So you have an idea for a new medical device. Now what? Coming up with a concept for a new medical device is an exciting moment. The possibility of solving a real unmet clinical need can seem so promising that you may overlook the myriad process challenges that go along with bringing this idea to…
In medical product development, correctly identifying and committing to your FDA approval process or pathway can make or break many new projects.
Medical technology innovators learn quickly that there is little, if any, flexibility in the FDA approval process. NFANT Labs knew they needed multidisciplinary partners able to build flexibility into an inflexible process, designing and developing their product with a constant eye on efficiency and the FDA approval prize. In the United States, up to 70%…
“Children aren’t little adults, yet we expect our physicians to retrofit adult devices to fit a pediatric patient,” says Sherry Farrugia, Chief Operating and Strategy Officer of the Pediatric Technology Center, and Director of Children’s Healthcare of Atlanta Partnership. “When adult devices are used it can often cause safety concerns in surgery, orthopedics – really…
GCMI’s Director of Product Development, Mike Fisher, recently spoke about the ins and outs of successful medical device development as a guest on Greenlight Guru’s Global Medical Device Podcast. “A good rule of thumb for innovators is that your product, your prototype, or your idea should lead the conversation but right behind it needs to…
With preclinical help from T3 Labs and the support of experts within the Atlanta medtech ecosystem, Dr. Rebecca Levit and her team is revolutionizing drug delivery for Atrial Fibrillation. Dr. Levit is Assistant Professor of Cardiology at Emory University in Atlanta, GA and adjunct faculty in the Department of Biomedical Engineering at the Georgia Institute…
Announced recently via the Georgia Tech News Center, Microneedle Patches for flu vaccination were found safe to use following a successful human clinical trial. “Despite the potentially severe consequences of illness and even death, only about 40 percent of adults in the United States receive flu shots each year,” writes Holly Korschun, Director, Research Communications…
Who better to address unmet clinical needs and life-changing improvements to medical devices of all types than clinicians themselves? Piedmont Healthcare and T3 Labs’ a subsidiary of GCMI, embark on a journey to create a self-sustaining innovation enterprise: concept to commercialization. All I.J. was trying to do was celebrate a friend’s wedding at the beach.…
Collaboration with BD adds significant new asset to medtech development ecosystem in Atlanta and the southeast. Media Release – February 28, 2017 (Atlanta, Ga.) – The Global Center for Medical Innovation (GCMI) announced today it is partnering with BD (Becton, Dickinson and Company) to support the launch of, and the first startup to enter, the…
GCMI and T3 Labs CEO Tiffany Wilson shares insights with Assembly Magazine on what it takes to bring a medical device from concept to commercialization. Developing a new medical technology is not for the faint of heart. It is a daunting, expensive, arduous process, but nevertheless, it is highly rewarding. The developmental pathway is enough…