The Children’s Healthcare of Atlanta Pediatric Technology Center’s (PTC) mission is to accelerate development, regulatory approval, and clinical utility of new medical technologies for pediatric patients. We connect researchers including engineers, data analysts, scientists, chemists, and others with front line pediatric clinicians to create new technologies for unmet pediatric healthcare needs. We further connect those parties to the funding, institutional, development, regulatory, and industrial resources needed to make them clinically and commercially viable.

We are one cornerstone of an interdisciplinary research alliance with our partners, along with affiliates like GCMI. We work daily to advance our collective mission of bringing medical technology innovation to life to improve the health outcomes of pediatric patients close to home and around the world.

In 2018 a collaboration between Children’s Healthcare of Atlanta, Georgia Tech, and GCMI made the first 3D-printed tracheal pediatric implant in Georgia possible.

The value of a ‘lifetime partnership’ between engineering expertise, unmet clinical needs, and expert navigation

The center’s former Executive Director Sherry Farrugia, now CEO of Georgia Tech affiliate GCMI, along with current Chief Engineer of Pediatric Technologies, Leanne West, each have deep experience in the pediatric technology field.

Sherry became aware of Scott Hollister’s 3D printed tracheal implant technology in 2014 through former Director of the Georgia Tech Parker H. Petit Institute for Bioengineering and Bioscience Bob Guldberg. (While an Assistant Professor of Orthopaedic Surgery doing research at the University of Michigan, Scott served on Bob’s PhD committee in Mechanical Engineering at the same institution.)

Sherry knew the center’s partnerships, ecosystem, and assets had high potential to extend the technology’s impact for pediatric patients at scale. But first, they had to convince Hollister that Georgia Tech was the best place to advance the endeavor.

“The existence of a center for pediatric research inside of a leading engineering institution partnering intimately with one of the leading pediatric hospitals in the country was of paramount importance in our ability to successfully recruit Scott to his position at Georgia Tech,” Sherry said. “This would not have been possible without the parties’ collective leadership, vision and, of course, funding from Children’s and the Petit Foundation. It is not a transactional relationship. It is a lifetime partnership.”

With program ‘startup support’ provided, and Hollister’s acceptance of the Patsy and Alan Dorris Endowed Chair in Pediatric Technology, a joint initiative supported by Georgia Tech and Children’s Healthcare of Atlanta, the team got to work.

“In preparation of the first implant surgery in Georgia, PTC worked to arrange lab space for his team at GCMI, and connected him with surgeon, Dr. Steven Goudy at Children’s.” Leanne said.

“After countless hours of team contributions to design, development, engineering production, and necessary legal requirements, President Peterson told me, ‘Sherry, I’ve got your back. Get this done,’” Sherry told us.

The first surgery to implant a 3D printed tracheal splint in a pediatric patient in Georgia occurred on August 17, 2018.

“3D-Printed Tracheal Splints Used in Groundbreaking Pediatric Surgery,” via Georgia Tech Research Horizons.

“The possibility of using 3D printing technology to save the life of a child is our motivation in the lab every day,” said Hollister, who is also the director of the Center for 3D Medical Fabrication at Georgia Tech and a professor in the Wallace H. Coulter Department of Biomedical Engineering at Georgia Tech and Emory University. “We’re determined to develop innovative solutions that meet the needs of Georgia’s most complex pediatric patients.”

The splints were created using reconstructions of the patient’s airways from CT scans. Hollister and his team of biomedical engineers collaborated with the Global Center for Medical Innovation (GCMI) so that GCMI could create multiple versions of the splint, of varying sizes, to ensure the perfect fit was available for the surgical team to select and place around the patient’s airways during surgery. GCMI will also support the ongoing development and commercialization of the technology.

In a complex 10-hour surgery, Children’s cross-functional team of surgeons successfully placed three 3D-printed splints around the patient’s trachea on the morning of August 17, 2018. The splints will eventually be absorbed into the body, allowing for expansion of the trachea and bronchus.

The Children’s tracheal splint team included Steve Goudy, M.D., and April Landry, M.D., (ENT), pediatric otolaryngologists; Subhadra Shashidharan, M.D., pediatric cardiothoracic surgeon; and Kevin Maher, M.D., pediatric cardiologist.”

Editor’s note: GCMI is the manufacturer of record for the 3D printed implants, each of which is produced in GCMI’s labs under FDA “Good Manufacturing Practice” guidelines.

Since 2018, the team has completed four tracheal implant operations in Georgia and one at Penn State under the U.S. FDA’s compassionate use approval and guidelines.

Moving forward: refinement and expanded application

As the technology’s design and associated intellectual property documentation has been refined since 2018, the time has now come to make the technology more widely available for pediatric patients nationwide under the FDA’s Investigational Device Exemption (IDE).

Achieving this designation will require preclinical studies to support an FDA IDE, a prerequisite to recruitment for and initiation of a formal clinical trial, initially projected for six to ten patients.

“We are currently using existing funding to develop the best way to 3D print the splints in their latest design status and support the personnel working on the data that we will submit to the FDA  IDE submission,” Scott wrote. “We also intend to seek NIH grant funding for the GLP (Good Laboratory Practice) preclinical studies, in six months and 30 months, which we estimate to cost around $700,000.”

The subsequent, prospective clinical trials are estimated in the $2 million to $3 million range, for which the team intends to seek further funding through other sources, as well as, follow-on NIH funding, for these kinds of endeavors.

“If we successfully complete an Early Feasibility Study (EFS)/Phase I Humanitarian Device Exemption clinical trial successfully, then the device would be approved by the FDA for clinical use,” Hollister wrote.

Again from Georgia Tech Research Horizons, Hollister, who is also the director of the Center for 3D Medical Fabrication at Georgia Tech said, “We’re determined to develop innovative solutions that meet the needs of Georgia’s most complex pediatric patients.”

And Georgia Tech Pediatric Technologies will help lead the way.

 

“Part of Georgia Tech’s mission is to improve the human condition,” Sherry said. “That isn’t just a sentence inside a strategic plan. It is something we believe in. It is something that we strive towards daily. We are making it happen, not just with Dr. Hollister, but with others like Omer Inan and his IV infiltration technology, and Leanne’s own laparoscopic grasper to name just two. We all live and breathe innovation for technologies to improve care for pediatric patients and will do whatever it takes to use our collective expertise to create solutions based on unmet clinical needs.”

If you are interested in learning more about this project, who we are, what we do and how we do it, contact Leanne West at lwest@gatech.edu or Sheri Russell at sheri.russell@gatech.edu.

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