CobiCure
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345 Park Ave South
New York, NY 10010
contactus@cobicure.org
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The field of pediatric medical technologies is fragmented, with a small market size, multiple stakeholders and few incentives to promote novel solutions, despite the obvious need. In pediatric cardiology alone, 40,000 congenital heart defects are reported annually in the United States.
63%
Off-Label
Use of Devices
40,000 congenital heart defects occur annually in the US, yet 63% of pediatric interventional cardiology procedures use off-label devices.
(i)
9%
Unmet Pediatric
Clinical Needs
Of the high-risk medical devices approved for pediatric populations, only 9% are for neonates and infants under two years of age.
(ii)
~1:4
Lagging
Innovation
The annual number of adult medical device FDA approvals is increasing at a rate 4x higher than pediatric devices.
(iii)
76%
Market Barriers
76% of Key Opinion Leaders in pediatric MedTech reported return on investment as the main barrier for entering the pediatric market.
(iv)
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SOURCES
i Beekman et al, 2010. Pediatric Interventional Cardiology in the United States is Dependent on the Off-label Use of Medical Devices. https://onlinelibrary.wiley.com/doi/abs/10.1111/j.1747-0803.2009.00364.x
ii & iii FDA Report to Congress: Premarket Approval of Pediatric Uses of Devices, FY 2017.
iv FDA Public Meeting – Pediatric Medical Device Development. August 13th & 14th, 2018.