Sunday, March 4, 2012

Innovation & Pediatric Devices

Since fewer children than adults get sick, companies in the past have projected a smaller profit potential for investing in pediatric medical devices, diagnostic devices, and for therapeutic research. Since children differ from adults in terms of size, growth, development, and body chemistry, the development of medical devices for children currently lags five to ten years behind the development of devices for adults.

However, today research and development companies, manufacturers, and academic researchers have shown increased interest in pediatric product innovation. To highlight pediatric device research and manufacturing, the University of Michigan is hosting a three day summit March 20-22, 2012 in Ann Arbor so that experts from diverse sectors will be able to share pediatric product success stories, strategies for overcoming commercial barriers, and design solutions to emerging pediatric clinical markets.

Some of the prominent speakers include Dan Strauch, Director of Marketing for Maternal Infant Care at GE Healthcare, Richard G. Ohye, MD., Associate Professor of Surgery and Director of Pediatric Cardiac Surgery and Pediatric Cardiovascular Transplant Program at the U-M, Martin Bocks, M.D., Assistant Professor of Pediatrics and Internal Medicine at U-M, Susan Alpert, Ph.D., M.D., Retired Senior Vice President and Chief Regulatory Officer at Medtronic, Robert H. Bartlett, M.D., U-M Professor Emeritus of General Surgery, Daniel Teitelbaum, M.D., U-M Professor of Surgery at the C.S. Mott Children’s Hospital, and James Geiger, M.D., U-M Professor of Surgery and Pediatric Surgeon at C.S Mott Children’s Hospital.

In 2009, the University of Michigan Medical Innovation Center’s Pediatric Device Consortium also known as M-PED received a $2.3 million grant from the FDA’s Pediatric Device Consortia Grant Program administered by FDA’s Office of Orphan Products Development. In 2011, M-PED along with its Roanoke Virginia based partner the Pediatric Medical Device Institute (PMDI) was awarded an additional $2.2 million for device development.

The American Academy of Pediatrics has been very active in driving pediatric device legislation and AAP appreciated the passage of the “Pediatric Medical Device Safety and Improvement Act of 2007”. PL 110-85 increases the ability to track pediatric device approvals by FDA, coordinates federal response to pediatric device needs, established a pediatric device research agenda, and strengthened post market surveillance of devices used in children.

The legislation also stimulates pediatric device development by eliminating the profit restriction on devices approved under the Humanitarian Device Exemption and also authorizes appropriations for grants to go to non-profit consortia to help develop, produce, and distribute pediatric medical devices.

Just recently the “Pediatric Medical Device Safety and Improvement Reauthorization Act of 2012” was introduced by Representatives Michael Rogers (R-MI) and Edward Markey (D-MA) in Congress. The AAP strongly supports the Act and is working with other groups to see that the legislation moves through Congress.

Go to for more details and to register for the Summit.