Healthcare Wireless and Device Connectivity

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

Integra Systems Predictive Modeling for Business Process

Over eighteen years ago a wise clinician looked at the auto rental industry and recognized that they use bar code scanners to validate and verify cars coming back from rental. This started the BCMA (Bar Code Medication Application,) revolution first at the Veterans Administration, then nationally.

In reality, healthcare delivery is a big supply chain, but often this has tended to be silo based by each department. Other industries such as manufacturing look at workflow, time measurement studies, cross-functional process, and predictive analytics. This type of big data has helped in providing the best ROI in not only capital expenditures, but also FTE costs.

Integra Systems has partnered with a world leading organization that together we can provide simulation modeling with resultant predictive analytics for improvements in healthcare.

Integra Systems V&V Testing for the Wireless Enterprise

Integra Systems, Inc. provides a variety of wireless networking validation and verification models for the enterprise and the medical device space. These V&V models include testing that has been architected for the enterprise, point to point, as well as wireless co-existence. The result of our years of experience and this testing has allowed many companies and organizations to pass the regulatory approval process and ensure success in field implementations.

IOT Medical Device Hospital VPN Cybersecurity Concerns

Medical Capital Equipment Support Costs and the Reluctance by IT Departments to provide VPN access to medical device companies is a reality in 2018.

Integra Systems, Inc. © www.integrasystems.org
The Services Market Requirement Today

• Many medical devices and capital equipment providers today are now
network connected and often have applications servers as a part of their
solution. They may or may not be connected to the hospital network.
These application servers require software updates and often the devices
themselves have a needed real time requirement of
diagnostic monitoring as a part of a contract.

How is Remote Medical Device Service being conducted today?
• The remote services environment for the medical device, application
support and equipment support really consists of two options today. The
company supplying the equipment application, or device either sets up a
hospital IT approved VPN or you fly service people to the site. Companies may have local
service people as an option. Both options require a person roll. However
at the end of day these are really the only current available service
options.

Challenges of the Current Remote Services Model
• Many challenges exist with the current remote services model. The first
challenge is getting a legal agreement in place. Obtaining a VPN approval
from the healthcare IT organization for the medical device company is not
an easy task. The time to get this contract documentation could be from three
to almost nine months, yet alone the overall administrative cost. Also,
there is more than likely push back from the IT organization which is occurring more and more today because of security concerns. Meanwhile to
support the overall service of the medical device the company is bleeding
service dollars because service engineers need to be sent to the site. It is
estimated that the overall support costs on site for any type of software or
application upgrade; could approach a $12,000 cost. This is a real hit to
service contracts, plus this is ongoing and not able to be controlled.

The New Opportunity - A Swiss Army Knife of Technology
• How do you approach this with an opportunity in a drastic fashion that will
lower service costs, while improving real time service contract response?
You can now combine for the first time network access, multi-mode
wireless, security, a 4G-cloud switch, and a software defined network.

The Proposed New Integra Systems Services Turn Key Technology Solution
• This solution provides the opportunity to negate the need for a hospital IT approved VPN, while there is a limited or
no need to send a service person on site. The real question is, how can
you make this happen in a reliable fashion? A VPN (virtual private
network), extends a private network across a public network, and enables
users to send and receive data across shared or public networks. VPNs
cannot make online connections completely anonymous, but they can
usually increase privacy and security. To prevent disclosure of private
information, VPNs typically allow only authenticated remote access using
tunneling protocols and encryption techniques. A VPN is not secure.

What does the Integra Systems provided solution technically look like?
• With the no requirement for a hospital approved VPN, there is no exposure to public IP
address schemes. There is no change to the network hospital network
infrastructure as there is no interface to the hospital network. On the
security side, encrypted 256 bit AES data is sent via a private IP address
space. Multi-layer authentication architecture is provided via the device, a
virtual network, the domain and a Auto PKI (X.509 CA) trusted certificate
of authentication is additionally provided. Fully redundant architecture is architected that
is self-healing and self-optimizing that runs on top tier cloud providers on a
global perspective. One pane of glass could provide nationwide or global a
real time GPS view of all current status or software downloads.

The Financial Return on the Investment
• With the low cost of the technology, dramatic reductions in 4G costs, the
ROI is significant. The first “person” roll; will literally pay for the
technology. Projected ROI models have been built that show $100s of
thousands in yearly savings with $ millions over a five year period.
Proactive monitoring of equipment could also determine when the person
goes on site that he or she has the right equipment for service, versus a
reactive services model today.

See the attached TrapEx Case Study Discussing the Challenges of CyberSecurity of IOT Medical Devices

Download Assuta-Hospitals-–-Customer-Case-Study

Integra Systems Wireless V&V Testing and Process

Integra Systems, Inc. received notice this week that the company that we have recently worked with to provide wireless testing received FDA approval on their product. This is one of many companies that we have provided this knowledge sense and overall hands on testing. This standardized process has allowed innovative connectivity products to come the market to improve the overall patient and clinical experience.

The Evolution to Trans Catheter Aortic and Mitral Valve Replacement Edwards

Edwards…this truly is a unique company. Edwards Lifesciences’ roots date to 1958, when Miles “Lowell” Edwards set out to build the first artificial heart.

Edwards was a 60-year-old, recently retired engineer holding 63 patents in an array of industries, with an entrepreneurial spirit and a dream of helping patients with heart disease. His fascination with healing the heart was sparked in his teens, when he suffered two bouts of rheumatic fever, which can scar heart valves and eventually cause the heart to fail.

With a background in hydraulics and fuel pump operations, Edwards believed the human heart could be mechanized. He presented the concept to Dr. Albert Starr, a young surgeon at the University of Oregon Medical School, who thought the idea was too complex. Instead, Starr encouraged Edwards to focus first on developing an artificial heart valve, for which there was an immediate need.

After just two years, the first Starr-Edwards mitral valve was designed, developed, tested, and successfully placed in a patient.

From my early days at Siemens, I learned about what a blood pressure transducer was. Then it was how to set up cardiac output thermo dilution at the point of care replacing FICK and Green Dye from the cath-lab then to cardiac care.That was in the 80’s. Edwards is the leader in this, but also the world’s leader in cardiac valves.

TAVR with the SAPIEN 3 valve: Better than surgery for intermediate-risk patients

Transcatheter aortic valve replacement (TAVR) with the SAPIEN 3 valve demonstrated 75% lower rates of 30-day all-cause mortality and disabling stroke compared to surgery in intermediate-risk patients.

Extreme Networks Connect Beyond the Network- The Edge

This is a end to end wired and wireless enterprise networking company that brings the total end game to the network edge. While a lot of attention has been focused on cloud computing, wireless, and IOT, the edge has often been on the back burner. Extreme's Smart OminEdge can provide the intelligence, agility and security to address the network edge.

Extreme has positioned itself as the the under the radar company that has all the components to disrupt the traditional networking space.

From a healthcare perspective, this can drive down risk from a cybersecurity perspective and ensure that wireless and networked enabled devices operate correctly.

Integra Systems, Inc., has previously authored a white paper for Extreme Networks.

Download Extended-edge-switching-a-verstaile-easy-to-deploy-option-for-the-switched-edge

Download Extremeanalytics-data-sheet