1 / 6

Project/Product Title

Project/Product Title. PI (and Co-PI) Affiliation. August 10, 2012. Background and Potential Market. *Premarket Assessment of Pediatric Medical Devices http :// www.fda.gov / MedicalDevices / ProductsandMedicalProcedures /ucm135104.htm. Description of the unmet clinical need

jadzia
Download Presentation

Project/Product Title

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. Project/Product Title PI (and Co-PI) Affiliation August 10, 2012

  2. Background and Potential Market *Premarket Assessment of Pediatric Medical Devices http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ucm135104.htm • 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

  3. Proposed Solution (Development Direction)

  4. One slide MAXIMUM to describe technology being used in this project. Technology Overview and Feasibility

  5. IP status of proposed product IP process to date Potential technology transfer targets (licensing, start-up, etc) Intellectual Property Landscape

  6. Development Goals, Milestones, Timelines • Table or Gantt Chart • Pro Forma Project Budget Summary

More Related