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

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

Oct 08, 2023 158 likes •461 views

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

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SLIDE 1

SMART IMPLANT MONITORING SYSTEM VERIFICATION AND VALIDATION

SPONSOR: DR. MATTHEW MACEWAN GROUP 9: LILY XU, RAY WANG, AND RUDY GELB-BICKNELL

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SLIDE 2

INTRODUCTION

  • Sponsor: provides bioresorbable sensors (pH)
  • Use: monitor hernia meshes for infection
  • Group 9: designs receiver

Kang et al. (2016) Nature

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SLIDE 3

OUTLINE

PROJECT CHANGES VERIFICATION PLAN VALIDATION PLAN FDA PROCESS PROJECT STATUS

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SLIDE 4

DESIGN SCHEDULE

  • Added: Acquire Chip
  • Adjusted time spans:

Device Testing ex vivo and in vivo

8/26/2018 10/15/2018 12/4/2018 1/23/2019 3/14/2019 5/3/2019 6/22/2019 Identify Project Establishing Contact with Sponsor Project Scope Design Specs Preliminary Report 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

Group 9 Design Schedule Gantt Chart

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SLIDE 5

DESIGN SPECIFICATIONS

  • Increased: Maximum

sampling rate

  • Removed: GUI

details

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/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

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SLIDE 6

TEAM RESPONSIBILITIES

Ray Rudy Lily

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SLIDE 7

NO CHANGES

  • Need Statement
  • Project Scope
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SLIDE 8

VERIFICATION PLAN Step 3

Integration and Software Verification (post-software loading)

Step 2

Mechanical Verification (post-assembly of device, pre-software loading)

Step 1

Controller and Electronics Verification (pre-assembly of device)

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SLIDE 9

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.

DESIGN SPECIFICATIONS

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SLIDE 10

STEP 1: CONTROLLER AND ELECTRONICS

Longevity

  • Lighter than 50 g
  • Battery life > 1 week

Sampling Rate

  • Maximum sampling rate > 1

sample/s

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SLIDE 11

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
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SLIDE 12

STEP 2: MECHANICAL

Durability

  • Withstand 6 ft drop and shaking

Safety

  • Operating temperature < 37°C
  • No electrical leakage
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SLIDE 13

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
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SLIDE 14

VERIFICATION NOTES

Receiver Functionality

  • Lifespan > 1 year
  • Reusable
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SLIDE 15

VALIDATION PLAN Step 3

Ease of Use

Step 2

Alert Effectiveness

Step 1

Infection Detection

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SLIDE 16

STEP 1: INFECTION DETECTION VALIDATION

  • Goal: Validation of chip

effectively detecting infection in vivo through a rat model

Kang et al. (2016) Nature

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SLIDE 17

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

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SLIDE 18

STEP 2: ALERT EFFECTIVENESS VALIDATION

  • Goal: Validation of

audio and visual alert effectiveness

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SLIDE 19

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

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SLIDE 20

STEP 3: EASE OF USE VALIDATION

  • Goal: Validation of UI

ease of use

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SLIDE 21

STEP 3: EASE OF USE VALIDATION

  • Participants
  • Blinded, no instructions
  • Participant tests
  • Silence alert
  • Temporarily mute device
  • Navigate readouts
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SLIDE 22

FDA PROCESS

Classification of Device:

  • Class III

Necessary Approvals from FDA:

  • Pre-Market Approval (PMA) Necessary

Exceptions:

  • None
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SLIDE 23

CLASS III DEVICE

  • Implantable device
  • Remains in the body for substantial time
  • Integrates new transient materials
  • Incorporates implantable power supply

through an energized system

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SLIDE 24

PMA NEEDED, NO EXCEPTIONS

Clinical tests needed

  • Biocompatibility testing
  • Animal trials
  • Pilot human clinical trials
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SLIDE 25

PROJECT STATUS AND RESULTS OF TESTING

  • Arduino Uno
  • I2C LED Display
  • Speaker
  • LED Indicator Lights
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SLIDE 26

RESULTS OF TESTING

  • I2C LED Display, Speaker, and LED Indicator Lights
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SLIDE 27

NEXT STEPS IN TESTING

  • Battery
  • Device encasing
  • pH testing
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SLIDE 28

QUESTIONS?

Kang et al. (2016) Nature

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SLIDE 29

WORKS CITED

Kang, S. K. et al. Bioresorbable silicon electronic sensors for the brain. Nature (2016). doi:10.1038/nature16492

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