Beyond the EU: DORA and NIS 2 Directive's Global Impact
CRE Medical Final NSF I-Corps Presentation
1.
2.
3.
4. The Business Model Canvas V1 Manufacturers Distributors Parts Suppliers Product Development End User Acceptance FDA Approval IP Protection ISO Certified Manufacturing Product Development Team Financing Improved Product Performance Unmet Needs Usability End Value to Customers End User Clinicians Hospitals Distributors Device Distributors Medical Supply Distributors??? Electrodes??? Physiological Signal Systems Sensors??? Development Costs Cost of Production Regulatory Legal Marketing Device Systems Sales Electrodes: Low Value??? Sensors : Any Value? Existing EEG Markets
5.
6.
7. The Business Model Canvas V4 Manufacturers Value Added Resellers Parts Suppliers Product Development End User Acceptance FDA Approval IP Protection ISO Certified Manufacturing Product Development Team Financing End User Clinicians Hospitals Development Costs Cost of Production Regulatory Legal Marketing Foundations Associations Societies Early Adoptors Improved SNR Improved Specificity Improved Spatial Resolution Improved Sensitivity End User Researchers Device Value Added Resellers Device Retailers / Resellers Neurologists, Neurosurgeons, Psychologists, Audiologists, Neuroscientists Anesthesiologists Existing EEG Markets Research Systems Tripolar EEG Front End Retrofit Sales Tripolar EEG Front End New Sales Electrode Replacement Sales Device Value Added Resellers Medical Supplies Retailers DMS Distributors Improved Product Performance Unmet Needs Usability End Value to Customers Distributors Clinical Systems
8.
9. Neurologist? EEG Diagnostic OR Surgery – Anesthesiologist Hospital Admin Patient
10.
11.
12. The Business Model Canvas V5 Manufacturers Value Added Resellers Parts Suppliers Product Development End User Acceptance FDA Approval IP Protection ISO Certified Manufacturing Product Development Team Financing End User Clinicians Hospitals Development Costs Cost of Production Regulatory Legal Marketing Foundations Associations Societies Early Adoptors Improved SNR Improved Specificity Improved Spatial Resolution Improved Sensitivity End User Researchers Device Value Added Resellers Device Retailers / Resellers Neurologists, Neurosurgeons, Psychologists, Audiologists, Neuroscientists Anesthesiologists Existing EEG Markets Research Systems Tripolar EEG Front End Retrofit Sales Tripolar EEG Front End New Sales Electrode Replacement Sales Device Value Added Resellers Sterile Disposable Sensor Sales Medical Supplies Retailers DMS Sterility Distributors Improved Product Performance Unmet Needs Usability End Value to Customers Distributors Operating Rooms Clinical Systems
13. Distribution Channels Contract Manufacturer Laboratories Scientists VAR Interface VAR / DMS Electrodes Hospitals Admin Neurologist Anesthesiologist Stock Product CREmedical DMS Disposable Channel Customers