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Medtech Startup Product Development Paul Hartung President & - PowerPoint PPT Presentation

Medtech Startup Product Development Paul Hartung President & CEO, Sonivance SO YOU HAVE A GREAT IDEA? WHO CARES? RESOURCE NEEDS CHANGE OVER TIME Regulatory SW Engineers Attorneys Biologists Chemists Manufacturing Sales HW Engineers


  1. Medtech Startup Product Development Paul Hartung President & CEO, Sonivance

  2. SO YOU HAVE A GREAT IDEA? WHO CARES?

  3. RESOURCE NEEDS CHANGE OVER TIME Regulatory SW Engineers Attorneys Biologists Chemists Manufacturing Sales HW Engineers Mechanical Engineers CMC Specialists Marketing Clinical Managers

  4. EMPLOYEES DEVELOPMENT CONSULTANTS PARTNERS BUILDING A FLEXIBLE TEAM

  5. Qualities to look for…. PASSION PERSISTENCE TENACITY CREATIVITY

  6. Regulatory Compliance Quality Process and Documentation are Essential

  7. How Do You Know It It Works? • Bench test • Prototyping • SW Verification & Validation (V&V) • In Vitro Testing • Preclinical Testing • Human Testing

  8. Contact: Paul Hartung phartung@sonivance.com

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