The San Antonio-Austin hub of a pediatric medical device consortium announced Monday it is actively looking for innovative pediatric medical device entrepreneurs in need of investment and development resources.
The Southwest National Pediatric Device Consortium (SWPDC) recently received a U.S. Food & Drug Administration (FDA) five-year grant for $6.75 million. Texas Children’s Hospital (TCH), the largest children’s hospital in the U.S., and Baylor College of Medicine (BCM), one of the largest recipients for pediatric federal research funding in the U.S. anchor the consortium. The FDA grant went into effect Sept. 1. and will enable the consortium to support pediatric medical device innovators with product, technology, and business acceleration services both regionally and nationally.
The Southwest consortium has a presence in Houston, Dallas, Phoenix, and San Antonio. InCube Labs leads the San Antonio-Austin hub which includes the Children’s Hospital of San Antonio, the Southwest Research Institute (SwRI), and VelocityTX. Each of the four partners will leverage its respective expertise to support pediatric device innovators who apply for funding. Mentors from the four San Antonio-based partners will advise selected project teams on intellectual property, engineering design, prototyping, laboratory testing, grant-writing, unmet clinical needs assessment, and clinical trial design for new pediatric medical devices.
“A great need currently exists for medical devices designed specifically for children,” said Dr. Chester Koh, founder of SWPDC and lead principal investigator, as well as a pediatric urologist at Texas Children’s Hospital and professor of urology, pediatrics and OB/GYN at Baylor. “With this support from the FDA, our consortium will continue to assist pediatric device innovators along all stages of development with the goal of improving our care of pediatric patients.”
When it comes to healthcare, the pediatric population is at risk of because few critical medical devices are designed for children. Unlike pharmaceuticals, companies are not required to develop medical devices in children. Over the past decade, only about nine percent of medical devices going through pre-market approval were approved for use in children under 18, according to FDA data. Pediatric device development can be challenging, and not only because of the extra regulatory hurdles of proving the concept works for those under 18 years of age. The small number of children with certain medical conditions makes it difficult to perform studies and commercialize devices. Younger patients also often react differently than adults to medical devices. If investors cannot see the market potential for a sufficient return on investment, they typically avoid funding pediatric medical devices.
Given the lag in developing medical and surgical devices for children, pediatricians, manufacturers, and regulators have joined forces to look for new solutions. Pratap Khanwilker, InCube vice president for product development and consortium steering committee member, worked on pediatric medical devices before joining InCube and understands the challenges in bringing a product to market.
“The consortium was formed several years ago to address this pressing need,” said Khanwilker. “It’s harder to get early-stage funding for pediatric device development, so the FDA grant provides seed funding for entrepreneurs working on promising devices.”
The Children’s Hospital of San Antonio offers clinical perspectives on the practical needs of children and their caregivers. InCube Labs brings its expertise in product development and how to bring a product to market. SwRI plans to share its expertise in developing technology in compliance with FDA requirements.
“SwRI is looking forward to leveraging our direct project experience in medical device and drug development programs to help consortium awardees advance their products,” said Joe McDonough, director of pharmaceuticals and bioengineering in SwRI’s chemistry and chemical engineering division.
VelocityTX will mentor entrepreneurs in building a successful company and teach them how to raise the next round of funding to support the device’s commercialization.
“We are very excited to be included in this partnership in developing pediatric devices,” VelocityTX CEO Randy Harig said. “The pediatric focus is important for San Antonio and has allowed us to create opportunities in this area already. I believe this grant will accelerate these individual opportunities and VelocityTX will be ready to bring them to market.”
The consortium will also work to increase awareness around the need for novel pediatric medical device development, as well as help identify and address current barriers to pediatric medical device development and commercialization. Their focus will be to establish a medical needs-driven pipeline of new products.
“Texas Children’s Hospital and the Baylor College of Medicine and Texas A&M are excited about the rapidly growing medtech ecosystem in San Antonio and look forward to working closely with the region to enable clinical translation and improved outcomes for pediatric patients,” said Dr. Balakrishna Haridas, co-founder and co-principal investigator of the SWPDC and professor in biomedical engineering at Texas A&MUniversity.
The consortia have assisted or advised more than 1,000 medical device projects since the program began. There are now 19 pediatric medical devices available to patients as a result of this grants program.“The FDA’s grant is a great first step to tackling the issue,” Khanwilkar said. “It's an opportunity to fund promising ideas and jumpstart pediatric device development in San Antonio.” Click To Tweet
Featured image is of an infant in neonatal care. Pediatric medical device development lags behind that for adults, according to the FDA. Image courtesy FDA Pediatric Medical Device Development conference, August 2018.