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…
In GCMI’s experience, the decision to commit to a design and development plan for a new medical product should not be understated in its significance. Prior to making this commitment of time, money, energy and focus, an innovator must truly understand the tasks ahead of them, what the finish line looks like, how long it…
In medical product development, correctly identifying and committing to your FDA approval process or pathway can make or break many new projects.
Dear customers, vendors, colleagues and friends, It is with great pleasure that we announce our newly integrated and rebranded GCMI website, www.gcmiatl.org. This new website gives a comprehensive look at all our service lines: Design & Development Preclinical Testing and Bioskills Training Lifecycle Advisory This website and our new organizational look and feel is a result…
The American Cancer Society (ACS) is partnering with the Atlanta-based Global Center for Medical Innovation (GCMI) to more rapidly bring groundbreaking research from the lab to the clinic. The American Cancer Society conducts research and funds research through grants to hundreds of scientists and health professionals nationwide. Bridging the gap between early research and actual…