Format

• 30-35 minute PowerPoint presentation

• Feel free to bring prototypes, drawings, etc.

Content

The need:

• Clinical problem and consequence of the problem

• Pediatric subpopulation (age range 0-21 years)

• Incidence of disease/condition in U.S. (How many people per year newly acquire this disease/condition?)

• Prevalence of disease/condition in U.S. (How many people have had this disease/condition during a specified time period?)

The device:

• Envisioned solution

• Potential value proposition of the technology

• Stage of the solution & milestones achieved

• Anticipated device class (Click here to learn more)

  • Class 1, Class 2, Class 3

• Anticipated regulatory pathway

  • Exempt, 510k clearance, Humanitarian Device Exemption, Premarket Approval

The market:

• Target users

• Competitive landscape & existing products on the market

• Market size

Challenges:

• Questions for the PDC