilot Facility 575 14th Street Northwest Atlanta, GA 30318 5:30 – 7:30 p.m. Medical device innovation and manufacturing is unique in its rigors, challenges and impact potential. It is easy to squander scarce resources wasting time with too many prototypes instead of verifying and validating the…
Beyond AI and ML, US / EU regulatory alignment, wearable tech, 3D printing, funding and the supply chain should lead medtech innovators’ awareness for the balance of 2024 and 2025 As we reported in the GCMI news and blog, in early 2024, the FDA issued a final rule amending the device current good manufacturing practice…
AI Dominates, But Attention to Manufacturing, Supply Chain and Funding Remain Paramount to Success in Medtech Innovation in 2024 and 2025 AI’s potential and momentum in healthcare and medtech are massive. But the need for safety assurance remains paramount as regulators try to mitigate the risk of a technology that has many waypoints to…
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…
“One of the region’s most influential health care conferences, underscoring the city’s role as an important health care hub in the Southeast.” – The Atlanta Business Chronicle The mission of Health Connect South is to serve the health community as a platform to promote health collaborations. It brings together the region’s top decision-makers, innovators…
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…
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.