Because so many novel medical devices are, by their nature, quite unique, and because safety is foremost, when a component supplier must be ISO 13485 certified depends on the specific component and what it does. If a component fails is it an annoyance or does it pose real risk? Is a particular component’s material entering…
Few students enter college knowing with certainty that their initial choice of major will become their true calling. Sanjana Singh, now a Product Development Manager GCMI, was no exception. Like many, she questioned whether biomedical engineering was the perfect fit. The turning point in Sanjana’s journey came during a third-year elective in Medical Device…
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…
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…