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…
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.…
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…
Overheating lighting instruments coupled with human error are a leading cause of intraoperative fires and patient burns. The healthcare system refers to these as “never events” so they should never happen, right? But, data suggests that they occur more than twice a day. This was a red flag for co-founders James Rains and Kamil Makhnejia.…
Earlier this week, the Southeastern Medical Device Association announced several industry leading plenary and keynote speakers set for next month’s 2018 SEMDA Annual Medtech Conference in Greenville, South Carolina. Representing GCMI, and its Design and Development line of service, our Product Development Director, Mike Fisher will serve on a panel led by Paul Snyder, VP of…
The Southeast Medical Device Association annual conference is right around the corner, May 2 – 4, 2018, this year in Greenville, South Carolina. GCMI closely shares and supports SEMDA’s mission of helping advance medtech innovation in the Southeast. GCMI CEO Tiffany Wilson (chair), Director of Training and Education Kelley Bennett and Project Engineer Dersi Patel…
Mass Device sister publication Drug Delivery Business News reported recently that Clearside Bio, a GCMI client, “has enrolled the first patient in a Phase III trial evaluating its eye drug combined with an intravitreally-administered anti-VEGF agent as a treatment for macular edema associated with retinal vein occlusion.” Reporter Sarah Faulkner goes on to write, “The…