National Capital Consortium for Pediatric Device Innovation10.01.20
The National Capital Consortium for Pediatric Device Innovation (NCC-PDI) announces six awardees chosen in its annual “Make Your Medical Device Pitch for Kids!” competition to share in $250,000 in grants funded by the U.S. Food and Drug Administration (FDA) to support the advancement of pediatric medical devices. The competition, powered by NCC-PDI partner MedTech Innovator, focused on cardiovascular, NICU, and orthopedic and spine devices, which are areas of critical need where innovation can significantly improve children's healthcare. The virtual event aired today as part of the 8th Annual Pediatric Device Innovation Symposium presented by Children’s National Hospital in conjunction with The MedTech Conference, powered by AdvaMed.
This year’s pediatric device innovation awardees are:
NCC-PDI is one of five consortia in the FDA’s Pediatric Device Consortia (PDC) Grant Program created to support the development and commercialization of medical devices for children and is led by the Sheikh Zayed Institute for Pediatric Surgical Innovation at Children’s National Hospital and the A. James Clark School of Engineering at the University of Maryland, with support from partners MedTech Innovator, BioHealth Innovation and design firm Archimedic.
"Congratulations to all 10 companies who competed in this year’s finals for developing pioneering innovations that can provide much-needed medical device advancements for children," said Kolaleh Eskandanian, Ph.D., MBA, PMP, vice president and chief innovation officer at Children’s National Hospital and principal investigator of NCC-PDI. "We thank the FDA for making these awards possible. Although more incentives for pediatric device development are needed, it is encouraging to witness the progress we have made since the inception of the PDC program."
In the last decade, only 24 percent of Class III life-saving devices approved by FDA were for pediatric use—and most of those were for children over 12. Less than 4 percent were labeled for pediatric patients ages 0-2 years old and the number of approved devices is even lower for neonatal patients.
"For far too long, pediatric specialists have been manipulating adult medical devices to create solutions for children’s bodies because it’s the only available option,” said Kurt Newman, M.D., president and CEO of Children’s National Hospital. “Children need and deserve devices that are conceived and designed with their biology and future in mind. I’m proud that the annual NCC-PDI symposium and pitch competition is spurring pediatric device innovation. The companies that were highlighted this year are creating solutions that will help children to lead healthier lives and grow up stronger."
Dr. Newman participated in a keynote panel discussion as part of the pediatric symposium alongside Dr. Michelle McMurry-Heath, recently named CEO of Biotechnology Innovation Organization (BIO). Moderated by former CNN correspondent Jeanne Meserve, the two leaders discussed the challenges and the changes needed to accelerate progress in bringing new pediatric devices to patient care.
Additional symposium programs included a panel discussion on real-world evidence featuring members of the Southwest National Pediatric Device Consortium, the West Coast Consortium for Technology and Innovation in Pediatrics, and the UCSF-Stanford Pediatric Device Consortium, as well as a fireside chat podcast about software as a medical device with experts Daniel Kraft, M.D., and Rosemarie Truman, founder and CEO of The Center for Advancing Innovation (CAIStartups).
The 10 pediatric device finalists were selected from a field of 30 semi-finalists who competed in March 2020 out of hundreds of applicants. Leading up to the September 2020 pitch competition, all ten finalists participated in the Pediatric Medical Device Innovation Accelerator sponsored by NCC-PDI with support from Children's National Hospital clinicians, and powered by MedTech Innovator, the largest accelerator of medical devices in the world. The 10 finalists joined 2019 winners AlgometRx, Epitel, Raydiant Oximetry, Rhaeos, and PyrAmes in the 2020 inaugural MedTech Innovator Pediatric Accelerator program.
“It has been a privilege getting to know and support the teams behind these winners and their emerging technologies in our accelerator,” said Paul Grand, CEO of MedTech Innovator. "Pediatric devices are extremely challenging to bring to market, and we're honored to leverage the world's leading device ecosystem to ensure that these life improving innovations successfully reach the children who so desperately need them."
COVID-19 has presented many unique challenges to the healthcare community in 2020 and NCC-PDI partners have continued to move innovation initiatives forward by leveraging virtual formats for programming and competitions.
"There are many exciting technological developments being accelerated in healthcare right now because COVID-19 has amplified the necessity," said William E. Bentley, Ph.D., Robert E. Fischell distinguished professor and director of the Robert E. Fischell Institute for Biomedical Devices at the University of Maryland. "This acceleration is a bit of a silver lining in these times because pediatric healthcare will more quickly receive the benefit.”
As Children's National continues to champion ways to accelerate pediatric device development, one focus is the first-of-its-kind, Children’s National Research and Innovation Campus, located on a nearly 12-acre portion of the former Walter Reed Army Medical Center campus in Washington, D.C. Currently under construction and expected to open in early 2021, the campus’ close proximity to federal research institutions and agencies, universities, academic research centers, and on-site incubator Johnson & Johnson Innovation – JLABS, will foster a rich ecosystem of public and private partners that can help to bolster pediatric medical device innovation and commercialization.
This year’s pediatric device innovation awardees are:
- Adipomics Inc. of Cambridge, Mass.—COVI-SPOT, a one-step COVID-19 diagnosis on the spot.
- BioSense of Beverly Hills, Mich.—The first working non-contact EKG for constant, non-invasive monitoring.
- Innara Health of Olathe, Kan.—A biofeedback device to help newborns and premature infants improve feeding readiness and promote the neuro and physiological aspects of feeding.
- Navi Medical Technologies of Melbourne, Australia—A non-invasive device to provide real-time feedback of central line tip location using ECG.
- Novonate of South San Francisco—Secures and protects the umbilical catheter insertion site for neonates in intensive care.
- Renata Medical of Costa Mesa, Calif.—A growth stent for treatment of congenital narrowed lesions in neonatal patients.
NCC-PDI is one of five consortia in the FDA’s Pediatric Device Consortia (PDC) Grant Program created to support the development and commercialization of medical devices for children and is led by the Sheikh Zayed Institute for Pediatric Surgical Innovation at Children’s National Hospital and the A. James Clark School of Engineering at the University of Maryland, with support from partners MedTech Innovator, BioHealth Innovation and design firm Archimedic.
"Congratulations to all 10 companies who competed in this year’s finals for developing pioneering innovations that can provide much-needed medical device advancements for children," said Kolaleh Eskandanian, Ph.D., MBA, PMP, vice president and chief innovation officer at Children’s National Hospital and principal investigator of NCC-PDI. "We thank the FDA for making these awards possible. Although more incentives for pediatric device development are needed, it is encouraging to witness the progress we have made since the inception of the PDC program."
In the last decade, only 24 percent of Class III life-saving devices approved by FDA were for pediatric use—and most of those were for children over 12. Less than 4 percent were labeled for pediatric patients ages 0-2 years old and the number of approved devices is even lower for neonatal patients.
"For far too long, pediatric specialists have been manipulating adult medical devices to create solutions for children’s bodies because it’s the only available option,” said Kurt Newman, M.D., president and CEO of Children’s National Hospital. “Children need and deserve devices that are conceived and designed with their biology and future in mind. I’m proud that the annual NCC-PDI symposium and pitch competition is spurring pediatric device innovation. The companies that were highlighted this year are creating solutions that will help children to lead healthier lives and grow up stronger."
Dr. Newman participated in a keynote panel discussion as part of the pediatric symposium alongside Dr. Michelle McMurry-Heath, recently named CEO of Biotechnology Innovation Organization (BIO). Moderated by former CNN correspondent Jeanne Meserve, the two leaders discussed the challenges and the changes needed to accelerate progress in bringing new pediatric devices to patient care.
Additional symposium programs included a panel discussion on real-world evidence featuring members of the Southwest National Pediatric Device Consortium, the West Coast Consortium for Technology and Innovation in Pediatrics, and the UCSF-Stanford Pediatric Device Consortium, as well as a fireside chat podcast about software as a medical device with experts Daniel Kraft, M.D., and Rosemarie Truman, founder and CEO of The Center for Advancing Innovation (CAIStartups).
The 10 pediatric device finalists were selected from a field of 30 semi-finalists who competed in March 2020 out of hundreds of applicants. Leading up to the September 2020 pitch competition, all ten finalists participated in the Pediatric Medical Device Innovation Accelerator sponsored by NCC-PDI with support from Children's National Hospital clinicians, and powered by MedTech Innovator, the largest accelerator of medical devices in the world. The 10 finalists joined 2019 winners AlgometRx, Epitel, Raydiant Oximetry, Rhaeos, and PyrAmes in the 2020 inaugural MedTech Innovator Pediatric Accelerator program.
“It has been a privilege getting to know and support the teams behind these winners and their emerging technologies in our accelerator,” said Paul Grand, CEO of MedTech Innovator. "Pediatric devices are extremely challenging to bring to market, and we're honored to leverage the world's leading device ecosystem to ensure that these life improving innovations successfully reach the children who so desperately need them."
COVID-19 has presented many unique challenges to the healthcare community in 2020 and NCC-PDI partners have continued to move innovation initiatives forward by leveraging virtual formats for programming and competitions.
"There are many exciting technological developments being accelerated in healthcare right now because COVID-19 has amplified the necessity," said William E. Bentley, Ph.D., Robert E. Fischell distinguished professor and director of the Robert E. Fischell Institute for Biomedical Devices at the University of Maryland. "This acceleration is a bit of a silver lining in these times because pediatric healthcare will more quickly receive the benefit.”
As Children's National continues to champion ways to accelerate pediatric device development, one focus is the first-of-its-kind, Children’s National Research and Innovation Campus, located on a nearly 12-acre portion of the former Walter Reed Army Medical Center campus in Washington, D.C. Currently under construction and expected to open in early 2021, the campus’ close proximity to federal research institutions and agencies, universities, academic research centers, and on-site incubator Johnson & Johnson Innovation – JLABS, will foster a rich ecosystem of public and private partners that can help to bolster pediatric medical device innovation and commercialization.
