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Vectorious V-LAP
Deep Dive into a Real World Class III IoMT Solution
2
UNPRECEDENTED ACCESS TO THE EARLIEST INDICATION OF HEART
PRESSURE CHANGES
Chronic Heart Failure
Decreased, varying heart
performance leads to lung fluid
accumulation.
Solution: adjust the medication
regimen more precisely.
Implant
Miniature, wireless, and battery-free
microcomputer
LAP reading utilizing MEMS. On daily basis
Friendly. Operated by button press
Applications
Physician - LAP waveforms
Study nurse – compliance calendar
Admin – user and device mgmt
3
4
ARCHITECTURE
5
IOMT DESIGN DILEMMAS
6
WHERE TO PLACE THE IOMT
GATEWAY
• Alternatives
• With the External (V-LAP-EX)
• Raspberri PI
• Phone as a GW
• Main consideration
• Time to First in Man. (Not market)
• Phone as a GW was chosen
• Built in cellular support vs. integration
• Xiaomi cost < $100
• Still the pricier solution but in
clinical trial don’t need many
• Temporary solution for FIM only
• How it works
• Dumb, channel-only SW architecture
• Including no CRC validation..
• Despite part of class III solution, acting
dumb approves it regulation-wise
7
PHONE AS TRUE GATEWAY
• Main consideration
• Usability. Elder Friendly.
• Requirement
• Always On gateway
• Except for charging it, 0 maintenance to
the phone.
• Solution
• Android kiosk-like mode
• HW Gateway look and feel
• How it works
• App is installed on fresh standard Android
• App supports “lock task” mode.
• Android is set up with App as Launcher.
• Nothing else on the Android works – not
even volume buttons
• Phone physically is packaged.
• Almost nothing is accessible, including
most of the screen
• => Doesn’t look like phone from the
outside
8
PAIRING OF
IMPLANT, EXTERNAL,
PATIENT
• Alternatives
• Classic IoT - Phone app login, discovery
and pairing
• Admin pairing
• Main consideration
• Usability. Elder and study nurse friendly.
• Both in setup and when replacing parts
• Admin pairing was chosen
• Enables out-of-the-box experience for the
elder, with minimal support from its
relatives or the medical stuff.
• How it works
• The implant has ID, the EX has ID, the
phone app displays its ID
("Secure.ANDROID_ID“), and patient has
Number
• Admin web app allows creating those
entities and attaching them together.
• Editing is allowed to support replacement
of belt or mobile phone.
• Implant ID is part of the payload.
• To be on the safe side
9
MITIGATING
DISCONNECTIONS
• Requirement
• Robustness
• Transparency to patients because class III
• Transparency to Vectorious R&D for debug
• Main consideration
• The phone is a temporary part of the
architecture
• Solution
• Only the EX (belt) manages retries
• If EX gives up the user hears failure beep
• How it works
• App ignores exceptions coming from cloud.
• EX sees timeout and retries for X times
• Cloud keeps payloads until disconnection.
• Cloud also keeps logs of app and EX.
10
DEVELOPMENT TOOLS OF
VECTORIOUS V-LAP
11
THE bio-T APPLICATION PLATFORM
Patient-care Insights
Adherence, recovery
management, real time
graphs and alerts.
Continuous Regulatory
Compliance
ISO 13485 QMS, FDA 820 QSR
GxP and HIPAA security
GDPR privacy
Billing & e-commerce
Pay-per-use billing
Disposables order management
Ownable IP Model
Full IP ownership over
source code & data
Code-level Control
Plug your algorithms and
custom code inside
User & Device Management
Patient | care provider | payer
Device | gateway | sensor
12
bio-T APPLICATION PLATFORM ARCHITECTURE
13
AWS CLOUD
14
QUESTIONS?
We’re Hiring 
JAVA / JAVASCRIPT DEVELOPERS
WE HAVE A PLACE FOR YOU !
16
www.biot-med.com
info@biot-med.com
Go Build Something

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Bio-T -

  • 1. Vectorious V-LAP Deep Dive into a Real World Class III IoMT Solution
  • 2. 2 UNPRECEDENTED ACCESS TO THE EARLIEST INDICATION OF HEART PRESSURE CHANGES Chronic Heart Failure Decreased, varying heart performance leads to lung fluid accumulation. Solution: adjust the medication regimen more precisely. Implant Miniature, wireless, and battery-free microcomputer LAP reading utilizing MEMS. On daily basis Friendly. Operated by button press Applications Physician - LAP waveforms Study nurse – compliance calendar Admin – user and device mgmt
  • 3. 3
  • 6. 6 WHERE TO PLACE THE IOMT GATEWAY • Alternatives • With the External (V-LAP-EX) • Raspberri PI • Phone as a GW • Main consideration • Time to First in Man. (Not market) • Phone as a GW was chosen • Built in cellular support vs. integration • Xiaomi cost < $100 • Still the pricier solution but in clinical trial don’t need many • Temporary solution for FIM only • How it works • Dumb, channel-only SW architecture • Including no CRC validation.. • Despite part of class III solution, acting dumb approves it regulation-wise
  • 7. 7 PHONE AS TRUE GATEWAY • Main consideration • Usability. Elder Friendly. • Requirement • Always On gateway • Except for charging it, 0 maintenance to the phone. • Solution • Android kiosk-like mode • HW Gateway look and feel • How it works • App is installed on fresh standard Android • App supports “lock task” mode. • Android is set up with App as Launcher. • Nothing else on the Android works – not even volume buttons • Phone physically is packaged. • Almost nothing is accessible, including most of the screen • => Doesn’t look like phone from the outside
  • 8. 8 PAIRING OF IMPLANT, EXTERNAL, PATIENT • Alternatives • Classic IoT - Phone app login, discovery and pairing • Admin pairing • Main consideration • Usability. Elder and study nurse friendly. • Both in setup and when replacing parts • Admin pairing was chosen • Enables out-of-the-box experience for the elder, with minimal support from its relatives or the medical stuff. • How it works • The implant has ID, the EX has ID, the phone app displays its ID ("Secure.ANDROID_ID“), and patient has Number • Admin web app allows creating those entities and attaching them together. • Editing is allowed to support replacement of belt or mobile phone. • Implant ID is part of the payload. • To be on the safe side
  • 9. 9 MITIGATING DISCONNECTIONS • Requirement • Robustness • Transparency to patients because class III • Transparency to Vectorious R&D for debug • Main consideration • The phone is a temporary part of the architecture • Solution • Only the EX (belt) manages retries • If EX gives up the user hears failure beep • How it works • App ignores exceptions coming from cloud. • EX sees timeout and retries for X times • Cloud keeps payloads until disconnection. • Cloud also keeps logs of app and EX.
  • 11. 11 THE bio-T APPLICATION PLATFORM Patient-care Insights Adherence, recovery management, real time graphs and alerts. Continuous Regulatory Compliance ISO 13485 QMS, FDA 820 QSR GxP and HIPAA security GDPR privacy Billing & e-commerce Pay-per-use billing Disposables order management Ownable IP Model Full IP ownership over source code & data Code-level Control Plug your algorithms and custom code inside User & Device Management Patient | care provider | payer Device | gateway | sensor
  • 15. We’re Hiring  JAVA / JAVASCRIPT DEVELOPERS WE HAVE A PLACE FOR YOU !