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Pediatric Medical Device Innovation for Neonates and Infants in Healthcare Market

This project aims to address unmet clinical needs in pediatric medical care for neonates and infants. As per FDA classification, the target subgroups include newborns, infants, children, and adolescents. The technology being developed will revolutionize the standard of practice in pediatric healthcare. The project timeline, milestones, IP status, and budget summary will be outlined for successful implementation.

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Pediatric Medical Device Innovation for Neonates and Infants in Healthcare Market

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  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

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