VERIFICATION AND VALIDATION SPONSOR: DR. MATTHEW MACEWAN GROUP 9: - PowerPoint PPT Presentation

SMART IMPLANT MONITORING SYSTEM VERIFICATION AND VALIDATION SPONSOR: DR. MATTHEW MACEWAN GROUP 9: LILY XU , RAY WANG, AND RUDY GELB-BICKNELL

INTRODUCTION • Sponsor: provides bioresorbable sensors (pH) • Use: monitor hernia meshes for infection • Group 9: designs receiver Kang et al . (2016) Nature

OUTLINE PROJECT VERIFICATION VALIDATION FDA PROJECT CHANGES PLAN PLAN PROCESS STATUS

DESIGN SCHEDULE Group 9 Design Schedule Gantt Chart • Added: Acquire Chip 8/26/2018 10/15/2018 12/4/2018 1/23/2019 3/14/2019 5/3/2019 6/22/2019 Identify Project • Adjusted time spans: Establishing Contact with Sponsor Project Scope Device Testing ex vivo Design Specs Preliminary Report and in vivo Device Design and Prototyping Acquire Chip Device Testing ex vivo Device Testing in vivo Verification and Validation Report Design Safety Analysis Project Demo BME Poster Presentation

DESIGN SPECIFICATIONS Category Metrics Longevity 1 A microcontroller motherboard or general-use controller will be used as the main computing tool. This controller will be lighter than 50g. • Increased: Maximum 2 It will be battery powered with battery life > 1 week without charging or replacing batteries. Receiver Functionality 4 The receiver dimensions will not exceed 15cm x 7cm x 3.5cm. sampling rate 4 The receiver will have a smooth outer finish for ease of use. 4 The receiver will weigh less than 300g including the battery. 4 The receiver will tolerate temperature range between 0°C-40°C. • Removed: GUI 10 The receiver will be reusable and should have a lifespan > 1yr. Cost · The receiver will cost < $400 including replaceable batteries. Safety 6 The receiver will have an operating temperature of < 37°C to prevent heat- details related injuries. 6 The receiver's electrical system will be fully contained and there will be no electrical leakage outside the receiver. Durability 4 The receiver will have a hardness > 5 on the Mohs scale of mineral hardness. 5 The receiver will withstand a 6ft drop. 5 The receiver will tolerate shaking. Sampling Rate 3 Maximum sampling rate > 1 sample/min. sample/s. 9 Sampling rate will be adjustable according to the need. Display and Sound 8 The receiver will have an LED display that can display the current status of the implant with delay < 1s. 8 The receiver will give an audio and visual warning when implant malfunctions are detected. Software 7 The software will be fully contained inside the receiver, including data gathering and processing capabilities. 7 The software will control an LED display and a speaker and output the current status of the implant on the display. A GUI will be made available to easily adjust displayed information

TEAM RESPONSIBILITIES Ray Lily Rudy

NO CHANGES • Need Statement • Project Scope

VERIFICATION PLAN Controller and Electronics Verification Step 1 (pre-assembly of device) Step 2 Mechanical Verification (post-assembly of device, pre-software loading) Step 3 Integration and Software Verification (post-software loading)

DESIGN SPECIFICATIONS Category Metrics Longevity 1 A microcontroller motherboard or general-use controller will be used as the main computing tool. This controller will be lighter than 50g. 2 It will be battery powered with battery life > 1 week without charging or replacing batteries. Receiver Functionality 4 The receiver dimensions will not exceed 15cm x 7cm x 3.5cm. 4 The receiver will have a smooth outer finish for ease of use. 4 The receiver will weigh less than 300g including the battery. 4 The receiver will tolerate temperature range between 0°C-40°C. 10 The receiver will be reusable and should have a lifespan > 1yr. Cost · The receiver will cost < $400 including replaceable batteries. Safety 6 The receiver will have an operating temperature of < 37°C to prevent heat-related injuries. 6 The receiver's electrical system will be fully contained and there will be no electrical leakage outside the receiver. Durability 4 The receiver will have a hardness > 5 on the Mohs scale of mineral hardness. 5 The receiver will withstand a 6ft drop. 5 The receiver will tolerate shaking. Sampling Rate 3 Maximum sampling rate > 1 sample/s. 9 Sampling rate will be adjustable according to the need. Display and Sound 8 The receiver will have an LED display that can display the current status of the implant with delay < 1s. 8 The receiver will give an audio and visual warning when implant malfunctions are detected. Software 7 The software will be fully contained inside the receiver, including data gathering and processing capabilities. 7 The software will control an LED display and a speaker and output the current status of the implant on the display.

STEP 1: CONTROLLER AND ELECTRONICS Longevity • Lighter than 50 g • Battery life > 1 week Sampling Rate • Maximum sampling rate > 1 sample/s

STEP 2: MECHANICAL Receiver Functionality • Dimensions within 15 cm x 7 cm x 3.5 cm • Smooth outer finish • Weight < 300 g • Hardness > 5 on Mohs scale • Temperature resistance 0°C-40°C

STEP 2: MECHANICAL Durability • Withstand 6 ft drop and shaking Safety • Operating temperature < 37°C • No electrical leakage

STEP 3: INTEGRATION AND SOFTWARE Software • Independence and compiling success Display and Sound • Visual and audio warning after 1 s Sampling Rate • Adjustable sampling rate

VERIFICATION NOTES Receiver Functionality • Lifespan > 1 year • Reusable

VALIDATION PLAN Step 1 Infection Detection Step 2 Alert Effectiveness Step 3 Ease of Use

STEP 1: INFECTION DETECTION VALIDATION • Goal: Validation of chip effectively detecting infection in vivo through a rat model Kang et al . (2016) Nature

STEP 1: INFECTION DETECTION VALIDATION • Non-infected rat • Implant chip • Collect 3 days of pH baseline • Infected rat • Inject with bacterial strain • Collect 3 days of infection data • Data analysis with thresholds Kang et al . (2016) Nature

STEP 2: ALERT EFFECTIVENESS VALIDATION • Goal: Validation of audio and visual alert effectiveness

STEP 2: ALERT EFFECTIVENESS VALIDATION • Obstruct speaker • Device in purse • Check speaker audio is still heard • Obstruct lights • Device 10 ft away • Check LED indicator lights are still visible

STEP 3: EASE OF USE VALIDATION • Goal: Validation of UI ease of use

STEP 3: EASE OF USE VALIDATION • Participants • Blinded, no instructions • Participant tests • Silence alert • Temporarily mute device • Navigate readouts

FDA PROCESS Classification of Device: • Class III Necessary Approvals from FDA: • Pre-Market Approval (PMA) Necessary Exceptions: • None

CLASS III DEVICE • Implantable device • Remains in the body for substantial time • Integrates new transient materials • Incorporates implantable power supply through an energized system

PMA NEEDED, NO EXCEPTIONS Clinical tests needed • Biocompatibility testing • Animal trials • Pilot human clinical trials

PROJECT STATUS AND RESULTS OF TESTING • Arduino Uno • I2C LED Display • Speaker • LED Indicator Lights

RESULTS OF TESTING • I2C LED Display, Speaker, and LED Indicator Lights

NEXT STEPS IN TESTING • Battery • Device encasing • pH testing

QUESTIONS? Kang et al . (2016) Nature

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