What Changes Underway at FDA Seem Most Pro-Innovation?
Two regulatory experts and a former FDA lead reviewer share their perspective on changes underway at the agency that may help medtech innovators.
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- TOPIC
- 1.1 Strategic Focus
- 1.2 Needs Exploration
- 1.3 Need Statement Development
- 2.1 Disease State Fundamentals
- 2.2 Existing Solutions
- 2.3 Stakeholder Analysis
- 2.4 Market Analysis
- 2.5 Needs Selection
- 3.1 Ideation
- 3.2 Initial Concept Selection
- 4.1 Intellectual Property Basics
- 4.2 Regulatory Basics
- 4.3 Reimbursement Basics
- 4.4 Business Models
- 4.5 Concept Exploration & Testing
- 4.6 Final Concept Selection
- 5.1 IP Strategy
- 5.2 R&D Strategy
- 5.3 Clinical Strategy
- 5.4 Regulatory Strategy
- 5.5 Quality Management
- 5.6 Reimbursement Strategy
- 5.7 Marketing & Stakeholder Strategy
- 5.8 Sales & Distribution Strategy
- 5.9 Competitive Advantage & Business Strategy
- 6.1 Operating Plan & Financial Model
- 6.2 Strategy Integration & Communication
- 6.3 Funding Approaches
- 6.4 Alternate Pathways
- ORGANIZATION
- SPEAKER
- Michael Ackermann
- Meredithe Applebury
- Dan Azagury
- Rush Bartlett
- Balram Bhargava
- Mike Billig
- Todd Brinton
- Brook Byers
- Wendy Chan
- Bill Chisholm
- Ian Connolly
- Stefano Curti
- Mark Deem
- Alex de Winter
- Bill Facteau
- Brandon Felkins
- Biodesign Fellows
- Kate Garrett
- Gary Guthart
- Sami Hamade
- John Hernandez
- Jessica Hudak
- Mir Imran
- David Kelley
- Tom Kelley
- Deb Kilpatrick
- Dorothea Koh
- Tom Krummel
- Uday Kumar
- Ted Lamson
- Josh Makower
- Juan-Pablo Mas
- Mika Mayer
- Milt McColl
- Victor McCray
- Peggy McLaughlin
- Ketan Mehta
- Craig Milroy
- Santiago Ocejo-Torres
- Julie Papanek
- Bakul Patel
- Jan Pietzsch
- Hank Plain
- Sandy Ruggles
- Jeff Shuren
- Jenna Tregarthen
- Brad Vale
- Ryan Van Wert
- Gerard von Hoffmann
- James Wall
- Paul Wang
- Jay Watkins
- John White
- Paul Yock
- Marta Zanchi
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