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
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