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…
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…
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.
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.