Safe and Effective Devices for Use In Neonatal, Perinatal and Pediatric Care Settings (R43/R44 Clinical Trial Optional)

Purpose           

A major objective of this funding opportunity announcement (FOA) is to invite SBIR applications to foster collaboration between clinical and bioengineering research communities to develop and test safe, accurate, and effective devices for use in neonatal, perinatal, and pediatric care settings. These can be new devices or improvements on existing devices. The studies may range from concept to developmental phases, with a clear commercialization plan to enable healthcare providers to use them in regular clinical care settings in the population, which is the focus of this FOA.

Background

Despite remarkable advances in perinatal, neonatal, and pediatric care, there is a great need to develop instruments and devices used in the care of this vulnerable population. Such devices need to be developed and tested for their efficacy and safety in these specific vulnerable populations because there are inherent physiological and pathophysiological differences. In addition, research endeavors need to focus on adapting recent biotechnology advances for developing products that can be used in the care of vulnerable populations. As for example, leveraging advances in miniaturized computers and microcomputer chips; communication and ultrafast, high-resolution imaging methods, nanotechnology and microfluidic methods; characterizing volatile products from epidermal layers, and IT technology (M-Health) could be incorporated into developing devices that are safe and effective in the care of vulnerable populations being addressed in this FOA.

Scope

Some of the topic areas for the R&D to be supported under this FOA include, but are not limited to:

Maternal Fetal Medicine: Bedside tests to improve diagnosis of maternal conditions/disease such as preeclampsia/eclampsia; methods to assess fetal well-being; fetal organ maturity; pregnancy surveillance; biomarkers in the management of pre-gestational diabetes and gestational diabetes mellitus; chorioamnionitis; preterm labor; postpartum hemorrhage; and new methods to accurately assess gestational age. 

Neonatal and Pediatric Cardio-pulmonary devices: non-invasive or minimally invasive instruments for assessing and supporting cardiovascular functions such as blood pressure (BP), cardiac output, global and organ-specific tissue perfusion and oxygenation and Methods to assess cardiac electrophysiology. Devices to measure pulmonary functions, including, but not limited to lung volume and their subcomponents, airway resistance, and ventilation/perfusion ratio. Improved systems for respiratory support and reducing air-leaks. Improving devices used in non-invasive ventilation, nasal continuous positive airway pressure (CPAP), synchronized ventilation, and patient triggered ventilation. Non-or minimally invasive methods to measure PCO2 and PO2, and improved aerosol delivery systems targeting small airways.

Brain: devices and instruments for assessing various cerebrovascular functions, including, but not limited to: brain electrical activity, cerebral and cerebellar functional monitoring, total and regional cerebral blood flow, regional cerebral oxygenation, and autoregulation of cerebral blood flow;

Metabolic: non-or minimally invasive devices to measure metabolic substrates, including, but not limited to: serum glucose, ketone bodies and lactate/pyruvate; serum and urinary electrolytes (e.g., Na, Cl, creatinine); measures of liver functions; micro-infusion pumps for administering small quantities of drugs (insulin) or nutrients (glucose) in neonates, infants and small children;

Infections: devices and instruments for diagnosing and treating neonatal and pediatric infections, including, but not limited to: pediatric-optimized culture media, optimized for 1-3 mL of blood to be used in the bottle, specifically for anaerobic microbial cultures; improved low-thrombogenic catheters and tubes (venous, arterial, umbilical, percutaneous, endotracheal, nasogastric) connector-hubs, and syringes. Applications may also address studies to improve the accuracy and speed of bacterial and fungal and viral diseases; including antimicrobial resistance/susceptibility characteristics utilizing small volumes of blood and/or other biological fluids.

Renal: methods of assessing renal function, acute kidney injury, and renal physiology, particularly for sick infants and children in the ICU setting.

Pharmacological: Micro methods to measure concentrations of prescription drugs and their metabolites that can help in clinical pharmacological research as well as patient care, for applications such as for monitoring drug concentrations. 

Commercialization Plan

The intent of all SBIR/STTR funding is to help the SBCs to develop innovative medical devices/products for eventual commercialization. Since the commercialization pathways can be complex, a useful strategy is to plan ahead during the early stages of product development research.

Therefore, SBIR Phase II awardees are encouraged to contact the NIH Small Business Office and request registration for NIH Commercialization Accelerator Program (NIH CAP visit: https://sbir.nih.gov/cap).  NIH CAP is a 9-month program that is well-regarded for its combination of deep domain expertise and access to industry connections, which have resulted in measurable gains and accomplishments by participating companies. Offered since 2004 to address the commercialization objectives of companies across the spectrum of experience and stage, 900+ companies have participated in the CAP. It is open only to HHS/NIH SBIR/STTR Phase II awardees, and 80 slots are available each year. The program enables participants to establish market and customer relevance, build commercial relationships, and focus on revenue opportunities available to them.

NIH offers distinct technical assistance programs to SBIR and STTR Phase I and II awardees. These programs offer specialized, strategic business training and provide access to a vast network of industry experts. (For additional details, see page 74-75 of the document   https://grants.nih.gov/grants/how-to-apply-application-guide/forms-e/sbir-sttr-forms-e.pdf

The NIH "Niche Assessment Program" is another useful source, specifically designed to help Phase I awardees to “jump start” commercialization efforts (https://sbir.nih.gov/nap).

Phase I applicants are also encouraged to develop the outlines for their commercialization plan, and to contact the Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) that offers pre-submission guidance for feedback regarding medical device approvals https://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm311176.pdf and Device Advice document (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/default.htm) on their websites.

Phase II (new and amended), and Fast Track applicants are REQUIRED to provide a clear and strong commercialization plan, including evidence of feedback from the FDA concerning steps to satisfy all regulatory requirements. The applicants are encouraged to contact FDA early, since the timeframe for feedback with regards to a pre-submission request is 70 days, as described in the pre-submission guidance document  https://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm311176.pdf provided on the FDA webpage.  They are also encouraged to visit Device Advice document (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/default.htm) to further gather information concerning device development and commercialization.

All applicants (Phase 1, Phase II, and Fast-track) who receive funding under this FOA are expected to attend a workshop in the metropolitan Washington, D.C., area that is jointly sponsored by the NICHD and FDA for de-briefing and guidance concerning the processes for commercialization. The workshop has no registration fee, but the applicants may include travel expenses in their budget to attend the one-to-two-day workshop.

In addition, all successfully funded applicants (Phase I, Phase II, and Fast-Track) are also required to provide, in their first annual or semiannual progress report, evidence of written feedback derived from meeting(s) or teleconference(s) with the FDA detailing the progress made on the issues concerning their device development and receiving regulatory approvals.

See Section VIII. Other Information for award authorities and regulations.