The Food & Drug Administration awarded the MISTRAL Collaborative of SRI International and the Stanford University School of Medicine a $1 million grant to support the agency’s work to commercialize medical devices for newborn intensive care units.
MISTRAL, which stands for Multidisciplinary Initiative for Surgical Technology Research Advanced Laboratory, is working in conjunction with the Cambridge, Mass.-based Institute for Pediatric Innovation, which has had success spurring commercialization of medical devices for treating children.
There are a lack of standards for the design and development of pediatric devices, SRI said in a press release, and insufficient data to demonstrate efficacy and support regulatory approvals. The comparatively small market size also adds a dimension to the investment environment already adverse for investors.
IPI has a "needs-driven innovation model," said COO Ross Trimby in the press release, and their process has already "resulted in industry agreements to develop three NICU devices."
IPI founder and CEO Donald Lombardi, a former intellectual property chief at Boston’s Children’s Hospital, told MassDevice in January that the institute goes through a rigorous process to find products that are both clinically needed and commercially viable.
Last week, IPI added Children’s National Medical Center in Washington, D.C. to the team of hospitals it has assembled to work on developing pediatric medical devices.