Blog Tag: Wireless
The market for medical device connectivity is projected to reach about $2.6 billion by the year 2023, according to a report published in April 2018 by several publishers. The report states that the connectivity market for 2018 is expected to be about $940 million. This equates to a compound annual growth rate (CAGR) from 2018 to 2023 of 23.2%.
According to news articles, the report states that “[t]he growth in this market is attributed to the increasing penetration of [electronic health records] and health information exchange systems in healthcare organizations, growing focus on care quality and patient safety, healthcare IT initiatives driving the integration of medical devices with hospital information systems, and the growing need to curtail healthcare costs through a connected healthcare environment.”
From 2018 to 2023, the medical device connectivity market CAGR is estimated to be 23.2%
The report further states the medical device connectivity services segment, as opposed to the device connectivity solutions segment, is anticipated to grow at the maximal CAGR during the “outlook period” from 2018 to 2023. The report divides the technology sectors into wired, wireless, and hybrid technologies. The wireless segment is projected to register the highest CAGR during the outlook period.
The report also breaks down the relevant markets into hospitals, home healthcare, ambulatory care settings, and imaging & diagnostic centers. It finds in 2017 hospitals controlled the medical device connectivity market. The report also finds that North America is expected to grow at the highest CAGR during the outlook period, followed by Europe.
The increase in the market is attributed in the report to “growing funding towards innovative projects in the medical market, [the] need to curtail the escalating healthcare costs in the USA, the presence of a big number of healthcare IT firms, rising investments in the healthcare sector by top market players, and increasing awareness about advanced technologies.”
According to the press release, Abbott produces the Confirm RxTM ICM, which is marketed as the slimmest ICM available. Pictured on the right, Abbott states that the Confirm RxTM is designed to continuously monitor a patient’s heart rhythm and proactively transmit information via the myMerlinTM mobile app, thereby allowing physicians to follow their patients remotely and accurately diagnose arrhythmias. As noted on the Confirm RxTM webpage, the ICM is placed by a physician under local anesthesia by making a small incision in the pectoral region, inserting the ICM under the skin using an insertion tool, and then closing the incision. “Patients can record symptoms directly on their smartphone without the need for a bedside transmitter or separate activator,” said Georg Nölker, M.D. in prepared remarks. Dr. Nölker was one of the first physicians to implant the Confirm Rx ICM after it received CE Mark approval.
According to Abbott, the myMerlinTM mobile app makes it easy for patients to stay connected to their physicians. A listing of the product features from the Confirm RxTM product website includes:
- Transmit nightly data reports automatically simply by being in range of the smartphone;
- Manually record patient symptoms on their own smartphone and specify events such as fainting or if they experience a fast heart rate;
- Confirm patient data was transmitted to their physician;
- Automatic alerts when they have missed a scheduled transmission;
- Offers secure transmission of patient data.
Mark D. Carlson, M.D., chief medical officer of Abbott’s cardiac arrhythmias and neuromodulation businesses, views these results as a step forward in ICM technology, stating:
Incorporating wireless technology directly into our devices enhances the quality of remote monitoring and patient compliance…The Confirm Rx ICM addresses a broad range of indications, such as syncope, palpitations and atrial fibrillation. The technology has been designed with robust data privacy and security measures to ensure peace of mind for both patients and providers.
Dr. Christopher Piorkowski, said to be one of the first physicians to implant the Confirm RxTM ICM, stated:
The Confirm Rx ICM will be particularly useful in monitoring for atrial fibrillation in my patients with paroxysmal AF, following AF ablation and with stroke of an unknown cause. It allows an objective way to quantify AF events to guide treatment decisions. The smartphone compatibility engages patients and allows better compliance to remote monitoring through a simple and intuitive user interface. This allows clinic staff to reduce follow-up burden and focus on reviewing transmitted data for AF.
As reported by the press release, the Confirm RxTM ICM is available in select European countries, with full European release expected during the second quarter of 2017. It further states that the device is currently under review by the U.S. Food and Drug Administration.
Medtronic recently announced continued success with what it describes as “the world’s smallest pacemaker.” The Micra® Transcatheter Pacing System (TPS) is less than one-tenth of the size of traditional pacemakers (examples of each type of pacemaker, both produced by Medtronic, are shown to the left). Medtronic states that the device provides select patients suffering from bradycardia with a minimally invasive treatment approach.
The Micra TPS, which is comparable in size to a large vitamin (as seen to the right), attaches to the heart with small tines and delivers electrical impulses that pace the heart. Thanks to its size and wireless technology, the Micra TPS does not require
leads under the patient’s skin. As such, the Micra TPS eliminates potential sources of complications that may be associated with more traditional pacemakers. Artist’s renderings comparing the Micra TPS and a traditional pacemaker when implanted are shown below.
Following what Medtronic describes as “the largest and longest clinical evaluation of leadless pacing patients to date,” the company released several statistics from its Micra TPS Global Clinical Trial that highlight the device’s long-term successes, including:
- 96% freedom-from-complication rate
- When compared to traditional pacemaker systems, the risk of
- major complications was reduced by 48% across all patient subgroups including age, gender and comorbidity
- hospitalization was lowered by 47%, and
- revision procedures was 82% lower
- The battery is projected to last an average of 12 years, based on data from 644 patients who have had the device for at least 12 months.
Regarding these results, John Liddicoat, M.D., senior vice president at Medtronic, stated:
The Micra TPS continues to deliver safe and effective pacing, while also providing a less invasive alternative to conventional pacemakers . . . . The Micra TPS has also shown a significant reduction in healthcare utilization compared to conventional pacemakers, which is promising for clinicians looking to adopt cost-effective therapies to improve patient outcomes.
These statistics follow preliminary results published in the New England Journal of Medicine in November 2015, showing that the Micra TPS was successfully implanted in 99.2% of patients. Medtronic interprets the studies as demonstrating consistent and sustained results from early performance through 12-month follow-up.
Dr. John Hummel, a cardiologist who participated in the clinical trials, explains his view that Medtronic’s wireless pacing technology is the future of pacemaker therapy.
We are looking at the beginning of the future . . . . We will no longer pace the heart in the way we have in the last 20 to 30 years. This is fundamentally a paradigm shift in how we’ll deliver this therapy.
The Micra TPS was awarded its CE Mark in April 2015. Additionally, the device was approved by the FDA for use in the United States in April 2016. The device is presently the only leadless pacemaker approved for use in both the United States and Europe.
Hanover, New Hampshire – Researchers at Dartmouth’s Department of Computer Science has unveiled “Wanda,” a prototype “magic wand” that securely transmits information to a medical device.
According to the paper authored by Timothy J. Pierson, Xiaohui Liang, Ronald Peterson, and David Kotz, Wanda is designed configure a target device to connect to a local Wi-Fi network and to other devices on the network. Wanda can also configure the target device to send data to a particular location in the cloud.
The paper states that Wanda consists of a wand that attaches via USB to a Wi-Fi access point and a protocol installed in the target device. To securely transmit network or other information, the user simply detaches the wand from the Wi-Fi access point and touches the wand to the target device. In lab testing, researchers transmitted network information to a blood pressure monitor by touching the wand to the monitor. Using the transmitted information, the monitor automatically connected to the local Wi-Fi network and uploaded information to a simulated Electronic Health Record.
The wand communicating with a blood pressure monitor. Credit: Dartmouth College
The paper states that the wand contains two antennae that detect radio signals from the target device and discerns the target device from potentially unsecure devices based on distance from the wand. After detecting the target device, the wand imparts its saved information onto the device.
Wanda was developed as part of the Trustworthy Health and Wellness (THaW) project. THaW aims to “provid[e] trustworthy information systems for health and wellness.” THaW is funded by the NSF’s Secure and Trustworthy Cyberspace Program. The Dartmouth researchers are scheduled to present their findings in April at IEEE INFOCOM 2016 in San Francisco, California.
Medical device development, as always, is shooting upwards – and it has just reached the clouds.
According to News Medical, Verizon just announced that it received 510(k) clearance for its Converged Health Management medical device (the first time Verizon has applied for and received FDA clearance). Converged is a remote patient-monitoring medical device based in the cloud and according to the press release should be available in late 2013.
Verizon claims that the new healthcare solution resides in its allegedly “HIPAA-ready cloud” and will provide easy access to nearly real-time patient data from connected medical devices. Theoretically, this will allow nearly constant medical monitoring – for example, you’re driving your car and you begin to display pre-stroke symptoms (which you can’t notice), if you’re hooked up to Verizon’s “HIPAA-ready cloud,” your primary care physician can call you to tell you to make your way to the nearest hospital.
The potential benefits of this technology could be very interesting (it doesn’t take much imagination to think of some). However, there are also potentially significant consequences. Clearance to fully wireless based devices was first granted in 2006. The FDA has recognized that, while it grants clearance to wireless and cloud-based medical devices, such wireless devices may present a significant security risk. On August 13, 2013 (a surprising 7 years after the first wireless based device clearance) the FDA issued “Radio Frequency Wireless Technology in Medical Devices – Guidance for Industry and Food and Drug Administration Staff,” a guide that attempts to offer “reasonable assurance of safety.” In recognition of the potential for cyber-attacks on wirelessly connected and internet-enabled medical devices (and the patients connected to them), the Center for Internet Security has publicized a new initiative attempting to better secure such systems from cyber-attacks.
All security systems have vulnerabilities which can be exploited – the question is how small they are and how smart a potential attacker must be to find them. Will Pelgrin, the president and CEO of the Center for Internet Security stated that:
[W]e wanted to be ahead of the curve. Instead of waiting for a major incident to happen, we wanted to provide guidance across the board. . . . As these devices become connected to the internet and networks, they become more than just clinical devices, they become IT systems. As we all know, the weakest node on a network can be your entry point for negative consequences that can affect those devices.
The EE Times points out that many medical devices (which can be connected to networks), such as sport watches, monitoring bracelets, heart rate monitors and pedometers, offer valuable information but would not harm the wearer upon malfunction. However, there are many medical devices which are life-sustaining, such as pacemakers, insulin pumps, defibrillators, and neural implants. If these medical devices were “hacked” through inherent weaknesses or through weaknesses in a node of the network to which they are connected, the consequences could obviously be fatal. According to the article, an insulin pump has already been hacked (by a diabetic white hat hacker demonstrating weaknesses in the system).