Healthcare Wireless and Device Connectivity

Moving to WPA3- Enterprise Security

WPA-3 Enterprise expands upon WPA2 offering an optional mode of using 192-bit minimum strength security protocols and cryptographic tools to enhance the protection of sensitive data:

The following capabilities are now provided

- Authenticated encryption: 256-bit Galios/Counter Mode Protocol (GCMP-256)
- Key deviation and confirmation: 384-bit Hashed Message Authentication Mode (HMAC) with Secure Hash Algorithm (HMAC-SHA384)
- Key establishment and authentication: Elliptic Curve Diffie-Hellman (ECDH) exchange and Elliptic Curve Digital Signature Algorithm (ECDSA) using a 384-bit elliptic curve.
- Robust management frame protection: 256-bit Broadcast/Multicast Integrity Protocol Galios Message Authentication Code (BIP-GMAC-256)

The 192-bit security mode offered by WPA-3 Enterprise ensures the right combination of cryptographic tools are used and sets a consistent baseline of security within a WPA3 network.

The Enterprise IOT Business Model for Healthcare

It is recognized that most medical device companies are challenged to provide remote service and software updates. This either requires a remote VPN session or a physical site visit. Also, most devices simply are not set up for proactive maintenance. Proactive maintenance means that the medical device and/or solution could prevent costly downtime. Other vertical markets have embraced this business model. For example the aviation industry can monitor jet engines in the sky and have a part ready when the jet lands. Expensive farming equipment can be monitored in a IOT wireless fashion enabling parts to be delivered literally in the field. Deployment of an IOT business model for the medical device community is no simple task. It consists moving parts to ensure that the IOT model is a success. This includes but is not limited to the hardware selection, but kitting, carrier onboarding, network monitoring, financial reporting, and support. Integra Systems, Inc., has formed a strategic business model and partnership that can make this easy and very straightforward.

Revive Solutions Disruptive Cardiac Innovation

Revive Solutions Raises $3.4M Seed Round to Develop Life-Saving Cardiac Technology

See the link to this press release

https://www.revive.life/blog/revive-solutions-raises-3-4m-seed-round-to-develop-life-saving-cardiac-technology

We consider what Revive Solutions is doing will be very disruptive to the current AED (Automated External Defibrillator) market.

Disruptive innovations often tend to be produced by outsiders and entrepreneurs in start-ups rather than existing big market leading companies. Big companies tend not to really innovate unless there are market and competitive pressures. As long as there is a market and we are making a profit, why spend R&D$?

There is a lot of detail that is presented in this press release; but here is our view of the current market and the value add of the potential Revive Solution.

1.
The golden window to save a patient’s life is ideally ten minutes or less in the case of a myocardial infarction (heart attack). Thus everyone should at least should know CPR as the first step before looking around to find the AED of which takes the window of time. In the meantime someone should ask what is the time window to the EMS response versus CPR and having the AED at hand? Have time motion studies been conducted to show the risk if not a better solution were present?

2.
AEDs are not always simply widely available and they are not always put perhaps not in the ideal locations. Think of the next time you are shopping or at a major event, our just in your local community; do you know where the latest AED is? It is a reality unless you have a cardiac condition; you simply perhaps do not think this way. Thus when an event happens, panic sometime attacks and folks are scrambling to the find the "box" on the wall taking precious minutes from the golden time.

3.
The AED of today in 2018 is pretty expensive; hence why this is not widely available. It seems the general consensus is to have one unit on site, thus this is a "check off box" for the building owner, community, school, or other public venue.

4.
The technology behind the current AED market is somewhat decades old with little to no innovation. There is also no business incentive to innovate it seems. We are thus left with legacy technology that simply cannot take advantage of the communication and networking technology available in 2018 and beyond.

5.
From a real life perspective a lot of people just panic in the moment of a heart attack or have the potential and do not use the AED because of current intimidating interfaces. (This is a true statement as have hand first hand experience.)

6.
Another final question is how do you know this AED will actually work when they have to work to ensure the proper real time maintenance of hardware, software, and other components. Where is the V&V data to back this up?

Revive Solutions has taking out a blank sheet of paper that is totally redesigning the AED experience. This solution will provide a affordable and reliable AED solution with the best of breed technology that lowers risk and ultimately could save a lot of lives. A great team working together that is changing the cardiac event experience in a positive way.

FDA to update forty year old process for approving medical devices

It seems that the FDA is moving forward to update their overall medical device approval process.

https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm626838.htm

Manufactures currently have essentially been able to expedite the approval process if they could prove that their new product was substantially equivalent to a predicate.

This new announcement is encouraging companies to base new products on devices that are no older than ten years.

It seems that 20% of products cleared through the 510(k) pathway are based on a predicate device that is more than ten years old.

It appears that the FDA has plans to finalize it's guidance on establishing an alternative accelerated pathway in 2019.

The "Smart" Surgical Drill Providing Intelligence and Safety to Surgery.

These are my observations in reviewing the attached article of which was extremely well written.
* Full disclosure, we are not taking any financial renumeration for writing this and have no financial stake in SMD.

Integra Systems has been involved with SMD (Smart Medical Devices) for the past twenty-four months in a consultative fashion. Our transferable expertise has been related to wireless design integration, specialized knowledge sense for electronic protection, and testing for FDA wireless co-existence.

It has been a real learning experience for us to understand the basics of orthopedic surgical drilling that has not changed in over fifty years.

We do have a background in orthopedic surgery, so we can relate a bit. While the surgical drill has progressed from a hand held drill to now a portable drill using a lithium ion battery (non-corded) essentially drilling in a surgical fashion has not changed. It is a drill bit connected to a chuck, the drill itself, and a rechargeable lithium-ion battery.

The surgical drill of today is essentially the kind of drill you would purchase at the hardware store…but much more expensive because of design requirements. See Shutterstock image of drill used for training medical students.

However for the surgical drill to perform correctly it has to meet unique challenges. If you take a standard drill (non-surgical drill), most likely you are drilling through an “end to end” solid interface (wood and or metal). You exert a constant pressure and feedback is continuous..density being the same. In the case of drilling through a bone interface this is not the case.

In layman’s terms, think of drilling through a 1/8 inch of wood, then solid foam, then of 1/8 inch of wood on the other side.

The challenge here is how do to you control not breaking out on the distal side of the bone not creating a plunge?

Today’s methodology is all about the surgeon and human feel to not plunge (orthopedic term) to harm a distal bone/tissue/nerve/arterial interface. So the surgeon has two choices. Slow down the drilling of which creates thermal energy of which can destroy bone marrow or plunge to ensure, “non thermal” energy. This is the current orthopedic surgical drill environment today. Either case of the use model this is not good.

While a image intensifier (X-Ray) is often used during the procedure to view current drilling status; is not ideal. It simply exposes that entire surgical team to added radiation that they simply do not need.

Smart Medical Device provides the surgeon essentially a HUD “Heads Up Display” on a real time basis to prevent the plunge and to eliminate thermal energy degrade of tissue. The surgeon sees the visual thus allowing the immediate surgical decision on the fly. It totally changes the game for the surgical experience driving down risk and cost.

I equate this solution to the fighter pilot of today having all the information real time providing sensor data, versus trying to figure out all the analog gauges of the past. However, in the case of the current surgical drill environment of today, there are zero gauges... but flying blindly through a thick layer of fog feeling your way.

The Smart Surgical Drill truly is a transformation of real time sensor robotics at a drill level and provides a multi-faceted feedback loop to the orthopedic surgeon of today and tomorrow. Should this be the new standard of care for orthopedic surgery?

Please also see the use of Bluetooth Low Energy in the use of medical devices, i.e. pacemakers that validates this new and innovative use model, i.e. the Smart Drill.

Download Dual_Motor_Drill_Continuously_Measures_Drilling.4

Download 201801292b-en_azure broch_p24_prnt

Bluetooth Low Energy has arrived for Implantable Pacemakers

Bluetooth made its debut several years ago in devices such as laptops and desktops for the un-tethering of keyboards and the mouse. When low power Bluetooth came on the scene…things really changed. The change occurred with the smart phone incorporating this...and as they say…the rest is history. Just like Wi-Fi, Bluetooth Low Energy (BTLE) is gradually changing the game in medical devices.

Most recently I had the opportunity to work with friend to help him set up his remote connection from his pacemaker to a cloud-based monitoring network. What amazed me was the pacemaker incorporated low power Bluetooth. I think that this is a first for the industry and for a implantable device. It is the Azure™ pacemaker with BlueSync™ technology from Medtronic.

Medtronic’s first generation of MyCareLink™, drove innovation in remote monitoring by enabling the Azure™ pacemaker with BlueSych™ technology to communicate with a patient owned mobile platform. Added features include an encryption module that encrypts data using NIST (National Institute of Standards and Technology), as well as a high density Integrated Circuit which increases longevity of the pacemaker.

The MyCareLink™ mobile application with can be downloaded on your smart phone allows patient’s to see all kinds of data from their implanted device. The value to the patient is tremendous. Integrating remote monitoring to your smart phone allows for real time engagement with the patient and eliminates the need for a bedside monitor. See attached the brochure from Medtronic’s web site.

Download 201801292b-en_azure broch_p24_prnt

Bluetooth Low Energy Medical Device Works in a Flawless Fashion

Integra Systems, Inc., has worked with a medical device manufacture to incorporate Bluetooth Low Energy into its solution. In this case we recommended www.lairdtech.com of which uses the www.nordicsemi.com SOC. Most recently we completed testing in surgical setting with a variety of wireless interferers. One of the worst offenders of interference is the electrosurgical generator. Real time information transmitted to a BTLE enabled tablet worked in a flawless fashion when the BTLE enabled medical device was less than 10cm from the ESU in a high power cutting mode.

See the latest Quarter 3/Autumn 2018 from Nordic Semiconductor

Download ULP_WQ_Autumn_2018

Integra Systems Wireless IOT and M2M Design and Deployment

Integra Systems, Inc., has a portfolio of solutions that can solve many requirements in the wireless IOT space. These solutions can provide remote medical device service for field forces and mobile networks - wherever secure and reliable 4G now moving to 5G is required. These solutions are also applicable to any mission critical application such as mobile command centers, failover, fleet management, secondary back-haul requirements, and intelligent industrial automation connectivity from PLCs and meters. All of these solutions are purpose built to withstand extreme environments and can include two 4G LTE modems, a multi-port ethernet switch, 802.11ac, GPS and ports for ignition and sensor integration. Multiple tunneling schemes allow you to secure data using a variety of VPN tunneling schemes including PPTP, L2TP, Open VPN, GRE, and IPsec. We additionally can provide the carrier interfaces on a global and can turnkey everything providing a one stop solution.

Medical Device Wearable Multi Sensor Market

This market is definitely crossing a lot of chasms between wearable patches and other communication devices. A large part of this is due to costs being driven down, SOCs (systems on chips) getting smaller, the advent of Bluetooth low energy, and of course the smart phone.

One of the major challenges with these new IOT devices is the need to measure a wide variety of parameters or vital signs on a continuous basis. Then there needs to be way to cross-correlate those parameters and look at trends before adverse events happen. By the time morphological change happens on a EKG, other parameters have been effected such as Sp02, blood pressure temperature, etc.

What you really want to look at is trends that provide alerting before something actually happens. It also would be valuable to create specialized algorithms that would provide this alerting. Perhaps by gathering this data into a centralized repository, the algorithms could also be learning on a on-going basis. Deep learning and AI (Artificial Intelligence) markets are now in their infancy. All of the aforementioned is based upon many years in the acute care patient monitoring space.

Integra Systems, Inc. has been fortunate to work with and follow one such company for several years. www.smartcardia.com This wearable multi-sensor measures a complete set of physiological and vital parameters on a continuous basis. These parameters include the EKG, heart rate, heart rate variability, pulse rate, oxygen saturation (Sp02), blood pressure variations and trends, skin temperature, activity and posture. The product has received CE Medical Device certification. SmartCardia SA is a Swiss medical device company with a focus on clinical quality data and scientific validation. It is an ISO 13485 and ISO 9001 certified medical device manufacture and meets the strict quality control standards for the solutions. The company is also ISO 27001 certified for data security and privacy.

The Worlds First Flexible PIFA Antennas for Wi-Fi MIMO Applications

This antenna is ideal for industrial applications and to include medical devices. This drastically simplifies the size, cost, and technical requirements for the implementation of the two antennas required for 802.11 MIMO radio applications. The flexible PIFA antennas allows for use on flat and curved surfaces.

Download ANT-DS-FlexMIMO 0818