An Evening of Medical Device Development: The FDA and Pediatric Medical Devices

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“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 any specialty.”

On October 5th, medical device experts from across the country will gather at JLABS of Texas Medical Center in Houston, Texas to discuss the latest in pediatric medical device innovation and what it truly takes to bring a pediatric device to market. Dr. Vasum Peiris, Chief Medical Officer of Pediatrics and Special Populations for the FDA CDRH, will provide insight into the current state of pediatric medical device development and the strategic direction of the FDA’s CDRH.

GCMI and its subsidiary T3 Labs will be represented by our CEO, Tiffany Wilson, who will be a part of the pediatric centered panel discussion on device development- providing a holistic view of the challenges of bringing a novel device to market, including the regulatory hurdles.

Now more than ever, physician innovators are experiencing a highly regulated and cost-constrained environment. Maneuvering through this world is not for the faint of heart and takes more than sheer will: it takes a multidisciplinary team. GCMI and T3 Labs team has worked with multiple innovators committed to bettering patient outcomes in pediatrics.

“Medical devices designed specifically for children often lag five years to 10 years behind new technology for adults,” says Farrugia. “Often it is difficult to even find a manufacturer for these orphan pediatric devices due to the size of the market.

“This is why the work GCMI is doing is so important. The team at GCMI will take a pediatric product idea from concept through to commercialization – including small batch manufacturing. This allows us for the first time to meet the needs of our children without retrofitting an adult device.”

“GCMI makes sure you check all of the boxes because at the end of the day, in order to innovate and improve pediatric patient outcomes for the betterment of the entire healthcare community, you have to first make the FDA happy,” says Lou Malice, CEO of NFANT Labs, a medtech company that has created a pediatric device that tracks infant progress in feeding.

We look forward to being a part of an evening with the FDA- a unique opportunity to be surrounded by the pediatric innovation community and to witness the future of pediatrics.

You can register to attend here.

GCMI and T3 Labs is an all-in-one resource for pediatric medical device innovators: bringing together the experts of the commercialization process, GCMI, and the professionals at T3 who are able to guide innovators through preclinical testing in an AAALAC accredited and GLP compliant facility. Email us at info@devices.net or info@t3labs.org  to learn more about how we can help you take your novel idea and turn it into the next medtech innovation.