$2.2 million FDA grant designed to create safe solutions for medical problems in children
ANN ARBOR, Mich. — Adapting adult medical devices to be used for children is a common but often problematic practice across U.S. hospitals.
At the University of Michigan and U-M C.S. Mott Children’s Hospital, pediatricians and researchers who care for children have been leading the charge to change this. They work to create, engineer and test medical devices and curb problems that come from using tools, implants, gadgets and procedures designed for adults.
This week, the Food and Drug Administration awarded a two-year, $2.2 million grant to University of Michigan researchers, under the leadership of pediatric surgeon James D. Geiger, M.D. The grant will support three of more than 40 ongoing pediatric device projects for children.
“This award will give us a great opportunity to meet our vision of creating a long-term sustainable effort in pediatric device development under the umbrella of the U-M Medical Innovation Center,” Geiger says. “We are humbled to receive this award.”
The grant is awarded to two groups that have been working together since late 2009. The Michigan Pediatric Device Consortium (M-PED) brings together business, engineering, dental, medical school resources to work on children-specific devices. The Virginia-based Pediatric Medical Device Institute (PMDI) is a consortium of children’s hospitals, including Mott, dedicated to facilitating the transition of pediatric medical device needs to clinically-beneficial tools. It is directed by Andre Muelenaer, M.D., who with Geiger is a co-recipient of the award.
The U-M grant is the largest given by the FDA this year to create pediatric medical devices and the second of such grants for U-M in the last two years. In 2009, the U-M Medical Innovation Center won a $2.3 million award to get the U-M Pediatric Device Consortium (M-PED) started.
The current grant will help fund work on three projects deemed by the FDA to have the most potential from a business and medical standpoint. Researchers working on these prototypes hope to ultimately find manufacturers to build and market these devices. The FDA will fund the following projects:
• Daniel H. Teitelbaum, M.D., a U-M C.S. Mott Children’s Hospital pediatric surgeon whose team has developed treatments for children with short bowel syndrome, won funding for work on a device that induces small intestinal lengthening without surgery.
Short bowel syndrome occurs when large portions of the small intestine are removed by surgery or are missing due to a birth defect. The small intestine is too short and cannot absorb enough nutrients from food. The condition can be treated with medication, bowel lengthening surgery and at times and with mixed results, a bowel transplant. Teitelbaum’s team has developed a prototype that has gone through various stages of testing in animals with positive results.
• Jeanne Nervina, D.M.D., Ph.D., assistant professor at the U-M School of Dentistry, is developing a smart rapid palatal expander to treat children with cleft palate. The project includes designing and testing the smart palate expander using microengineering and low power circuits that sense and respond to orthopedic forces.
• Robert H. Bartlett, M.D. and Gail M. Annich, M.D., are working on non-clotting, biofilm- resistant catheters for use in newborns. This was one of M-PED’s first two projects and has made substantial progress in the last two years. The overall goal of this project is to develop small intravascular catheter for neonates to address the clotting and infection problems with catheters in children. This project expects to go to commercialization within two to three years.
Developing medical devices for children has been a priority for the FDA in recent years. There are no good data that track problems caused by using the wrong device or procedure in children. Pediatric devices have traditionally taken a long time to reach the market. The market for pediatric devices is small and because there are few patients, it can be difficult to gather the data required for FDA approval of high-risk devices.
Doctors work around these problems by adapting devices to fit children. This solution has limits and risks. Problems range from using catheters or stents that are too large for children or pacemaker batteries running out because children's hearts beat faster.
“This award is a tremendous honor and will allow us to build upon early success with our pediatric partners, says Medical Innovation Center Commercialization Director Lindsay Klee. We look forward to supporting new stages of clinical development, manufacturing, and clinical uptake of portfolio devices and diagnostics.”
While the U.S. market for medical devices is estimated at more than $90 billion, the demand for pediatric devices is small, creating little financial incentive for companies to invest in the space. Development of new pediatric devices lags about 10 years behind similar devices for adults, according to the FDA.
The grant is a shot in the arm for the University and for other groups who work with the university, such as Michigan Critical Care Consultants, or MC3, which is working with U-M researchers on developing a pediatric blood pump.
“I look forward to continuing to collaborate with MPED,” says Scott Merz, president of MC3. “Michigan researchers continue to pursue innovative solutions to conditions that affect children. MC3 brings experience in product development and commercialization, which can help the U-M’s device concepts reach the market.”