Heterogeneity of Treatment Effect and Pediatric Medical Device - - PowerPoint PPT Presentation

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Heterogeneity of Treatment Effect and Pediatric Medical Device Development

Vasum Peiris, MD MPH FAAP, FACC, FASE Chief Medical Officer – Pediatrics and Special Populations Center for Devices and Radiological Health U.S. Food and Drug Administration

FDA – Johns Hopkins University CERSI Workshop 2018

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Challenge Question: How long can a neonate tolerate a heart rate

• f 220 beats per minute?

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Birth – 28 days 29 days - < 2yrs 2yrs - < 12yrs 12yrs - < 22yrs

FDA CDRH - Pediatrics and Special Populations

Pediatric Age Groups

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A world where it can be made for children first is here…

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y = 0.96x + 5.1 R² = 0.41 p=0.046 y = 3.8x + 13.1 R² = 0.67 p=0.004

10 20 30 40 50 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017

# of Approved Devices Fiscal Year

Approved PMA and HDE Devices (Pediatric) Approved PMA and HDE Devices (Non-Pediatric) Linear (Approved PMA and HDE Devices (Pediatric)) Linear (Approved PMA and HDE Devices (Non-Pediatric))

Upward trajectory in the total number of PMA and HDE applications Adult approvals significantly greater than pediatric approvals

n=29 n=31 n=20 n=41 n=52 n=39 n=37 n=61 n=71 n=66

Adult Devices Increasing Faster than Pediatric

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y = -0.0032x + 6.775 R² = 0.0137 p=0.8 0% 20% 40% 60% 80% 100% 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017 % of Approved Devices with a Pediatric Indication Fiscal Year Percentage of Pediatric Indications Linear (Percentage of Pediatric Indications)

Novel devices are not being developed for children at a similar rate as for adults

Little Change in Percentage of Pediatric Approvals

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Steps Toward a Contemporary System for Adults and Children

If we can foster a system that supports technology innovation that serves the complex needs of children, then we will accelerate device development for everyone

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Thank You

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Thank You