Healthcare Wireless and Device Connectivity

Proprietary versus Standards Based Wireless 2019

Over the past twenty years in the medical device community and within the healthcare enterprise there has been this debate about proprietary versus standards based wireless offerings. It started out when the Wireless Medical Telemetry Service was introduced in the late 1990's and then 802.11b being approved in 1999. The start of the Wi-Fi revolution as we know it.

The author provided OEM guidance on the first medical telemetry system using 802.11 FHSS around 1999. This was ahead of it' time but followed the logical next steps in the WLAN revolution which kicked off with the Wi-Fi Alliance forming in 2000.

Then came the whole era of smart pumps incorporating 802.11 advances from the early 2000's to another medical telemetry company architecting 802.11 as a part of their enterprise solution.

Just like Wi-Fi, Bluetooth has provided a standards based approach and is enjoyed by a surrounding community of interoperability and product roll-outs in multiple vertical markets. Millions of $ of investment in R&D has driven innovation and security advances.

The introduction of the smart phone incorporating BTLE pretty much has solidified BTLE as the standards based personal area network of choice.

Most recently several medical device companies have incorporated BTLE into their solutions to also include an implantable device. This is huge as it overcomes that argument that Wi-Fi and or BTLE is not safe, reliable, or secure. The implantable device company followed all NIST guidelines. https://www.nist.gov/topics/cryptography

We additionally see the whole proprietary real time location system model becoming legacy as BTLE 5.1 provides the granularity of accuracy. Also BTLE is fast becoming incorporated in WLAN enterprise AP(s) to include mesh capabilities

Bottom line, while proprietary wireless technology may have had it's place in healthcare; standards based architecture always wins out. It wins out because of the ground swell of investment, standards, interoperability, security, and wide spread adoption driving down cost.

Download 1901_Enhancing-Bluetooth-Location-Service_FINAL

Download 2019-Bluetooth-Market-Update

Download 1903_Mesh-Models-Overview_FINAL

Download Fulham-Health-Estate-Journal-Bluetooth

Medtronic Bluetooth Low Energy Arrival in Cardiac Pacing

This is truly a milestone by Medtronic to provide Bluetooth LE in the Azure pacemaker together with their BlueSync Technology. Both Azsure and BlueSync as well as MyCareLink are trademarked. These are my views of the technology transition and value proposition to the patient and clinician.

As one who was actually in the cardiac pacing field for a number of years; this is a total win-win for the patient and as mentioned the clinician. Never before have they both have had this synergistic type of real time connectivity.

Validation of the Patient Experience
The first generation of smart technology using the MyCareLink Smart monitor resulted in 95,000 users with over a score of 85% patient satisfaction, that resulted in 2,300 recommendations.

Moving to the Next Value Proposition Level
Based upon this high level of patient satisfaction and compliance, BTLE was it seems was decided to be integrated into the pacemaker itself and to provide a secure connection to a application via a tablet and smart phone interface. This could perhaps eventually replace the home bedside monitor thus allowing the patient to become truly mobile and connected on a global basis. The MyCareLink heart mobile application could in essence provide a better piece of mind of those living with a pacemaker anywhere.

Clinician Value Proposition
The Medtronic smart phone application thus acts as gateway to MyCareLink from the the pacemaker to provide relevant data to the clinician remotely and per desired requirements. Notifications can be pushed out to monitor AT/AF burden notification, lead impedance, lower battery voltage@RRT, VT Episodes, Fast VRate during AT/AF, Capture Management and % V Pacing. Previous to this integrated software, smart phone, and cloud based model, patients would have to have the pacemaker interrogated in a office environment or connected to the home monitoring solution.
Medtronic it seems will be also incorporating BTLE in the pacing systems analyzer thus also allowing the clinician to directly make programming changes via a BTLE to BTLE link, versus the legacy wand interrogation up link and down link.

Security of Patient Information
To address any wireless concerns about security Medtronic has provided into the Azure pacemaker an encryption module. This encryption module uses the NIST (National Institute of Technology) standard.

Wireless BTLE and Battery Life of the Pacemaker
While using BTLE may seem to perhaps effect battery life of the pacing generator, this seems to be not the case. It seems that new hardware architecture optimizes circuitry to reduce current drain and battery life that will provide lifetime use of 10.8 years to a high a high of degree of 15.8 years. This is huge to years past.

Hats off to Medtronic to providing a secure BTLE pacemaker to smart phone application to the cloud to allow a huge value add to the clinical and patient care experience.

See attached.

Download 201801292b-en_azure broch_p24_prnt

Ascom Digistat(R) Connect Medical Device Integration

Digistat® Connect Medical Device Integration...checking off all the boxes!

Some interesting statistics.

19% of Nurses spend less that one fifth of their time on direct patient care.
Reference: Hendrick, A, Chow, MP, Sklerczynski, BA, Lu, Z (2008) A 36 Hospital Time and Motion Study: How do Medical-Surgical Nurses Spending their time? The Permanente Journal 12 (3), 25-34

United States Hospitals waste $12billon dollars annually due to poor communications.
Reference: Robert H. Smith School of Business, University of Maryland (2009), US Hospitals Waste $12 Billion Annually Because of Poor Communications (online) available from http://www.rhsmith.umed.edu/news/us-hospitals-waste-12-billion-annually-because-poor-communications (12 February 2016)

Digistat ® Connect software acquires information about clinical data, alarms and events from medical devices such as patient monitors, ventilators, and infusion pumps in near real time and creates a common, standard, automatic data stream that feeds a single source of clinical patient data to hospital information systems.

By feeding multiple independent downstream systems with a tailored flow of patient data and related contextual information this can provide a great deal of benefit to the clinician. For example:

- Avoidance of transcription errors
- Saving of time thus creating more efficiency for direct clinical care.
- A log can be provided for alarms from medical devices and all user actions.

Ascom has now the complete mobility and integration tool belt of a best of class nurse call system, healthcare well designed mobile devices, and complete medical device integration to the Electronic Healthcare Record. All the boxes have been checked off!

Download 01352-ProductSheet-DigistatConnect

Download Digistat-smart-central-product-sheet-01104-01-enx-low-res

NordicSemi Summer Wireless Quarterly 2019

It is amazing to see the growth of BTLE for all kinds of applications never before thought possible! It never stops.

Have a good read with the attached Wireless Quarterly.

Integra Systems, Inc., continues drive forward the use of Nordic's BTLE SOC for unique applications of which we consider the gold standard in the industry.

As a side, as a scuba diver, I like the BTLE enabled dive watch.

https://www.atmos.app

Download NS_WQ_Q2_Summer_2019

Integra Systems Partners with Sentry Card on 2nd Generation Solution

The SentryCard Solution : An All-In-One Security Credential

KeyFob/OATG OTP Logical Security + iClass or MIFARE Physical Security + RFID Tags/Badges Proximity Tracking + NFC Tags Check In + Employee Identification = The Sentry Card "All-In-One Converged Security"

Integra Systems, Inc. has been working with Sentry Card on the first generation of what we think of as a Smart Phone in a Smart Card.

This first generation solution consisted of packing in a lot of technology in a complex design with the form factor of a smart card. The technology included a ultra thin flex circuit, a 32-bit ARM, 256-bit AES, BTLE, NFC, and USB, with 8GB of flash, and a rechargeable battery.

Fast forward to 2019, there is now a family of Converged Security Credentials
SentryCard P and P+ adds up to four antennas, ISO spec flex circuit, Electronic Window (one time password), Battery with a 10-year Utility Life. SentryCard A adds active security with the ability to unlock and/or re-activate the credential based upon a unique tap combination. The Model M is a reusable "All-in-One" multi-function credential with built in investment protection against obsolescence.

See attached the latest presentation.
The SentryCard is available and in production.

Download SentryCard_Technologies_Overview_July_2019

Cellular IoT Growth will be Staggering

LTE-M and NB-IoT's remarkable battery life, costs effective data usage and ubiquitous cell infrastructure will enable this growth. The projected number of cellular connected devices will grow to 1.8 billion by 2023. Please find attached "Choosing the right route to low power cellular IOT". A user guide to simplifying LTE-M/NB-IoT Design Projects y Laird Connectivity. Integra Systems is currently developing cellular IoT solutions to solve unique business requirements for healthcare and multiple vertical markets.

Download 062019 - White Paper - Cellular

Ivenix Achieves FDA 510(k) Approval

www.ivenix.com

This is a huge milestone for this company that now can now look to redefine the infusion therapy marketplace.

Many years of hard work by the entire small company that was entirely focused and working night and day that made this happen!

The cleared Invenix Infusion Systems solution includes.

- A large-volume infusion pump with a smartphone-like user interface, advanced pumping technology that measures flow to maximize accuracy, and a system that is able to anticipate and prevent critical use errors.

- A portfolio of administration sets to accommodate the diverse infusion needs of healthcare organizations.

- An infusion management suite of end-to-end administration tools, applications and analytics to remotely monitor infusions and proactively manage improvements.

The Ivenvix team has set a new standard for safety, simplicity, and interoperability.

Congrats to all that made this happen!

Integra Systems, Inc. provided wireless co-existence testing for Ivenix.

www.ivenix.com

Bluetooth LE 5.1 Standard for RTLS

Over the past twenty years Integra Systems, Inc. has been involved in the RTLS (Real Time Location System) space around the timing of the approval of 802.11b in 1999.

This has included but has not been limited to ultra wideband, Zigbee, ultrasound, Wi-Fi, low frequency RF, and UHF.

Our opinion with BTLE becoming the dominant PAN (personal area network) a lot has changed. What has moved the needle across the RTLS landscape was the smart phone validation as the standard incorporating BTLE. Add on to this the continued revolution of BTLE across multiple enterprise vertical markets.

Also the major WLAN manufactures are also now incorporating BTLE into their enterprise solutions both at the AP and WLAN controller for location based services.

Just like Wi-Fi becoming the standard in wireless networking; the same case is happening that BTLE 5.1 will become the standard for indoor RTLS.

According to ABI Research, over 400 million Bluetooth locations service devices are forecasted to be shipped per year 2022.

See the attached white paper: "Enhancing Bluetooth Location Services with Direction Finding"

Download 1901_Enhancing-Bluetooth-Location-Service_FINAL

Bluetooth RTLS and Wireless Nordic Quarter 2019 Spring Newsletter

Nordic www.nordicsemi.com and Quuppa combine Bluetooth 5.1 Direction Finding SoCs with a Intelligent Locating System platform to support a wide range of Bluetooth RTLS, asset tracking and IPS applications. Quuppas Intelligent Locating System which is trademarked is a proven platform for novel location-based services and applications. The company has partnered with Nordic since 2016. The current version of it's firmware runs on the Nordic nRF52832 Bluetooth Lower (Bluetooth LE)/Bluetooth 4 SoC which uses the Bluetooth LE protocol to transmit the 'Angle of Arrival' (AoA) radio packets which in turn determines the position in space of a Bluetooth LE transceiver.

Integra Systems, Inc. is continuing to help companies develop unique and high value solutions in the BTLE space in multiple vertical markets.

Please see the attached the latest Spring 2019 quarterly.

Download NS_WQ_Q1_Spring_2019

Bluetooth Market Growth 2019 and Further

While Bluetooth in the early days was a communications modality for small peripherals such as computer mice and keyboard, the major cross the chasm event was the introduction of the smart phone. Moore's went into effect and the growth parallels that of Wi-Fi when 802.11b was introduced in 1999. Look at the projected growth in device networks and location based services. We are actively involved in several projects for device networks, client devices, and also location based services using BTLE.