SRI International and Stanford University School of Medicine have reported that their MISTRAL Collaborative (the Multidisciplinary Initiative for Surgical Technology Research Advanced Laboratory), in conjunction with the Institute for Pediatric Innovation, has been recently awarded a $1m grant by the FDA to support its work to commercialise medical devices for pediatric care.
The objective of the FDA-funded project is expected to identify opportunities for new medical devices specific to the newborn intensive care unit (NICU) setting. Other focus areas for pediatric product development include surgical tools and catheter-related products.
Reportedly, the economic challenges mean that the return on the investment required to develop and test pediatric devices usually falls below the profit goals of medical device companies.
The work of the MISTRAL pediatric device consortium is expected to be performed by a cross-functional team comprised of technical staff from SRI, physicians and medical staff from Stanford and Packard Children’s, consultants, and industry professionals.
To improve opportunities for the successful commercialisation of pediatric devices, researchers will work closely with a distinguished group of advisors that will evaluate technologies and provide feedback on business plans.
The FDA-funded pediatric device consortium project will be led by MISTRAL co-founders Sanjeev Dutta and Pablo Garcia. Mr Garcia leads research in medical systems and medical product development, telemedicine and robotic surgery. Mr Dutta is a nationally recognised leader in minimal-access surgery and defined the area of stealth surgery, a ‘scarless’ approach to pediatric operations.
Mr Dutta, associate professor of surgery and of pediatrics at the Stanford University School of Medicine and attending surgeon at Lucile Packard Children’s Hospital at Stanford, said: “Children are the ‘orphans’ of the medical device industry. The MISTRAL Collaborative, with this tremendous boost from the FDA, hopes to catalyze pediatric device development by performing the initial R&D, partnering with industry, and identifying paths to market for badly needed pediatric devices.”