The Food & Drug Administration hosted a public meeting on Pediatric Medical Device Development on August 13-14, 2018, in Silver Spring, Maryland. This meeting was meant to identify strategies that could improve the medical device ecosystem for the development and innovation of devices that will serve the complex needs of children, thus accelerating the medical…
On August 14, 2018, GCMI CEO Tiffany Wilson will present before an open public meeting hosted by the U.S. FDA on Pediatric Medical Device Development in Silver Spring, MD. This meeting provides a discussion about strategies to enhance the medical device ecosystem to cultivate development and innovation of devices that serve the unique needs of…
The Transcatheter Cardiovascular Therapeutics (TCT) meeting is the world’s largest educational meeting specializing in interventional cardiovascular medicine. This year, it will take place on September 21-25, 2018 in San Diego, California. GCMI and T3 Labs will be attending as an exhibitor at TCT again this year. Our booth number is 334. We’re excited to spend…
GCMI hosts the fifth cohort of Project Engages Last year, we wrote about the amazing work Georgia Tech Professor Emeritus Dr. Robert Nerem and others are doing with students in six inner-city Atlanta high schools. This year, GCMI had the opportunity to host the fifth Project Engages cohort for an introduction to the medical product…
Welcome to the third episode in our series about what it takes to get from an idea to a new medical device. We started the series recommending you consider how invested you are in your medtech idea and then get input to find out if your idea really fulfills an unmet clinical need. In the…
Your innovative medtech or medical device idea may solve a problem that you face on a regular basis, but that doesn’t always make it a good candidate for commercialization. It’s not just your idea that matters, but also others’ need for your idea because you’re not the only person that’s going to be using your product.…
The Marketing & Regulatory Session at SEMDA 2018 explored the goals, responsibilities, and possible pathways of medtech marketers when building awareness and adoption for their products. This session featured panelists Mike Fisher, Director of Product Development for GCMI; Allyson Bower-Willner, Senior Marketing Manager for Molnlycke; and Machelle Shields, Senior Executive Healthcare Policy & Compliance Advisor…
“We have not once veered from our relationship with T3 Labs and have no intentions of doing so. I wish I could bring the T3 staff to Europe for research programs that must be done there. The T3 staff handle everything required with the utmost professionalism and consideration.” – Vesalio CEO Steve Rybka Dr.…
As the leading annual electrophysiology event, HRS will always bring the latest advancements in pacing, ablation and mapping to the society’s annual meeting. The 2018 edition was no exception and included a few variations on atrial fibrillation (AF) ablations. Catheter Ablation vs/ Antiarrhythmic Drug Therapy The big news from the show was the dissemination of…
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…