The FDA awarded a $1 million grant to accelerate commercialization of pediatric medical devices to the Institute for Pediatric Innovation (IPI), SRI International and the Stanford University School of Medicine's MISTRAL Collaborative. The award will be shared across the three entities.

The key objective of the FDA-funded project will be to identify the opportunities for new medical devices that are a necessity in the neonatal (newborn) intensive care unit (NICU) setting.

"Pediatric devices are an area that the industry has largely ignored, so there are hundreds of unmet needs in pediatric care for medical devices that are designed specifically for treating especially small children and babies," Don Lombardi, president, CEO and founder of IPI, told DOTmed News. "Without some input from the federal government to help address and overcome some of the barriers to getting products developed for pediatrics, there is very little chance that the pediatric practice using medical devices is going to have a chance to improve," he said.

Pediatrics make up a small part of the health care market and the approval process is more stringent, explained Lombardi. "So if you add a smaller upside and a higher challenge to get the products FDA approved, the companies don't have the incentive," he said.

Massachusetts-based IPI works by assessing the unmet needs in a given clinical area. This process includes on-site visits to IPI's seven consortium hospitals and other facilities. The organization also meets with hundreds of physicians to figure out issues with the current devices and identify the gaps in pediatric care, explained Lombardi. Once the needs are established, IPI puts the products through a product sustainability analysis to figure out if it will be feasible to get the devices to the market.

"That's the end stage of our needs assessment process and it's the beginning stage of our product development program," said Lombardi.

With the FDA grant, IPI plans to work with SRI International and the MISTRAL Collaborative to develop four pediatric-specific products.

SRI International is a Silicon-Valley based independent research and technology organization. The MISTRAL Collaborative at the Stanford University School of Medicine is the Multidisciplinary Initiative for Surgical Technology Research Advanced Laboratory.

IPI recently added a seventh facility to its consortium and hopes to bring some products to advance pediatrics soon.

"At this time, we have three products from our previous needs analysis that are currently being funded by a major medical device company to take to the point of actual product. These products, we believe, will start getting into the market starting in 2011," said Lombardi.

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