At Phase Zero, 6 things innovators need to know about the FDA approval process.
In medical product development, correctly identifying and committing to your FDA approval process or pathway can make or break many new projects.
Engaging a flexible third party medical product development firm to help you tackle an inflexible process
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%…
An Evening of Medical Device Development: The FDA and Pediatric Medical Devices
“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…
How process excellence leads to product excellence
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…
T3 Labs sets gold standard in preclinical testing for CorAmi: a medtech company revolutionizing drug delivery for Atrial Fibrillation
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…
Emory, Georgia Tech, and GCMI collaborate to Combat Influenza
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…
Fostering Medical Innovation in the Clinical Setting: Piedmont Innovations & GCMI
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.…
GCMI Launches New Medtech Accelerator
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…
The importance of innovators working with third party design firms to get novel medical technologies to market
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…
Can you really bootstrap a medtech company? The answer is yes.
Innovators seeking to enter the world of medtech face a daunting path from concept to commercialization. Design, engineering, prototyping and preclinical testing to prepare a single FDA regulatory submission are just a few examples of the many hurdles medtech innovators must successfully clear before event attempting to realize any revenue. For John O’Shaughnessy, Founder and…