UMD 2014 Presentation - University of Minnesota Duluthsburns/EE1001Fall2014/UMD 2014... ·...

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Phrazer® From Idea to Qualified Medical Device: Roadmap

Transcript of UMD 2014 Presentation - University of Minnesota Duluthsburns/EE1001Fall2014/UMD 2014... ·...

Page 1: UMD 2014 Presentation - University of Minnesota Duluthsburns/EE1001Fall2014/UMD 2014... · Manufacturing Operations GeaCom Corporate GeaCom Marketing/Sales (3 and 6 month) Strategy

Phrazer®From Idea to Qualified Medical Device:

Roadmap

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MAT JOHNSONCEO AND FOUNDER OF GEACOM, INC.

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Invention: Starting Point

• What is wanted and why

• Resources and team

• Partners and proxies

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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.

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Design Needs

• Mechanical

• Electrical

• Functional

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Mechanical

• What must it do?

• What are the big part needs?

• What makes it special?

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Mechanicals

• SolidWorks

• 3D Prints

• Urethane Test

• FDA Steel Molds

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Electrical

• What must it do?

• What are the big part needs?

• What makes it special?

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Electrical: Getting Started

• Open Source Hardware start point

• Compatible components

• Component engineer assistance

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HIGH DENSITY, HIGH SOPHISTICATION BOARDTRACE MAP - 1 LAYER

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PCB

• 2 main boards

• 8 layers and 14 layers

• Challenges in design

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Battery & Power

• Size

• Chemistry

• Life / Charge Cycle

• Circuit Protection

• Hot Swapping

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Other Key Components

• P-Cap TS & High Bright Display

• Camera and Microphone

• Multi-Antenna

• LEDs and Controllers

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Functional

• Drivers and Operating System

• Testing and Manufacturability

• User Interfaces

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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

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PUT IT ALL TOGETHERA FULLY FUNCTIONAL MANUFACTURED, MARKET READY PRODUCT

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