Insights shared by industry relative to healthcare and the advancement of medical technology.
Brad Jolly is a Senior Applications Engineer at Keysight Technologies
Medical Devices and Cybersecurity
Hospitals and medical device manufacturers collaborate to mitigate cybersecurity risks associated with legacy medical devices
The Cybersecurity Teammates You May Not Know
The FDA has promulgated regulations requiring ongoing medical testing for new medical devices. However, millions of connected medical devices are already being utilized, and few are designed to address today’s cybersecurity risks. Many of these legacy devices can’t be updated and, therefore, pose a significant cybersecurity risk that cannot be solved via firmware or software patches. Industry experts have been thinking about this problem, and there are several methods by which medical device manufacturers and healthcare organizations can mitigate the cybersecurity issues posed by legacy devices.
Cybersecurity concerns cause device manufacturers to reconsider the need for multiple wireless technologies on medical devices
The Downside of Versatile Medical Device Connectivity
Cybersecurity concerns cause manufacturers to reconsider multiple wireless technologies on medical devices. The new FDA regulations for medical devices require ongoing testing of every communications interface. However, they don’t require those interfaces to be available. Medical device manufacturers may want to limit their testing obligations by reducing the number of interfaces, and health delivery organizations may prefer the reduced surface area. This will lead to future devices with fewer interfaces than they would have had if convenience and flexibility were the top priorities.
The design validation and verification process for a medical device typically includes a very long series of tests, but one key bit of testing is often overlooked, and it leads to risk for patients and medical professionals.
How Can a Bad Medical Device Pass Every Test?
The design validation and verification process for a medical device typically includes a very long series of tests. Some of these are required by regulators, some by companies’ internal processes, some are required by medical necessity, and still others are simply a matter of good engineering judgment. Despite the breadth and depth of the tests, it is still possible to pass every test with a good margin and still produce a product that fails in the field, possibly even leading to a recall.
Smaller, less expensive microwave sensors enable new detection and diagnostic applications
Are Higher Quality Medical Images Always Better?
Technology innovation will enable diagnosis in the field to become a reality at scale. Rather than being in a hospital environment with the latest state-of-the-art diagnostic capabilities, smaller and less expensive microwave sensors will enable new detection and diagnostic applications. For example, first responders with these tools can identify stroke victims and immediately commence the appropriate treatment, which will improve outcomes and drive efficiencies. In rural areas or developing countries without the latest medical systems, this will transform access to care and treatment, helping address healthcare inequalities.
Technical comment
Systems of vector network analyzers have long been used to detect variations in dielectric properties, and depending on the application, these variations may be caused by different materials, different densities, or variations in water content. The accuracy of is related to the number of microwave transmitters and receivers in the network; typically, more nodes mean more information and improved accuracy. Smaller, higher-speed microwave sensors are becoming less expensive and more widely available, and these will lead to a wider variety of mobile, high-speed diagnostic systems.
Healthcare & Hospitals
Hospitals implement new tools, policies, and training to respond to increasing ransomware challenges
Your Money or Your Patient’s Life?
The alarming increase in ransomware attacks against hospitals, insurers, testing laboratories, and other healthcare entities shows no sign of slowing. As a result, the healthcare industry is stepping up its efforts to prevent future attacks by limiting exposure and building resistance and resilience into systems. Technology will play a significant role in mitigating the threat, but addressing the human elements, such as errors, negligence, or even outright insider malfeasance, is even more vital.
Governments and standards bodies regulate the rollout of AI in healthcare
How Long Will AI/ML Outrun Regulators?
Consumer applications have predominantly driven the rapid growth of AI and machine learning such as apps that automatically improve the appearance or sound quality of digital photos or videos. Generative AI produces complex images from simple text descriptions, and machine learning finds trends or anomalies in complex data sets. In most cases, the consequences of errors or misuse are small, so laws and regulations are light or non-existent. However, for medical applications, the end result can be injurious or even deadly, and the very speed at which AI and ML operate means that errors can spread broadly and quickly. For this reason, governments, standards bodies, and regulatory agencies are eager to limit the risk of these technologies in healthcare settings.
Wireless & Wi-Fi
More wireless devices transmitting in unlicensed spectrum makes coexistence testing more important
Coexistence testing in the spotlight
With more wireless devices transmitting in unlicensed spectrum, coexistence testing will move into the spotlight. Coexistence testing is essential in healthcare settings to ensure devices maintain their functional wireless performance despite numerous interfering signals. Failure to do so can impact patient care and result in harmful outcomes. Many radio technologies, such as cell phones and police radios, operate in licensed parts of the electromagnetic spectrum. Other radios function in unlicensed spectrum, which includes the industrial, scientific, and medical (ISM) bands. For example, Bluetooth(R) Low Energy (BLE) devices and many Wi-Fi devices operate in a spectrum around 2.4 GHz.
Wi-Fi 7: What are the True Costs, Risks, and Benefits for Medical Devices?
Wi-Fi 7 enables new healthcare applications
The IEEE 802.11be standard, informally known as Wi-Fi 7, is expected to be ratified around the end of 2024, and it is expected to provide extra high throughput (EHT) at rates in the tens of gigabits per second (Gb/s) and very low latency relative to previous versions of Wi-Fi.. The standard is designed to operate indoors and outdoors, and it can transmit at 2.4, 5, and 6 GHz simultaneously in a mode called multi-link operation (MLO). The standard also supports low-speed roaming, such as with a person walking around a home or hospital.
Battery Life Safety & Power
Governments and regulatory agencies implement new rules to improve the safety of medical device batteries
Safety Concerns with Medical Device Batteries Drive Surge in Regulations
The increase in battery-powered devices in the healthcare industry shows no signs of slowing. Much of the growth is driven by developing lithium-ion and lithium polymer batteries with a relatively high gravimetric (weight-based) or volumetric energy density. However, the downside is the safety risks associated with all that energy in a small space, especially if the battery is improperly handled, charged, discharged, or transported. As a result of these concerns, new standards, regulations, and laws already in development will be accelerated, and new initiatives started.
Medical device manufacturers take advantage of new, lower power chipsets to achieve longer battery life in wearable and implanted devices.
Your Best Medical Device Battery Life Experts May Not be On Your Payroll
The basic idea of Moore’s Law is that computing power doubles every 18 to 24 months, and this has roughly held true for the past several decades. A less dramatic and less well-known trend is the fact that the electrical power required to achieve a given level of electronic capability has also decreased. For example, the original IBM 5150 PC had a 63.5-W power supply and supported up to 640K of memory and an optional 10-MB hard drive. A typical laptop power adapter consumes approximately the same amount of power, but the 24-GB RAM and 2-TB hard drive are several orders of magnitude larger, to say nothing of the fact that the laptop adapter also powers a display and multiple radios. In short, were it not for massive improvements in energy efficiency, a modern laptop computer would have roughly the same power requirements as a small town.
Modern electronic medical devices ride many of the same waves of power improvements that office computers enjoy, and this trend will continue for the foreseeable future. Low-power chipsets and modules have shrunk in size, and they consume much less power for a given level of functionality.
Battery Technology
Solid state battery technology continues to improve on multiple fronts
Are Solid State Medical Device Batteries Inevitable?
The vast majority of lithium-ion and lithium-polymer cells use liquid electrolytes. These are appropriate for countless applications, but there are advantages that could be obtained from solid-state batteries, especially for medical applications. Much work remains to be done, but proponents claim that solid state batteries are expected to be safer than liquid batteries, with higher energy densities, and better high temperature stability. Proponents also claim that solid state batteries will be compatible with surface mount technology (SMT) manufacturing processes. Of course, liquid electrolyte batteries also have advantages, so solid state technology manufacturers will have to make significant improvements if they want to take market share from the older, more widely used technology.
Solid state battery technology continues to face challenges to broad adoption
Are Solid State Medical Device Batteries a Good Option?
Despite the many advantages of solid state batteries over batteries with liquid electrolytes, solid state batteries will not dominate for the next several years. Issues related to cost, supply chain, uncertain cycle life, and high-rate power draw are likely to delay adoption.
Sodium ion batteries take market share from lithium ion in high-power applications, freeing up lithium and production capacities for smaller, less power-hungry medical device batteries
A Salt of the Earth Solution for Medical Devices
Recent issues associated with fire safety and natural resource availability have encouraged engineers to look for alternatives to lithium-ion batteries. One alternative is sodium-ion batteries, but these are not yet widely used. Some of the likely uses for sodium-ion battery adoption include solar power battery systems and electric cars, and to whatever degree sodium-ion batteries displace lithium-ion batteries, the availability of manufacturing processes and raw lithium improves for low-power applications in medical devices.
