Download - Project/Product Title
Project/Product Title
PI (and Co-PI)Affiliation
August 10, 2012
2
Background and Potential Market
• Description of the unmet clinical need• Current standard of practice• Description of target subgroup in pediatric
market (FDA definition*)
– Newborn (neonate): birth to 1 mo.– Infant: 1 mo. to 2 yrs.– Child: 2 yrs. to 12 yrs.– Adolescent: 12 yrs. to 21 yrs.
• Application/market size – number procedures or patients*Premarket Assessment of Pediatric Medical Devices
http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ucm135104.htm
3
Proposed Solution (Development Direction)
Technology Overview and Feasibility
4
• One slide MAXIMUM to describe technology being used in this project.
Intellectual Property Landscape
5
• IP status of proposed product• IP process to date• Potential technology transfer targets
(licensing, start-up, etc)
6
Development Goals, Milestones, Timelines
• Table or Gantt Chart
• Pro Forma Project Budget Summary