umd 2014 presentation - university of minnesota duluthsburns/ee1001fall2014/umd 2014... ·...
TRANSCRIPT
Phrazer®From Idea to Qualified Medical Device:
Roadmap
MAT JOHNSONCEO AND FOUNDER OF GEACOM, INC.
Invention: Starting Point
• What is wanted and why
• Resources and team
• Partners and proxies
MARKET ALIGNMENT
• Just behind Heart Disease and Cancer, Medical Error ranks as the third leading cause of death in the US.
• The US alone spends over $750 Billion on care that does not improve health outcomes.
Design Needs
• Mechanical
• Electrical
• Functional
Mechanical
• What must it do?
• What are the big part needs?
• What makes it special?
Mechanicals
• SolidWorks
• 3D Prints
• Urethane Test
• FDA Steel Molds
Electrical
• What must it do?
• What are the big part needs?
• What makes it special?
Electrical: Getting Started
• Open Source Hardware start point
• Compatible components
• Component engineer assistance
HIGH DENSITY, HIGH SOPHISTICATION BOARDTRACE MAP - 1 LAYER
PCB
• 2 main boards
• 8 layers and 14 layers
• Challenges in design
Battery & Power
• Size
• Chemistry
• Life / Charge Cycle
• Circuit Protection
• Hot Swapping
Other Key Components
• P-Cap TS & High Bright Display
• Camera and Microphone
• Multi-Antenna
• LEDs and Controllers
Functional
• Drivers and Operating System
• Testing and Manufacturability
• User Interfaces
GETTING SUPPLY SUPPLY CHAIN INTEGRATION PARTNER AND GENERAL SOURCING
Approved Venders
Supply ChainIntegration Partner
SCIPClientOn-Site Services
SCIP SupportedClient Transaction Portal
GeaComManufacturingOperations
GeaComCorporate
GeaCom Marketing/Sales (3 and 6 month)
Strategy
Schedule material deliveries to SCIP
Warehousing
Allocation deliveries to Geacom
Schedule material deliveries to
GeaCom
Place orders for deficiencies
Compare forecast to Allocations, Pipe-
line Orders and Inventory
Supply Chain Integration
Projections and Planning
GeaCom Manufacturing
Operations Planning Forecast
Receive Materials Qualify Material Receipt
Move Material to Point of Use
Inventory
Monthly material Invoice to GeaCom
Material Shipment to SCIP Inentory
Vender Operations Vender Invoice to SCIP
SCIP Accounts Payable to Vender
GeaComAccounts Payable to
SCIP
SCIPAccount Recievable
Rectify Consignment/
KanBan Inventories
Sales Order Recieved
Manufacturing to Order
Unit Packaged for Distribution
Part Lot Tracking Unit Tracking, UID and shipping label
Unit/Bundle Distribution
Accounts receivable from customer
Customer Billing
Order tracking
Vender PerformanceMonitoring
Vender Sourcing Umbrella
Vender Qualification
Supply Chain Integration Partner Model
PUT IT ALL TOGETHERA FULLY FUNCTIONAL MANUFACTURED, MARKET READY PRODUCT