UPDATE: IPI blazes "clear path" to market for neonatal medical devices

January 14, 2010 by MassDevice staff

The Institute for Pediatric Innovation Inc. is working with a pair of hospitals to develop medical devices for infants in neonatal intensive care units.

The Cambridge, Mass.-based institute said it's working with California's Lucile Packard Children's Hospital at Stanford on a new pediatric endotracheal tube optimized for neonatal care and with University Hospitals Rainbow Babies & Children's Hospital of Cleveland on a vein transilluminator designed to reduce the number of needle sticks required to locate a vein.

IPI, which will manage the development of the devices, said the work is being funded by a $200,000 contract with an un-named medical device company, according to a press release. The hospitals will provide end-user input on the design of the devices, which are expected to be ready for the marketplace by the fourth quarter.

Donald Lombardi, founder and CEO of the four-year-old nonprofit, is a former intellectual property chief at Boston’s Children’s Hospital. Lombardi told MassDevice that the institute goes through a rigorous process to find products that are both clinically needed and commercially viable. Lombardi declined to name the medical device company funding the program, saying the firm had requested anonymity.

The IPI development process begins with an intensive round of interviews at pediatric facilities to determine needs and proceeds through a stringent evaluation process to arrive at product ideas worth backing, he said.

"We've developed a very thorough and analytical approach to working with our consortium hospitals, other hospitals and their clinical staffs asking them where the problems are — where is your current set of tools inadequate, where are you 'klugeing together, bending, resizing, making do," Lombardi said. "The whole approach that IPI is using — our whole reason for existence — is to try and overcome some of the historic barriers to getting products developed and commercialized for pediatrics."

The IPI's "pediatric product sustainability plan" is essentially a road map to market for the un-named medical device company backing the project, he added. The backer of the endotracheal tube and the vein illuminator has agreed to take those two products to market once they're out of the development phase, Lombardi said.

"There's no point in putting an effort into something that can't hold itself up in the marketplace," he said. "It's a funding package that says, basically, 'You can create this product with this functionality, sell for this price; it has these human factors, here's how many you can sell and here's what it's going to cost you to try to market it."

The two devices were selected as priorities for development after the institute and its consortium of pediatric hospitals ran an in-depth needs analysis at children's hospitals across the country. That process identified devices designed for adults that are too large or otherwise unsuited for use with infants.

The new endotracheal tube addresses the high level of intubations in NICUs, where about 90 percent of patients require respiratory assistance. Neonatal infants, especially those born prematurely, have minute and fragile airways that can easily be damaged by an adult-size endotracheal tube.

The vein illuminator addresses a similar problem of scale: The tiny size of veins in newborn and premature infants, which makes them difficult to locate when doctors or nurses need to introduce IV needles or perform other injections. The device will allow medical professionals to "see" the blood vessels in premature infants, according to the press release.

Permalink