Name stages and gates of the stage gate Process
S: Needs
G: Concept choice
S: Ideas
G: Project definition
S: Selection
G: Initial Design
S: Manufacture
G: Final design
S: Scale Up
G: Product release
S: Roll-out
Differences between medical devices and pharmaceuticals
medical devices
pharmaceuticals
engineering based object
chemistry based compounds
localized treatment effect
often systemic application
can become obsolete within months
innovation cycle 10-20 years
fragmented industry with many med. sized companys
small numer of large companies
require user interaction
sehfl-life requirements play a significant role
Stage Needs
Identifikation of clinical needs by backwards developing
Reduction of needs to one clinical need
Selection of need and proposed concept
Stage ideas
Market analysis and competitive assessment
Legal/IP anaylsis
risk classifikation of med. devices
financial review
regulatory path
reimbursement path
Stage selection:
Core team selection
Iniating design history file (dhf)
Risk analysis
Risk assessment matrix
risk management
Stage Manufacture:
Stage Scale-Up:
Approval
Clinical validation
Process validation
Limits of the stage gate process
SGP is a linear model
Iterative reality leads to fuzzy model boundaries
Last changed2 years ago
