This document provides an overview of Vectorious V-LAP, a Class III IoMT solution for monitoring chronic heart failure. It includes a deep dive into the architecture and design choices made, such as using a phone as a temporary gateway and an admin pairing process. It also discusses development tools from Vectorious including the bio-T application platform for building IoMT solutions with continuous regulatory compliance, billing/ordering, and full IP ownership.

1. Vectorious V-LAP
Deep Dive into a Real World Class III IoMT Solution

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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

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ARCHITECTURE

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IOMT DESIGN DILEMMAS

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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

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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

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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

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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.

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DEVELOPMENT TOOLS OF
VECTORIOUS V-LAP

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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

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bio-T APPLICATION PLATFORM ARCHITECTURE

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AWS CLOUD

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QUESTIONS?

15. We’re Hiring 
JAVA / JAVASCRIPT DEVELOPERS
WE HAVE A PLACE FOR YOU !

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www.biot-med.com
info@biot-med.com
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