11

Developing Biomedical Devices with Bluetooth

22

BLE is a low power wireless technology for Personal Area Networks:

Operates in 2.4 GHz with over-the-air throughput of up to 300 kbps (PHY Rate: 1 Mbps)

Optimized for low-power/coin-cell battery operation

Designed for Point-to-Point or STAR topologies

BLE devices are typically limited to a range of 10’s of meters

Smartphones are used for local control and as a Gateway to the Internet

Profiles target wearables, health & fitness, phone accessories, and medical

: Overview

33

Medical Device Market

Changing demographics

Advent of Electronic Health Records

Increasing healthcare costs

Increased consumer health consciousness

Evolving patient-care models

44

55

Annual Bluetooth Medical Device Shipments*

4.9M 22M2016 2019

*IHS

66

Interoperability/Ease of Use

Why Medical + Bluetooth with Low Energy Functionality?

Low-power

Security

Coexistence

77

Established medical device producers

Integrate multiple devices into medical ecosystem

Pivot focus to consumer

Adding Wireless to Mature Medical Applications

88

Holter Monitor

Medical standard

Cardiac arrhythmias

24-72 hr. continuous

use

Doctor reviews data

Multifunction Patch

Monitor non-lethal events

Size/comfort factor

1-2 week battery life

Real-time data sharing

Potentially disposable

Electrocardiogram (ECG): Use Cases

Chest Strap

Wellness monitoring

Athletic applications

Single HRM sensor

Smartphone app

99

Component New Gen Holter monitor Patch Chest Strap

Sensors 8-10 biotransducers Single biotransducer

Accelerometer

Temperature

Electro Chemical

Single biotransducer

Analog 12 channel mux

16-bit ADC

6 channel mux

16-bit ADC

12-bit ADC

MCU class Cortex-M4 Cortex-M4 Cortex M0

Memory 256k 256k 128k

Display Hi-end LCD No display No display

Battery Type Li-Ion CR2032 CR2032

Connectivity BLE BLE BLE

ECG: Requirements

1010

Old Gen:

2 functions: measure and store

Small memory

Basic display/UI

USB-PC connectivity

New Gen:

Input caloric data bolus recommendations

Insulin reminders/warnings

Share data immediately with doctor

LCD or export UI to cell phone

Wireless comm. with related wearables:

continuous glucose monitor

insulin pump

Blood Glucose Monitor: Use Cases

1111

Component Old Gen Requirements New Gen Requirements

Sensors/Analog 12-bit ADC

Electrochemical sensor

16-bit ADC

Electrochemical sensor

Temperature sensor

Mux

MCU class 16b or Cortex-M0+ Cortex-M4

Memory 64kB ROM + 64kB Flash 256kB Flash

Display LCD LCD

Battery Type AAA Li-Ion

Connectivity None/USB Bluetooth

Proprietary

Blood Glucose Monitor: Requirements

1212

Mary’s Story

1313

MCU

BLE

MUXAmplifier

Electrochemical

Sensors

Temp Sensor

Prop

Glucose Meter

ADC

6.0mmol/L

1414

6.0mmol/L

1515

6.0mmol/L

1616

6.0mmol/L

1717

6.0mmol/L

1818

6.0mmol/L

1919

2020

Startup oriented

New, undefined markets

Small size and unobtrusive

New Applications Enabled by Wireless

2121

Value: Parental “peace of mind”

Consumer focus puts importance on:

Connectivity – wireless, phone app, share with

family/clinicians

Convenience – small, low power, ease of use

Old sensor tech for new applications

Temperature

Heart Rate

Pulse oximetry used to prevent SIDS

Accelerometers track breathing/movement

Infant Monitors

2222

Value: Improving prescription adherence

Add simple sensor + BLE to make medication smart

Reminders via device (LED) or phone (app)

Track own/family member’s medication habits

Use in clinical trials for higher accuracy and insights

Connected Medication

2323

Value: Improve medical operational efficiency

Hospitals need to lower costs

Asset tracking/geofencing

Use case in nursing homes/Alzheimer’s patients

BT 4.0 adds new adv. modes for ultra low power

ADV_NONCONN_IND

ADV_DISCOVER_IND

Medical Location Beaconing

2424

Evolving use-case & features of Bluetooth Low Energy

Point-to-Point

Smartphone, cloud &

connectivity (4.X)

Indoor Positioning

Beaconing (4.X)

Precise Location (Future)

Smart Mesh

Flooding (Phase 1)

Routing (Phase 2)

Higher Data Rate

Extended Packets (4.2)

2 Mbps PHY (BT 5.0)

Longer Range

Higher TX Power (4.X)

Long Range PHY (5.0)

2525

Bluetooth SoC Tools, Modules, SDK, & Ref Designs

Introducing the Blue Gecko

ARM Cortex-M4, 40 MHz

HW Crypto Accelerator (AES, ECC, SHA)

RTC, Timers, Oscillators

Integrated DC/DC

Low active/sleep currents

1.85-3.8 V

Multi-protocol radio

2.4 GHz +19.5 dBm PA

Sub-GHz +20 dBm PA

32-256 kB Flash

16-32 kB RAM

QFN, CSP options

ADC, USARTS, I2C

Timers/PWM/Comparator

Pulse counter

Software Stacks

• Bluetooth Smart

• Proprietary RAIL, Connect, Sigfox

BLE Modules

Demos

• Blue Gecko + HRM Watch

Simplicity Studio

• Application Notes

• Data sheets

• Reference Manuals

• Driver Libraries

• Application Builder

• Network Analyzer

• Advanced Energy Monitor

• Part configuration

• Modem calculator

• Packet configurator

2626

Thank You!

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