201710 Safe and Effective Devices for Use in Neonatal, Perinatal and Pediatric Care Settings (Raju, PPB)

Program seeks Council approval for an initiative titled “Safe and Effective Devices for use in Neonatal, Perinatal and Pediatric Care Settings.” A major objective of this FOA is to foster collaboration between clinical and bioengineering research communities to develop, test and optimize devices for use in neonatal, perinatal and pediatric care settings.

Despite major advances in pediatric and perinatal care, we still need to adapt invasive procedures for monitoring of blood pressure and cardiac output; draw blood for routine biochemical monitoring, and wait for hours to receive results from diagnostic tests.  Given the rapid pace of technological development it is critical that NICHD find ways to enhance the application of these technologies to improve neonatal, perinatal, and pediatric care. Examples of technologies relevant to these issues are:  telecommunication technology; ultrafast high-resolution imaging methods; miniaturized computers and microcomputer chips; nano-technology and microfluidic methods for POC diagnosis by measuring biochemical products with low volumes of specimen (saliva, urine); the ability to characterize volatile products from epidermal layers; and IT technology (M-Health). While these technologies are revolutionizing other areas of healthcare, few of these have been incorporated into developing devices that safe and effective for use in pediatric and perinatal populations. There is also a greater interest by the FDA to stimulate and bring pediatric devices to market.

In addition to stimulating the development of new, safe, and effective devices for use in neonatal, perinatal, and pediatric care settings, this FOA also will seek to facilitate interactions with FDA early in the development pipeline so that successful products can be brought to the market more efficiently.

Improving pregnancy outcome is a major Branch Priority, and improving outcomes of all children is the scientific mission of NICHD.

Program Contact

Tonse Raju
Pregnancy and Perinatology Branch

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