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

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Feb 21, 2024 162 likes •261 views

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

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Medtech Startup Product Development

Paul Hartung President & CEO, Sonivance

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SO YOU HAVE A GREAT IDEA? WHO CARES?

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SW Engineers Regulatory Clinical Managers Chemists HW Engineers Mechanical Engineers CMC Specialists Marketing Sales Manufacturing Attorneys Biologists

RESOURCE NEEDS CHANGE OVER TIME

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EMPLOYEES DEVELOPMENT PARTNERS CONSULTANTS

BUILDING A FLEXIBLE TEAM

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PASSION PERSISTENCE TENACITY CREATIVITY

Qualities to look for….

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Process and Documentation are Essential Regulatory Quality Compliance

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How Do You Know It It Works?

Bench test
Prototyping
SW Verification &

Validation (V&V)

In Vitro Testing
Preclinical Testing
Human Testing

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