Get ready, because a new pediatric medical device may hit the market.
Judges of the National Capital Consortium for Pediatric Device Innovation competition judged 12 finalists at the Fifth Annual Pediatric Device Innovation Symposium.
A total of 98 applications were submitted from across the U.S., and finalists had five minutes to pitch their devices. Half of the finalists were awarded prize money and consultation services from the United States Food and Drug Administration (FDA)-funded consortium
“The goal of the competition is to provide financial support coupled with consultation services that will help bring pediatric devices to market faster by bridging the gap, which often follows the prototyping phase in the device development life cycle,” says Kolaleh Eskandanian, Ph.D., executive director of the Sheikh Zayed Institute for Pediatric Surgical Innovation at Children’s National and the National Capital Consortium for Pediatric Device Innovation (NCC-PDI).
One finalist, Jamie Haggard, co-founder and CEO of Green Sun Medical, won for inventing a tech-enabled scoliosis brace. It’s designed with a dynamic mechanism that provides continuous corrective pressure to the spine, and the pressure sensing system enables physicians to remotely monitor the brace’s performance.
When the team was first designing the brace, their main concern was developing a device that provided enough force to correct the spinal deformity, even by just a small degree. The team tested the brace by putting the device on a torso covered with pressure sensors. Upon passing the bench test, they took a further step by designing the sensor system to collect accelerometer and pressure data, and upload it to a mobile device using Bluetooth Low Energy (BLE). The last step was adding soft fabric so users feel more comfortable while wearing the device.
One of the primary difficulties with the device was designing around soft tissue.
“We were always worried about developing a lesion or transferring forces effectively through the soft tissue to the spine,” says Haggard.
The spine is also complex, he continues to explain. One of the main differences between this type of device and other orthopedic application, is designing around one joint verses several joints. With other devices, designers have to work around one uniaxial joint (like a knee or elbow). When it comes to devices for scoliosis, many complex joints have to be taken into consideration.
“If we had unlimited time and budget we could have identified a better approach,” says Haggard. “But we spent a lot of our early development time casting a very broad net. We’ve constantly worked to improve the brace, and there have even been some different approaches that we abandoned because they just didn’t work as well as we thought they would. Ultimately, we are very happy with the device now.”
The idea for the device came from cofounder Matt Thompson, a biomedical engineer who used to work on braces for straightening fingers. Upon entering the implant industry, Thompson wondered about there being a better way to heal spines affected by scoliosis. Using his knowledge of biomedical engineering and soft tissue correction, he started designing an advanced brace.
“We are honored that the panel of expert judges chose to select Green Sun Medical,” says Haggard. “It’s a tremendous validation for the journey that we have been on.”
The competition judges included Susan Alpert, M.D. from SFA Consulting, a former director of the FDA Office of Device Evaluation, former senior vice president and chief regulatory officer of Medtronic, Charles Berul, M.D., Children’s National, Andrew Elbardissi M.D., Deerfield Management, Rick Greenwald, Ph.D., of the New England Pediatric Device Consortium (NEPDC), Josh Makower, M.D., of NEA, Jennifer McCaney, Ph.D., of MedTech Innovator, Jacki Phillips, M.D., of Johnson&Johnson, and Tracy Warren, M.B.A, of Astarte Ventures.
The competition is hosted by Sheikh Zayed Institute for Pediatric Surgical Innovation Children’s National Health System. Presentations took place Sunday, Sept. 24, 2017 in San Jose, Ca.