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