PRODUCT DESIGN, ENGINEERING DEVELOPMENT AND CONTRACT MANUFACTURING

Infinite Vision

CLIENT OWNS ALL IP AND PATENTS CREATED DURING THE COURSE OF A PROJECT

Infinite VisionDedicated to Generating and Protecting

Intellectual Property

Transparency

RFP Detailed Review of Product Requirements Document (PRD) Statement of Understanding (SOU)

MSP Schedule of Activities MSP Schedule & Budget

Labor Rates by Task, Milestone & Individual Contributor Detailed Proposal Contract Negotiation

Overview

Product Design and Development Electronics

FW, SW, RFID, FPGA

Imaging for Industrial Applications, Surgical Tools and Instruments Mechanical Engineering

Industrial and Commercial, Fluidics, Surgical Tools, Laboratory Equipment, Robotics

Industrial Design Regulatory – Experien Group Manufacturing Engineering

GE Healthcare / U-Systems

Ultrasonic Breast Imaging System Engineering Support

System Engineering / Mechanical Engineering

Electrical, PCBA, Backplane design and layout

Formal System Design Review

ZOLL Ambulatory Monitoring

System• Concept through release to

manufacturing• Mechanical Engineering

and Industrial Design• Electrical Engineering• Firmware and Software

Engineering• Verification / Validation• Test System Design• Manufacturing Process

Instructions• Release to

Manufacturing

Cook Endoscopy

Miniature Imaging System Complete Video Data Path

Design and Development Miniature Image Sense Module

for Endoscopic Application Electrical Engineering Image Sense Sourcing and

Implementation Mechanical Design Support

for Image Sense Mounting, Illumination and Strain Relief

Image Sensor to Display Camera, Aperture, Filters

Integration Configured to 3mm Outside Diameter

Closed loop Illumination Output

Athena Feminine Technology

Female incontinence pelvic muscle Trainer Concept through Release to

Manufacturing Electrical and Firmware

Engineering Industrial and Mechanical

Design RF Communication from

cradle to trainer Regulatory Support Test and Fixture

Development Manufacturing Process

Instructions Release to Manufacturing

Support

CryoDynamics

Portable Heating/Cooling and Compression Therapy Electrical and Firmware

Engineering Smart Battery Sourcing,

Programming and Implementation

Fluidic heating/cooling Compression and Wrap

Design Support Mechanical Engineering PCBA layout and design GUI Interface Design and

Support Test and Regulatory Support

Skeletal Dynamics

Carpal Tunnel Surgical Tool with Image Sense and Illumination Electrical and Firmware

Engineering Mechanical Engineering

Complete Video Data Path Design and Development Expertise

Image Sensor to Display Camera Module Development Camera, Aperture, Filters

Integration Configured to 3mm Outside Diameter

Closed loop Illumination Output

Biocare Medical

Automated Pathology Slide Stainer Electrical Engineering concept and design support Firmware Engineering

Motor, Heating, Cooling , Fluidic Control and Monitoring Mechanical Engineering oversight and design support Project Management Ongoing effort. Estimated 12 months of support going forward

ApoCell Molecular Profiling and Diagnostics

ApoStream Device IV developed the

ApoStream Device for ApoCell

University of Texas Bread-Board Prototype to Production Ready Molecular Profiling and Diagnostic Instrument

OptiMedica-Abbott

Laser Treatment of Cataract Disposable Fluidic Catchment

System Mechanical Engineering Design and Development of

Redundant Systems Utilizing Float Sensors Mechanical Fail Safe

Lumenetix - Sunnex

Medical Operating Light Utilizing LED Module Technology Concept through Release

to Manufacturing Support Electrical Engineering Mechanical Engineering Project Management Successful Launch

Support

Next Lighting / Intellilight

LED Module for Florescent Light Replacement Concept through Release to

Manufacturing Electrical Engineering Industrial Design and

Mechanical Engineering Manufacturing Drawings Manufacturing Process

Instructions Manufacturing Supplier

Selection Support Manufacturing and Test

Fixture Support Release to Manufacturing

Support

Cero

LED Modules for Illumination of Quarries, Worksites. Mounted on Heavy Equipment in Highly Toxic Environments Electrical Engineering and Illumination Expertise PCBA Engineering and Layout with Exotic Materials and

Manufacturing Process Considerations

Able to withstand higher temperatures, direct impacts and vibration levels exceeding 500Gs

Able to withstand higher temperatures, direct impacts and vibration levels exceeding 500Gs

CERO XD-16 Extreme Duty

IV Capabilities

Mechanical engineering Electronics, Firmware & Software Visualization and Imaging Industrial Design

Regulatory - Experien Group Manufacturing Engineering Machine Shop Innerstep Production Domestic (USA), Low Cost

Country

Product Design Capabilities

Handheld Therapy Lab Instrumentation & Diagnostics Therapy Delivery Systems Point of Care Diagnostics Surgical Tools Video & Imaging Technology Carts & Structural Support Micro-fluidics Lifts, Robotics & Automation RFID

Industrial Design

Image Developments Form / Shape Studies Color Studies User Interface Design Storyboards 3D Rendering & Animation Rapid Prototyping

Labeling

Graphic Design: Membrane Panels, Regulatory and Packaging Labels Human Factors Legibility Material / Environment Compatibility: Abrasion/Chemical Testing Product Identity Safety Requirement Labels Instructions for Use (IFU)

Product Development Phases

Research Phase

Brainstorming Proof of Concept Prototyping Bench-top Testing Human Factors Risks and Hazards Analysis Product Definition

Development Phase

Design forManufacturabilityMaterials SelectionAssemblySterilizationBiocompatibility

Test

Engineering Tools3D Modeling3D SimulationFluid SimulationStress Analysis

Strict GuidanceFDAISOTUVULCSA

Design for Manufacturability and Test

Material Selection Stress and Tolerance Analysis Lean Manufacturing Practices

Design for Test

Material Selection and Sourcing

Domestic Sourcing Low Cost Country Sourcing Metals Plastics Components Sub-Assemblies ISO 13485 USA and Asia Contract Manufacturing

Verified Design Output

Design Verification Testing Protocol Development & Execution NRTL Testing Support Software/Firmware Verification & Validation

Design History File

Pilot Production Phase

Tooling Fixtures

For Manufacturing For Test

Supply Chain Management AVL & BOM Development

Pilot Production Phase

MPI Development Lean Manufacturing Considerations and Planning Work Flow Planning Manufacturing Implementation

Device Master Record

Contract Manufacturing

ISO 13485 & FDB Turnkey or Consignment

Material Procurement & Handling (MRP) System Integration and Test

Class 10,000 Clean Room

Contract Manufacturing

Full Service Assembly Outsource SterilizationPackaging and Fulfillment Functional and Affordable Kit Designs

Easy User AccessLogical Component Layout and Retention

Rapid Thermoforming/Tooling CapabilityProduct Kits: Comprehensive Pouching, Sterile Boxes, Cartons