GCMI’s foremost goal as an affiliate of the Georgia Institute of Technology is to partner with Georgia Tech faculty and engineers in the innovation process of new medical products. One successful example of this partnership has been our work with Dr. Scott Hollister. With GCMI’s help, Children’s Healthcare of Atlanta surgeons used Dr. Hollister’s process…
At GCMI, medtech and medical device innovation are at the core of our efforts including our work within our industry leading preclinical CRO. While our team constantly focuses on the advancement of our sponsors’ journeys from concept to commercialization to cure, we actively seek to attend events that connect us with medtech innovators across the…
GCMI’s 2018 year end review and 2019 look ahead Thanks to our staff, customers, sponsors and fellow industry, academic and philanthropic visionaries, GCMI has tangibly advanced our mission of accelerating the development, testing, training and commercialization of innovative medical products that improve quality based outcomes and delivery of healthcare for patients. 2018 Highlights Leading…
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 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.
Michael Fisher, Director of Product Development for GCMI, shares his insights from the IEEE-NIH Healthcare Innovations and Point of Care Technology conference. Recently, GCMI attended and spearheaded a presentation during the IEEE-NIH Healthcare Innovations and Point of Care Technology conference which focuses on innovation and technologies for precision health and their clinical translation, to address…
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…