What does M-PED stand for?
University of Michigan PEDiatric Device Consortium.
How is M-PED funded?
In 2009 the FDA distributed P50 grants intended to spur commercialization of pediatric devices.
Why did the FDA do this?
The grant process is part of the requirements spelled out in the Pediatric Medical Device Safety and Improvement Act of 2007. The program, called PDC, is being operated by the Office of Orphan Product Development (OOPD)
What does the P50 grant from the FDA support?
When distributing the grants, the FDA specifically targeted most of the funds toward what we call an “innovation engine”….mechanism that multiple innovators can use to address the challenges unique to pediatric device commercialization. On a quarterly basis, we report the progress on each project that has been brought to the Consortium for help.
Who else received funding for Pediatric Device Consortia?
Subsequent to the initial award, the FDA funded the launch of MISTRAL in collaboration with the Institute for Pediatric Innovation
What is the time frame for the P50 Grant?
The funding goes through August 31, 2011. M-PED has partnered with PMDI in response to the 2011 FDA RFA.
How is M-PED fulfilling the FDA’s vision?
Pediatric device innovators are being assisted through the Medical Innovation Center’s Concept to Commercialization Program. Through this program, we help innovators find collaborators, make prototypes, assess intellectual property, determine the regulatory path, determine the reimbursement landscape, identify licensees, manage their project and find funding for all of the above.
Do you only help University of Michigan innovators?
No, we provide this service to anyone interested in advancing pediatric devices.
Did the P50 grant include any funds to support pediatric device projects?
Yes, a small part of the grant was targeted to support two specific projects. There is no additional funding available for other projects. The mission of the Consortium is to help pediatric device innovators find funding of that sort.
Is the Consortium granting any funds to support pediatric device projects?
No, we do not have funds to distribute to specific projects. However, we are exploring creative ideas to raise funds for this purpose.
How many pediatric device projects are you supporting at this time?
In our latest quarterly report to the FDA (April 2011), we reported on 62 innovations ranging in stage from concept stage to post-market surveillance. The list includes innovations from the University of Michigan as well as from the Pediatric Medical Device Institute (PMDI), our collaborator in the Roanoke, VA area.
What do I do if I have a pediatric device idea to M-PED?
Submit an Intake Form to UM-MIC@med.umich.edu and we will begin the process of evaluating IP, regulatory, reimbursement and commercial options.
Who runs M-PED?
The Medical Innovation Center operates the Consortium through its existing faculty and administrative staff.
Leadership
Operations
How can industry help?
© 2013 Created by Samuel M. Keith.
